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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.
Edupuganti S, Hurt CB, Stephenson KE, Huang Y, Paez CA, Yu C, Yen C, Hanscom B, He Z, Miner MD, Gamble T, Heptinstall J, Seaton KE, Domin E, Lin BC, McKee K, Doria-Rose N, Regenold S, Spiegel H, Anderson M, McClosky N, Zhang L, Piwowar-Manning E, Ackerman ME, Pensiero M, Dye BJ, Landovitz RJ, Mayer K, Siegel M, Sobieszczyk M, Walsh SR, Gama L, Barouch DH, Montefiori DC, Tomaras GD; HVTN 136/HPTN 092 Study Team. Edupuganti S, et al. Among authors: pensiero m. Lancet HIV. 2024 Dec 9:S2352-3018(24)00247-9. doi: 10.1016/S2352-3018(24)00247-9. Online ahead of print. Lancet HIV. 2024. PMID: 39667379
Safety and immunogenicity of a polyvalent DNA-protein HIV vaccine with matched Env immunogens delivered as a prime-boost regimen or coadministered in HIV-uninfected adults in the USA (HVTN 124): a phase 1, placebo-controlled, double-blind randomised controlled trial.
Frank I, Li SS, Grunenberg N, Overton ET, Robinson ST, Zheng H, Seaton KE, Heptinstall JR, Allen MA, Mayer KH, Culver DA, Keefer MC, Edupuganti S, Pensiero MN, Mehra VL, De Rosa SC, Morris DE, Wang S, Seaman MS, Montefiori DC, Ferrari G, Tomaras GD, Kublin JG, Corey L, Lu S; HVTN 124 Study Team. Frank I, et al. Among authors: pensiero mn. Lancet HIV. 2024 May;11(5):e285-e299. doi: 10.1016/S2352-3018(24)00036-5. Lancet HIV. 2024. PMID: 38692824 Clinical Trial.
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.
Mayer BT, Zhang L, deCamp AC, Yu C, Sato A, Angier H, Seaton KE, Yates N, Ledgerwood JE, Mayer K, Caskey M, Nussenzweig M, Stephenson K, Julg B, Barouch DH, Sobieszczyk ME, Edupuganti S, Kelley CF, McElrath MJ, Gelderblom HC, Pensiero M, McDermott A, Gama L, Koup RA, Gilbert PB, Cohen MS, Corey L, Hyrien O, Tomaras GD, Huang Y. Mayer BT, et al. Among authors: pensiero m. Pharmaceutics. 2024 Apr 27;16(5):594. doi: 10.3390/pharmaceutics16050594. Pharmaceutics. 2024. PMID: 38794258 Free PMC article.
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.
Tieu HV, Karuna S, Huang Y, Sobieszczyk ME, Zheng H, Tomaras GD, Montefiori DC, Shen M, DeRosa S, Cohen K, Isaacs MB, Regenold S, Heptinstall J, Seaton KE, Sawant S, Furch B, Pensiero M, Corey L, Bar KJ; HVTN 122 Study Team. Tieu HV, et al. Among authors: pensiero m. Vaccine. 2023 Oct 6;41(42):6309-6317. doi: 10.1016/j.vaccine.2023.07.046. Epub 2023 Sep 9. Vaccine. 2023. PMID: 37679276 Free PMC article. Clinical Trial.
Trivalent mosaic or consensus HIV immunogens prime humoral and broader cellular immune responses in adults.
Cohen KW, Fiore-Gartland A, Walsh SR, Yusim K, Frahm N, Elizaga ML, Maenza J, Scott H, Mayer KH, Goepfert PA, Edupuganti S, Pantaleo G, Hutter J, Morris DE, De Rosa SC, Geraghty DE, Robb ML, Michael NL, Fischer W, Giorgi EE, Malhi H, Pensiero MN, Ferrari G, Tomaras GD, Montefiori DC, Gilbert PB, McElrath MJ, Haynes BF, Korber BT, Baden LR; NIAID HVTN 106 Study Group. Cohen KW, et al. Among authors: pensiero mn. J Clin Invest. 2023 Feb 15;133(4):e163338. doi: 10.1172/JCI163338. J Clin Invest. 2023. PMID: 36787249 Free PMC article. Clinical Trial.
