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1. Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.

Author

Turley, Christine B, Tables, LaKesha, Fuller, Trevon, Sanders, Lisa J, Scott, Hyman, Moodley, Amaran, Woodward Davis, Amanda, Leav, Brett, Miller, Jacqueline, Schoemaker, Kathryn, Vandebosch, An, Sadoff, Jerald, Woo, Wayne, Cho, Iksung, Dunkle, Lisa M, Li, Sijia, van der Laan, Lars, Gilbert, Peter B, Follmann, Dean, Jaynes, Holly, Kublin, James G, Baden, Lindsey R, Goepfert, Paul, Kotloff, Karen, Gay, Cynthia L, Falsey, Ann R, El Sahly, Hana M, Sobieszczyk, Magdalena E, Huang, Yunda, Neuzil, Kathleen M, Corey, Lawrence, Grinsztejn, Beatriz, Gray, Glenda, Rouphael, Nadine, Luedtke, Alex, and COVID-19 Prevention Network CoVPN

Subjects
COVID-19 Prevention Network CoVPN, Humans, Adult, COVID-19, COVID-19 Vaccines, 2019-nCoV Vaccine mRNA-1273, Ad26COVS1, ChAdOx1 nCoV-19, Comorbidity, Effect modifier, Environmental exposure, Epidemiologic, Occupational exposure, SARS-CoV-2, Vaccine efficacy, Clinical Research, Prevention, Clinical Trials and Supportive Activities, Infectious Diseases, Vaccine Related, Immunization, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Prevention of disease and conditions, and promotion of well-being, 3.4 Vaccines, Infection, Good Health and Well Being, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Virology
Abstract

Questions remain regarding the effect of baseline host and exposure factors on vaccine efficacy (VE) across pathogens and vaccine platforms. We report placebo-controlled data from four Phase 3 COVID-19 trials during the early period of the pandemic. This was a cross-protocol analysis of four randomized, placebo-controlled efficacy trials (Moderna/mRNA1273, AstraZeneca/AZD1222, Janssen/Ad26.COV2.S, and Novavax/NVX-CoV2373) using a harmonized design. Trials were conducted in the United States and international sites in adults ≥ 18 years of age. VE was assessed for symptomatic and severe COVID-19. We analyzed 114,480 participants from both placebo and vaccine arms, enrolled July 2020 to February 2021, with follow up through July 2021. VE against symptomatic COVID-19 showed little heterogeneity across baseline socio-demographic, clinical or exposure characteristics, in either univariate or multivariate analysis, regardless of vaccine platform. Similarly, VE against severe COVID-19 in the single trial (Janssen) with sufficient endpoints for analysis showed little evidence of heterogeneity. COVID-19 VE is not influenced by baseline host or exposure characteristics across efficacy trials of different vaccine platforms and countries when well matched to circulating virus strains. This supports use of these vaccines, regardless of platform type, as effective tools in the near term for reducing symptomatic and severe COVID-19, particularly for older individuals and those with common co-morbidities during major variant shifts. Clinical trial registration numbers: NCT04470427, NCT04516746, NCT04505722, and NCT04611802.

Published
2023

2. Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial

Author

Walsh, Stephen R., Gay, Cynthia L., Karuna, Shelly T., Hyrien, Ollivier, Skalland, Timothy, Mayer, Kenneth H., Sobieszczyk, Magdalena E., Baden, Lindsey R., Goepfert, Paul A., del Rio, Carlos, Pantaleo, Guiseppe, Andrew, Philip, Karg, Carissa, He, Zonglin, Lu, Huiyin, Paez, Carmen A., Baumblatt, Jane A. G., Polakowski, Laura L., Chege, Wairimu, Anderson, Maija A., Janto, Sophie, Han, Xue, Huang, Yunda, Dumond, Julie, Ackerman, Margaret E., McDermott, Adrian B., Flach, Britta, Piwowar-Manning, Estelle, Seaton, Kelly, Tomaras, Georgia D., Montefiori, David C., Gama, Lucio, and Mascola, John R.

Subjects
AIDS vaccines -- Physiological aspects -- Dosage and administration, HIV infection -- Prevention, Biological sciences
Abstract

Background Broadly neutralizing antibodies (bnAbs) are a promising approach for HIV-1 prevention. In the Antibody Mediated Prevention (AMP) trials, a CD4-binding site targeting bnAb, VRC01, administered intravenously (IV), demonstrated 75% prevention efficacy against highly neutralization-sensitive viruses but was ineffective against less sensitive viruses. VRC07-523LS is a next-generation bnAb targeting the CD4-binding site and was engineered for increased neutralization breadth and half-life. We conducted a multicenter, randomized, partially blinded Phase I clinical trial to evaluate the safety and serum concentrations of VRC07-523LS, administered in multiple doses and routes to healthy adults without HIV. Methods and findings Participants were recruited between 2 February 2018 and 9 October 2018. A total of 124 participants were randomized to receive 5 VRC07-523LS administrations via IV (T1: 2.5 mg/kg, T2: 5 mg/kg, T3: 20 mg/kg), subcutaneous (SC) (T4: 2.5 mg/kg, T5: 5 mg/kg), or intramuscular (IM) (T6: 2.5 mg/kg or P6: placebo) routes at 4-month intervals. Participants and site staff were blinded to VRC07-523LS versus placebo for the IM group, while all other doses and routes were open-label. Safety data were collected for 144 weeks following the first administration. VRC07-523LS serum concentrations were measured by ELISA through Day 112 in all participants and by binding antibody multiplex assay (BAMA) thereafter in 60 participants (10 per treatment group) through Day 784. Compartmental population pharmacokinetic (PK) analyses were conducted to evaluate the VRC07-523LS serum PK. Neutralization activity was measured in a TZM-bl assay and antidrug antibodies (ADAs) were assayed using a tiered bridging assay testing strategy. Injections and infusions were well tolerated, with mild pain or tenderness reported commonly in the SC and IM groups, and mild to moderate erythema or induration reported commonly in the SC groups. Infusion reactions reported in 3 of 20 participants in the 20 mg/kg IV group. Peak geometric mean (GM) concentrations (95% confidence intervals [95% CIs]) following the first administration were 29.0 [mu]g/mL (25.2, 33.4), 58.5 [mu]g/mL (49.4, 69.3), and 257.2 [mu]g/mL (127.5, 518.9) in T1-T3 with IV dosing; 10.8 [mu]g/mL (8.8, 13.3) and 22.8 [mu]g/mL (20.1, 25.9) in T4-T5 with SC dosing; and 16.4 [mu]g/mL (14.7, 18.2) in T6 with IM dosing. Trough GM (95% CIs) concentrations immediately prior to the second administration were 3.4 [mu]g/mL (2.5, 4.6), 6.5 [mu]g/mL (5.6, 7.5), and 27.2 [mu]g/mL (23.9, 31.0) with IV dosing; 0.97 [mu]g/mL (0.65, 1.4) and 3.1 [mu]g/mL (2.2, 4.3) with SC dosing, and 2.6 [mu]g/mL (2.05, 3.31) with IM dosing. Peak VRC07-523LS serum concentrations increased linearly with the administered dose. At a given dose, peak and trough concentrations, as well as serum neutralization titers, were highest in the IV groups, reflecting the lower bioavailability following SC and IM administration. A single participant was found to have low titer ADA at a lone time point. VRC07-523LS has an estimated mean half-life of 42 days across all doses and routes (95% CI: 40.5, 43.5), over twice as long as VRC01 (15 days). Conclusions VRC07-523LS was safe and well tolerated across a range of doses and routes and is a promising long-acting bnAb for inclusion in HIV-1 prevention regimens. Trial registration ClinicalTrials.gov/ NCT03387150 (posted on 21 December 2017)., Author(s): Stephen R. Walsh 1,2,*, Cynthia L. Gay 3, Shelly T. Karuna 4, Ollivier Hyrien 4, Timothy Skalland 4, Kenneth H. Mayer 2,5, Magdalena E. Sobieszczyk 6, Lindsey R. Baden [...]

Published
2024
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3. Publisher Correction: Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author

Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.

Published
2023
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4. Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial

Author

Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.

Published
2023
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5. Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico

Author

Dunkle, Lisa M, Kotloff, Karen L, Gay, Cynthia L, Áñez, Germán, Adelglass, Jeffrey M, Barrat Hernández, Alejandro Q, Harper, Wayne L, Duncanson, Daniel M, McArthur, Monica A, Florescu, Diana F, McClelland, R Scott, Garcia-Fragoso, Veronica, Riesenberg, Robert A, Musante, David B, Fried, David L, Safirstein, Beth E, McKenzie, Mark, Jeanfreau, Robert J, Kingsley, Jeffrey K, Henderson, Jeffrey A, Lane, Dakotah C, Ruíz-Palacios, Guillermo M, Corey, Lawrence, Neuzil, Kathleen M, Coombs, Robert W, Greninger, Alex L, Hutter, Julia, Ake, Julie A, Smith, Katherine, Woo, Wayne, Cho, Iksung, Glenn, Gregory M, and Dubovsky, Filip

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Emerging Infectious Diseases, Clinical Trials and Supportive Activities, Immunization, Vaccine Related, Genetics, Prevention, Infectious Diseases, Clinical Research, Lung, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adolescent, Adult, Aged, COVID-19, COVID-19 Nucleic Acid Testing, COVID-19 Vaccines, Humans, Incidence, Male, Mexico, Middle Aged, SARS-CoV-2, Single-Blind Method, United States, Vaccine Efficacy, 2019nCoV-301 Study Group, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundNVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b-3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America.MethodsWe conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reverse-transcriptase-polymerase-chain-reaction-confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed.ResultsOf the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted - 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P

