1,595 results on '"Baden, Lindsey R."'
Search Results
2. Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases
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Baden, Lindsey R., El Sahly, Hana M., Essink, Brandon, Follmann, Dean, Hachigian, Gregory, Strout, Cynthia, Overcash, J. Scott, Doblecki-Lewis, Susanne, Whitaker, Jennifer A., Anderson, Evan J., Neuzil, Kathleen, Corey, Lawrence, Priddy, Frances, Tomassini, Joanne E., Brown, Mollie, Girard, Bethany, Stolman, Dina, Urdaneta, Veronica, Wang, Xiaowei, Deng, Weiping, Zhou, Honghong, Dixit, Avika, Das, Rituparna, and Miller, Jacqueline M.
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- 2024
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3. Immune profiling of age and adjuvant-specific activation of human blood mononuclear cells in vitro
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Schüller, Simone S., Barman, Soumik, Mendez-Giraldez, Raul, Soni, Dheeraj, Daley, John, Baden, Lindsey R., Levy, Ofer, and Dowling, David J.
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- 2024
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4. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials
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Axfors, Cathrine, Schmitt, Andreas M., Janiaud, Perrine, van’t Hooft, Janneke, Abd-Elsalam, Sherief, Abdo, Ehab F., Abella, Benjamin S., Akram, Javed, Amaravadi, Ravi K., Angus, Derek C., Arabi, Yaseen M., Azhar, Shehnoor, Baden, Lindsey R., Baker, Arthur W., Belkhir, Leila, Benfield, Thomas, Berrevoets, Marvin A. H., Chen, Cheng-Pin, Chen, Tsung-Chia, Cheng, Shu-Hsing, Cheng, Chien-Yu, Chung, Wei-Sheng, Cohen, Yehuda Z., Cowan, Lisa N., Dalgard, Olav, de Almeida e Val, Fernando F., de Lacerda, Marcus V. G., de Melo, Gisely C., Derde, Lennie, Dubee, Vincent, Elfakir, Anissa, Gordon, Anthony C., Hernandez-Cardenas, Carmen M., Hills, Thomas, Hoepelman, Andy I. M., Huang, Yi-Wen, Igau, Bruno, Jin, Ronghua, Jurado-Camacho, Felipe, Khan, Khalid S., Kremsner, Peter G., Kreuels, Benno, Kuo, Cheng-Yu, Le, Thuy, Lin, Yi-Chun, Lin, Wu-Pu, Lin, Tse-Hung, Lyngbakken, Magnus Nakrem, McArthur, Colin, McVerry, Bryan J., Meza-Meneses, Patricia, Monteiro, Wuelton M., Morpeth, Susan C., Mourad, Ahmad, Mulligan, Mark J., Murthy, Srinivas, Naggie, Susanna, Narayanasamy, Shanti, Nichol, Alistair, Novack, Lewis A., O’Brien, Sean M., Okeke, Nwora Lance, Perez, Léna, Perez-Padilla, Rogelio, Perrin, Laurent, Remigio-Luna, Arantxa, Rivera-Martinez, Norma E., Rockhold, Frank W., Rodriguez-Llamazares, Sebastian, Rolfe, Robert, Rosa, Rossana, Røsjø, Helge, Sampaio, Vanderson S., Seto, Todd B., Shahzad, Muhammad, Soliman, Shaimaa, Stout, Jason E., Thirion-Romero, Ireri, Troxel, Andrea B., Tseng, Ting-Yu, Turner, Nicholas A., Ulrich, Robert J., Walsh, Stephen R., Webb, Steve A., Weehuizen, Jesper M., Velinova, Maria, Wong, Hon-Lai, Wrenn, Rebekah, Zampieri, Fernando G., Zhong, Wu, Moher, David, Goodman, Steven N., Ioannidis, John P. A., and Hemkens, Lars G.
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- 2024
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5. Features of acute COVID-19 associated with post-acute sequelae of SARS-CoV-2 phenotypes: results from the IMPACC study
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Ozonoff, Al, Jayavelu, Naresh Doni, Liu, Shanshan, Melamed, Esther, Milliren, Carly E., Qi, Jingjing, Geng, Linda N., McComsey, Grace A., Cairns, Charles B., Baden, Lindsey R., Schaenman, Joanna, Shaw, Albert C., Samaha, Hady, Seyfert-Margolis, Vicki, Krammer, Florian, Rosen, Lindsey B., Steen, Hanno, Syphurs, Caitlin, Dandekar, Ravi, Shannon, Casey P., Sekaly, Rafick P., Ehrlich, Lauren I. R., Corry, David B., Kheradmand, Farrah, Atkinson, Mark A., Brakenridge, Scott C., Higuita, Nelson I. Agudelo, Metcalf, Jordan P., Hough, Catherine L., Messer, William B., Pulendran, Bali, Nadeau, Kari C., Davis, Mark M., Sesma, Ana Fernandez, Simon, Viviana, van Bakel, Harm, Kim-Schulze, Seunghee, Hafler, David A., Levy, Ofer, Kraft, Monica, Bime, Chris, Haddad, Elias K., Calfee, Carolyn S., Erle, David J., Langelier, Charles R., Eckalbar, Walter, Bosinger, Steven E., Peters, Bjoern, Kleinstein, Steven H., Reed, Elaine F., Augustine, Alison D., Diray-Arce, Joann, Maecker, Holden T., Altman, Matthew C., Montgomery, Ruth R., Becker, Patrice M., and Rouphael, Nadine
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- 2024
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6. IgM N-glycosylation correlates with COVID-19 severity and rate of complement deposition
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Ozonoff, Al, Ehrlich, Lauren IR, Melamed, Esther, Sesma, Ana Fernandez, Simon, Viviana, Pulendran, Bali, Nadeau, Kari C, Davis, Mark M, McCoey, Grace A, Sekaly, Rafick, Baden, Lindsey R, Levy, Ofer, Schaenman, Joanna, Reed, Elaine F, Shaw, Albert C, Hafler, David A, Montgomery, Ruth R, Kleinstein, Steven H, Becker, Patrice M, Augustine, Alison D, Calfee, Carolyn S, Erle, David J, DeBakey, Michael E, Corry, David B, Kheradmand, Farrah, Atkinson, Mark A, Brakenridge, Scott C, Higuita, Nelson I Agudelo, Metcalf, Jordan P, Hough, Catherine L, Messer, William B, Kraft, Monica, Bime, Chris, Peters, Bjoern, Milliren, Carly E, Syphurs, Caitlin, McEnaney, Kerry, Barton, Brenda, Lentucci, Claudia, Saluvan, Mehmet, Chang, Ana C, Hoch, Annmarie, Albert, Marisa, Shaheen, Tanzia, Kho, Alvin T, Liu, Shanshan, Thomas, Sanya, Chen, Jing, Murphy, Maimouna D, Cooney, Mitchell, Hayati, Arash Nemati, Bryant, Robert, Abraham, James, Jayavelu, Naresh Doni, Presnell, Scott, Jancsyk, Tomasz, Maguire, Cole, Qi, Jingjing, Lee, Brian, Fourati, Slim, Esserman, Denise A, Guan, Leying, Gygi, Jeremy, Pawar, Shrikant, Brito, Anderson, Fragiadakis, Gabriela K, Patel, Ravi, Overton, James A, Vita, Randi, Westendorf, Kerstin, Shannon, Casey P, Tebbutt, Scott J, Thyagarajan, Rama V, Rousseau, Justin F, Wylie, Dennis, Triplett, Todd A, Kojic, Erna, Chinthrajah, Sharon, Ahuja, Neera, Rogers, Angela J, Artandi, Maja, Geng, Linda, Yendewa, George, Powell, Debra L, Kim, James N, Simmons, Brent, Goonewardene, I Michael, Smith, Cecilia M, Martens, Mark, Sherman, Amy C, Walsh, Stephen R, Issa, Nicolas C, Salehi-Rad, Ramin, Dela Cruz, Charles, Farhadian, Shelli, Iwasaki, Akiko, Ko, Albert I, Anderson, Evan J, Mehta, Aneesh K, and Sevransky, Jonathan E
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Biological Sciences ,Biomedical and Clinical Sciences ,Immunology ,Coronaviruses ,Infectious Diseases ,Emerging Infectious Diseases ,Lung ,Inflammatory and immune system ,Good Health and Well Being ,Humans ,COVID-19 ,Glycosylation ,SARS-CoV-2 ,Glycosyltransferases ,Complement System Proteins ,Immunoglobulin M ,IMPACC Network - Abstract
The glycosylation of IgG plays a critical role during human severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, activating immune cells and inducing cytokine production. However, the role of IgM N-glycosylation has not been studied during human acute viral infection. The analysis of IgM N-glycosylation from healthy controls and hospitalized coronavirus disease 2019 (COVID-19) patients reveals increased high-mannose and sialylation that correlates with COVID-19 severity. These trends are confirmed within SARS-CoV-2-specific immunoglobulin N-glycan profiles. Moreover, the degree of total IgM mannosylation and sialylation correlate significantly with markers of disease severity. We link the changes of IgM N-glycosylation with the expression of Golgi glycosyltransferases. Lastly, we observe antigen-specific IgM antibody-dependent complement deposition is elevated in severe COVID-19 patients and modulated by exoglycosidase digestion. Taken together, this work links the IgM N-glycosylation with COVID-19 severity and highlights the need to understand IgM glycosylation and downstream immune function during human disease.
