Safety and antiviral effect of a triple combination of HIV-1 broadly neutralizing antibodies: a phase 1/2a trial

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Julg B, Walker-Sperling VEK, Wagh K, Aid M, Stephenson KE, Zash R, Liu J, Nkolola JP, Hoyt A, Castro M, Serebryannyy L, Yanosick K, Speidel T, Borducchi EN, Murzda T, Maxfield L, Arduino R, McDermott AB, Gama L, Giorgi EE, Koup RA, Seaman MS, Rolle CP, DeJesus E, Li W, Korber B, Barouch DH. Safety and antiviral effect of a triple combination of HIV-1 broadly neutralizing antibodies: a phase 1/2a trial. Nat Med. 2024 Sep 12. doi: 10.1038/s41591-024-03247-5. Epub ahead of print. PMID: 39266747.

Patterns and predictors of COVID-19 vaccination among young adults at 44 US sites: Secondary analysis of a randomized, controlled, open-label trial, March – December 2021

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Vielot, N. A., Kelly, N. K., Ludema, C., Rosenberg, M., Brown, E. R., Janes, H. E., Kublin, J. G., Stephenson, K. E., Marcelin, J. R., & Pettifor, A. (2024). Patterns and predictors of COVID-19 vaccination among young adults at 44 US sites: Secondary analysis of a randomized, controlled, open-label trial, March – December 2021. Vaccine, 42(23), 126237. https://doi.org/10.1016/j.vaccine.2024.126237

Impact of LS Mutation on Pharmacokinetics of Preventive HIV Broadly Neutralizing Monoclonal Antibodies: A Cross-Protocol Analysis of 16 Clinical Trials in People without HIV

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Mayer BT, Zhang L, deCamp AC, Yu C, Sato A, Angier H, Seaton KE, Yates N, Ledgerwood JE, Mayer K, et al. Impact of LS Mutation on Pharmacokinetics of Preventive HIV Broadly Neutralizing Monoclonal Antibodies: A Cross-Protocol Analysis of 16 Clinical Trials in People without HIV. Pharmaceutics. 2024; 16(5):594. https://doi.org/10.3390/pharmaceutics16050594

Modeling resistance to the broadly neutralizing antibody PGT121 in people living with HIV-1

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Cassidy T, Stephenson KE, Barouch DH, Perelson AS (2024) Modeling resistance to the broadly neutralizing antibody PGT121 in people living with HIV-1. PLOS Computational Biology 20(3): e1011518. https://doi.org/10.1371/journal.pcbi.1011518

Efficacy of Messenger RNA–1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021

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Stephenson KE, Marcelin JR, Pettifor AE, Janes H, Brown E, Neradilek M, Yen C, Andriesen J, Grunenberg N, Espy N, Trahey M, Fischer RSB, DeSouza CA, Shisler JL, Connick E, Houpt ER, Chu HY, McCulloh RJ, Becker-Dreps S, Vielot NA, Kalbaugh CA, Cherabuddi K, Krueger KM, Rosenberg M, Greenberg RN, Joaquin A, Immergluck LC, Corey L, Kublin JG. Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021. Open Forum Infect Dis. 2023 Nov 2;10(11):ofad511. doi: 10.1093/ofid/ofad511. PMID: 38023544; PMCID: PMC10655942.

Activation of coagulation and proinflammatory pathways in thrombosis with thrombocytopenia syndrome and following COVID-19 vaccination

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Aid M, Stephenson KE, Collier AY, Nkolola JP, Michael JV, McKenzie SE, Barouch DH. Activation of coagulation and proinflammatory pathways in thrombosis with thrombocytopenia syndrome and following COVID-19 vaccination. Nat Commun. 2023 Oct 23;14(1):6703. doi: 10.1038/s41467-023-42559-x. PMID: 37872311; PMCID: PMC10593859.