Published
2022

6. Risk of COVID-19 after natural infection or vaccination

Author

Adams, Atoya, Miller, Eric, Rankin, Bruce G., Shinn, Steven, Nash, Marshall, Green, Sinikka L., Jacobsen, Colleen, Krishnankutty, Jayasree, Phungwayo, Sikhongi, Glover, Richard M., II, Slechta, Stacy, Holdeman, Troy, Hartvickson, Robyn, Grant, Amber, Poling, Terry L., Klein, Terry D., Klein, Thomas C., Klein, Tracy R., Smith, William B., Gibson, Richard L., Winbigler, Jennifer, Parker, Elizabeth, Wijewardane, Priyantha N., Bravo, Eric, Thessing, Jeffrey, Maxwell, Michelle, Horn, Amanda, Healy, Catherine Mary, Akamine, Christine, Chu, Laurence, Chouteau, R. Michelle, Cotugno, Michael J., Bauer, George H., Jr., Hachigian, Greg, Oshita, Masaru, Cancilla, Michael, Kiersey, Kristen, Seger, William, Antwi, Mohammed, Green, Allison, Kim, Anthony, Desjardins, Michael, Johnson, Jennifer A., Sherman, Amy, Walsh, Stephen R., Borger, Judith, Saleem, Nafisa, Solis, Joel, Medina, Martha Carmen, Keating, Westly, Garcia, Edgar, Bueno, Cynthia, Segall, Nathan, Denham, Douglas S., Weiss, Thomas, Avworo, Ayoade, Hedges, Parke, Strout, Cynthia Becher, Santiago, Rica, Davis, Yvonne, Howenstine, Patty, Bondell, Alison, Marks, Kristin, Wang, Tina, Wilkin, Timothy, Vogler, Mary, Johnston, Carrie, Andrasik, Michele P., Andriesen, Jessica G., Broder, Gail, Eaton, Niles, Gelderblom, Huub G., McClennen, Rachael, Michael, Nelson, Robb, Merlin, Sopher, Carrie, Miller, Vicki E., Santiago, Fredric, Gomez, Blanca, Valika, Insiya, Starr, Amy, Cantos, Valeria D., Kandiah, Sheetal, Rio, Carlos del, Rouphael, Nadine, Edupuganti, Srilatha, Anderson, Evan J., Camacho-Gonzalez, Andres, Kamidani, Satoshi, Teherani, Meghan, Diemert, David J., Malkin, Elissa, Siegel, Marc, Roberts, Afsoon, Simon, Gary, Balani, Bindu, Stephenson, Carolene, Sperber, Steven, Cicogna, Cristina, Zervos, Marcus J., Kilgore, Paul, Ramesh, Mayur, Herc, Erica, Zenlea, Kate, Burgher, Abram, Milliken, Ann M., Davis, Joseph D., Levy, Brendan, Kelman, Sandra, Doust, Matthew W., Sample, Denise, Erickson, Sandra, Christensen, Shane G., Matich, Christopher, Longe, James, Witbeck, John, Peterson, James T., Clark, Alexander, Kelty, Gerald, Pena-Renteria, Issac, Koren, Michael J., Bartilucci, Darlene, Patel, Alpa, Tran, Carolyn, Kennelly, Christina, Brownlee, Robert, Coleman, Jacob, Webster, Hala, Fierro, Carlos A., Leistner, Natalia, Thompson, Amy, Gonzalez, Celia, Jackson, Lisa A., Suyehira, Janice, Haber, Milton, Regalado, Maria M., Procasky, Veronica, Lutat, Alisha, Griffin, Carl P., Hollister, Ripley R., Brown, Jeremy, Ronk, Melody, Harper, Wayne L., Cohen, Lisa, Eckert, Lynn, Hong, Matthew, Rouhbakhsh, Rambod, Danford, Elizabeth, Johnson, John, Calderone, Richard, Khetan, Shishir K., Olanrewaju, Oyebisi, Zhai, Nan, Nieves, Kimberly, O'Brien, Allison, Bradley, Paul S., Lilienthal, Amanda, Callis, Jim, Brosz, Adam B., Clement, Andrea, West, Whitney, Friesen, Luke, Cramer, Paul, Eder, Frank S., Little, Ryan, Engler, Victoria, Rattenbury-Shaw, Heather, Ensz, David J., Oplinger, Allie, Essink, Brandon J., Meyer, Jay, Raiser, Frederick, III, Mueller, Kimberly, Vrbicky, Keith W., Harper, Charles, Nutsch, Chelsie, Lewis, Wendell, III, Laflan, Cathy, Whatley, Jordan L., Harrell, Nicole, Shannon, Amie, Rowell, Crystal, Dedon, Christopher, Makhene, Mamodikoe, Gottschlich, Gregory M., Harden, Kate, Gottschlich, Melissa, Smith, Mary, Powell, Richard, Kimmel, Murray A., Pinto, Simmy, Vachris, Timothy P., Hutchens, Mark, Daniels, Stephen, Wells, Margaret, Van Der Leden, Mimi, Jackson-Booth, Peta-Gay, Baron, Mira, Kane, Pamela, Seversen, Shannen, Kryvicky, Mara, Lord, Julia, Saleh, Jamshid, Miles, Matthew, Lupercio, Rafael, McGettigan, John W., Jr., Patton, Walter, Brakema, Riemke, Choquette, Karin, McGettigan, Jonlyn, Kirstein, Judith L., Bernard, Marcia, Manning, Mary Beth, Rothenberg, Joan, Briskin, Toby, Roadman, Denise, Tedder-Edwards, Sharita, Schwartz, Howard I., Mederos, Surisday, Swaminathan, Shobha, Nyaku, Amesika, Varughese, Tilly, DallaPiazza, Michelle, Frey, Sharon E., Graham, Irene, Abate, Getahun, Hoft, Daniel, Allen, Leland N., III, Edwards, Leslie A., Davis, William S., Jr., Mena, Jessica M., Kutner, Mark E., Caso, Jorge, Moran, Maria Hernandez, Carvajal, Marianela, Mendez, Janet, Wadsworth, Larkin T., III, Adams, Michael R., Iverson, Leslie, Newberg, Joseph L., Pearlman, Laura, Nugent, Paul J., Reynolds, Michele D., Bashour, Jennifer, Schmidt, Robert, Sheth, Neil P., Steil, Kenneth, Toma, Ramy J., Kirby, William, Folmar, Pink, Williams, Samantha, Pickrell, Paul, Mott, Stefanie, Linebarger, Carol Ann, Malbari, Hussain, Pampe, David, Fragoso, Veronica G., Holloway, Lisa, McKeown-Bragas, Cecilia, Becker, Teresa, Williams, Barton G., Jones, William H., Clark, Jesse L., Shoptaw, Steven, Vertucci, Michele, Hernandez, Will, Spector, Stephen A., Moodley, Amaran, Blumenthal, Jill, Stangl, Lisa, Deutsch, Karen, Mullane, Kathleen M., Pitrak, David, Nuss, Cheryl, Pi, Judy, Fichtenbaum, Carl, Powers-Fletcher, Margaret, Saemann, Michelle, Kohrs, Sharon, Campbell, Thomas B., Lauria, Andrew, Mancilla, Jose C., Dunlevy, Hillary, Novak, Richard M., Wendrow, Andrea, Borgetti, Scott, Ladner, Ben, Chrisley, Lisa, Young, Cheryl, Doblecki-Lewis, Susanne, Alcaide, Maria L., Gonzales-Zamora, Jose, Morris, Stephen, Wohl, David, Eron, Joseph, Jr., Frank, Ian, Dunbar, Debora, Metzger, David, Momplaisir, Florence, Martin, Judith, Hoberman, Alejandro, Shope, Timothy, Muniz, Gysella, Rupp, Richard, Stanford, Amber, Berman, Megan, Porterfield, Laura, Lewis, Michael, Ghadishah, Elham, Yusin, Joseph, Pham, Mai, Creech, Clarence B., II, Walker, Shannon, Rolsma, Stephanie, Samuels, Robert, Thomsen, Isaac, Kalams, Spyros A., Wilson, Greg, Lucksinger, Gregg H., Parks, Kevin, Israelsen, Ryan, Ostovar, Jaleh, Kelly, Kary, Overcash, Jeffrey S., Chu, Hanh, Lee, Kia, De La Cruz, Luis I., Clemons, Steve, Everette, Elizabeth, Studdard, Suzanna, Mohan, Gowdhami, Tyson, Stefanie, Peay, Alyssa-Kay, Johnson, Danyel, Feldman, Gregory J., Suen, May-Yin, Muenzner, Jacqueline, Boscia, Joseph, Siddiqui, Farhan, Sanders, John, Peacock, James, Nasim, Julio, Levin, Michael L., Hussey, Julie, Kulic, Marcy, McKenzie, Mark M., Deese, Teresa, Osmundsen, Erica, Sweet, Christy, Ebuh, Valentine M., Elnagar, Elwaleed, Ebuh, Georgette, Iwuala, Genevieve, Han-Conrad, Laurie J., Simmons, Todd, Tarakjian, Denis, Ackermann, Jeremy, Adams, Mark S., Alemán, José O., Al-Ibrahim, Mohamed S., Andes, David R., Andrews, Jeb, Arduino, Roberto C., Bäcker, Martín, Badillo, Diana, Bainbridge, Emma, Batteiger, Teresa A., Bazan, Jose A., Bedimo, Roger J., Benitez, Jorge A., Bennett, Annette R., Bernstein, David I., Bialobok, Kristin, Boas, Rebecca, Brady, Judith, Brown, Cynthia, Bunce, Catherine A., Call, Robert S., Campbell, Wesley, Carmody, Ellie, Carpenter, Christopher, Carsons, Steven E., Castellon, Marvin, Castro, Mario, Catan, Hannah, Chang, Jennifer, Chebib, Mouna G., Chen, Corey M., Cheng, Margaret, Chow, Brian D.W., Ciambruschini, Annie, Connor, Joseph P., Conway, James H., Cooney, Maureen, Curlin, Marcel, De La Matta Rodriguez, Claudia, Dedon, Jon F., Degan, Emily, Dickey, Michelle, Dietz, Craig, Dong, Jennifer L., Dorcely, Brenda, Dube, Michael P., Dyer, Carmel B., Eckhardt, Benjamin, Ellerbeck, Edward, Ewers, Evan C., Falk, Amy, Feijoo, Brittany, Felsen, Uriel R., Fiel, Tom, Fitz-Patrick, David, Fogarty, Charles M., Ford, Stacy, Forero, Lina M., Formentini, Elizabeth, Franco-Vitteri, Doris, Frenck, Robert W., Jr., Gharib, Elie, Gharib, Suzanne, Rucker, Rola G., Goldenberg, James N., González, Luis H., Gray, Brett, Greene, Rusty, Grossberg, Robert M., Guanira-Carranza, Juan V., Guerreros Benavides, Alfredo Gilberto, Guillory, Clint C., Gunaratne, Shauna H., Halpert, David, Hamilton, Holli, Hartman, William R., Henderson, Sheryl L., Herati, Ramin, Guarin, Laura Hernandez, Hilder, Robin, Ho, Ken, Hojat, Leila, Hosek, Sybil G., Jacobson, Jeffrey M., Jay, Melanie, Johnson, Diane H., Jones, Kathleen S., Jones-López, Edward C., Justman, Jessica E., Kahney, Scott, Katz, Lois, Katz, Melinda, Kaul, Daniel, Keefer, Michael C., Kennedy, Ashley, Knishinsky, Jennifer, Kogelman, Laura, Koletar, Susan L., Kottkamp, Angelica, Laguio-Vila, Maryrose, Landovitz, Raphael J., Lee, Jessica L., Liu, Albert, Llerena Zegarra, Eneyda Giuvanela, Lok, Anna S., Lovell, James, Lubelchek, Ronald, Lucaj, John, Luckasen, Gary, Luetkemeyer, Annie, Lugogo, Njira Lucia, Maenza, Janine, Malvestutto, Carlos, Mauri, Monica, Maves, Ryan C., Mayer, Kenneth H., McCartney, Michael J., McCort, Margaret E., McElrath, M. Juliana, McNairy, Meredith, Merino, Fernando L., Meyerowitz, Eric A., Mitchell, Carol L., Monaco, Cynthia L., Muhammad, Sauda, Muñoz-Gómez, Sigridh, Munsiff, Sonal, Nee, Paul, Nollen, Nicole L., Noor, Asif, Lagos, Claudio Nuñez, Okulicz, Jason F., Oliver, Patrick A., Ortega, Jessica, Palmer, Steven, Parameswaran, Lalitha, Parikh, Purvi, Parker, Susan, Parungao, Reza, Pavie, Juana R., Madan, Rebecca P., Peralta, Henry, Petts, Jennifer, Pierce, Kristen K., Pretell Alva, E. Javier, Purpura, Lawrence J., Raabe, Vanessa, Recuenco, Sergio E., Richards, Tamara, Riddler, Sharon A., Rizzardi, Barbara, Rokser, Rachel, Rolle, Charlotte-Paige, Rosen, Adam, Rosen, Jeffrey, Freese, Lena R., Santolaya, María E., Schipani, Linda M., Schwartz, Adam, Schwasinger-Schmidt, Tiffany, Scott, Hyman, Sha, Beverly E., Shankaran, Shivanjali, Shapiro, Adrienne E., Sharp, Stephan C., Shopsin, Bo, Sims, Matthew D., Skipper, Stephanie, Smith, Derek M., Smith, Michael J., Sobhanie, M. Mahdee, Sovic, Brit, Sterling, Stephanie, Striker, Robert, Tafur Bances, Karla Beatriz, Talaat, Kawsar R., Tavel, Edward M., Jr., Tieu, Hong V., Tomaszewski, Christian, Tomlinson, Ryan, Torres, Juan P., Torres, Julian A., Treanor, John J., Tukuru, Sade, Ulrich, Robert J., Utz, Gregory C., Viar, Veronica, Viau Colindres, Roberto A., Walsh, Edward E., Walsh, Mary C., Walter, Emmanuel B., Weidler, Jessica L., Wu, Yi H., Yang, Kinara S., Yrivarren Giorza, Juan Luis, Zemanek, Arthur L., Zhang, Kevin, Zingman, Barry S., Gorman, Richard, Paez, Carmen A., Swann, Edith, Takuva, Simbarashe G., Greninger, Alex, Roychoudhury, Pavitra, Coombs, Robert W., Jerome, Keith R., Castellino, Flora, Tong, Xiaomi, Pavetto, Corrina, Gipson, Teletha, Tong, Tina, Lee, Marina, Zhou, James, Fay, Michael, McQuarrie, Kelly, Nnadi, Chimeremma, Sogbetun, Obiageli, Ahmad, Nina, De Proost, Ian, Hoseyni, Cyrus, Coplan, Paul, Khan, Najat, Ronco, Peter, Furey, Dawn, Meck, Jodi, Vingerhoets, Johan, Brandenburg, Boerries, Custers, Jerome, Hendriks, Jenny, Juraszek, Jarek, Marit de Groot, Anne, Van Roey, Griet, Heerwegh, Dirk, Van Dromme, Ilse, Méndez Galván, Jorge F., Carrascal, Monica B., Duran, Adriana Sordo, Sanchez Guerrero, Laura Ruy, Gómora Madrid, Martha Cecilia, Barrat Hernández, Alejandro Quintín, Guizar, Sharzhaad Molina, González Estrada, Denisse Alejandra, Martínez Pérez, Silvano Omar, Zárate Hinojosa, Zindy Yazmín, Ruiz-Palacios, Guillermo Miguel, Cruz-Valdez, Aurelio, Pacheco-Flores, Janeth, Lara, Anyela, Díaz-Miralrio, Secia, Reyes Fentanes, María José, Olmos Vega, Jocelyn Zuleica, Méndez, Daniela Pineda, Martínez, Karina Cano, Alvarez León, Winniberg Stephany, Ruiz Herrera, Vida Veronica, Vázquez Saldaña, Eduardo Gabriel, Camacho Choza, Laura Julia, Vega Orozco, Karen Sofia, Ortega Domínguez, Sandra Janeth, Chacón, Jorge A., Rivera, Juan J., Cutz, Erika A., Ortegón, Maricruz E., Rivera, María I., Browder, David, Burch, Cortney, Moye, Terri, Bondy, Paul, Browder, Lesley, Manning, Rickey D., Hurst, James W., Sturgeon, Rodney E., Wakefield, Paul H., Kirby, John A., Andersen, James, Fearon, Szheckera, Negron, Rosa, Medina, Amy, Hill, John M., Rajasekhar, Vivek, Williams, Hayes, Cade, LaShondra, Fouts, Rhodna, Moya, Connie, Anderson, Corey G., Devine, Naomi, Ramsey, James, Perez, Ashley, Tatelbaum, David, Jacobs, Michael, Menasche, Kathleen, Mirkil, Vincent, Winkle, Peter J., Haggag, Amina Z., Haynes, Michelle, Villegas, Marysol, Raja, Sabina, Riesenberg, Robert, Plavin, Stanford, Lerman, Mark, Woodside, Leana, Johnson, Maria, Healy, C. Mary, Whitaker, Jennifer A., Keitel, Wendy A., Atmar, Robert L., Horwith, Gary, Mason, Robin, Johnson, Lisa, Dora, Tambra, Murray, Deborah, Ledbetter, Logan, Ewing, Beverly, Stephenson, Kathryn E., Tan, Chen S., Zash, Rebecca, Ansel, Jessica L., Jaegle, Kate, Guiney, Caitlin J., Henderson, Jeffrey A., O'Leary, Marcia, Enright, Kendra, Kessler, Jill, Ducheneaux, Pete, Inniss, Asha, Brandon, Donald M., Davis, William B., Lawler, Daniel T., Oppong, Yaa D., Starr, Ryan P., Syndergaard, Scott N., Shelly, Rozeli, Majumder, Mashrur Islam, Sugimoto, Danny, Dugas, Jeffrey, Sr., Rijos, Dolores, Shelton, Sandra, Hong, Stephan, Schwartz, Howard, Sanchez-Crespo, Nelia, Schwartz, Jennifer, Piedra, Terry, Corral, Barbara, Medina, Carmen, Dever, Michael E., Shah, Mitul, Delgado, Michael, Scott, Tameika, Usdan, Lisa S., McGill, Lora J., Arnold, Valerie K., Scatamacchia, Carolyn, Anthony, Codi M., Merchant, Rajan, Yoon, Anelgine C., Hill, Janet, Ng-Price, Lucy, Thompson-Seim, Teri, Ackerman, Ronald, Ackerman, Jamie, Aristy, Florida, Ketter, Nzeera, Finley, Jon, Stull, Mildred, Murray, Monica, Rizvi, Zainab, Guerrero, Sonia, Paliwal, Yogesh K., Paliwal, Amit, Gordon, Sarah, Gordon, Bryan, Montano-Pereira, Cynthia, Galloway, Christopher, Montros, Candice, Aleman, Lily, Shairi, Samira, Van Ever, Wesley, Freeman, George H., Harmon, Esther L., Cross, Marshall A., Sales, Kacie, Gular, Catherine Q., Hepburn, Matthew, Alderson, Nathan, Harshell, Shana, Mahgoub, Siham, Maxwell, Celia, Mellman, Thomas, Thompson, Karl M., Wortman, Glenn, Kingsley, Jeff, Pixler, April, Curry, LaKondria, Afework, Sarah, Swanson, Austin, Jacqmein, Jeffry, Bowers, Maggie, Robison, Dawn, Mosteller, Victoria, Garvey, Janet, Easley, Mary, Kurnat, Rebecca J., Cornelison, Raymond, Gower, Shanda, Schnitz, William, Heinzig-Cartwright, Destiny S., Lewis, Derek, Newton, Fred E., Duhart, Aeiress, Watkins, Breanz, Ball, Brandy, York, Jill, Pickle, Shelby, Musante, David B., Silver, William P., Belhorn, Linda R., Viens, Nicholas A., Dellaero, David, Patel, Priti, Lisec, Kendra, Safirstein, Beth, Zapata, Luz, Gonzalez, Lazaro, Quevedo, Evelyn, Irani, Farah, Grillo, Joseph, Potts, Amy, White, Julie, Flume, Patrick, Headden, Gary, Taylor, Brandie, Warden, Ashley, Chamberlain, Amy, Jeanfreau, Robert, Jeanfreau, Susan, Matherne, Paul G., Caldwell, Amy, Stahl, Jessica, Vowell, Mandy, Newhouse, Lauren, Berthaud, Vladimir, Takizala, Zudi-Mwak, Beninati, Genevieve, Snell, Kimberly, Baker, Sherrie, Walker, James, Harrison, Tavane, Miller, Meagan, Otto, Janet, Gray, Roni, Wilson, Christine, Nemecek, Tiffany, Harrington, Hannah, Eppenbach, Sally, Lewis, Wendell, Bourgeois, Tana, Folsom, Lyndsea, Holt, Gregory, Mirsaeidi, Mehdi, Calderon, Rafael, Lichtenberger, Paola, Quintero, Jalima, Martinez, Becky, Immergluck, Lilly, Johnson, Erica, Chan, Austin, Fas, Norberto, Thomas-Seaton, LaTeshia, Khizer, Saadia, Staben, Jonathan, Beresnev, Tatiana, Jahromi, Maryam, Marovich, Mary A., Hutter, Julia, Nason, Martha, Ledgerwood, Julie, Mascola, John, Leibowitz, Mark, Morales, Fernanda, Delgado, Mike, Sanchez, Rosario, Vega, Norma, Áñez, Germán, Albert, Gary, Coston, Erin, Desai, Chinar, Dunbar, Haoua, Eickhoff, Mark, Garcia, Jenina, Kautz, Margaret, Lee, Angela, Lewis, Maggie, McGarry, Alice, McKnight, Irene, Nelson, Joy, Newingham, Patrick, Price-Abbott, Patty, Reed, Patty, Vegas, Diana, Wilkinson, Bethanie, Smith, Katherine, Woo, Wayne, Cho, Iksung, Glenn, Gregory M., Dubovsky, Filip, Fried, David L., Haughey, Lynne A., Stanton, Ariana C., Rameaka, Lisa Stevens, Rosenberg, David, Tomatsu, Lee, Gonzalez, Viviana, Manalo, Millie, Grunstra, Bernard, Quinn, Donald, Claybrook, Phillip, Olds, Shelby, Dye, Amy, Cannon, Kevin D., Chadwick, Mesha M., Jordan, Bailey, Hussey, Morgan, Nevarez, Hannah, Kelley, Colleen F., Chung, Michael, Moran, Caitlin, Rebolledo, Paulina, Bacher, Christina, Barranco-Santana, Elizabeth, Rodriguez, Jessica, Mendoza, Rafael, Ruperto, Karen, Olivieri, Odette, Ocaña, Enrique, Wylie, Paul E., Henderson, Renea, Jenson, Natasa, Yang, Fan, Kelley, Amy, Finkelstein, Kenneth, Beckmann, David, Hutchins, Tanya, Escallon, Sebastian Garcia, Johnson, Kristen, Sligh, Teresa S., Desai, Parul, Huynh, Vincent, Lopez, Carlos, Mendoza, Erika, Adelglass, Jeffrey, Naifeh, Jerome G., Kucera, Kristine J., Chughtai, Waseem, Jaffer, Shireen H., Davis, Matthew G., Foley, Jennifer, Burgett, Michelle L., Shlotzhauer, Tammi L., Ingalsbe-Geno, Sarah M., Duncanson, Daniel, Kush, Kelly, Nesbitt, Lori, Sonnier, Cora, McCarter, Jennifer, Butcher, Michael B., Fry, James, Percy, Donna, Freudemann, Karen, Gebhardt, Bruce C., Mangu, Padma N., Schroeck, Debra B., Davit, Rajesh K., Hennekes, Gayle D., Luft, Benjamin J., Carr, Melissa, Nachman, Sharon, Pellecchia, Alison, Smith, Candace, Valenti, Bruno, Bermudez, Maria I., Peraita, Noris, Delgado, Ernesto, Arrazcaeta, Alicia, Ramirez, Natalie, Amador, Carmen, Marafioti, Horacio, Dang, Lyly, Clement, Lauren, Berry, Jennifer, Allaw, Mohammed, Geuss, Georgettea, Miles, Chelsea, Bittner, Zachary, Werne, Melody, Calinescu, Cornell, Rodman, Shannon, Rindt, Joshua, Cooksey, Erin, Harrison, Kristina, Cooper, Deanna, Horton, Manisha, Philyaw, Amanda, Jennings, William, Alvarado, Hilario, Baka, Michele, Regalado, Malina, Murray, Linda, Naguib, Sherif, Singletary, Justin, Richmond, Sha-Wanda, Omodele, Sarah, Oppenheim, Emily, Martinez, Reuben, Andriulis, Victoria, Singer, Leonard, Blevins, Jeanne, Thomas, Meagan, Hull, Christine, Pereira, Isabel, Rivero, Gina, Okonya, Tracy, Downing, Frances, Miller, Paulina, Rhee, Margaret, Stapleton, Katherine, Klein, Jeffrey, Hong, Rosamond, Swan, Suzanne, Wahlin, Tami, Bennett, Elizabeth, Salzl, Amy, Phan, Sharine, White, Jewel J., Occhino, Amanda, Paiano, Ruth, McLaughlin, Morgan, Swieboda, Elisa, Garcia-Fragoso, Veronica, Becerra, Maria G., White, Toni, Turley, Christine B., McWilliams, Andrew, Esinhart, Tiffany, Montoya, Natasha, Huskey, Shamika, Paul, Leena, Tashima, Karen, Johnson, Jennie, Neill, Marguerite, Sanchez, Martha, Rybak, Natasha, Mileno, Maria, Cohen, Stuart H., Ruiz, Monica, Boswell, Dean M., Robison, Elizabeth E., Reynolds, Trina L., Neumeister, Sonja, Zorrilla, Carmen D., Rivera, Juana, Ibarra, Jessica, García, Iris, Sierra, Dianca, Ramon, Wanda, Fiorillo, Suzanne, Pitotti, Rebecca, Anderson, Victoria R., Mancilla, Jose Castillo, Le, Nga, Winokur, Patricia L., Ince, Dilek, Hegmann, Theresa, Meier, Jeffrey, Stapleton, Jack, Stulken, Laura, McArthur, Monica, Berry, Andrea, Tapia, Milagritos, Hammershaimb, Elizabeth, Robinson, Toni, MacBryde, Rosa, Kline, Susan, Billings, Joanne L., Cavert, Winston, Forgosh, Les B., Schacker, Timothy W., Bold, Tyler D., Dandachi, Dima, Nelson, Taylor, Bran, Andres, Geiger, Grant, Naqvi, S. Hasan, Florescu, Diana F., Starlin, Richard, Kline, David, Zimmer, Andrea, Abbas, Anum, Wilson, Natasha, Eron, Joseph J., Sciaudone, Michael, Rosengren, A. Lina, Kizer, John S., Rutstein, Sarah E., Bruce, Elizabeth, Espinosa, Claudia, Sanders, Lisa J., Kim, Kami, Casey, Denise, Taylor, Barbara S., Patterson, Thomas, Pinilla, Ruth S., Bullock, Delia, Ponce, Philip, Patterson, Jan, McClelland, R. Scott, Lane, Dakotah C., Wald, Anna, James, Frank, Duke, Elizabeth, Hauge, Kirsten, Heimonen, Jessica, Goecker, Erin A., Huang, Yunda, Fong, Youyi, Kauffman, Carol, Linder, Kathleen, Nofz, Kimberly, McConnell, Andrew, Buynak, Robert J., Webb, Angella, Petty, Taryn, Andree, Stephanie, Sanchez, Erica, Mackey, Nolan, Baudelaire, Clarisse, Dzigiel, Sarah, Marquez, Adrienna, Quillin, Kim, King, Michelle, Abad, Vanessa, Knowles, Jennifer, Waters, Michael, Zepeda, Karla, Coslet, Jordan, Tovar, Dalia, Shaw, Marian E., Turner, Mark A., Huffine, Cory J., Huffine, Esther S., Ake, Julie A., Secord, Elizabeth, McGrath, Eric, Levy, Phillip, Stewart, Brittany, Cromer, Charnell, Walters, Ayanna, Ellsworth, Grant, Greene, Caroline, Galloway, Sarah, Kapadia, Shashi, DeHaan, Elliot, Wilson, Clint, Milligan, Jason, Raley, Danielle, Bocchini, Joseph, McClenathan, Bruce, Hussain, Mary, Lomasney, Evelyn, Hall, Evelyn, Lamberth, Sherry, Schmeck, Christy, Leathers, Vickie, Theodore, Deborah A., Branche, Angela R., Graciaa, Daniel S., Hatlen, Timothy J., Miller, Jacqueline, Sadoff, Jerald, Falsey, Ann R., Sobieszczyk, Magdalena E., Rick, Anne-Marie, Laurens, Matthew B., Huang, Ying, Yu, Chenchen, Martin, Thomas C.S., Rodriguez, Carina A., Rostad, Christina A., Maboa, Rebone M., Baden, Lindsey R., El Sahly, Hana M., Grinsztejn, Beatriz, Gray, Glenda E., Gay, Cynthia L., Gilbert, Peter B., Janes, Holly E., Kublin, James G., Leav, Brett, Hirsch, Ian, Struyf, Frank, Dunkle, Lisa M., Neuzil, Kathleen M., Corey, Lawrence, Goepfert, Paul A., Follmann, Dean, and Kotloff, Karen L.