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- 2024
7. Risk of COVID-19 after natural infection or vaccination
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Rick, Anne-Marie, Laurens, Matthew B, Huang, Ying, Yu, Chenchen, Martin, Thomas CS, Rodriguez, Carina A, Rostad, Christina A, Maboa, Rebone M, Baden, Lindsey R, Sahly, Hana M El, Grinsztejn, Beatriz, Gray, Glenda E, Gay, Cynthia L, Gilbert, Peter B, Janes, Holly E, Kublin, James G, Huang, Yunda, Leav, Brett, Hirsch, Ian, Struyf, Frank, Dunkle, Lisa M, Neuzil, Kathleen M, Corey, Lawrence, Goepfert, Paul A, Walsh, Stephen R, Follmann, Dean, Kotloff, Karen L, Adams, Atoya, Miller, Eric, Rankin, Bruce G, Shinn, Steven, Nash, Marshall, Green, Sinikka L, Jacobsen, Colleen, Krishnankutty, Jayasree, Phungwayo, Sikhongi, Glover, Richard M, 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, Hachigian, Greg, Oshita, Masaru, Cancilla, Michael, Kiersey, Kristen, Seger, William, Antwi, Mohammed, Green, Allison, Kim, Anthony, Desjardins, Michael, Johnson, Jennifer A, Sherman, Amy, 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, and McClennen, Rachael
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Biomedical and Clinical Sciences ,Clinical Sciences ,Vaccine Related ,Biotechnology ,Prevention ,Clinical Trials and Supportive Activities ,Immunization ,Clinical Research ,Emerging Infectious Diseases ,Infectious Diseases ,Coronaviruses ,6.1 Pharmaceuticals ,3.4 Vaccines ,Infection ,Good Health and Well Being ,Humans ,COVID-19 ,COVID-19 Vaccines ,Pandemics ,SARS-CoV-2 ,United States ,Vaccination ,Natural infection ,Hybrid immunity ,NIAID-funded COVID-19 Prevention Network ,natural infection ,hybrid immunity ,vaccination ,Public Health and Health Services ,Clinical sciences ,Epidemiology - Abstract
BackgroundWhile vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection.MethodsIn this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7-15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures.FindingsPrevious infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05-0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01-0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease.InterpretationPrevious infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection.FundingNational Institutes of Health.
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- 2023
8. Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.
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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
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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.
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- 2023
9. Multi-omic longitudinal study reveals immune correlates of clinical course among hospitalized COVID-19 patients
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Diray-Arce, Joann, Fourati, Slim, Jayavelu, Naresh Doni, Patel, Ravi, Maguire, Cole, Chang, Ana C, Dandekar, Ravi, Qi, Jingjing, Lee, Brian H, van Zalm, Patrick, Schroeder, Andrew, Chen, Ernie, Konstorum, Anna, Brito, Anderson, Gygi, Jeremy P, Kho, Alvin, Chen, Jing, Pawar, Shrikant, Gonzalez-Reiche, Ana Silvia, Hoch, Annmarie, Milliren, Carly E, Overton, James A, Westendorf, Kerstin, Network, IMPACC, Abraham, James, Adkisson, Michael, Albert, Marisa, Torres, Luz Altamirano, Alvarenga, Bonny, Anderson, Matthew L, Anderson, Evan J, Arnett, Azlann, Asashima, Hiromitsu, Atkinson, Mark A, Baden, Lindsey R, Barton, Brenda, Beach, Katherine, Beagle, Elizabeth, Becker, Patrice M, Bell, Matthew R, Bernui, Mariana, Bime, Chris, Kumar, Arun Boddapati, Booth, Leland J, Borresen, Brittney, Brakenridge, Scott C, Bristow, Laurel, Bryant, Robert, Calfee, Carolyn S, Manuel, Juan Carreño, Carrillo, Sidney, Chak, Suzanna, Chang, Iris, Connors, Jennifer, Conway, Michelle, Corry, David B, Cowan, David, Croen, Brett, Dela Cruz, Charles S, Cusimano, Gina, Eaker, Lily, Edwards, Carolyn, Ehrlich, Lauren IR, Elashoff, David, Erickson, Heidi, Erle, David J, Farhadian, Shelli, Farrugia, Keith, Fatou, Benoit, Fernandes, Andrea, Fernandez-Sesma, Ana, Fragiadakis, Gabriela K, Furukawa, Sara, Geltman, Janelle N, Ghale, Rajani, Bermúdez, Maria González Carolina, Goonewardene, Michael I, Sanchez, Estella Guerrero, Guirgis, Faheem W, Hafler, David A, Hamilton, Sydney, Harris, Paul, Nemati, Arash Hayati, Hendrickson, Carolyn M, Agudelo, Nelson I Higuita, Hodder, Thomas, Holland, Steven M, Hough, Catherine L, Huerta, Christopher, Hurley, Kerin C, Hutton, Scott R, Iwasaki, Akiko, Jauregui, Alejandra, Jha, Meenakshi, Johnson, Brandi, Joyner, David, Kangelaris, Kirsten N, Kelly, Geoffrey, Khalil, Zain, and Khan, Zenab
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Biomedical and Clinical Sciences ,Immunology ,Infectious Diseases ,Coronaviruses ,Clinical Research ,Human Genome ,Genetics ,Precision Medicine ,Lung ,Emerging Infectious Diseases ,4.1 Discovery and preclinical testing of markers and technologies ,Inflammatory and immune system ,Good Health and Well Being ,Humans ,COVID-19 ,SARS-CoV-2 ,Longitudinal Studies ,Multiomics ,Disease Progression ,IMPACC Network ,immunophenotyping ,longitudinal modeling ,multi-omics ,systems immunology ,Biomedical and clinical sciences - Abstract
The IMPACC cohort, composed of >1,000 hospitalized COVID-19 participants, contains five illness trajectory groups (TGs) during acute infection (first 28 days), ranging from milder (TG1-3) to more severe disease course (TG4) and death (TG5). Here, we report deep immunophenotyping, profiling of >15,000 longitudinal blood and nasal samples from 540 participants of the IMPACC cohort, using 14 distinct assays. These unbiased analyses identify cellular and molecular signatures present within 72 h of hospital admission that distinguish moderate from severe and fatal COVID-19 disease. Importantly, cellular and molecular states also distinguish participants with more severe disease that recover or stabilize within 28 days from those that progress to fatal outcomes (TG4 vs. TG5). Furthermore, our longitudinal design reveals that these biologic states display distinct temporal patterns associated with clinical outcomes. Characterizing host immune responses in relation to heterogeneity in disease course may inform clinical prognosis and opportunities for intervention.