Cellular and humoral responses to an HIV DNA prime by electroporation boosted with recombinant vesicular stomatitis virus expressing HIV subtype C Env in a randomized controlled clinical trial.
Wilson GJ, Rodriguez B, Li SS, Allen M, Frank I, Rudnicki E, Trahey M, Kalams S, Hannaman D, Clarke DK, Xu R, Egan M, Eldridge J, Pensiero M, Latham T, Ferrari G, Montefiori DC, Tomaras GD, De Rosa SC, Jacobson JM, Miner MD, Elizaga M; HIV Vaccine Trials Network 112 Protocol Team. Wilson GJ, et al. Among authors: pensiero m. Vaccine. 2023 Apr 17;41(16):2696-2706. doi: 10.1016/j.vaccine.2023.03.015. Epub 2023 Mar 17. Vaccine. 2023. PMID: 36935288 Free PMC article. Clinical Trial.
Focusing HIV-1 Gag T cell responses to highly conserved regions by DNA vaccination in HVTN 119.
Kalams SA, Felber BK, Mullins JI, Scott HM, Allen MA, De Rosa SC, Heptinstall J, Tomaras GD, Hu J, DeCamp AC, Rosati M, Bear J, Pensiero MN, Eldridge J, Egan MA, Hannaman D, McElrath MJ, Pavlakis GN; HIV Vaccine Trials Network 119(HVTN 119) Study Team. Kalams SA, et al. Among authors: pensiero mn. JCI Insight. 2024 Aug 1;9(18):e180819. doi: 10.1172/jci.insight.180819. JCI Insight. 2024. PMID: 39088271 Free PMC article. Clinical Trial.
Robust antibody and cellular responses induced by DNA-only vaccination for HIV.
De Rosa SC, Edupuganti S, Huang Y, Han X, Elizaga M, Swann E, Polakowski L, Kalams SA, Keefer MC, Maenza J, Lu Y, Wise MC, Yan J, Morrow MP, Khan AS, Boyer JD, Humeau L, White S, Pensiero M, Sardesai NY, Bagarazzi ML, Weiner DB, Ferrari G, Tomaras GD, Montefiori DC, Corey L, McElrath MJ; HIV Vaccine Trials Network (HVTN) 098 Study Team. De Rosa SC, et al. Among authors: pensiero m. JCI Insight. 2020 Jul 9;5(13):e137079. doi: 10.1172/jci.insight.137079. JCI Insight. 2020. PMID: 32437332 Free PMC article.
Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines.
Laher F, Moodie Z, Cohen KW, Grunenberg N, Bekker LG, Allen M, Frahm N, Yates NL, Morris L, Malahleha M, Mngadi K, Daniels B, Innes C, Saunders K, Grant S, Yu C, Gilbert PB, Phogat S, DiazGranados CA, Koutsoukos M, Van Der Meeren O, Bentley C, Mkhize NN, Pensiero MN, Mehra VL, Kublin JG, Corey L, Montefiori DC, Gray GE, McElrath MJ, Tomaras GD. Laher F, et al. Among authors: pensiero mn. PLoS Med. 2020 Feb 24;17(2):e1003038. doi: 10.1371/journal.pmed.1003038. eCollection 2020 Feb. PLoS Med. 2020. PMID: 32092060 Free PMC article. Clinical Trial.
HIV-1 Vaccine Sequences Impact V1V2 Antibody Responses: A Comparison of Two Poxvirus Prime gp120 Boost Vaccine Regimens.
Shen X, Laher F, Moodie Z, McMillan AS, Spreng RL, Gilbert PB, Huang Y, Yates NL, Grunenberg N, Juliana McElrath M, Allen M, Pensiero M, Mehra VL, Der Meeren OV, Barnett SW, Phogat S, Gray GE, Bekker LG, Corey L, Tomaras GD. Shen X, et al. Among authors: pensiero m. Sci Rep. 2020 Feb 7;10(1):2093. doi: 10.1038/s41598-020-57491-z. Sci Rep. 2020. PMID: 32034163 Free PMC article.
42 results