Published
2023
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7. The HIV-1 latent reservoir is largely sensitive to circulating T cells.

Author

Warren, Joanna A, Zhou, Shuntai, Xu, Yinyan, Moeser, Matthew J, MacMillan, Daniel R, Council, Olivia, Kirchherr, Jennifer, Sung, Julia M, Roan, Nadia R, Adimora, Adaora A, Joseph, Sarah, Kuruc, JoAnn D, Gay, Cynthia L, Margolis, David M, Archin, Nancie, Brumme, Zabrina L, Swanstrom, Ronald, and Goonetilleke, Nilu

Subjects
CD8, HIV, T cell, hiv cure, hiv reservoir, human, immunology, inflammation, Biochemistry and Cell Biology
Abstract

HIV-1-specific CD8+ T cells are an important component of HIV-1 curative strategies. Viral variants in the HIV-1 reservoir may limit the capacity of T cells to detect and clear virus-infected cells. We investigated the patterns of T cell escape variants in the replication-competent reservoir of 25 persons living with HIV-1 (PLWH) durably suppressed on antiretroviral therapy (ART). We identified all reactive T cell epitopes in the HIV-1 proteome for each participant and sequenced HIV-1 outgrowth viruses from resting CD4+ T cells. All non-synonymous mutations in reactive T cell epitopes were tested for their effect on the size of the T cell response, with a≥50% loss defined as an escape mutation. The majority (68%) of T cell epitopes harbored no detectable escape mutations. These findings suggest that circulating T cells in PLWH on ART could contribute to control of rebound and could be targeted for boosting in curative strategies.