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- 2023
10. 2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases
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Bass, Anne R, Chakravarty, Eliza, Akl, Elie A, Bingham, Clifton O, Calabrese, Leonard, Cappelli, Laura C, Johnson, Sindhu R, Imundo, Lisa F, Winthrop, Kevin L, Arasaratnam, Reuben J, Baden, Lindsey R, Berard, Roberta, Bridges, S Louis, Cheah, Jonathan TL, Curtis, Jeffrey R, Ferguson, Polly J, Hakkarinen, Ida, Onel, Karen B, Schultz, Grayson, Sivaraman, Vidya, Smith, Benjamin J, Sparks, Jeffrey A, Vogel, Tiphanie P, Williams, Eleanor Anderson, Calabrese, Cassandra, Cunha, Joanne S, Fontanarosa, Joann, Gillispie‐Taylor, Miriah C, Gkrouzman, Elena, Iyer, Priyanka, Lakin, Kimberly S, Legge, Alexandra, Lo, Mindy S, Lockwood, Megan M, Sadun, Rebecca E, Singh, Namrata, Sullivan, Nancy, Tam, Herman, Turgunbaev, Marat, Turner, Amy S, and Reston, James
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Biomedical and Clinical Sciences ,Clinical Sciences ,Autoimmune Disease ,Immunization ,Prevention ,Vaccine Related ,3.4 Vaccines ,Prevention of disease and conditions ,and promotion of well-being ,Good Health and Well Being ,Child ,Humans ,United States ,Rheumatology ,Antirheumatic Agents ,Musculoskeletal Diseases ,Vaccination - Abstract
ObjectiveTo provide evidence-based recommendations on the use of vaccinations in children and adults with rheumatic and musculoskeletal diseases (RMDs).MethodsThis guideline follows American College of Rheumatology (ACR) policy guiding management of conflicts of interest and disclosures and the ACR guideline development process, which includes the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. It also adheres to the Appraisal of Guidelines for Research and Evaluation (AGREE) criteria. A core leadership team consisting of adult and pediatric rheumatologists and a guideline methodologist drafted clinical population, intervention, comparator, outcomes (PICO) questions. A review team performed a systematic literature review for the PICO questions, graded the quality of evidence, and produced an evidence report. An expert Voting Panel reviewed the evidence and formulated recommendations. The panel included adult and pediatric rheumatology providers, infectious diseases specialists, and patient representatives. Consensus required ≥70% agreement on both the direction and strength of each recommendation.ResultsThis guideline includes expanded indications for some vaccines in patients with RMDs, as well as guidance on whether to hold immunosuppressive medications or delay vaccination to maximize vaccine immunogenicity and efficacy. Safe approaches to the use of live attenuated vaccines in patients taking immunosuppressive medications are also addressed. Most recommendations are conditional and had low quality of supporting evidence.ConclusionApplication of these recommendations should consider patients' individual risk for vaccine-preventable illness and for disease flares, particularly if immunosuppressive medications are held for vaccination. Shared decision-making with patients is encouraged in clinical settings.
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- 2023
11. Stochastic Interventional Vaccine Efficacy and Principal Surrogate Analyses of Antibody Markers as Correlates of Protection against Symptomatic COVID-19 in the COVE mRNA-1273 Trial
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Huang, Ying, Hejazi, Nima S, Blette, Bryan, Carpp, Lindsay N, Benkeser, David, Montefiori, David C, McDermott, Adrian B, Fong, Youyi, Janes, Holly E, Deng, Weiping, Zhou, Honghong, Houchens, Christopher R, Martins, Karen, Jayashankar, Lakshmi, Flach, Britta, Lin, Bob C, O’Connell, Sarah, McDanal, Charlene, Eaton, Amanda, Sarzotti-Kelsoe, Marcella, Lu, Yiwen, Yu, Chenchen, Kenny, Avi, Carone, Marco, Huynh, Chuong, Miller, Jacqueline, Sahly, Hana M El, Baden, Lindsey R, Jackson, Lisa A, Campbell, Thomas B, Clark, Jesse, Andrasik, Michele P, Kublin, James G, Corey, Lawrence, Neuzil, Kathleen M, Pajon, Rolando, Follmann, Dean, Donis, Ruben O, Koup, Richard A, Gilbert, Peter B, Assays, on behalf of the Immune, Moderna, Inc, Efficacy, Coronavirus Vaccine Prevention Network Coronavirus, and Teams, Government CoVPN Biostatistics
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Microbiology ,Biological Sciences ,Infectious Diseases ,Biotechnology ,Vaccine Related ,Emerging Infectious Diseases ,Immunization ,Coronaviruses ,Good Health and Well Being ,Humans ,2019-nCoV Vaccine mRNA-1273 ,Antibodies ,Neutralizing ,Antibodies ,Viral ,COVID-19 ,Immunoglobulin G ,Vaccine Efficacy ,binding antibody assay ,immune correlates of protection ,modified treatment policy ,neutralizing antibody assay ,principal stratification ,principal surrogate ,SARS-CoV-2 ,stochastic intervention ,stochastic interventional vaccine efficacy - Abstract
The COVE trial randomized participants to receive two doses of mRNA-1273 vaccine or placebo on Days 1 and 29 (D1, D29). Anti-SARS-CoV-2 Spike IgG binding antibodies (bAbs), anti-receptor binding domain IgG bAbs, 50% inhibitory dilution neutralizing antibody (nAb) titers, and 80% inhibitory dilution nAb titers were measured at D29 and D57. We assessed these markers as correlates of protection (CoPs) against COVID-19 using stochastic interventional vaccine efficacy (SVE) analysis and principal surrogate (PS) analysis, frameworks not used in our previous COVE immune correlates analyses. By SVE analysis, hypothetical shifts of the D57 Spike IgG distribution from a geometric mean concentration (GMC) of 2737 binding antibody units (BAU)/mL (estimated vaccine efficacy (VE): 92.9% (95% CI: 91.7%, 93.9%)) to 274 BAU/mL or to 27,368 BAU/mL resulted in an overall estimated VE of 84.2% (79.0%, 88.1%) and 97.6% (97.4%, 97.7%), respectively. By binary marker PS analysis of Low and High subgroups (cut-point: 2094 BAU/mL), the ignorance interval (IGI) and estimated uncertainty interval (EUI) for VE were [85%, 90%] and (78%, 93%) for Low compared to [95%, 96%] and (92%, 97%) for High. By continuous marker PS analysis, the IGI and 95% EUI for VE at the 2.5th percentile (519.4 BAU/mL) vs. at the 97.5th percentile (9262.9 BAU/mL) of D57 Spike IgG concentration were [92.6%, 93.4%] and (89.2%, 95.7%) vs. [94.3%, 94.6%] and (89.7%, 97.0%). Results were similar for other D29 and D57 markers. Thus, the SVE and PS analyses additionally support all four markers at both time points as CoPs.
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- 2023
12. The BNT162b2 mRNA vaccine demonstrates reduced age-associated TH1 support in vitro and in vivo
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Brook, Byron, Checkervarty, Abhinav Kumar, Barman, Soumik, Sweitzer, Cali, Bosco, Anna-Nicole, Sherman, Amy C., Baden, Lindsey R., Morrocchi, Elena, Sanchez-Schmitz, Guzman, Palma, Paolo, Nanishi, Etsuro, O’Meara, Timothy R., McGrath, Marisa E., Frieman, Matthew B., Soni, Dheeraj, van Haren, Simon D., Ozonoff, Al, Diray-Arce, Joann, Steen, Hanno, Dowling, David J., and Levy, Ofer
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- 2024
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13. Infective Endocarditis Antibiotic Prophylaxis: Review of the Evidence and Guidelines
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Pries-Heje, Mia M., Bundgaard, Henning, Iversen, Kasper K., Baden, Lindsey R., and Woolley, Ann E.