Safety, tolerability, pharmacokinetics, and immunological activity of dual-combinations and triple-combinations of anti-HIV monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered intravenously to HIV-uninfected adults: a phase 1 randomised trial

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Sobieszczyk ME, Mannheimer S, Paez CA, Yu C, Gamble T, Theodore DA, Chege W, Yacovone M, Hanscom B, Heptinstall J, Seaton KE, Zhang L, Miner MD, Eaton A, Weiner JA, Mayer K, Kalams S, Stephenson K, Julg B, Caskey M, Nussenzweig M, Gama L, Barouch DH, Ackerman ME, Tomaras GD, Huang Y, Montefiori D; HVTN 130/HPTN 089 Study Team. Safety, tolerability, pharmacokinetics, and immunological activity of dual-combinations and triple-combinations of anti-HIV monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered intravenously to HIV-uninfected adults: a phase 1 randomised trial. Lancet HIV. 2023 Oct;10(10):e653-e662. doi: 10.1016/S2352-3018(23)00140-6. PMID: 37802566; PMCID: PMC10629933.https://www.sciencedirect.com/science/article/abs/pii/S2352301823001406?via%3Dihub

Safety and Immunogenicity of Ad26-Vectored HIV Vaccine With Mosaic Immunogens and a Novel Mosaic Envelope Protein in HIV-Uninfected Adults: A Phase 1/2a Study

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Daniel J Stieh, Dan H Barouch, Christy Comeaux, Michal Sarnecki, Kathryn E Stephenson, Stephen R Walsh, Sheetal Sawant, Jack Heptinstall, Georgia D Tomaras, James G Kublin, M Juliana McElrath, Kristen W Cohen, Stephen C De Rosa, Galit Alter, Guido Ferrari, David Montefiori, Philipp Mann, Steven Nijs, Katleen Callewaert, Paul A Goepfert, Srilatha Edupuganti, Etienne Karita, Michael S Seaman, Lawrence Corey, Lindsey R Baden, Maria G Pau, Hanneke Schuitemaker, Frank Tomaka, the ASCENT/HVTN118/HPX2003 Study Team , Safety and Immunogenicity of Ad26-Vectored HIV Vaccine With Mosaic Immunogens and a Novel Mosaic Envelope Protein in HIV-Uninfected Adults: A Phase 1/2a Study, The Journal of Infectious Diseases, Volume 227, Issue 8, 15 April 2023, Pages 939–950, https://doi.org/10.1093/infdis/jiac445

Durable Humoral and Cellular Immune Responses 8 Months after Ad26.COV2.S Vaccination

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Barouch DH, Stephenson KE, Sadoff J, Yu J, Chang A, Gebre M, McMahan K, Liu J, Chandrashekar A, Patel S, Le Gars M, de Groot AM, Heerwegh D, Struyf F, Douoguih M, van Hoof J, Schuitemaker H. Durable Humoral and Cellular Immune Responses 8 Months after Ad26.COV2.S Vaccination. N Engl J Med. 2021 Jul 14:NEJMc2108829. doi: 10.1056/NEJMc2108829. Epub ahead of print. PMID: 34260834; PMCID: PMC8314733.

Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19

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Stephenson KE, Le Gars M, Sadoff J, de Groot AM, Heerwegh D, Truyers C, Atyeo C, Loos C, Chandrashekar A, McMahan K, Tostanoski LH, Yu J, Gebre MS, Jacob-Dolan C, Li Z, Patel S, Peter L, Liu J, Borducchi EN, Nkolola JP, Souza M, Tan CS, Zash R, Julg B, Nathavitharana RR, Shapiro RL, Azim AA, Alonso CD, Jaegle K, Ansel JL, Kanjilal DG, Guiney CJ, Bradshaw C, Tyler A, Makoni T, Yanosick KE, Seaman MS, Lauffenburger DA, Alter G, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H, Barouch DH. Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. JAMA. 2021 Mar 11:e213645. doi: 10.1001/jama.2021.3645. Epub ahead of print. PMID: 33704352; PMCID: PMC7953339.