Published
2020

8. HIV-Specific T Cell Responses Are Highly Stable on Antiretroviral Therapy

Author

Xu, Yinyan, Trumble, Ilana M, Warren, Joanna A, Clutton, Genevieve, Abad-Fernandez, Maria, Kirchnerr, Jennifer, Adimora, Adaora A, Deeks, Steven G, Margolis, David M, Kuruc, JoAnn D, Gay, Cynthia L, Archin, Nancie M, Mollan, Katie R, Hudgens, Michael, and Goonetilleke, Nilu

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Immunotherapy, Clinical Trials and Supportive Activities, Clinical Research, Infectious Diseases, HIV/AIDS, Sexually Transmitted Infections, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, CD8, HIV, T cell, immunotherapy, Medical biotechnology
Abstract

HIV infection induces a robust T cell response that is sustained by high viremia, but falls following the onset of antiretroviral therapy (ART). Relatively little has been reported on the subsequent stability of the HIV-specific T cell response in individuals on durable therapy. Such data are critical for powering clinical trials testing T cell-based immunotherapies. In a cross-sectional study, HIV-specific T cell responses were detectable by ex vivo interferon (IFN)-γ ELISpot (average ∼1,100 spot-forming units [SFUs]/106 peripheral blood mononuclear cells) in persons living with HIV (PLWH; n = 34), despite median durable ART suppression of 5.0 years. No substantial association was detected between the summed HIV-specific T cell response and the size of the replication-competent HIV reservoir. T cell responses were next measured in participants sampled weekly, monthly, or yearly. HIV-specific T cell responses were highly stable over the time periods examined; within-individual variation ranged from 16% coefficient of variation (CV) for weekly to 27% CV for yearly sampling. These data were used to generate power calculations for future immunotherapy studies. The stability of the HIV-specific T cell response in suppressed PLWH will enable powered studies of small sizes (e.g., n = 6-12), facilitating rapid and iterative testing for T cell-based immunotherapies against HIV.

Published
2019

10. Sequence Analysis of Inducible, Replication-Competent Virus Reveals No Evidence of HIV-1 Evolution During Suppressive Antiviral Therapy Indicating A Lack Of Ongoing Viral Replication

Author

Lee, Sook-Kyung, primary, Sondgeroth, Amy, additional, Xu, Yinyan, additional, Warren, Joanna, additional, Zhou, Shuntai, additional, Gilleece, Maria, additional, Hauser, Blake M, additional, Gay, Cynthia L, additional, Kuruc, JoAnn D, additional, Archin, Nancie M, additional, Eron, Joseph J, additional, Margolis, David M, additional, Goonetilleke, Nilu, additional, and Swanstrom, Ronald, additional

Published
2024
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11. COVID-19 vaccine efficacy in participants with weakened immune systems from four randomized-controlled trials

Author

Sherman, Amy, primary, Tuan, Jessica, additional, Cantos, Valeria D, additional, Adeyiga, Oladunni, additional, Mahoney, Scott, additional, Ortega-Villa, Ana M, additional, Tillman, Amy, additional, Whitaker, Jennifer, additional, Woodward Davis, Amanda S, additional, Leav, Brett, additional, Hirsch, Ian, additional, Sadoff, Jerald, additional, Dunkle, Lisa M, additional, Gilbert, Peter B, additional, Janes, Holly E, additional, Kublin, James G, additional, Goepfert, Paul A, additional, Kotloff, Karen, additional, Rouphael, Nadine, additional, Falsey, Ann R, additional, El Sahly, Hana M, additional, Sobieszczyk, Magdalena E, additional, Huang, Yunda, additional, Neuzil, Kathleen M, additional, Corey, Lawrence, additional, Grinsztejn, Beatriz, additional, Gray, Glenda, additional, Nason, Martha, additional, Baden, Lindsey R, additional, and Gay, Cynthia L, additional

Published
2024
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12. Durability of Protection Against COVID-19 Through the Delta Surge for the NVX-CoV2373 Vaccine.

Author

Follmann, Dean, Mateja, Allyson, Fay, Michael P, Magaret, Craig A, Huang, Yunda, Fong, Youyi, Angier, Heather, Nason, Martha, Gay, Cynthia L, Kotloff, Karen, Woo, Wayne, Cho, Iksung, and Dunkle, Lisa M

Subjects
IMMUNIZATION, PUBLIC health surveillance, RESEARCH funding, SECONDARY analysis, VACCINE effectiveness, COVID-19 vaccines, DESCRIPTIVE statistics, GENETIC mutation, CONFIDENCE intervals, COVID-19
Abstract

Background Protein-based vaccines for coronavirus disease 2019 (COVID-19) provide a traditional vaccine platform with long-lasting protection for non–severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogens and may complement messenger RNA vaccines as a booster dose. While NVX-CoV2373 showed substantial early efficacy, the durability of protection has not been delineated. Methods The PREVENT-19 vaccine trial used a blinded crossover design; the original placebo arm received NVX-CoV2373 after efficacy was established. Using novel statistical methods that integrate surveillance data of circulating strains with post-crossover cases, we estimated placebo-controlled vaccine efficacy and durability of NVX-CoV2373 against both pre-Delta and Delta strains of SARS-CoV-2. Results Vaccine efficacy against pre-Delta strains of COVID-19 was 89% (95% CI, 75–95%) and 87% (72–94%) at 0 and 90 days after 2 doses of NVX-CoV2373, respectively, with no evidence of waning (P =.93). Vaccine efficacy against the Delta strain was 88% (71–95%), 82% (56–92%), and 77% (44–90%) at 40, 120, and 180 days, respectively, with evidence of waning (P <.01). In sensitivity analyses, the estimated Delta vaccine efficacy at 120 days ranged from 66% (15–86%) to 89% (74–95%) per various assumptions of the surveillance data. Conclusions NVX-CoV2373 has high initial efficacy against pre-Delta and Delta strains of COVID-19 with little evidence of waning for pre-Delta strains through 90 days and moderate waning against Delta strains over 180 days. [ABSTRACT FROM AUTHOR]

Published
2024
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14. The Effects of Human Immunodeficiency Virus Type 1 (HIV-1) Antigen-Expanded Specific T-Cell Therapy and Vorinostat on Persistent HIV-1 Infection in People With HIV on Antiretroviral Therapy

Author

Gay, Cynthia L, primary, Hanley, Patrick J, additional, Falcinelli, Shane D, additional, Kuruc, JoAnn D, additional, Pedersen, Susan M, additional, Kirchherr, Jennifer, additional, Raines, Samuel L M, additional, Motta, Cecilia M, additional, Lazarski, Chris, additional, Chansky, Pamela, additional, Tanna, Jay, additional, Shibli, Abeer, additional, Datar, Anushree, additional, McCann, Chase D, additional, Sili, Uluhan, additional, Ke, Ruian, additional, Eron, Joseph J, additional, Archin, Nancie, additional, Goonetilleke, Nilu, additional, Bollard, Catherine M, additional, and Margolis, David M, additional

Published
2024
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16. HIVepsilon-seq—scalable characterization of intact persistent proviral HIV reservoirs in women

Author

Barton, Kirston, primary, Ferguson, James M., additional, Deveson, Ira W., additional, Falcinelli, Shane D., additional, James, Katherine S., additional, Kirchherr, Jennifer, additional, Ramirez, Catalina, additional, Gay, Cynthia L., additional, Hammond, Jillian M., additional, Bevear, Brent, additional, Carswell, Shaun L., additional, Margolis, David M., additional, Smith, Martin A., additional, Adimora, Adaora A., additional, and Archin, Nancie M., additional

Published
2023
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17. Risk of COVID-19 after natural infection or vaccination