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- 2023
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14. Phenotypes of disease severity in a cohort of hospitalized COVID-19 patients: Results from the IMPACC study
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Ozonoff, Al, Schaenman, Joanna, Jayavelu, Naresh Doni, Milliren, Carly E, Calfee, Carolyn S, Cairns, Charles B, Kraft, Monica, Baden, Lindsey R, Shaw, Albert C, Krammer, Florian, van Bakel, Harm, Esserman, Denise A, Liu, Shanshan, Sesma, Ana Fernandez, Simon, Viviana, Hafler, David A, Montgomery, Ruth R, Kleinstein, Steven H, Levy, Ofer, Bime, Christian, Haddad, Elias K, Erle, David J, Pulendran, Bali, Nadeau, Kari C, Davis, Mark M, Hough, Catherine L, Messer, William B, Higuita, Nelson I Agudelo, Metcalf, Jordan P, Atkinson, Mark A, Brakenridge, Scott C, Corry, David, Kheradmand, Farrah, Ehrlich, Lauren IR, Melamed, Esther, McComsey, Grace A, Sekaly, Rafick, Diray-Arce, Joann, Peters, Bjoern, Augustine, Alison D, Reed, Elaine F, Altman, Matthew C, Becker, Patrice M, Rouphael, Nadine, Bime, Chris, McEnaney, Kerry, Barton, Brenda, Lentucci, Claudia, Saluvan, Mehmet, Chang, Ana C, Hoch, Annmarie, Albert, Marisa, Shaheen, Tanzia, Kho, Alvin T, Thomas, Sanya, Chen, Jing, Murphy, Maimouna D, Cooney, Mitchell, Presnell, Scott, and Fragiadakis, Gabriela K
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Biomedical and Clinical Sciences ,Clinical Sciences ,Infectious Diseases ,Coronaviruses ,Lung ,Emerging Infectious Diseases ,Prevention ,Genetics ,Clinical Research ,Good Health and Well Being ,COVID-19 ,Creatinine ,Female ,Hospitalization ,Humans ,Male ,Phenotype ,Prospective Studies ,RNA ,Viral ,SARS-CoV-2 ,Severity of Illness Index ,Troponin ,Post-Acute COVID-19 Syndrome ,Viral load ,Antibody ,IMPACC study group members ,Public Health and Health Services ,Clinical sciences ,Epidemiology - Abstract
BackgroundBetter understanding of the association between characteristics of patients hospitalized with coronavirus disease 2019 (COVID-19) and outcome is needed to further improve upon patient management.MethodsImmunophenotyping Assessment in a COVID-19 Cohort (IMPACC) is a prospective, observational study of 1164 patients from 20 hospitals across the United States. Disease severity was assessed using a 7-point ordinal scale based on degree of respiratory illness. Patients were prospectively surveyed for 1 year after discharge for post-acute sequalae of COVID-19 (PASC) through quarterly surveys. Demographics, comorbidities, radiographic findings, clinical laboratory values, SARS-CoV-2 PCR and serology were captured over a 28-day period. Multivariable logistic regression was performed.FindingsThe median age was 59 years (interquartile range [IQR] 20); 711 (61%) were men; overall mortality was 14%, and 228 (20%) required invasive mechanical ventilation. Unsupervised clustering of ordinal score over time revealed distinct disease course trajectories. Risk factors associated with prolonged hospitalization or death by day 28 included age ≥ 65 years (odds ratio [OR], 2.01; 95% CI 1.28-3.17), Hispanic ethnicity (OR, 1.71; 95% CI 1.13-2.57), elevated baseline creatinine (OR 2.80; 95% CI 1.63- 4.80) or troponin (OR 1.89; 95% 1.03-3.47), baseline lymphopenia (OR 2.19; 95% CI 1.61-2.97), presence of infiltrate by chest imaging (OR 3.16; 95% CI 1.96-5.10), and high SARS-CoV2 viral load (OR 1.53; 95% CI 1.17-2.00). Fatal cases had the lowest ratio of SARS-CoV-2 antibody to viral load levels compared to other trajectories over time (p=0.001). 589 survivors (51%) completed at least one survey at follow-up with 305 (52%) having at least one symptom consistent with PASC, most commonly dyspnea (56% among symptomatic patients). Female sex was the only associated risk factor for PASC.InterpretationIntegration of PCR cycle threshold, and antibody values with demographics, comorbidities, and laboratory/radiographic findings identified risk factors for 28-day outcome severity, though only female sex was associated with PASC. Longitudinal clinical phenotyping offers important insights, and provides a framework for immunophenotyping for acute and long COVID-19.FundingNIH.
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- 2022
15. Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial
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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.
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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 [...]
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- 2024
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16. Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial
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Branche, Angela R., Rouphael, Nadine G., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Anderson, Evan J., Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Malkin, Elissa, Bethony, Jeffrey M., Walsh, Edward E., Graciaa, Daniel S., Samaha, Hady, Sherman, Amy C., Walsh, Stephen R., Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana M., Martin, Thomas C. S., Kamidani, Satoshi, Smith, Michael J., Ladner, Benjamin G., Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert L., Mulligan, Mark J., Lyke, Kirsten E., Posavad, Christine M., Meagher, Megan A., Stephens, David S., Neuzil, Kathleen M., Abebe, Kuleni, Hill, Heather, Albert, Jim, Telu, Kalyani, Mu, Jinjian, Lewis, Teri C., Giebeig, Lisa A., Eaton, Amanda, Netzl, Antonia, Wilks, Samuel H., Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Montefiori, David C., Makowski, Mat, Smith, Derek J., Nayak, Seema U., Roberts, Paul C., and Beigel, John H.
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- 2023
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17. Original SARS-CoV-2 monovalent and Omicron BA.4/BA.5 bivalent COVID-19 mRNA vaccines: phase 2/3 trial interim results
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Chalkias, Spyros, Whatley, Jordan L., Eder, Frank, Essink, Brandon, Khetan, Shishir, Bradley, Paul, Brosz, Adam, McGhee, Nichole, Tomassini, Joanne E., Chen, Xing, Zhao, Xiaoping, Sutherland, Andrea, Shen, Xiaoying, Girard, Bethany, Edwards, Darin K., Feng, Jing, Zhou, Honghong, Walsh, Stephen, Montefiori, David C., Baden, Lindsey R., Miller, Jacqueline M., and Das, Rituparna
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- 2023
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18. Vaccine induction of heterologous HIV-1-neutralizing antibody B cell lineages in humans
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Williams, Wilton B., Alam, S. Munir, Ofek, Gilad, Erdmann, Nathaniel, Montefiori, David C., Seaman, Michael S., Wagh, Kshitij, Korber, Bette, Edwards, Robert J., Mansouri, Katayoun, Eaton, Amanda, Cain, Derek W., Martin, Mitchell, Hwang, JongIn, Arus-Altuz, Aria, Lu, Xiaozhi, Cai, Fangping, Jamieson, Nolan, Parks, Robert, Barr, Maggie, Foulger, Andrew, Anasti, Kara, Patel, Parth, Sammour, Salam, Parsons, Ruth J., Huang, Xiao, Lindenberger, Jared, Fetics, Susan, Janowska, Katarzyna, Niyongabo, Aurelie, Janus, Benjamin M., Astavans, Anagh, Fox, Christopher B., Mohanty, Ipsita, Evangelous, Tyler, Chen, Yue, Berry, Madison, Kirshner, Helene, Van Itallie, Elizabeth, Saunders, Kevin O., Wiehe, Kevin, Cohen, Kristen W., McElrath, M. Juliana, Corey, Lawrence, Acharya, Priyamvada, Walsh, Stephen R., Baden, Lindsey R., and Haynes, Barton F.
