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1. Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial

Author

Ackerley, Cassie Grimsley, Graciaa, Daniel, Kelley, Colleen, Rouphael, Nadine, Curate-Ingram, Sharon, Korber, Bette, Wagh, Kshitij, Sane, Nandini, Grossman, Jennifer, Hasan, Sophie, Robinson, Michelle, Lucas, Jonathan, Gildea, Marianne, Babinec, Amber, Coomes, Bethany, Dumond, Julie, Beck, Justine, Chege, Wairimu, Han, Xue, Hanke, Jen, Karg, Carissa, Rinn, Laurie, Chicurel-Bayard, Miriam, Nagar, Shashikala, White, Hakeem, Cooley, W Scott, Broder, Gail, Hunt, Machel, Cummings, Vanessa, Donaty, Kristine, Randhawa, April, Fair, Ramey, Darden-Tabb, Noshima, Chaturvedi, Richa, Baden, Lindsey, Sherman, Amy, Gothing, Jon, Paz, Andres Avila, Klopfer, Julia, Powell, Megan, Piermattei, Anna, Heithoff, August, Weiner, Joshua A., Kovacikova, Gabriela, Axelrod, Katherine S., Zhang, Lu, Baral, Saman, Yates, Nicole, Chiong, Kelvin, Kuo, Irene, Jordan, Jeanne, Lintner, Madison, Langlands, Kayley, Saintilma, Bitana, Yellin, Hannah, Balachandran, Madhu, Magnus, Manya, Baumblatt, Jane, Tindale, India, Fortier, Samantha, Khodabakhshian, Aleen, Pierce, Nick, Gonzalez, Maricela, Mark, Lisa, Kuo, Melinda, Afemata, Ste'von, Edupuganti, Srilatha, Hurt, Christopher B, Stephenson, Kathryn E, Huang, Yunda, Paez, Carmen A, Yu, Chenchen, Yen, Catherine, Hanscom, Brett, He, Zonglin, Miner, Maurine D, Gamble, Theresa, Heptinstall, Jack, Seaton, Kelly E, Domin, Elizabeth, Lin, Bob C, McKee, Krisha, Doria-Rose, Nicole, Regenold, Stephanie, Spiegel, Hans, Anderson, Maija, McClosky, Nadia, Zhang, Lily, Piwowar-Manning, Estelle, Ackerman, Margaret E, Pensiero, Michael, Dye, Bonnie J, Landovitz, Raphael J, Mayer, Kenneth, Siegel, Marc, Sobieszczyk, Magdalena, Walsh, Stephen R, Gama, Lucio, Barouch, Dan H, Montefiori, David C, and Tomaras, Georgia D

Published
2025
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3. Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial

Author

Edupuganti, Srilatha, Hurt, Christopher B, Stephenson, Kathryn E, Huang, Yunda, Paez, Carmen A, Yu, Chenchen, Yen, Catherine, Hanscom, Brett, He, Zonglin, Miner, Maurine D, Gamble, Theresa, Heptinstall, Jack, Seaton, Kelly E, Domin, Elizabeth, Lin, Bob C, McKee, Krisha, Doria-Rose, Nicole, Regenold, Stephanie, Spiegel, Hans, Anderson, Maija, McClosky, Nadia, Zhang, Lily, Piwowar-Manning, Estelle, Ackerman, Margaret E, Pensiero, Michael, Dye, Bonnie J, Landovitz, Raphael J, Mayer, Kenneth, Siegel, Marc, Sobieszczyk, Magdalena, Walsh, Stephen R, Gama, Lucio, Barouch, Dan H, Montefiori, David C, Tomaras, Georgia D, Ackerley, Cassie Grimsley, Graciaa, Daniel, Kelley, Colleen, Rouphael, Nadine, Curate-Ingram, Sharon, Korber, Bette, Wagh, Kshitij, Sane, Nandini, Grossman, Jennifer, Hasan, Sophie, Robinson, Michelle, Lucas, Jonathan, Gildea, Marianne, Babinec, Amber, Coomes, Bethany, Dumond, Julie, Beck, Justine, Chege, Wairimu, Han, Xue, Hanke, Jen, Karg, Carissa, Rinn, Laurie, Chicurel-Bayard, Miriam, Nagar, Shashikala, White, Hakeem, Cooley, W Scott, Broder, Gail, Hunt, Machel, Cummings, Vanessa, Donaty, Kristine, Randhawa, April, Fair, Ramey, Darden-Tabb, Noshima, Chaturvedi, Richa, Baden, Lindsey, Sherman, Amy, Gothing, Jon, Paz, Andres Avila, Klopfer, Julia, Powell, Megan, Piermattei, Anna, Heithoff, August, Weiner, Joshua A., Kovacikova, Gabriela, Axelrod, Katherine S., Zhang, Lu, Baral, Saman, Yates, Nicole, Chiong, Kelvin, Kuo, Irene, Jordan, Jeanne, Lintner, Madison, Langlands, Kayley, Saintilma, Bitana, Yellin, Hannah, Balachandran, Madhu, Magnus, Manya, Baumblatt, Jane, Tindale, India, Fortier, Samantha, Khodabakhshian, Aleen, Pierce, Nick, Gonzalez, Maricela, Mark, Lisa, Kuo, Melinda, and Afemata, Ste'von