Author

Rick, Anne-Marie, primary, Laurens, Matthew B., additional, Huang, Ying, additional, Yu, Chenchen, additional, Martin, Thomas C.S., additional, Rodriguez, Carina A., additional, Rostad, Christina A., additional, Maboa, Rebone M., additional, Baden, Lindsey R., additional, El Sahly, Hana M., additional, Grinsztejn, Beatriz, additional, Gray, Glenda E., additional, Gay, Cynthia L., additional, Gilbert, Peter B., additional, Janes, Holly E., additional, Kublin, James G., additional, Huang, Yunda, additional, Leav, Brett, additional, Hirsch, Ian, additional, Struyf, Frank, additional, Dunkle, Lisa M., additional, Neuzil, Kathleen M., additional, Corey, Lawrence, additional, Goepfert, Paul A., additional, Walsh, Stephen R., additional, Follmann, Dean, additional, Kotloff, Karen L., additional, Adams, Atoya, additional, Miller, Eric, additional, Rankin, Bruce G., additional, Shinn, Steven, additional, Nash, Marshall, additional, Green, Sinikka L., additional, Jacobsen, Colleen, additional, Krishnankutty, Jayasree, additional, Phungwayo, Sikhongi, additional, Glover, Richard M., additional, Slechta, Stacy, additional, Holdeman, Troy, additional, Hartvickson, Robyn, additional, Grant, Amber, additional, Poling, Terry L., additional, Klein, Terry D., additional, Klein, Thomas C., additional, Klein, Tracy R., additional, Smith, William B., additional, Gibson, Richard L., additional, Winbigler, Jennifer, additional, Parker, Elizabeth, additional, Wijewardane, Priyantha N., additional, Bravo, Eric, additional, Thessing, Jeffrey, additional, Maxwell, Michelle, additional, Horn, Amanda, additional, Healy, Catherine Mary, additional, Akamine, Christine, additional, Chu, Laurence, additional, Chouteau, R. Michelle, additional, Cotugno, Michael J., additional, Bauer, George H., additional, Hachigian, Greg, additional, Oshita, Masaru, additional, Cancilla, Michael, additional, Kiersey, Kristen, additional, Seger, William, additional, Antwi, Mohammed, additional, Green, Allison, additional, Kim, Anthony, additional, Desjardins, Michael, additional, Johnson, Jennifer A., additional, Sherman, Amy, additional, Borger, Judith, additional, Saleem, Nafisa, additional, Solis, Joel, additional, Medina, Martha Carmen, additional, Keating, Westly, additional, Garcia, Edgar, additional, Bueno, Cynthia, additional, Segall, Nathan, additional, Denham, Douglas S., additional, Weiss, Thomas, additional, Avworo, Ayoade, additional, Hedges, Parke, additional, Strout, Cynthia Becher, additional, Santiago, Rica, additional, Davis, Yvonne, additional, Howenstine, Patty, additional, Bondell, Alison, additional, Marks, Kristin, additional, Wang, Tina, additional, Wilkin, Timothy, additional, Vogler, Mary, additional, Johnston, Carrie, additional, Andrasik, Michele P., additional, Andriesen, Jessica G., additional, Broder, Gail, additional, Eaton, Niles, additional, Gelderblom, Huub G., additional, McClennen, Rachael, additional, Michael, Nelson, additional, Robb, Merlin, additional, Sopher, Carrie, additional, Miller, Vicki E., additional, Santiago, Fredric, additional, Gomez, Blanca, additional, Valika, Insiya, additional, Starr, Amy, additional, Cantos, Valeria D., additional, Kandiah, Sheetal, additional, Rio, Carlos del, additional, Rouphael, Nadine, additional, Edupuganti, Srilatha, additional, Anderson, Evan J., additional, Camacho-Gonzalez, Andres, additional, Kamidani, Satoshi, additional, Teherani, Meghan, additional, Diemert, David J., additional, Malkin, Elissa, additional, Siegel, Marc, additional, Roberts, Afsoon, additional, Simon, Gary, additional, Balani, Bindu, additional, Stephenson, Carolene, additional, Sperber, Steven, additional, Cicogna, Cristina, additional, Zervos, Marcus J., additional, Kilgore, Paul, additional, Ramesh, Mayur, additional, Herc, Erica, additional, Zenlea, Kate, additional, Burgher, Abram, additional, Milliken, Ann M., additional, Davis, Joseph D., additional, Levy, Brendan, additional, Kelman, Sandra, additional, Doust, Matthew W., additional, Sample, Denise, additional, Erickson, Sandra, additional, Christensen, Shane G., additional, Matich, Christopher, additional, Longe, James, additional, Witbeck, John, additional, Peterson, James T., additional, Clark, Alexander, additional, Kelty, Gerald, additional, Pena-Renteria, Issac, additional, Koren, Michael J., additional, Bartilucci, Darlene, additional, Patel, Alpa, additional, Tran, Carolyn, additional, Kennelly, Christina, additional, Brownlee, Robert, additional, Coleman, Jacob, additional, Webster, Hala, additional, Fierro, Carlos A., additional, Leistner, Natalia, additional, Thompson, Amy, additional, Gonzalez, Celia, additional, Jackson, Lisa A., additional, Suyehira, Janice, additional, Haber, Milton, additional, Regalado, Maria M., additional, Procasky, Veronica, additional, Lutat, Alisha, additional, Griffin, Carl P., additional, Hollister, Ripley R., additional, Brown, Jeremy, additional, Ronk, Melody, additional, Harper, Wayne L., additional, Cohen, Lisa, additional, Eckert, Lynn, additional, Hong, Matthew, additional, Rouhbakhsh, Rambod, additional, Danford, Elizabeth, additional, Johnson, John, additional, Calderone, Richard, additional, Khetan, Shishir K., additional, Olanrewaju, Oyebisi, additional, Zhai, Nan, additional, Nieves, Kimberly, additional, O'Brien, Allison, additional, Bradley, Paul S., additional, Lilienthal, Amanda, additional, Callis, Jim, additional, Brosz, Adam B., additional, Clement, Andrea, additional, West, Whitney, additional, Friesen, Luke, additional, Cramer, Paul, additional, Eder, Frank S., additional, Little, Ryan, additional, Engler, Victoria, additional, Rattenbury-Shaw, Heather, additional, Ensz, David J., additional, Oplinger, Allie, additional, Essink, Brandon J., additional, Meyer, Jay, additional, Raiser, Frederick, additional, Mueller, Kimberly, additional, Vrbicky, Keith W., additional, Harper, Charles, additional, Nutsch, Chelsie, additional, Lewis, Wendell, additional, Laflan, Cathy, additional, Whatley, Jordan L., additional, Harrell, Nicole, additional, Shannon, Amie, additional, Rowell, Crystal, additional, Dedon, Christopher, additional, Makhene, Mamodikoe, additional, Gottschlich, Gregory M., additional, Harden, Kate, additional, Gottschlich, Melissa, additional, Smith, Mary, additional, Powell, Richard, additional, Kimmel, Murray A., additional, Pinto, Simmy, additional, Vachris, Timothy P., additional, Hutchens, Mark, additional, Daniels, Stephen, additional, Wells, Margaret, additional, Van Der Leden, Mimi, additional, Jackson-Booth, Peta-Gay, additional, Baron, Mira, additional, Kane, Pamela, additional, Seversen, Shannen, additional, Kryvicky, Mara, additional, Lord, Julia, additional, Saleh, Jamshid, additional, Miles, Matthew, additional, Lupercio, Rafael, additional, McGettigan, John W., additional, Patton, Walter, additional, Brakema, Riemke, additional, Choquette, Karin, additional, McGettigan, Jonlyn, additional, Kirstein, Judith L., additional, Bernard, Marcia, additional, Manning, Mary Beth, additional, Rothenberg, Joan, additional, Briskin, Toby, additional, Roadman, Denise, additional, Tedder-Edwards, Sharita, additional, Schwartz, Howard I., additional, Mederos, Surisday, additional, Swaminathan, Shobha, additional, Nyaku, Amesika, additional, Varughese, Tilly, additional, DallaPiazza, Michelle, additional, Frey, Sharon E., additional, Graham, Irene, additional, Abate, Getahun, additional, Hoft, Daniel, additional, Allen, Leland N., additional, Edwards, Leslie A., additional, Davis, William S., additional, Mena, Jessica M., additional, Kutner, Mark E., additional, Caso, Jorge, additional, Moran, Maria Hernandez, additional, Carvajal, Marianela, additional, Mendez, Janet, additional, Wadsworth, Larkin T., additional, Adams, Michael R., additional, Iverson, Leslie, additional, Newberg, Joseph L., additional, Pearlman, Laura, additional, Nugent, Paul J., additional, Reynolds, Michele D., additional, Bashour, Jennifer, additional, Schmidt, Robert, additional, Sheth, Neil P., additional, Steil, Kenneth, additional, Toma, Ramy J., additional, Kirby, William, additional, Folmar, Pink, additional, Williams, Samantha, additional, Pickrell, Paul, additional, Mott, Stefanie, additional, Linebarger, Carol Ann, additional, Malbari, Hussain, additional, Pampe, David, additional, Fragoso, Veronica G., additional, Holloway, Lisa, additional, McKeown-Bragas, Cecilia, additional, Becker, Teresa, additional, Williams, Barton G., additional, Jones, William H., additional, Clark, Jesse L., additional, Shoptaw, Steven, additional, Vertucci, Michele, additional, Hernandez, Will, additional, Spector, Stephen A., additional, Moodley, Amaran, additional, Blumenthal, Jill, additional, Stangl, Lisa, additional, Deutsch, Karen, additional, Mullane, Kathleen M., additional, Pitrak, David, additional, Nuss, Cheryl, additional, Pi, Judy, additional, Fichtenbaum, Carl, additional, Powers-Fletcher, Margaret, additional, Saemann, Michelle, additional, Kohrs, Sharon, additional, Campbell, Thomas B., additional, Lauria, Andrew, additional, Mancilla, Jose C., additional, Dunlevy, Hillary, additional, Novak, Richard M., additional, Wendrow, Andrea, additional, Borgetti, Scott, additional, Ladner, Ben, additional, Chrisley, Lisa, additional, Young, Cheryl, additional, Doblecki-Lewis, Susanne, additional, Alcaide, Maria L., additional, Gonzales-Zamora, Jose, additional, Morris, Stephen, additional, Wohl, David, additional, Eron, Joseph, additional, Frank, Ian, additional, Dunbar, Debora, additional, Metzger, David, additional, Momplaisir, Florence, additional, Martin, Judith, additional, Hoberman, Alejandro, additional, Shope, Timothy, additional, Muniz, Gysella, additional, Rupp, Richard, additional, Stanford, Amber, additional, Berman, Megan, additional, Porterfield, Laura, additional, Lewis, Michael, additional, Ghadishah, Elham, additional, Yusin, Joseph, additional, Pham, Mai, additional, Creech, Clarence B., additional, Walker, Shannon, additional, Rolsma, Stephanie, additional, Samuels, Robert, additional, Thomsen, Isaac, additional, Kalams, Spyros A., additional, Wilson, Greg, additional, Lucksinger, Gregg H., additional, Parks, Kevin, additional, Israelsen, Ryan, additional, Ostovar, Jaleh, additional, Kelly, Kary, additional, Overcash, Jeffrey S., additional, Chu, Hanh, additional, Lee, Kia, additional, De La Cruz, Luis I., additional, Clemons, Steve, additional, Everette, Elizabeth, additional, Studdard, Suzanna, additional, Mohan, Gowdhami, additional, Tyson, Stefanie, additional, Peay, Alyssa-Kay, additional, Johnson, Danyel, additional, Feldman, Gregory J., additional, Suen, May-Yin, additional, Muenzner, Jacqueline, additional, Boscia, Joseph, additional, Siddiqui, Farhan, additional, Sanders, John, additional, Peacock, James, additional, Nasim, Julio, additional, Levin, Michael L., additional, Hussey, Julie, additional, Kulic, Marcy, additional, McKenzie, Mark M., additional, Deese, Teresa, additional, Osmundsen, Erica, additional, Sweet, Christy, additional, Ebuh, Valentine M., additional, Elnagar, Elwaleed, additional, Ebuh, Georgette, additional, Iwuala, Genevieve, additional, Han-Conrad, Laurie J., additional, Simmons, Todd, additional, Tarakjian, Denis, additional, Ackermann, Jeremy, additional, Adams, Mark S., additional, Alemán, José O., additional, Al-Ibrahim, Mohamed S., additional, Andes, David R., additional, Andrews, Jeb, additional, Arduino, Roberto C., additional, Bäcker, Martín, additional, Badillo, Diana, additional, Bainbridge, Emma, additional, Batteiger, Teresa A., additional, Bazan, Jose A., additional, Bedimo, Roger J., additional, Benitez, Jorge A., additional, Bennett, Annette R., additional, Bernstein, David I., additional, Bialobok, Kristin, additional, Boas, Rebecca, additional, Brady, Judith, additional, Brown, Cynthia, additional, Bunce, Catherine A., additional, Call, Robert S., additional, Campbell, Wesley, additional, Carmody, Ellie, additional, Carpenter, Christopher, additional, Carsons, Steven E., additional, Castellon, Marvin, additional, Castro, Mario, additional, Catan, Hannah, additional, Chang, Jennifer, additional, Chebib, Mouna G., additional, Chen, Corey M., additional, Cheng, Margaret, additional, Chow, Brian D.W., additional, Ciambruschini, Annie, additional, Connor, Joseph P., additional, Conway, James H., additional, Cooney, Maureen, additional, Curlin, Marcel, additional, De La Matta Rodriguez, Claudia, additional, Dedon, Jon F., additional, Degan, Emily, additional, Dickey, Michelle, additional, Dietz, Craig, additional, Dong, Jennifer L., additional, Dorcely, Brenda, additional, Dube, Michael P., additional, Dyer, Carmel B., additional, Eckhardt, Benjamin, additional, Ellerbeck, Edward, additional, Ewers, Evan C., additional, Falk, Amy, additional, Feijoo, Brittany, additional, Felsen, Uriel R., additional, Fiel, Tom, additional, Fitz-Patrick, David, additional, Fogarty, Charles M., additional, Ford, Stacy, additional, Forero, Lina M., additional, Formentini, Elizabeth, additional, Franco-Vitteri, Doris, additional, Frenck, Robert W., additional, Gharib, Elie, additional, Gharib, Suzanne, additional, Rucker, Rola G., additional, Goldenberg, James N., additional, González, Luis H., additional, Gray, Brett, additional, Greene, Rusty, additional, Grossberg, Robert M., additional, Guanira-Carranza, Juan V., additional, Guerreros Benavides, Alfredo Gilberto, additional, Guillory, Clint C., additional, Gunaratne, Shauna H., additional, Halpert, David, additional, Hamilton, Holli, additional, Hartman, William R., additional, Henderson, Sheryl L., additional, Herati, Ramin, additional, Guarin, Laura Hernandez, additional, Hilder, Robin, additional, Ho, Ken, additional, Hojat, Leila, additional, Hosek, Sybil G., additional, Jacobson, Jeffrey M., additional, Jay, Melanie, additional, Johnson, Diane H., additional, Jones, Kathleen S., additional, Jones-López, Edward C., additional, Justman, Jessica E., additional, Kahney, Scott, additional, Katz, Lois, additional, Katz, Melinda, additional, Kaul, Daniel, additional, Keefer, Michael C., additional, Kennedy, Ashley, additional, Knishinsky, Jennifer, additional, Kogelman, Laura, additional, Koletar, Susan L., additional, Kottkamp, Angelica, additional, Laguio-Vila, Maryrose, additional, Landovitz, Raphael J., additional, Lee, Jessica L., additional, Liu, Albert, additional, Llerena Zegarra, Eneyda Giuvanela, additional, Lok, Anna S., additional, Lovell, James, additional, Lubelchek, Ronald, additional, Lucaj, John, additional, Luckasen, Gary, additional, Luetkemeyer, Annie, additional, Lugogo, Njira Lucia, additional, Maenza, Janine, additional, Malvestutto, Carlos, additional, Mauri, Monica, additional, Maves, Ryan C., additional, Mayer, Kenneth H., additional, McCartney, Michael J., additional, McCort, Margaret E., additional, McElrath, M. Juliana, additional, McNairy, Meredith, additional, Merino, Fernando L., additional, Meyerowitz, Eric A., additional, Mitchell, Carol L., additional, Monaco, Cynthia L., additional, Muhammad, Sauda, additional, Muñoz-Gómez, Sigridh, additional, Munsiff, Sonal, additional, Nee, Paul, additional, Nollen, Nicole L., additional, Noor, Asif, additional, Lagos, Claudio Nuñez, additional, Okulicz, Jason F., additional, Oliver, Patrick A., additional, Ortega, Jessica, additional, Palmer, Steven, additional, Parameswaran, Lalitha, additional, Parikh, Purvi, additional, Parker, Susan, additional, Parungao, Reza, additional, Pavie, Juana R., additional, Madan, Rebecca P., additional, Peralta, Henry, additional, Petts, Jennifer, additional, Pierce, Kristen K., additional, Pretell Alva, E. Javier, additional, Purpura, Lawrence J., additional, Raabe, Vanessa, additional, Recuenco, Sergio E., additional, Richards, Tamara, additional, Riddler, Sharon A., additional, Rizzardi, Barbara, additional, Rokser, Rachel, additional, Rolle, Charlotte-Paige, additional, Rosen, Adam, additional, Rosen, Jeffrey, additional, Freese, Lena R., additional, Santolaya, María E., additional, Schipani, Linda M., additional, Schwartz, Adam, additional, Schwasinger-Schmidt, Tiffany, additional, Scott, Hyman, additional, Sha, Beverly E., additional, Shankaran, Shivanjali, additional, Shapiro, Adrienne E., additional, Sharp, Stephan C., additional, Shopsin, Bo, additional, Sims, Matthew D., additional, Skipper, Stephanie, additional, Smith, Derek M., additional, Smith, Michael J., additional, Sobhanie, M. Mahdee, additional, Sovic, Brit, additional, Sterling, Stephanie, additional, Striker, Robert, additional, Tafur Bances, Karla Beatriz, additional, Talaat, Kawsar R., additional, Tavel, Edward M., additional, Tieu, Hong V., additional, Tomaszewski, Christian, additional, Tomlinson, Ryan, additional, Torres, Juan P., additional, Torres, Julian A., additional, Treanor, John J., additional, Tukuru, Sade, additional, Ulrich, Robert J., additional, Utz, Gregory C., additional, Viar, Veronica, additional, Viau Colindres, Roberto A., additional, Walsh, Edward E., additional, Walsh, Mary C., additional, Walter, Emmanuel B., additional, Weidler, Jessica L., additional, Wu, Yi H., additional, Yang, Kinara S., additional, Yrivarren Giorza, Juan Luis, additional, Zemanek, Arthur