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- 2024
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19. Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase
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El Sahly, Hana M, Baden, Lindsey R, Essink, Brandon, Doblecki-Lewis, Susanne, Martin, Judith M, Anderson, Evan J, Campbell, Thomas B, Clark, Jesse, Jackson, Lisa A, Fichtenbaum, Carl J, Zervos, Marcus, Rankin, Bruce, Eder, Frank, Feldman, Gregory, Kennelly, Christina, Han-Conrad, Laurie, Levin, Michael, Neuzil, Kathleen M, Corey, Lawrence, Gilbert, Peter, Janes, Holly, Follmann, Dean, Marovich, Mary, Polakowski, Laura, Mascola, John R, Ledgerwood, Julie E, Graham, Barney S, August, Allison, Clouting, Heather, Deng, Weiping, Han, Shu, Leav, Brett, Manzo, Deb, Pajon, Rolando, Schödel, Florian, Tomassini, Joanne E, Zhou, Honghong, and Miller, Jacqueline
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Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Trials and Supportive Activities ,Coronaviruses ,Immunization ,Infectious Diseases ,Emerging Infectious Diseases ,Vaccine Related ,Biotechnology ,Clinical Research ,Prevention ,Genetics ,6.1 Pharmaceuticals ,Infection ,Good Health and Well Being ,2019-nCoV Vaccine mRNA-1273 ,Adolescent ,Adult ,Aged ,COVID-19 ,COVID-19 Vaccines ,Follow-Up Studies ,Humans ,Immunization ,Secondary ,Immunogenicity ,Vaccine ,Incidence ,Intention to Treat Analysis ,Male ,Middle Aged ,Patient Acuity ,Single-Blind Method ,Treatment Outcome ,Young Adult ,COVE Study Group ,Medical and Health Sciences ,General & Internal Medicine ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundAt interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy in preventing coronavirus disease 2019 (Covid-19). After emergency use of the vaccine was authorized, the protocol was amended to include an open-label phase. Final analyses of efficacy and safety data from the blinded phase of the trial are reported.MethodsWe enrolled volunteers who were at high risk for Covid-19 or its complications; participants were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo, 28 days apart, at 99 centers across the United States. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The data cutoff date was March 26, 2021.ResultsThe trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA-1273 vaccine, and 15,206 to receive placebo. More than 96% of participants received both injections, 2.3% had evidence of SARS-CoV-2 infection at baseline, and the median follow-up was 5.3 months in the blinded phase. Vaccine efficacy in preventing Covid-19 illness was 93.2% (95% confidence interval [CI], 91.0 to 94.8), with 55 confirmed cases in the mRNA-1273 group (9.6 per 1000 person-years; 95% CI, 7.2 to 12.5) and 744 in the placebo group (136.6 per 1000 person-years; 95% CI, 127.0 to 146.8). The efficacy in preventing severe disease was 98.2% (95% CI, 92.8 to 99.6), with 2 cases in the mRNA-1273 group and 106 in the placebo group, and the efficacy in preventing asymptomatic infection starting 14 days after the second injection was 63.0% (95% CI, 56.6 to 68.5), with 214 cases in the mRNA-1273 group and 498 in the placebo group. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified.ConclusionsThe mRNA-1273 vaccine continued to be efficacious in preventing Covid-19 illness and severe disease at more than 5 months, with an acceptable safety profile, and protection against asymptomatic infection was observed. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).
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- 2021
20. Three-month antibody persistence of a bivalent Omicron-containing booster vaccine against COVID-19
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Chalkias, Spyros, Harper, Charles, Vrbicky, Keith, Walsh, Stephen R., Essink, Brandon, Brosz, Adam, McGhee, Nichole, Tomassini, Joanne E., Chen, Xing, Ying Chang, Sutherland, Andrea, Montefiori, David C., Girard, Bethany, Edwards, Darin K., Jing Feng, Zhou, Honghong, Baden, Lindsey R., Miller, Jacqueline M., and Das, Rituparna
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- 2023
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21. Publisher Correction: Carbohydrate fatty acid monosulphate: oil-in-water adjuvant enhances SARS-CoV-2 RBD nanoparticle-induced immunogenicity and protection in mice
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Nanishi, Etsuro, Borriello, Francesco, Seo, Hyuk-Soo, O’Meara, Timothy R., McGrath, Marisa E., Saito, Yoshine, Chen, Jing, Diray-Arce, Joann, Song, Kijun, Xu, Andrew Z., Barman, Soumik, Menon, Manisha, Dong, Danica, Caradonna, Timothy M., Feldman, Jared, Hauser, Blake M., Schmidt, Aaron G., Baden, Lindsey R., Ernst, Robert K., Dillen, Carly, Yu, Jingyou, Chang, Aiquan, Hilgers, Luuk, Platenburg, Peter Paul, Dhe-Paganon, Sirano, Barouch, Dan H., Ozonoff, Al, Zanoni, Ivan, Frieman, Matthew B., Dowling, David J., and Levy, Ofer
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- 2023
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22. Carbohydrate fatty acid monosulphate: oil-in-water adjuvant enhances SARS-CoV-2 RBD nanoparticle-induced immunogenicity and protection in mice
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Nanishi, Etsuro, Borriello, Francesco, Seo, Hyuk-Soo, O’Meara, Timothy R., McGrath, Marisa E., Saito, Yoshine, Chen, Jing, Diray-Arce, Joann, Song, Kijun, Xu, Andrew Z., Barman, Soumik, Menon, Manisha, Dong, Danica, Caradonna, Timothy M., Feldman, Jared, Hauser, Blake M., Schmidt, Aaron G., Baden, Lindsey R., Ernst, Robert K., Dillen, Carly, Yu, Jingyou, Chang, Aiquan, Hilgers, Luuk, Platenburg, Peter Paul, Dhe-Paganon, Sirano, Barouch, Dan H., Ozonoff, Al, Zanoni, Ivan, Frieman, Matthew B., Dowling, David J., and Levy, Ofer
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- 2023
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23. Immunophenotyping assessment in a COVID-19 cohort (IMPACC): A prospective longitudinal study
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Rouphael, Nadine, Maecker, Holden, Montgomery, Ruth R, Diray-Arce, Joann, Kleinstein, Steven H, Altman, Matthew C, Bosinger, Steven E, Eckalbar, Walter, Guan, Leying, Hough, Catherine L, Krammer, Florian, Langelier, Charles, Levy, Ofer, McEnaney, Kerry, Peters, Bjoern, Rahman, Adeeb, Rajan, Jayant V, Sigelman, Steven, Steen, Hanno, van Bakel, Harm, Ward, Alyssa, Wilson, Michael R, Woodruff, Prescott, Zamecnik, Colin R, Augustine, Alison D, Ozonoff, Al, Reed, Elaine F, Becker, Patrice M, Higuita, Nelson Agudelo, Atkinson, Mark A, Baden, Lindsey R, Bime, Christian, Brakenridge, Scott C, Calfee, Carolyn S, Cairns, Charles B, Corry, David, Davis, Mark M, Ehrlich, Lauren IR, Haddad, Elias K, Erle, David J, Fernandez-Sesma, Ana, Hafler, David A, Kheradmand, Farrah, Kraft, Monica, McComsey, Grace A, Melamed, Esther, Messer, William, Metcalf, Jordan, Nadeau, Kari C, Pulendran, Bali, Sarwal, Minnie, Schaenman, Joanna, Sekaly, Rafick, Shaw, Albert C, and Simon, Viviana
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Biomedical and Clinical Sciences ,Clinical Sciences ,Infectious Diseases ,Coronaviruses Therapeutics and Interventions ,Clinical Research ,Minority Health ,Emerging Infectious Diseases ,Coronaviruses ,2.4 Surveillance and distribution ,4.2 Evaluation of markers and technologies ,4.1 Discovery and preclinical testing of markers and technologies ,Biomarkers ,COVID-19 ,Computational Biology ,Data Analysis ,Gene Expression Profiling ,Hospitalization ,Humans ,Immunophenotyping ,Longitudinal Studies ,Molecular Diagnostic Techniques ,Prospective Studies ,Proteomics ,SARS-CoV-2 ,United States ,IMPACC Manuscript Writing Team ,IMPACC Network Steering Committee ,Clinical sciences ,Immunology - Abstract
The IMmunoPhenotyping Assessment in a COVID-19 Cohort (IMPACC) is a prospective longitudinal study designed to enroll 1000 hospitalized patients with COVID-19 (NCT04378777). IMPACC collects detailed clinical, laboratory and radiographic data along with longitudinal biologic sampling of blood and respiratory secretions for in depth testing. Clinical and lab data are integrated to identify immunologic, virologic, proteomic, metabolomic and genomic features of COVID-19-related susceptibility, severity and disease progression. The goals of IMPACC are to better understand the contributions of pathogen dynamics and host immune responses to the severity and course of COVID-19 and to generate hypotheses for identification of biomarkers and effective therapeutics, including optimal timing of such interventions. In this report we summarize the IMPACC study design and protocols including clinical criteria and recruitment, multi-site standardized sample collection and processing, virologic and immunologic assays, harmonization of assay protocols, high-level analyses and the data sharing plans.
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- 2021
24. Stochastic interventional approach to assessing immune correlates of protection: Application to the COVE messenger RNA-1273 vaccine trial
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Hejazi, Nima S., Shen, Xiaoying, Carpp, Lindsay N., Benkeser, David, Follmann, Dean, Janes, Holly E., Baden, Lindsey R., El Sahly, Hana M., Deng, Weiping, Zhou, Honghong, Leav, Brett, Montefiori, David C., and Gilbert, Peter B.
