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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
The Lancet HIV ( IF 12.8 ) Pub Date : 2024-12-10 , DOI: 10.1016/s2352-3018(24)00247-9 Prof Srilatha Edupuganti MD, Prof Christopher B Hurt MD, Prof Kathryn E Stephenson MD, Yunda Huang PhD, Carmen A Paez MD, Chenchen Yu MS, Catherine Yen MD, Brett Hanscom PhD, Zonglin He PhD, Maurine D Miner PhD, Theresa Gamble PhD, Jack Heptinstall BS, Kelly E Seaton PhD, Elizabeth Domin BS, Bob C Lin BS, Krisha McKee MS, Nicole Doria-Rose PhD, Stephanie Regenold MD, Hans Spiegel MD, Maija Anderson MN, Nadia McClosky RN, Lily Zhang MS, Estelle Piwowar-Manning BS, Prof Margaret E Ackerman PhD, Michael Pensiero PhD, Bonnie J Dye MPH, Prof Raphael J Landovitz MD, Prof Kenneth Mayer MD, Prof Marc Siegel MD, Prof Magdalena Sobieszczyk MD, Prof Stephen R Walsh MD, Lucio Gama PhD, Prof Dan H Barouch MD, Prof David C Montefiori PhD, Prof Georgia D Tomaras PhD, HVTN 136/HPTN 092 Study Team, Cassie Grimsley Ackerley, Daniel Graciaa, Colleen Kelley, Nadine Rouphael, Sharon Curate-Ingram, Bette Korber, Kshitij Wagh, Nandini Sane, Jennifer Grossman, Sophie Hasan, Michelle Robinson, Jonathan Lucas, Marianne Gildea, Amber Babinec, Bethany Coomes, Julie Dumond, Justine Beck, Wairimu Chege, Xue Han, Jen Hanke, Carissa Karg, Laurie Rinn, Miriam Chicurel-Bayard, Shashikala Nagar, Hakeem White, W Scott Cooley, Gail Broder, Machel Hunt, Vanessa Cummings, Kristine Donaty, April Randhawa, Ramey Fair, Noshima Darden-Tabb, Richa Chaturvedi, Lindsey Baden, Amy Sherman, Jon Gothing, Andres Avila Paz, Julia Klopfer, Megan Powell, Anna Piermattei, August Heithoff, Joshua A. Weiner, Gabriela Kovacikova, Katherine S. Axelrod, Lu Zhang, Saman Baral, Nicole Yates, Kelvin Chiong, Irene Kuo, Jeanne Jordan, Madison Lintner, Kayley Langlands, Bitana Saintilma, Hannah Yellin, Madhu Balachandran, Manya Magnus, Jane Baumblatt, India Tindale, Samantha Fortier, Aleen Khodabakhshian, Nick Pierce, Maricela Gonzalez, Lisa Mark, Melinda Kuo, Ste'von Afemata
The Lancet HIV ( IF 12.8 ) Pub Date : 2024-12-10 , DOI: 10.1016/s2352-3018(24)00247-9 Prof Srilatha Edupuganti MD, Prof Christopher B Hurt MD, Prof Kathryn E Stephenson MD, Yunda Huang PhD, Carmen A Paez MD, Chenchen Yu MS, Catherine Yen MD, Brett Hanscom PhD, Zonglin He PhD, Maurine D Miner PhD, Theresa Gamble PhD, Jack Heptinstall BS, Kelly E Seaton PhD, Elizabeth Domin BS, Bob C Lin BS, Krisha McKee MS, Nicole Doria-Rose PhD, Stephanie Regenold MD, Hans Spiegel MD, Maija Anderson MN, Nadia McClosky RN, Lily Zhang MS, Estelle Piwowar-Manning BS, Prof Margaret E Ackerman PhD, Michael Pensiero PhD, Bonnie J Dye MPH, Prof Raphael J Landovitz MD, Prof Kenneth Mayer MD, Prof Marc Siegel MD, Prof Magdalena Sobieszczyk MD, Prof Stephen R Walsh MD, Lucio Gama PhD, Prof Dan H Barouch MD, Prof David C Montefiori PhD, Prof Georgia D Tomaras PhD, HVTN 136/HPTN 092 Study Team, Cassie Grimsley Ackerley, Daniel Graciaa, Colleen Kelley, Nadine Rouphael, Sharon Curate-Ingram, Bette Korber, Kshitij Wagh, Nandini Sane, Jennifer Grossman, Sophie Hasan, Michelle Robinson, Jonathan Lucas, Marianne Gildea, Amber Babinec, Bethany Coomes, Julie Dumond, Justine Beck, Wairimu Chege, Xue Han, Jen Hanke, Carissa Karg, Laurie Rinn, Miriam Chicurel-Bayard, Shashikala Nagar, Hakeem White, W Scott Cooley, Gail Broder, Machel Hunt, Vanessa Cummings, Kristine Donaty, April Randhawa, Ramey Fair, Noshima Darden-Tabb, Richa Chaturvedi, Lindsey Baden, Amy Sherman, Jon Gothing, Andres Avila Paz, Julia Klopfer, Megan Powell, Anna Piermattei, August Heithoff, Joshua A. Weiner, Gabriela Kovacikova, Katherine S. Axelrod, Lu Zhang, Saman Baral, Nicole Yates, Kelvin Chiong, Irene Kuo, Jeanne Jordan, Madison Lintner, Kayley Langlands, Bitana Saintilma, Hannah Yellin, Madhu Balachandran, Manya Magnus, Jane Baumblatt, India Tindale, Samantha Fortier, Aleen Khodabakhshian, Nick Pierce, Maricela Gonzalez, Lisa Mark, Melinda Kuo, Ste'von Afemata
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.
中文翻译：
在美国没有 HIV 的成人中单独给药和与 VRC07-523LS 联合给药的抗 HIV-1 单克隆 PGT121.414.LS 抗体的安全性、耐受性、药代动力学和中和活性 （HVTN 136/HPTN 092）：一项首次人体、开放标签、随机对照 1 期试验
多种广泛中和单克隆抗体 （mAb） 正在开发中，用于预防 HIV-1。该试验的目的是测试 PGT121.414.LS 和 VRC07-523LS mAb 在成人中的安全性和药代动力学。
更新日期：2024-12-10
中文翻译：
在美国没有 HIV 的成人中单独给药和与 VRC07-523LS 联合给药的抗 HIV-1 单克隆 PGT121.414.LS 抗体的安全性、耐受性、药代动力学和中和活性 （HVTN 136/HPTN 092）：一项首次人体、开放标签、随机对照 1 期试验
多种广泛中和单克隆抗体 （mAb） 正在开发中，用于预防 HIV-1。该试验的目的是测试 PGT121.414.LS 和 VRC07-523LS mAb 在成人中的安全性和药代动力学。
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