L., additional, Zhang, Kevin, additional, Zingman, Barry S., additional, Gorman, Richard, additional, Paez, Carmen A., additional, Swann, Edith, additional, Takuva, Simbarashe G., additional, Greninger, Alex, additional, Roychoudhury, Pavitra, additional, Coombs, Robert W., additional, Jerome, Keith R., additional, Castellino, Flora, additional, Tong, Xiaomi, additional, Pavetto, Corrina, additional, Gipson, Teletha, additional, Tong, Tina, additional, Lee, Marina, additional, Zhou, James, additional, Fay, Michael, additional, McQuarrie, Kelly, additional, Nnadi, Chimeremma, additional, Sogbetun, Obiageli, additional, Ahmad, Nina, additional, De Proost, Ian, additional, Hoseyni, Cyrus, additional, Coplan, Paul, additional, Khan, Najat, additional, Ronco, Peter, additional, Furey, Dawn, additional, Meck, Jodi, additional, Vingerhoets, Johan, additional, Brandenburg, Boerries, additional, Custers, Jerome, additional, Hendriks, Jenny, additional, Juraszek, Jarek, additional, Marit de Groot, Anne, additional, Van Roey, Griet, additional, Heerwegh, Dirk, additional, Van Dromme, Ilse, additional, Méndez Galván, Jorge F., additional, Carrascal, Monica B., additional, Duran, Adriana Sordo, additional, Sanchez Guerrero, Laura Ruy, additional, Gómora Madrid, Martha Cecilia, additional, Barrat Hernández, Alejandro Quintín, additional, Guizar, Sharzhaad Molina, additional, González Estrada, Denisse Alejandra, additional, Martínez Pérez, Silvano Omar, additional, Zárate Hinojosa, Zindy Yazmín, additional, Ruiz-Palacios, Guillermo Miguel, additional, Cruz-Valdez, Aurelio, additional, Pacheco-Flores, Janeth, additional, Lara, Anyela, additional, Díaz-Miralrio, Secia, additional, Reyes Fentanes, María José, additional, Olmos Vega, Jocelyn Zuleica, additional, Méndez, Daniela Pineda, additional, Martínez, Karina Cano, additional, Alvarez León, Winniberg Stephany, additional, Ruiz Herrera, Vida Veronica, additional, Vázquez Saldaña, Eduardo Gabriel, additional, Camacho Choza, Laura Julia, additional, Vega Orozco, Karen Sofia, additional, Ortega Domínguez, Sandra Janeth, additional, Chacón, Jorge A., additional, Rivera, Juan J., additional, Cutz, Erika A., additional, Ortegón, Maricruz E., additional, Rivera, María I., additional, Browder, David, additional, Burch, Cortney, additional, Moye, Terri, additional, Bondy, Paul, additional, Browder, Lesley, additional, Manning, Rickey D., additional, Hurst, James W., additional, Sturgeon, Rodney E., additional, Wakefield, Paul H., additional, Kirby, John A., additional, Andersen, James, additional, Fearon, Szheckera, additional, Negron, Rosa, additional, Medina, Amy, additional, Hill, John M., additional, Rajasekhar, Vivek, additional, Williams, Hayes, additional, Cade, LaShondra, additional, Fouts, Rhodna, additional, Moya, Connie, additional, Anderson, Corey G., additional, Devine, Naomi, additional, Ramsey, James, additional, Perez, Ashley, additional, Tatelbaum, David, additional, Jacobs, Michael, additional, Menasche, Kathleen, additional, Mirkil, Vincent, additional, Winkle, Peter J., additional, Haggag, Amina Z., additional, Haynes, Michelle, additional, Villegas, Marysol, additional, Raja, Sabina, additional, Riesenberg, Robert, additional, Plavin, Stanford, additional, Lerman, Mark, additional, Woodside, Leana, additional, Johnson, Maria, additional, Healy, C. Mary, additional, Whitaker, Jennifer A., additional, Keitel, Wendy A., additional, Atmar, Robert L., additional, Horwith, Gary, additional, Mason, Robin, additional, Johnson, Lisa, additional, Dora, Tambra, additional, Murray, Deborah, additional, Ledbetter, Logan, additional, Ewing, Beverly, additional, Stephenson, Kathryn E., additional, Tan, Chen S., additional, Zash, Rebecca, additional, Ansel, Jessica L., additional, Jaegle, Kate, additional, Guiney, Caitlin J., additional, Henderson, Jeffrey A., additional, O'Leary, Marcia, additional, Enright, Kendra, additional, Kessler, Jill, additional, Ducheneaux, Pete, additional, Inniss, Asha, additional, Brandon, Donald M., additional, Davis, William B., additional, Lawler, Daniel T., additional, Oppong, Yaa D., additional, Starr, Ryan P., additional, Syndergaard, Scott N., additional, Shelly, Rozeli, additional, Majumder, Mashrur Islam, additional, Sugimoto, Danny, additional, Dugas, Jeffrey, additional, Rijos, Dolores, additional, Shelton, Sandra, additional, Hong, Stephan, additional, Schwartz, Howard, additional, Sanchez-Crespo, Nelia, additional, Schwartz, Jennifer, additional, Piedra, Terry, additional, Corral, Barbara, additional, Medina, Carmen, additional, Dever, Michael E., additional, Shah, Mitul, additional, Delgado, Michael, additional, Scott, Tameika, additional, Usdan, Lisa S., additional, McGill, Lora J., additional, Arnold, Valerie K., additional, Scatamacchia, Carolyn, additional, Anthony, Codi M., additional, Merchant, Rajan, additional, Yoon, Anelgine C., additional, Hill, Janet, additional, Ng-Price, Lucy, additional, Thompson-Seim, Teri, additional, Ackerman, Ronald, additional, Ackerman, Jamie, additional, Aristy, Florida, additional, Ketter, Nzeera, additional, Finley, Jon, additional, Stull, Mildred, additional, Murray, Monica, additional, Rizvi, Zainab, additional, Guerrero, Sonia, additional, Paliwal, Yogesh K., additional, Paliwal, Amit, additional, Gordon, Sarah, additional, Gordon, Bryan, additional, Montano-Pereira, Cynthia, additional, Galloway, Christopher, additional, Montros, Candice, additional, Aleman, Lily, additional, Shairi, Samira, additional, Van Ever, Wesley, additional, Freeman, George H., additional, Harmon, Esther L., additional, Cross, Marshall A., additional, Sales, Kacie, additional, Gular, Catherine Q., additional, Hepburn, Matthew, additional, Alderson, Nathan, additional, Harshell, Shana, additional, Mahgoub, Siham, additional, Maxwell, Celia, additional, Mellman, Thomas, additional, Thompson, Karl M., additional, Wortman, Glenn, additional, Kingsley, Jeff, additional, Pixler, April, additional, Curry, LaKondria, additional, Afework, Sarah, additional, Swanson, Austin, additional, Jacqmein, Jeffry, additional, Bowers, Maggie, additional, Robison, Dawn, additional, Mosteller, Victoria, additional, Garvey, Janet, additional, Easley, Mary, additional, Kurnat, Rebecca J., additional, Cornelison, Raymond, additional, Gower, Shanda, additional, Schnitz, William, additional, Heinzig-Cartwright, Destiny S., additional, Lewis, Derek, additional, Newton, Fred E., additional, Duhart, Aeiress, additional, Watkins, Breanz, additional, Ball, Brandy, additional, York, Jill, additional, Pickle, Shelby, additional, Musante, David B., additional, Silver, William P., additional, Belhorn, Linda R., additional, Viens, Nicholas A., additional, Dellaero, David, additional, Patel, Priti, additional, Lisec, Kendra, additional, Safirstein, Beth, additional, Zapata, Luz, additional, Gonzalez, Lazaro, additional, Quevedo, Evelyn, additional, Irani, Farah, additional, Grillo, Joseph, additional, Potts, Amy, additional, White, Julie, additional, Flume, Patrick, additional, Headden, Gary, additional, Taylor, Brandie, additional, Warden, Ashley, additional, Chamberlain, Amy, additional, Jeanfreau, Robert, additional, Jeanfreau, Susan, additional, Matherne, Paul G., additional, Caldwell, Amy, additional, Stahl, Jessica, additional, Vowell, Mandy, additional, Newhouse, Lauren, additional, Berthaud, Vladimir, additional, Takizala, Zudi-Mwak, additional, Beninati, Genevieve, additional, Snell, Kimberly, additional, Baker, Sherrie, additional, Walker, James, additional, Harrison, Tavane, additional, Miller, Meagan, additional, Otto, Janet, additional, Gray, Roni, additional, Wilson, Christine, additional, Nemecek, Tiffany, additional, Harrington, Hannah, additional, Eppenbach, Sally, additional, Bourgeois, Tana, additional, Folsom, Lyndsea, additional, Holt, Gregory, additional, Mirsaeidi, Mehdi, additional, Calderon, Rafael, additional, Lichtenberger, Paola, additional, Quintero, Jalima, additional, Martinez, Becky, additional, Immergluck, Lilly, additional, Johnson, Erica, additional, Chan, Austin, additional, Fas, Norberto, additional, Thomas-Seaton, LaTeshia, additional, Khizer, Saadia, additional, Staben, Jonathan, additional, Beresnev, Tatiana, additional, Jahromi, Maryam, additional, Marovich, Mary A., additional, Hutter, Julia, additional, Nason, Martha, additional, Ledgerwood, Julie, additional, Mascola, John, additional, Leibowitz, Mark, additional, Morales, Fernanda, additional, Delgado, Mike, additional, Sanchez, Rosario, additional, Vega, Norma, additional, Áñez, Germán, additional, Albert, Gary, additional, Coston, Erin, additional, Desai, Chinar, additional, Dunbar, Haoua, additional, Eickhoff, Mark, additional, Garcia, Jenina, additional, Kautz, Margaret, additional, Lee, Angela, additional, Lewis, Maggie, additional, McGarry, Alice, additional, McKnight, Irene, additional, Nelson, Joy, additional, Newingham, Patrick, additional, Price-Abbott, Patty, additional, Reed, Patty, additional, Vegas, Diana, additional, Wilkinson, Bethanie, additional, Smith, Katherine, additional, Woo, Wayne, additional, Cho, Iksung, additional, Glenn, Gregory M., additional, Dubovsky, Filip, additional, Fried, David L., additional, Haughey, Lynne A., additional, Stanton, Ariana C., additional, Rameaka, Lisa Stevens, additional, Rosenberg, David, additional, Tomatsu, Lee, additional, Gonzalez, Viviana, additional, Manalo, Millie, additional, Grunstra, Bernard, additional, Quinn, Donald, additional, Claybrook, Phillip, additional, Olds, Shelby, additional, Dye, Amy, additional, Cannon, Kevin D., additional, Chadwick, Mesha M., additional, Jordan, Bailey, additional, Hussey, Morgan, additional, Nevarez, Hannah, additional, Kelley, Colleen F., additional, Chung, Michael, additional, Moran, Caitlin, additional, Rebolledo, Paulina, additional, Bacher, Christina, additional, Barranco-Santana, Elizabeth, additional, Rodriguez, Jessica, additional, Mendoza, Rafael, additional, Ruperto, Karen, additional, Olivieri, Odette, additional, Ocaña, Enrique, additional, Wylie, Paul E., additional, Henderson, Renea, additional, Jenson, Natasa, additional, Yang, Fan, additional, Kelley, Amy, additional, Finkelstein, Kenneth, additional, Beckmann, David, additional, Hutchins, Tanya, additional, Escallon, Sebastian Garcia, additional, Johnson, Kristen, additional, Sligh, Teresa S., additional, Desai, Parul, additional, Huynh, Vincent, additional, Lopez, Carlos, additional, Mendoza, Erika, additional, Adelglass, Jeffrey, additional, Naifeh, Jerome G., additional, Kucera, Kristine J., additional, Chughtai, Waseem, additional, Jaffer, Shireen H., additional, Davis, Matthew G., additional, Foley, Jennifer, additional, Burgett, Michelle L., additional, Shlotzhauer, Tammi L., additional, Ingalsbe-Geno, Sarah M., additional, Duncanson, Daniel, additional, Kush, Kelly, additional, Nesbitt, Lori, additional, Sonnier, Cora, additional, McCarter, Jennifer, additional, Butcher, Michael B., additional, Fry, James, additional, Percy, Donna, additional, Freudemann, Karen, additional, Gebhardt, Bruce C., additional, Mangu, Padma N., additional, Schroeck, Debra B., additional, Davit, Rajesh K., additional, Hennekes, Gayle D., additional, Luft, Benjamin J., additional, Carr, Melissa, additional, Nachman, Sharon, additional, Pellecchia, Alison, additional, Smith, Candace, additional, Valenti, Bruno, additional, Bermudez, Maria I., additional, Peraita, Noris, additional, Delgado, Ernesto, additional, Arrazcaeta, Alicia, additional, Ramirez, Natalie, additional, Amador, Carmen, additional, Marafioti, Horacio, additional, Dang, Lyly, additional, Clement, Lauren, additional, Berry, Jennifer, additional, Allaw, Mohammed, additional, Geuss, Georgettea, additional, Miles, Chelsea, additional, Bittner, Zachary, additional, Werne, Melody, additional, Calinescu, Cornell, additional, Rodman, Shannon, additional, Rindt, Joshua, additional, Cooksey, Erin, additional, Harrison, Kristina, additional, Cooper, Deanna, additional, Horton, Manisha, additional, Philyaw, Amanda, additional, Jennings, William, additional, Alvarado, Hilario, additional, Baka, Michele, additional, Regalado, Malina, additional, Murray, Linda, additional, Naguib, Sherif, additional, Singletary, Justin, additional, Richmond, Sha-Wanda, additional, Omodele, Sarah, additional, Oppenheim, Emily, additional, Martinez, Reuben, additional, Andriulis, Victoria, additional, Singer, Leonard, additional, Blevins, Jeanne, additional, Thomas, Meagan, additional, Hull, Christine, additional, Pereira, Isabel, additional, Rivero, Gina, additional, Okonya, Tracy, additional, Downing, Frances, additional, Miller, Paulina, additional, Rhee, Margaret, additional, Stapleton, Katherine, additional, Klein, Jeffrey, additional, Hong, Rosamond, additional, Swan, Suzanne, additional, Wahlin, Tami, additional, Bennett, Elizabeth, additional, Salzl, Amy, additional, Phan, Sharine, additional, White, Jewel J., additional, Occhino, Amanda, additional, Paiano, Ruth, additional, McLaughlin, Morgan, additional, Swieboda, Elisa, additional, Garcia-Fragoso, Veronica, additional, Becerra, Maria G., additional, White, Toni, additional, Turley, Christine B., additional, McWilliams, Andrew, additional, Esinhart, Tiffany, additional, Montoya, Natasha, additional, Huskey, Shamika, additional, Paul, Leena, additional, Tashima, Karen, additional, Johnson, Jennie, additional, Neill, Marguerite, additional, Sanchez, Martha, additional, Rybak, Natasha, additional, Mileno, Maria, additional, Cohen, Stuart H., additional, Ruiz, Monica, additional, Boswell, Dean M., additional, Robison, Elizabeth E., additional, Reynolds, Trina L., additional, Neumeister, Sonja, additional, Zorrilla, Carmen D., additional, Rivera, Juana, additional, Ibarra, Jessica, additional, García, Iris, additional, Sierra, Dianca, additional, Ramon, Wanda, additional, Fiorillo, Suzanne, additional, Pitotti, Rebecca, additional, Anderson, Victoria R., additional, Mancilla, Jose Castillo, additional, Le, Nga, additional, Winokur, Patricia L., additional, Ince, Dilek, additional, Hegmann, Theresa, additional, Meier, Jeffrey, additional, Stapleton, Jack, additional, Stulken, Laura, additional, McArthur, Monica, additional, Berry, Andrea, additional, Tapia, Milagritos, additional, Hammershaimb, Elizabeth, additional, Robinson, Toni, additional, MacBryde, Rosa, additional, Kline, Susan, additional, Billings, Joanne L., additional, Cavert, Winston, additional, Forgosh, Les B., additional, Schacker, Timothy W., additional, Bold, Tyler D., additional, Dandachi, Dima, additional, Nelson, Taylor, additional, Bran, Andres, additional, Geiger, Grant, additional, Naqvi, S. Hasan, additional, Florescu, Diana F., additional, Starlin, Richard, additional, Kline, David, additional, Zimmer, Andrea, additional, Abbas, Anum, additional, Wilson, Natasha, additional, Eron, Joseph J., additional, Sciaudone, Michael, additional, Rosengren, A. Lina, additional, Kizer, John S., additional, Rutstein, Sarah E., additional, Bruce, Elizabeth, additional, Espinosa, Claudia, additional, Sanders, Lisa J., additional, Kim, Kami, additional, Casey, Denise, additional, Taylor, Barbara S., additional, Patterson, Thomas, additional, Pinilla, Ruth S., additional, Bullock, Delia, additional, Ponce, Philip, additional, Patterson, Jan, additional, McClelland, R. Scott, additional, Lane, Dakotah C., additional, Wald, Anna, additional, James, Frank, additional, Duke, Elizabeth, additional, Hauge, Kirsten, additional, Heimonen, Jessica, additional, Goecker, Erin A., additional, Fong, Youyi, additional, Kauffman, Carol, additional, Linder, Kathleen, additional, Nofz, Kimberly, additional, McConnell, Andrew, additional, Buynak, Robert J., additional, Webb, Angella, additional, Petty, Taryn, additional, Andree, Stephanie, additional, Sanchez, Erica, additional, Mackey, Nolan, additional, Baudelaire, Clarisse, additional, Dzigiel, Sarah, additional, Marquez, Adrienna, additional, Quillin, Kim, additional, King, Michelle, additional, Abad, Vanessa, additional, Knowles, Jennifer, additional, Waters, Michael, additional, Zepeda, Karla, additional, Coslet, Jordan, additional, Tovar, Dalia, additional, Shaw, Marian E., additional, Turner, Mark A., additional, Huffine, Cory J., additional, Huffine, Esther S., additional, Ake, Julie A., additional, Secord, Elizabeth, additional, McGrath, Eric, additional, Levy, Phillip, additional, Stewart, Brittany, additional, Cromer, Charnell, additional, Walters, Ayanna, additional, Ellsworth, Grant, additional, Greene, Caroline, additional, Galloway, Sarah, additional, Kapadia, Shashi, additional, DeHaan, Elliot, additional, Wilson, Clint, additional, Milligan, Jason, additional, Raley, Danielle, additional, Bocchini, Joseph, additional, McClenathan, Bruce, additional, Hussain, Mary, additional, Lomasney, Evelyn, additional, Hall, Evelyn, additional, Lamberth, Sherry, additional, Schmeck, Christy, additional, Leathers, Vickie, additional, Theodore, Deborah A., additional, Branche, Angela R., additional, Graciaa, Daniel S., additional, Hatlen, Timothy J., additional, Miller, Jacqueline, additional, Sadoff, Jerald, additional, Falsey, Ann R., additional, and Sobieszczyk, Magdalena E., additional