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- 2023
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25. Risk of COVID-19 after natural infection or vaccination
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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.
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- 2023
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26. Immunogenicity of quadrivalent meningococcal conjugate vaccine in frequent platelet donors
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Desjardins, Michaël, Cunningham, Phoebe, Mitre, Xhoi, Pierre, Djenane, Montesano, Christina, Woods, Tenaizus, Oganezova, Karina, Krauss, Jonathan H., Von, Salena S., Kupelian, John A., Li, Xiaofang, Gothing, Jon A., Kleinjan, Jane A., Zhou, Guohai, Piantadosi, Steven, Sherman, Amy C., Walsh, Stephen R., Issa, Nicolas C., Kaufman, Richard M., and Baden, Lindsey R.
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- 2023
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27. Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility
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Tolan, Nicole V., DeSimone, Mia S, Fernandes, Maria D, Lewis, Joshua E., Simmons, Daimon P, Schur, Peter H, Brigl, Manfred, Tanasijevic, Milenko J, Desjardins, Michaël, Sherman, Amy C, Baden, Lindsey R, Snyder, Marion, and Melanson, Stacy EF
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- 2023
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28. Safety, immunogenicity and antibody persistence of a bivalent Beta-containing booster vaccine against COVID-19: a phase 2/3 trial
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Chalkias, Spyros, Eder, Frank, Essink, Brandon, Khetan, Shishir, Nestorova, Biliana, Feng, Jing, Chen, Xing, Chang, Ying, Zhou, Honghong, Montefiori, David, Edwards, Darin K., Girard, Bethany, Pajon, Rolando, Dutko, Frank J., Leav, Brett, Walsh, Stephen R., Baden, Lindsey R., Miller, Jacqueline M., and Das, Rituparna
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- 2022
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29. Diagnostic TR-FRET assays for detection of antibodies in patient samples
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Yue, Hong, Nowak, Radosław P., Overwijn, Daan, Payne, N. Connor, Fischinger, Stephanie, Atyeo, Caroline, Lam, Evan C., St. Denis, Kerri, Brais, Lauren K., Konishi, Yoshinobu, Sklavenitis-Pistofidis, Romanos, Baden, Lindsey R., Nilles, Eric J., Karlson, Elizabeth W., Yu, Xu G., Li, Jonathan Z., Woolley, Ann E., Ghobrial, Irene M., Meyerhardt, Jeffrey A., Balazs, Alejandro B., Alter, Galit, Mazitschek, Ralph, and Fischer, Eric S.
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- 2023
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30. Longitudinal SARS-CoV-2 Nucleocapsid Antibody Kinetics, Seroreversion, and Implications for Seroepidemiologic Studies
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Loesche, Michael, Karlson, Elizabeth W., Talabi, Opeyemi, Zhou, Guohai, Boutin, Natalie, Atchley, Rachel, Loevinsohn, Gideon, Chang, Jun Bai Park, Hasdianda, Mohammad A., Okenla, Adetoun, Sampson, Elizabeth, Schram, Haley, Magsipoc, Karen, Goodman, Kirsten, Donahue, Lauren, MacGowan, Maureen, Novack, Lewis A., Jarolim, Petr, Baden, Lindsey R., and Nilles, Eric J.
- Subjects
Epidemiologic methods ,Immune system -- Testing ,Viral proteins -- Measurement -- Physiological aspects ,Health - Abstract
Estimating the incidence of infections caused by SARS-CoV-2 that are frequently asymptomatic is challenging when using routine passive surveillance methods. Antibodies can provide a record of previous infection, whether symptomatic [...]
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- 2022
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31. Association Between SARS-CoV-2 Viral Load and COVID-19 Vaccination in 4 Phase 3 Trials.
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Janes, Holly, Fisher, Leigh H, Kee, Jia Jin, Parameswaran, Lalitha, Goepfert, Paul A, Falsey, Ann R, Ludwig, James, Magaret, Craig A, Gilbert, Peter B, Kublin, James G, Rouphael, Nadine, Sobieszczyk, Magdalena E, Sahly, Hana M El, Baden, Lindsey R, Grinsztejn, Beatriz, Walsh, Stephen R, Gray, Glenda E, Kotloff, Karen L, Gay, Cynthia L, and Greninger, Alexander L
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SARS-CoV-2 ,COVID-19 ,CLINICAL trial registries ,CLINICAL trials ,COVID-19 vaccines - Abstract
Coronavirus disease 2019 (COVID-19) vaccines reduce severe disease and mortality and may lessen transmission, measured by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load (VL). Evaluating vaccine associations in VL at COVID-19 diagnosis in 4 phase 3 randomized, placebo-controlled vaccine trials, July 2020 to July 2021, VL reductions were 2.78 log
10 copies/mL (95% confidence interval [CI], 1.38–4.18; n = 60 placebo, 11 vaccine) and 2.12 log10 copies/mL (95% CI, 1.44–2.80; n = 594 placebo, 36 vaccine) for NVX-CoV2373 and mRNA-1273, respectively. Associations were not significant for AZD1222 (0.59 log10 copies/mL; 95% CI, −.19 to 1.36; n = 90 placebo, 78 vaccine) or Ad26.COV2.S (0.23 log10 copies/mL; 95% CI, −.01 to.47; n = 916 placebo, 424 vaccine). Thus, vaccines potentially decreased transmission when ancestral SARS-CoV-2 predominated. Clinical Trials Registration. NCT04470427, NCT04505722, NCT04516746, NCT04611802. [ABSTRACT FROM AUTHOR]- Published
- 2024
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32. Who to Boost When: The Effect of Age and Dosing Interval on Delta and Omicron COVID-19 Incidence in the Open-label Phase of the COVE Trial.
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Follmann, Dean, Wang, Xiaowei, Baden, Lindsey R, Sahly, Hana M El, Essink, Brandon, Gilbert, Peter, Janes, Holly E, Kelley, Colleen F, Berman, Megan A, Frank, Ian, Chu, Eric, Deng, Weiping, Priddy, Frances, Dixit, Avika, Tomassini, Joanne E, Das, Rituparna, Miller, Jacqueline, and Zhou, Honghong
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BOOSTER vaccines ,SARS-CoV-2 Omicron variant ,COMMUNICABLE diseases ,COVID-19 vaccines ,COVID-19 - Abstract
Background To help inform COVID-19 vaccination recommendations, we evaluated the impact of age and dosing interval on clinical benefit of a third dose of mRNA-1273. Methods Approximately 17 000 participants from the phase 3 Coronavirus Efficacy trial who previously received 2 doses of 100 µg mRNA-1273 were evaluated for COVID-19 between September 2021 and April 2022 during uptake of a third booster dose of 50 µg of mRNA-1273. Cox models assessed booster relative efficacy of a third dose. Results Initial booster relative efficacy against Delta COVID-19 was 83% (95% confidence interval, 60–93) 14 days postdose and 83% (67–91) 60 days later. Initial booster efficacy against Omicron COVID-19 was 56% (44–65) at 14 days postdose and 4% (−27 to 28) 120 days later. For those aged ≥65 years, initial booster efficacy against Omicron COVID-19 was 86% (69–93) compared with 50% (36–61) for those <65 years. Placebo crossover to 2 doses of mRNA-1273 induced a median 5-month difference from the second to third dose between the original randomized arms. Postboost, the mRNA-1273 arm had a 24% (16%, 32%) lower risk of Omicron COVID-19 compared to the placebo-mRNA-1273 arm. Modeling predicted a 41% postboost reduction in Omicron COVID-19 for a 15- versus 7-month interval between the second and third doses. Conclusions Boosting reduced Delta COVID-19 risk by 83% through 2 months and reduced Omicron COVID-19 risk by 56% but declined by 4 months. A 15- versus 7-month dosing interval predicted a 41% postboost reduction in Omicron COVID-19 but increased preboost risk. Primary Funding Source The National Institutes of Health/National Institute of Allergy and Infectious Diseases. Registration for the COVE Trial. ClinicalTrials.gov ID# NCT04470427 [ABSTRACT FROM AUTHOR]
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- 2024
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33. Vaccine-Induced Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection)
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Sherman, Amy C., Desjardins, Michaël, and Baden, Lindsey R.