Abstract

Multiple broadly neutralising monoclonal antibodies (mAbs) are in development for HIV-1 prevention. The aim of this trial was to test the PGT121.414.LS and VRC07-523LS mAbs for safety and pharmacokinetics in adults.

Published
2025
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9. MONUMENTAL OR NOT: PRESIDENTIAL AUTHORITY UNDER THE ANTIQUITIES ACT OF 1906.

Author

REGENOLD, STEPHANIE

Subjects
ANTIQUITIES Act of 1906, NATIONAL monuments, PROCLAMATIONS, PRESIDENTS of the United States
Abstract

The article offers information on the presidential authority under the Antiquities Act of 1906. Topics discussed include presidents have designated 157 national monuments under its authority; proclamations modifying two national monuments in Utah, reducing the lands included in the Bears Ears National Monument by President Donald Trump; and ability of U.S. Congress to limit the president's authority through congressional action.

Published
2018

10. Safety and immunogenicity of a recombinant oligomeric gp145 subtype C Env protein (gp145 C.6980) HIV vaccine candidate in healthy, HIV-1–uninfected adult participants in the US.

Author

Tieu, Hong-Van, Karuna, Shelly, Huang, Yunda, Sobieszczyk, Magdalena E., Zheng, Hua, Tomaras, Georgia D., Montefiori, David C., Shen, Mingchao, DeRosa, Stephen, Cohen, Kristen, Isaacs, Margaret Brewinski, Regenold, Stephanie, Heptinstall, Jack, Seaton, Kelly E., Sawant, Sheetal, Furch, Brianna, Pensiero, Michael, Corey, Lawrence, and Bar, Katharine J.

Subjects
*AIDS vaccines, *IMMUNE response, *HIV-1 glycoprotein 120, *CLINICAL trial registries, *VACCINE effectiveness, *HIV
Abstract

• Three doses of novel subtype C gp145 Env protein with alum in a Phase 1 HIV vaccine trial were safe and well-tolerated. • Participants demonstrated effector binding antibodies, Env-specific CD4 + T-cell, and tier 1 neutralizing antibodies. • However, the regimen failed to induce tier 2 or heterologous neutralizing antibody responses. An approach to a preventive HIV vaccine is induction of effective broadly neutralizing antibodies (bnAbs) and effector binding antibodies (bAbs). Preclinical studies suggest that trimeric envelope (Env) proteins may elicit nAbs, which led to the development of the recombinant gp145 subtype C Env protein (gp145 C.6980) immunogen. HVTN 122 was a Phase 1 trial that evaluated the safety, tolerability, and immunogenicity of gp145 C.6980 in adults. Healthy, HIV-1 seronegative adults received three intramuscular injections of gp145 C.6980 with aluminum hydroxide (alum) at months 0, 2, and 6 at either 300 mcg (high dose, n = 25) or 100 mcg (low dose, n = 15), or placebo/saline (placebo, n = 5). Participants were followed for 12 months. Forty-five participants were enrolled. High and low doses of the study protein were well-tolerated, with mild or moderate reactogenicity commonly reported. Only one adverse event (mild injection site pruritis) in one participant (low dose) was considered product-related; there were no dose-limiting toxicities. High and low dose recipients demonstrated robust bAb responses to vaccine-matched consensus gp140 Env and subtype-matched gp120 Env proteins two weeks post-last vaccination (response rates >90 %), while no responses were detected to a heterologous subtype-matched V1V2 antigen. No significant differences were seen between high and low dose groups. Participants in both experimental arms demonstrated nAb response rates of 76.5 % to a tier 1 virus (MW9635.26), but no responses to tier 2 isolates. Env-specific CD4 + T-cell responses were elicited in 36.4 % of vaccine recipients, without significant differences between groups; no participants demonstrated CD8 + T-cell responses. Three doses of novel subtype C gp145 Env protein with alum were safe and well-tolerated. Participants demonstrated bAb, Env-specific CD4 + T-cell, and tier 1 nAb responses, but the regimen failed to induce tier 2 or heterologous nAb responses. Clinical Trials Registration: NCT03382418 [ABSTRACT FROM AUTHOR]

Published
2023
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