Published
2023
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18. Combined noncanonical NF-[kappa]B agonism and targeted BET bromodomain inhibition reverse HIV latency ex vivo

Author

Falcinelli, Shane D., Peterson, Jackson J., Turner, Anne-Marie W., Irlbeck, David, Read, Jenna, Raines, Samuel L.M., James, Katherine S., Sutton, Cameron, Sanchez, Anthony, Emery, Ann, Sampey, Gavin, Ferris, Robert, Allard, Brigitte, Ghofrani, Simon, Kirchherr, Jennifer L., Baker, Caroline, Kuruc, JoAnn D., Gay, Cynthia L., James, Lindsey I., Wu, Guoxin, Zuck, Paul, Rioja, Inmaculada, Furze, Rebecca C., Prinjha, Rab K., Howell, Bonnie J., Swanstrom, Ronald, Browne, Edward P., Strahl, Brian D., Dunham, Richard M., Archin, Nancie M., and Margolis, David M.

Subjects
Agonists (Biochemistry) -- Research, Immunological research, Virus latency -- Research, Antiviral agents -- Research, Molecular targeted therapy -- Methods, Transcription factors -- Health aspects, HIV infection -- Care and treatment, Health care industry
Abstract

Latency reveRsaI strategies for HIV cure using inhibitor of apoptosis protein (IAP) antagonists (IAPi) induce unprecedented levels of latent reservoir expression without immunotoxicity during suppressive antiretroviral therapy (ART). However, full targeting of the reservoir may require combinatorial approaches. A Jurkat latency model screen for IAPi combination partners demonstrated synergistic latency reveRsaI with bromodomain (BD) and extraterminal domain protein inhibitors (BETi). Mechanistic investigations using CRISPR-CAS9 and single-cell RNA-Seq informed comprehensive ex vivo evaluations of IAPi plus pan-BET, bD-selective BET, or selective BET isoform targeting in [CD4.sup.+] T cells from ART-suppressed donors. IAPi+BETi treatment resulted in striking induction of cell-associated HIV gag RNA, but lesser induction of fully elongated and tat-rev RNA compared with T cell activation-positive controls. IAPi+BETi resulted in HIV protein induction in bulk cultures of [CD4.sup.+] T cells using an ultrasensitive p24 assay, but did not result in enhanced viral outgrowth frequency using a standard quantitative viral outgrowth assay. This study defines HIV transcriptional elongation and splicing as important barriers to latent HIV protein expression following latency reveRsaI, delineates the roles of BET proteins and their BDs in HIV latency, and provides a rationale for exploration of IAPi+BETi in animal models of HIV latency., Introduction HIV cure remains elusive because of latent but replication-competent HIV DNA within host [CD4.sup.+] T cells during long-term suppressive antiretroviral therapy (ART) (1, 2). HIV latency is maintained by [...]

Published
2022
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19. Safety and Immune Responses Following Anti-PD-1 Monoclonal Antibody Infusions in Healthy Persons With Human Immunodeficiency Virus on Antiretroviral Therapy.

Author

Gay, Cynthia L, Bosch, Ronald J, McKhann, Ashley, Cha, Raymond, Morse, Gene D, Wimbish, Chanelle L, Campbell, Danielle M, Moseley, Kendall F, Hendrickx, Steven, Messer, Michael, Benson, Constance A, Overton, Edgar T, Paccaly, Anne, Jankovic, Vladimir, Miller, Elizabeth, Tressler, Randall, Li, Jonathan Z, Kuritzkes, Daniel R, Macatangay, Bernard J C, and Eron, Joseph J

Abstract

Background T cells in people with human immunodeficiency virus (HIV) demonstrate an exhausted phenotype, and HIV-specific CD4+ T cells expressing programmed cell death 1 (PD-1) are enriched for latent HIV, making antibody to PD-1 a potential strategy to target the latent reservoir. Methods This was a phase 1/2, randomized (4:1), double-blind, placebo-controlled study in adults with suppressed HIV on antiretroviral therapy with CD4+ counts ≥350 cells/μL who received 2 infusions of cemiplimab versus placebo. The primary outcome was safety, defined as any grade 3 or higher adverse event (AE) or any immune-related AE (irAE). Changes in HIV-1–specific polyfunctional CD4+ and CD8+ T-cell responses were evaluated. Results Five men were enrolled (median CD4+ count, 911 cells/μL; median age, 51 years); 2 received 1 dose of cemiplimab, 2 received 2 doses, and 1 received placebo. One participant had a probable irAE (thyroiditis, grade 2); another had a possible irAE (hepatitis, grade 3), both after a single low-dose (0.3 mg/kg) infusion. The Safety Monitoring Committee recommended no further enrollment or infusions. All 4 cemiplimab recipients were followed for 48 weeks. No other cemiplimab-related serious AEs, irAEs, or grade 3 or higher AEs occurred. One 2-dose recipient of cemiplimab had a 6.2-fold increase in polyfunctional, Gag-specific CD8+ T-cell frequency with supportive increases in plasma HIV RNA and decreases in total HIV DNA. Conclusions One of 4 participants exhibited increased HIV-1 - specific T-cell responses and transiently increased HIV-1 expression following 2 cemiplimab infusions. The occurrence of irAEs after a single, low dose may limit translating the promising therapeutic results of cemiplimab for cancer to immunotherapeutic and latency reversal strategies for HIV. Clinical Trials Registration. NCT03787095. [ABSTRACT FROM AUTHOR]

Published
2024
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22. Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine

Author

Underwood, Eddie, primary, Dunkle, Lisa M., additional, Madhi, Shabir A., additional, Gay, Cynthia L., additional, Heath, Paul T., additional, Kotloff, Karen L., additional, Smith, Katherine, additional, Chau, Gordon, additional, Galbiati, Shirley, additional, McGarry, Alice, additional, Woo, Wayne, additional, Cho, Iksung, additional, Alves, Katia, additional, Áñez, Germán, additional, Bennett, Chijioke, additional, Shinde, Vivek, additional, Fries, Louis, additional, Mallory, Raburn M., additional, Glenn, Gregory M., additional, and Toback, Seth, additional

Published
2023
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23. Immunogenicity of NVX-CoV2373 in PREVENT-19: A Phase 3, Randomized, Placebo-Controlled Trial in Adults in the United States and Mexico

Author

Áñez, Germán, primary, Kotloff, Karen L, additional, Gay, Cynthia L., additional, Nelson, Joy, additional, Dunbar, Haoua, additional, Cloney-Clark, Shane, additional, McGarry, Alice, additional, Woo, Wayne, additional, Cho, Iksung, additional, Plested, Joyce S., additional, Glenn, Gregory M., additional, and Dunkle, Lisa M., additional

Published
2023
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27. T cells establish and maintain CNS viral infection in HIV-infected humanized mice

Author

Honeycutt, Jenna B., Liao, Baolin, Nixon, Christopher C., Cleary, Rachel A., Thayer, William O., Birath, Shayla L., Swanson, Michael D., Sheridan, Patricia, Zakharova, Oksana, Prince, Francesca, Kuruc, JoAnn, Gay, Cynthia L., Evans, Chris, Eron, Joseph J., Wahl, Angela, and Garcia, J. Victor

Subjects
HIV infections -- Research, Antiretroviral agents -- Dosage and administration, Central nervous system -- Genetic aspects -- Research, Health care industry
Abstract

The human brain is an important site of HIV replication and persistence during antiretroviral therapy (ART). Direct evaluation of HIV infection in the brains of otherwise healthy individuals is not feasible; therefore, we performed a large-scale study of bone marrow/liver/thymus (BLT) humanized mice as an in vivo model to study HIV infection in the brain. Human immune cells, including [CD4.sup.+] T cells and macrophages, were present throughout the BLT mouse brain. HIV DNA, HIV RNA, and/or [p24.sup.+] cells were observed in the brains of HIV-infected animals, regardless of the HIV isolate used. HIV infection resulted in decreased numbers of [CD4.sup.+] T cells, increased numbers of [CD8.sup.+] T cells, and a decreased [CD4.sup.+]/[CD8.sup.+]T cell ratio in the brain. Using humanized T cell-only mice (ToM), we demonstrated that T cells establish and maintain HIV infection of the brain in the complete absence of human myeloid cells. HIV infection of ToM resulted in [CD4.sup.+] T cell depletion and a reduced [CD4.sup.+]/[CD8.sup.+] T cell ratio. ART significantly reduced HIV levels in the BLT mouse brain, and the immune cell populations present were indistinguishable from those of uninfected controls, which demonstrated the effectiveness of ART in controlling HIV replication in the CNS and returning cellular homeostasis to a pre-HIV state., Introduction The advent and widespread use of effective antiretroviral therapy (ART) to treat HIV infection has dramatically curtailed the severity of the neurocognitive impairment previously observed in HIV-infected patients (1). [...]