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- 2022
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34. Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial
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Pajon, Rolando, Paila, Yamuna D., Girard, Bethany, Dixon, Groves, Kacena, Katherine, Baden, Lindsey R., El Sahly, Hana M., Essink, Brandon, Mullane, Kathleen M., Frank, Ian, Denhan, Douglas, Kerwin, Edward, Zhao, Xiaoping, Ding, Baoyu, Deng, Weiping, Tomassini, Joanne E., Zhou, Honghong, Leav, Brett, and Schödel, Florian
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- 2022
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35. Bacteriophage treatment of disseminated cutaneous Mycobacterium chelonae infection
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Little, Jessica S., Dedrick, Rebekah M., Freeman, Krista G., Cristinziano, Madison, Smith, Bailey E., Benson, Constance A., Jhaveri, Tulip A., Baden, Lindsey R., Solomon, Daniel A., and Hatfull, Graham F.
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- 2022
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36. Unsupervised outlier detection applied to SARS-CoV-2 nucleotide sequences can identify sequences of common variants and other variants of interest
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Hahn, Georg, Lee, Sanghun, Prokopenko, Dmitry, Abraham, Jonathan, Novak, Tanya, Hecker, Julian, Cho, Michael, Khurana, Surender, Baden, Lindsey R., Randolph, Adrienne G., Weiss, Scott T., and Lange, Christoph
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- 2022
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37. Heterologous SARS-CoV-2 booster vaccine for individuals with hematological malignancies after a primary SARS-CoV-2 mRNA vaccine series
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Sherman, Amy C., primary, van Haren, Simon D., additional, Borberg, Ella, additional, Swank, Zoe, additional, Aleissa, Muneerah, additional, Tong, Alexandra, additional, Rooks, Rebecca, additional, Kanwal, Urwah, additional, Levine, Hannah, additional, Yates, Bridget, additional, Izaguirre, Natalie, additional, Ryff, Kevin, additional, Thomas, Sanya, additional, Parisi, Lindsey, additional, Li, Xiaofang, additional, Walt, David R., additional, Levy, Ofer, additional, Walsh, Stephen R., additional, Issa, Nicolas C., additional, and Baden, Lindsey R., additional
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- 2024
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38. How To Measure Benefit in a Changing Pandemic — Olgotrelvir for SARS-CoV-2
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Sherman, Amy C., primary and Baden, Lindsey R., additional
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- 2024
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39. HIV BG505 SOSIP.664 trimer with 3M-052-AF/alum induces human autologous tier-2 neutralizing antibodies
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Hahn, William O., primary, Parks, K. Rachael, additional, Shen, Mingchao, additional, Ozorowski, Gabriel, additional, Janes, Holly, additional, Ballweber-Fleming, Lamar, additional, Woodward-Davis, Amanda, additional, Duplessis, Chris, additional, Tomei, Mark, additional, Dey, Antu K., additional, Sagawa, Zachary K., additional, De Rosa, Stephen C., additional, Seese, Aaron, additional, Siddaramaiah, Latha Kallur, additional, Stamatatos, Leonidas, additional, Lee, Wen-Hsin, additional, Sewall, Leigh M., additional, Karlinsey, Dalton, additional, Turner, Hannah L., additional, Rubin, Vanessa, additional, Furth, Sarah, additional, MacPhee, Kellie, additional, Duff, Michael, additional, Corey, Lawrence, additional, Keefer, Michael C., additional, Edupuganti, Srilattha, additional, Frank, Ian, additional, Maenza, Janine, additional, Baden, Lindsey R., additional, Hyrien, Ollivier, additional, Sanders, Rogier W., additional, Moore, John P., additional, Ward, Andrew B., additional, Tomaras, Georgia D., additional, Montefiori, David C., additional, Rouphael, Nadine, additional, and McElrath, M. Juliana, additional
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- 2024
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40. Opportunistic Infections in Patients Receiving Post-Transplantation Cyclophosphamide: Impact of Haploidentical versus Unrelated Donor Allograft
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Little, Jessica S., Duléry, Rémy, Shapiro, Roman M., Aleissa, Muneerah M., Prockop, Susan E., Koreth, John, Ritz, Jerome, Antin, Joseph H., Cutler, Corey, Nikiforow, Sarah, Romee, Rizwan, Issa, Nicolas C., Ho, Vincent T., Baden, Lindsey R., Soiffer, Robert J., and Gooptu, Mahasweta
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- 2024
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41. 2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases
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Bass, Anne R., Chakravarty, Eliza, Akl, Elie A., Bingham, Clifton O., Calabrese, Leonard, Cappelli, Laura C., Johnson, Sindhu R., Imundo, Lisa F., Winthrop, Kevin L., Arasaratnam, Reuben J., Baden, Lindsey R., Berard, Roberta, Bridges, S. Louis, Jr., Cheah, Jonathan T. L., Curtis, Jeffrey R., Ferguson, Polly J., Hakkarinen, Ida, Onel, Karen B., Schultz, Grayson, Sivaraman, Vidya, Smith, Benjamin J., Sparks, Jeffrey A., Vogel, Tiphanie P., Williams, Eleanor Anderson, Calabrese, Cassandra, Cunha, Joanne S., Fontanarosa, Joann, Gillispie‐Taylor, Miriah C., Gkrouzman, Elena, Iyer, Priyanka, Lakin, Kimberly S., Legge, Alexandra, Lo, Mindy S., Lockwood, Megan M., Sadun, Rebecca E., Singh, Namrata, Sullivan, Nancy, Tam, Herman, Turgunbaev, Marat, Turner, Amy S., and Reston, James
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- 2023
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42. Protective heterologous T cell immunity in COVID-19 induced by the trivalent MMR and Tdap vaccine antigens
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Mysore, Vijayashree, Cullere, Xavier, Settles, Matthew L., Ji, Xinge, Kattan, Michael W., Desjardins, Michaël, Durbin-Johnson, Blythe, Gilboa, Tal, Baden, Lindsey R., Walt, David R., Lichtman, Andrew H., Jehi, Lara, and Mayadas, Tanya N.
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- 2021
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43. The Cost-effectiveness of Transplanting Hearts From Hepatitis C-infected Donors Into Uninfected Recipients
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Woolley, Ann E., Gandhi, Aditya R., Jones, Michelle L., Kim, Jane J., Mallidi, Hari R., Givertz, Michael M., Baden, Lindsey R., Mehra, Mandeep R., and Neilan, and Anne M.
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- 2022
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44. B cell genomics behind cross-neutralization of SARS-CoV-2 variants and SARS-CoV
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Scheid, Johannes F., Barnes, Christopher O., Eraslan, Basak, Hudak, Andrew, Keeffe, Jennifer R., Cosimi, Lisa A., Brown, Eric M., Muecksch, Frauke, Weisblum, Yiska, Zhang, Shuting, Delorey, Toni, Woolley, Ann E., Ghantous, Fadi, Park, Sung-Moo, Phillips, Devan, Tusi, Betsabeh, Huey-Tubman, Kathryn E., Cohen, Alexander A., Gnanapragasam, Priyanthi N.P., Rzasa, Kara, Hatziioanno, Theodora, Durney, Michael A., Gu, Xiebin, Tada, Takuya, Landau, Nathaniel R., West, Anthony P., Jr., Rozenblatt-Rosen, Orit, Seaman, Michael S., Baden, Lindsey R., Graham, Daniel B., Deguine, Jacques, Bieniasz, Paul D., Regev, Aviv, Hung, Deborah, Bjorkman, Pamela J., and Xavier, Ramnik J.
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- 2021
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45. Safety and reactogenicity of the recombinant zoster vaccine after allogeneic hematopoietic cell transplantation
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Baumrin, Emily, Izaguirre, Natalie E., Bausk, Bruce, Feeley, Monica M., Bay, Camden P., Yang, Qiheng, Ho, Vincent T., Baden, Lindsey R., and Issa, Nicolas C.
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- 2021
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46. Trivalent mosaic or consensus HIV immunogens prime humoral and broader cellular immune responses in adults
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Cohen, Kristen W., Fiore-Gartland, Andrew, Walsh, Stephen R., Yusim, Karina, Frahm, Nicole, Elizaga, Marnie L., Maenza, Janine, Scott, Hyman, Mayer, Kenneth H., Goepfert, Paul A., Edupuganti, Srilatha, Pantaleo, Giuseppe, Hutter, Julia, Morris, Daryl E., de Rosa, Stephen C., Geraghty, Daniel E., Robb, Merlin L., Michael, Nelson L., Fischer, Will, Giorgi, Elena E., Malhi, Harmandeep, Pensiero, Michael N., Ferrari, Guido, Tomaras, Georgia D., Montefiori, David C., Gilbert, Peter B., McElrath, M. Juliana, Haynes, Barton F., Korber, Bette T., and Baden, Lindsey R.
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Cellular immunity -- Health aspects ,Immune response -- Health aspects ,DNA vaccines -- Testing ,Antigens -- Health aspects ,AIDS vaccines -- Testing ,HIV infection -- Drug therapy ,Health care industry - Abstract
BACKGROUND. Mosaic and consensus HIV-1 immunogens provide two distinct approaches to elicit greater breadth of coverage against globally circulating HIV-1 and have shown improved immunologic breadth in nonhuman primate models. METHODS. This double-blind randomized trial enrolled 105 healthy HIV-uninfected adults who received 3 doses of either a trivalent global mosaic, a group M consensus (CON-S), or a natural clade B (Nat-B) gp160 env DNA vaccine followed by 2 doses of a heterologous modified vaccinia Ankara-vectored HIV-1 vaccine or placebo. We performed prespecified blinded immunogenicity analyses at day 70 and day 238 after the first immunization. T cell responses to vaccine antigens and 5 heterologous Env variants were fully mapped. RESULTS. Env-specific [CD4.sup.+] T cell responses were induced in 71% of the mosaic vaccine recipients versus 48% of the CON-S recipients and 48% of the natural Env recipients. The mean number of T cell epitopes recognized was 2.5 (95% CI, 1.2-4.2) for mosaic recipients, 1.6 (95% CI, 0.82-2.6) for CON-S recipients, and 1.1 (95% CI, 0.62-1.71) for Nat-B recipients. Mean breadth was significantly greater in the mosaic group than in the Nat-B group using overall (P = 0.014), prime-matched (P = 0.002), heterologous (P = 0.046), and boost-matched (P = 0.009) measures. Overall T cell breadth was largely due to Env-specific [CD4.sup.+] T cell responses. CONCLUSION. Priming with a mosaic antigen significantly increased the number of epitopes recognized by Env-specific T cells and enabled more, albeit still limited, cross-recognition of heterologous variants. Mosaic and consensus immunogens are promising approaches to address global diversity of HIV-1. TRIAL REGISTRATION. ClinicalTrials.gov NCT02296541. FUNDING. US NIH grants UM1 AI068614, UM1 AI068635, UM1 AI068618, UM1 AI069412, UL1 RR025758, P30 AI064518, UM1 AI100645, and UM1 AI144371, and Bill & Melinda Gates Foundation grant OPP52282., Introduction The tremendous global genetic diversity of HIV-1 poses a formidable challenge in the development of a globally effective HIV-1 vaccine (1, 2). Several vaccine concepts have completed efficacy trials [...]
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- 2023
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47. Disseminated Mycobacterium avium Complex Infection Following CD3/CD20 Bispecific Antibody Therapy in a Patient With Follicular Lymphoma.
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Little, Jessica S, Hurtado, Rocio M, Boire, Nicholas, Baden, Lindsey R, Laga, Alvaro C, Silk, Ann W, and Jacobson, Caron A
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BISPECIFIC antibodies ,MYCOBACTERIUM avium ,OPPORTUNISTIC infections ,FOLLICULAR lymphoma ,INFECTION - Abstract
Infections remain a major concern following bispecific antibody therapy but are not well described in pivotal trials. We present the first well-documented case of a classic but rare opportunistic infection, disseminated Mycobacterium avium complex, in a patient receiving bispecific antibody therapy. [ABSTRACT FROM AUTHOR]
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- 2024
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48. Interim Report of the Reactogenicity and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 XBB–Containing Vaccines.
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Chalkias, Spyros, McGhee, Nichole, Whatley, Jordan L, Essink, Brandon, Brosz, Adam, Tomassini, Joanne E, Girard, Bethany, Edwards, Darin K, Wu, Kai, Nasir, Arshan, Lee, Diana, Avena, Laura E, Feng, Jing, Deng, Weiping, Montefiori, David C, Baden, Lindsey R, Miller, Jacqueline M, and Das, Rituparna
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SARS-CoV-2 ,SARS-CoV-2 Omicron variant ,COVID-19 ,MESSENGER RNA ,COVID-19 vaccines - Abstract
Background Monovalent Omicron XBB.1.5–containing vaccines were approved for coronavirus disease 2019 (COVID-19) 2023–2024 immunizations. Methods This ongoing, open-label, phase 2/3 study evaluated messenger RNA (mRNA)-1273.815 monovalent (50-µg Omicron XBB.1.5 spike mRNA) and mRNA-1273.231 bivalent (25-µg each Omicron XBB.1.5 and BA.4/BA.5 spike mRNAs) vaccines, administered as fifth doses to adults who previously received primary series, third doses of an original mRNA COVID-19 vaccine, and fourth doses of an Omicron BA.4/BA.5 bivalent vaccine. Interim safety and immunogenicity 29 days after vaccination are reported. Results Participants (randomized 1:1) received 50-µg of mRNA-1273.815 (n = 50) or mRNA-1273.231 (n = 51); median intervals (interquartile range) from prior BA.4/BA.5 bivalent doses were 8.2 (8.1–8.3) and 8.3 (8.1–8.4) months, respectively. Fold increases in neutralizing antibody (nAb) against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants from prebooster nAb levels were numerically higher against XBB.1.5, XBB.1.16, EG.5.1, BA.2.86, and JN.1 than BA.4/BA.5, BQ.1.1, or D614G on day 29. Monovalent vaccine also cross-neutralized FL.1.5.1, EG.5.1, BA.2.86, HK.3.1, HV.1, and JN.1 variants in a participant subset (n = 20) 15 days after vaccination. Reactogenicity was similar to that of mRNA-1273 vaccines. Conclusions XBB.1.5-containing mRNA-1273 vaccines elicit robust, diverse nAb responses against more recent SARS-CoV-2 variants, including JN.1, supporting the XBB.1.5-spike update for COVID-19 vaccines. [ABSTRACT FROM AUTHOR]
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- 2024
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49. Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120.
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Chirenje, Zvavahera Mike, Laher, Fatima, Dintwe, One, Muyoyeta, Monde, deCamp, Allan C, He, Zonglin, Grunenberg, Nicole, Omar, Faatima Laher, Seaton, Kelly E, Polakowski, Laura, Davis, Amanda S Woodward, Maganga, Lucas, Baden, Lindsey R, Mayer, Kenneth, Kalams, Spyros, Keefer, Michael, Edupuganti, Srilatha, Rodriguez, Benigno, Frank, Ian, and Scott, Hyman
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CLINICAL trial registries ,HIV-1 glycoprotein 120 ,VACCINE trials ,HIV ,AIDS vaccines - Abstract
Background HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled human immunodeficiency virus (HIV) vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01
B -adjuvanted bivalent subtype C gp120 Env protein at 2 dose levels in healthy HIV-uninfected adults. Methods Participants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200 μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B , or ALVAC-HIV (vCP2438) with 40 μg of bivalent subtype C gp120 adjuvanted with AS01B . Primary outcomes were safety and immune responses. Results We enrolled 160 participants, 55% women, 18–40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B -adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40 μg gp120/AS01B group were higher than in either of the 200 μg gp120 groups. Conclusions The 40 μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses. Clinical Trials Registration. NCT03122223. [ABSTRACT FROM AUTHOR]- Published
- 2024
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50. Evaluating enrollment and representation in COVID-19 and HIV vaccine clinical trials.
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Lezo Ramirez, Daisy, Koleske, Emily, Ometoruwa, Omolola, Jun Bai Park Chang, Kanwal, Urwah, Morreale, Nicholas, Avila Paz, Andres Alberto, Tong, Alexandra, Baden, Lindsey R., Sherman, Amy C., and Walsh, Stephen R.
- Published
- 2024
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