Published
2018
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28. A Novel Algorithm to Improve PrEP Adherence Monitoring Using Dried Blood Spots

Author

Devanathan, Aaron S., primary, Dumond, Julie B., additional, Anderson, Daijha J.C., additional, Moody, Kristen, additional, Poliseno, Amanda J., additional, Schauer, Amanda P., additional, Sykes, Craig, additional, Gay, Cynthia L., additional, Rosen, Elias P., additional, Kashuba, Angela D.M., additional, and Cottrell, Mackenzie L., additional

Published
2023
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29. NVX-CoV2373 Efficacy in Preventing SARS-CoV-2 Infection in Adolescents

Author

Deming, Meagan, primary, Brown, Elizabeth R., additional, McArthur, Monica A., additional, Schrag, Stephanie J., additional, Arvay, Melissa, additional, Humphrys, Mike, additional, Ravel, Jacques, additional, Adelglass, Jeffrey, additional, Essink, Brandon, additional, Musante, David B., additional, Maguire, Rebecca, additional, Gorman, Richard, additional, Formentini, Elizabeth, additional, Mason, Robin, additional, Robb, Merlin L., additional, Neuzil, Kathleen M., additional, Rapaka, Rekha R., additional, Wolff, Peter, additional, Kotloff, Karen L., additional, Ackerman, Ronald, additional, Barranco, Elizabeth, additional, Chu, Laurence, additional, Cohen, Stuart H., additional, Daly, Wendy, additional, Etokhana, Kenneth, additional, Gay, Cynthia L., additional, Hachigian, Greg, additional, Jeanfreau, Robert, additional, Miller, Vicki E., additional, Seger, William, additional, Sexter, Joanna, additional, Shaw, Marian E., additional, Steil, Kenneth, additional, Turley, Christine B., additional, and Waters, Michael, additional

Published
2023
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31. 1253. Acceptability and feasibility of long-acting injectable antiretroviral therapy for persons who inject drugs in Vietnam: using the Consolidated Framework on Implementation Research to identify determinants and inform implementation strategies

Author

Rutstein, Sarah E, primary, Sibley, Adams L, additional, Nguyen, Trang Thu Do, additional, Tran, Ha Viet, additional, Giang, Le Minh, additional, Sripaipan, Teerada, additional, Nguyen, Minh, additional, Huffstetler, Hanna E, additional, Miller, William C, additional, Eron, Joseph J, additional, Gay, Cynthia L, additional, and Go, Vivian F, additional

Published
2022
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33. Interval dosing with the HDAC inhibitor vorinostat effectively reverses HIV latency

Author

Archin, Nancie M., Kirchherr, Jennifer L., Sung, Julia A.M., Clutton, Genevieve, Sholtis, Katherine, Xu, Yinyan, Allard, Brigitte, Stuelke, Erin, Kashuba, Angela D., Kuruc, Joann D., Eron, Joseph, Gay, Cynthia L., Goonetilleke, Nilu, and Margolis, David M.

Subjects
HIV infections -- Health aspects -- Drug therapy -- Research, Vorinostat -- Dosage and administration, T cells -- Health aspects -- Research, Histones -- Research, Health care industry
Abstract

BACKGROUND. The histone deacetylase (HDAC) inhibitor vorinostat (VOR) can increase HIV RNA expression in vivo within resting [CD4.sup.+] T cells of aviremic HIV+ individuals. However, while studies of VOR or other HDAC inhibitors have reported reversal of latency, none has demonstrated clearance of latent infection. We sought to identify the optimal dosing of VOR for effective serial reversal of HIV latency. METHODS. In a study of 16 HIV-infected, aviremic individuals, we measured resting [CD4.sup.+] T cell-associated HIV RNA ex vivo and in vivo following a single exposure to VOR, and then in vivo after a pair of doses separated by 48 or 72 hours, and finally following a series of 10 doses given at 72-hour intervals. RESULTS. Serial VOR exposures separated by 72 hours most often resulted in an increase in cell-associated HIV RNA within circulating resting [CD4.sup.+] T cells. VOR was well tolerated by all participants. However, despite serial reversal of latency over 1 month of VOR dosing, we did not observe a measurable decrease (>0.3 [log.sub.10]) in the frequency of latent infection within resting [CD4.sup.+] T cells. CONCLUSIONS. These findings outline parameters for the experimental use of VOR to clear latent infection. Latency reversal can be achieved by VOR safely and repeatedly, but effective depletion of persistent HIV infection will require additional advances. In addition to improvements in latency reversal, these advances may include the sustained induction of potent antiviral immune responses capable of recognizing and clearing the rare cells in which HIV latency has been reversed. TRIAL REGISTRATION. Clinicaltrials.gov NCT01319383. FUNDING. NIH grants U01 AI095052, AI50410, and P30 CA016086 and National Center for Advancing Translational Sciences grant KL2 TR001109., Introduction Current approaches to achieve a cure for HIV infection include the administration of latency-reversing agents (LRAs) to induce latently HIV-infected cells to reexpress virions or viral antigens, in concert [...]

Published
2017
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36. Safety, Immunogenicity and Efficacy of NVX-CoV2373 in Adolescents in PREVENT-19: A Randomized, Phase 3 Trial

Author

Áñez, Germán, Dunkle, Lisa M., Gay, Cynthia L., Kotloff, Karen L., Adelglass, Jeffrey M., Essink, Brandon, Campbell, James D., Cloney-Clark, Shane, Zhu, Mingzhu, Plested, Joyce S., Roychoudhury, Pavitra, Greninger, Alexander L., Patel, Nita, McGarry, Alice, Woo, Wayne, Cho, Iksung, Glenn, Gregory M., and Dubovsky, Filip

Subjects
Article
Abstract

BACKGROUNDOver 20% of cases and 0.4% of deaths from Covid-19 occur in children. Following demonstration of safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial enrolled adolescents.METHODSSafety, immunogenicity, and efficacy of NVX-CoV2373 were evaluated in adolescents aged 12 to RESULTSAmong 2,247 participants randomized between April–June 2021, 1,491 were allocated to NVX-CoV2373 and 756 to placebo. Post-vaccination, the ratio of NA geometric mean titers in adolescents compared to young adults was 1.5 (95% confidence interval [CI] 1.3 to 1.7). Twenty Covid-19 cases (all mild) occurred: 6 among NVX-CoV2373 and 14 among placebo recipients (vaccine efficacy [VE]: 79.5%, 95% CI, 46.8 to 92.1). All sequenced viral genomes (11/20) were identified as Delta variant (Delta variant VE: 82.0% [95% CI: 32.4 to 95.2]). Reactogenicity was largely mild-to-moderate, transient, and more frequent in NVX-CoV2373 recipients and after the second dose. Serious adverse events were rare and evenly distributed between treatments.CONCLUSIONSNVX-CoV2373 was safe, immunogenic, and efficacious in the prevention of Covid-19 and those cases caused by the Delta variant in adolescents.(Funded by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health; PREVENT-19 ClinicalTrials.gov number, NCT04611802).

Published
2022

37. Acceptability and feasibility of long-acting injectable antiretroviral therapy for HIV-infected persons who inject drugs in Vietnam: A qualitative study

Author

Rutstein, Sarah E., primary, Sibley, Adams L., additional, Huffstetler, Hanna E., additional, Nguyen, Trang Thu Do, additional, Tran, Ha Viet, additional, Le Minh, Giang, additional, Sripaipan, Teerada, additional, Nguyen, Minh, additional, Miller, William C., additional, Eron, Joseph J., additional, Gay, Cynthia L., additional, and Go, Vivian F., additional

Published
2022
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40. Dual-affinity re-targeting proteins direct T cell-mediated cytolysis of latently HIV-infected cells

Author

Sung, Julia A.M., Pickeral, Joy, Liu, Liqin, Stanfield-Oakley, Sherry A., Lam, Chia-Ying Kao, Garrido, Carolina, Pollara, Justin, LaBranche, Celia, Bonsignori, Mattia, Moody, M. Anthony, Yang, Yinhua, Parks, Robert, Archin, Nancie, Allard, Brigitte, Kirchherr, Jennifer, Kuruc, JoAnn D., Gay, Cynthia L., Cohen, Myron S., Ochsenbauer, Christina, Soderberg, Kelly, Liao, Hua-Xin, Montefiori, David, Moore, Paul, Johnson, Syd, Koenig, Scott, Haynes, Barton F., Nordstrom, Jeffrey L., Margolis, David M., and Ferrari, Guido

Subjects
T cells -- Genetic aspects, Viral proteins -- Properties, Immune response -- Regulation, HIV infection -- Genetic aspects -- Development and progression, Health care industry
Abstract

Enhancement of HIV-specific Immunity Is likely required to eliminate latent HIV Infection. Here, we have developed an Immunotherapeutic modality aimed to improve T cell-mediated clearance of HIV-1-infected cells. Specifically, we employed Dual-Affinity Re-Targeting (DART) proteins, which are bispecific, antibody-based molecules that can bind 2 distinct cell-surface molecules simultaneously. We designed DARTs with a monovalent HIV-1 envelope-binding (Env-binding) arm that was derived from broadly binding, antibody-dependent cellular cytotoxicity-mediating antibodies known to bind to HIV- infected target cells coupled to a monovalent CD3 binding arm designed to engage cytolytic effector T cells (referred to as HIVxCD3 DARTs). Thus, these DARTs redirected polyclonal T cells to specifically engage with and kill Env-expressing cells, including [CD4.sup.+] T cells infected with different HIV-1 subtypes, thereby obviating the requirement for HIV- specific immunity. Using lymphocytes from patients on suppressive antiretroviral therapy (ART), we demonstrated that DARTs mediate [CD8.sup.+] T cell clearance of [CD4.sup.+] T cells that are superinfected with the HIV-1 strain JR-CSF or infected with autologous reservoir viruses isolated from HIV-infected-patient resting [CD4.sup.+] T cells. Moreover, DARTs mediated [CD8.sup.+] T cell clearance of HIV from resting [CD4.sup.+] T cell cultures following induction of latent virus expression. Combined with HIV latency reversing agents, HIVxCD3 DARTs have the potential to be effective immunotherapeutic agents to clear latent HIV-1 reservoirs in HIV-infected individuals., Introduction The inability of antiretroviral therapy (ART) to eradicate HIV was first suggested by the demonstration of latent infection of resting [CD4.sup.+] T cells (1) and then by the recovery [...]

Published
2015
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41. Combined noncanonical NF-κB agonism and targeted BET bromodomain inhibition reverse HIV latency ex vivo

Author

Falcinelli, Shane D., primary, Peterson, Jackson J., additional, Turner, Anne-Marie W., additional, Irlbeck, David, additional, Read, Jenna, additional, Raines, Samuel L.M., additional, James, Katherine S., additional, Sutton, Cameron, additional, Sanchez, Anthony, additional, Emery, Ann, additional, Sampey, Gavin, additional, Ferris, Robert, additional, Allard, Brigitte, additional, Ghofrani, Simon, additional, Kirchherr, Jennifer L., additional, Baker, Caroline, additional, Kuruc, JoAnn D., additional, Gay, Cynthia L., additional, James, Lindsey I., additional, Wu, Guoxin, additional, Zuck, Paul, additional, Rioja, Inmaculada, additional, Furze, Rebecca C., additional, Prinjha, Rab K., additional, Howell, Bonnie J., additional, Swanstrom, Ronald, additional, Browne, Edward P., additional, Strahl, Brian D., additional, Dunham, Richard M., additional, Archin, Nancie M., additional, and Margolis, David M., additional

Published
2022
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49. Screening Yield of HIV Antigen/Antibody Combination and Pooled HIV RNA Testing for Acute HIV Infection in a High-Prevalence Population

Author

Peters, Philip J., Westheimer, Emily, Cohen, Stephanie, Hightow-Weidman, Lisa B., Moss, Nicholas, Tsoi, Benjamin, Hall, Laura, Fann, Charles, Daskalakis, Demetre C., Beagle, Steve, Patel, Pragna, Radix, Asa, Foust, Evelyn, Kohn, Robert P., Marmorino, Jenni, Pandori, Mark, Fu, Jie, Samandari, Taraz, and Gay, Cynthia L.

Published
2016
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50. Stable Latent HIV Infection and Low-level Viremia Despite Treatment With the Broadly Neutralizing Antibody VRC07-523LS and the Latency Reversal Agent Vorinostat

Author

Gay, Cynthia L, primary, James, Katherine S, additional, Tuyishime, Marina, additional, Falcinelli, Shane D, additional, Joseph, Sarah B, additional, Moeser, Matthew J, additional, Allard, Brigitte, additional, Kirchherr, Jennifer L, additional, Clohosey, Matthew, additional, Raines, Samuel L M, additional, Montefiori, David C, additional, Shen, Xiaoying, additional, Gorelick, Robert J, additional, Gama, Lucio, additional, McDermott, Adrian B, additional, Koup, Richard A, additional, Mascola, John R, additional, Floris-Moore, Michelle, additional, Kuruc, JoAnn D, additional, Ferrari, Guido, additional, Eron, Joseph J, additional, Archin, Nancie M, additional, and Margolis, David M, additional

Published
2021
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