biostudies-literatureJulg BRagon Institute of MGH, MIT and Harvard (Ragon Institute)U.S. Department of Health & Human Services | NIH | National Institute of Allergy and Infectious DiseasesNIAID NIH HHSU.S. Department of Health & Human Services | NIH | National Institute of Allergy and Infectious Diseases (NIAID)Ragon Institute of MGH, MIT and Harvard89https://www.ebi.ac.uk/biostudies/studies/S-EPMC11116546biostudies-literatureUnknown9(1)Mosaic HIV-1 vaccines have been shown to elicit robust humoral and cellular immune responses in people living with HIV-1 (PLWH), that had started antiretroviral therapy (ART) during acute infection. We evaluated the safety and immunogenicity of 2 mosaic vaccine regimens in virologically suppressed individuals that had initiated ART during the chronic phase of infection, exemplifying the majority of PLWH. In this double-blind, placebo-controlled phase 1 trial (IPCAVD013/HTX1002) 25 ART-suppressed PLWH were randomized to receive Ad26.Mos4.HIV/MVA-Mosaic (Ad26/MVA) (n = 10) or Ad26.Mos4.HIV/Ad26.Mos4.HIV plus adjuvanted gp140 protein (Ad26/Ad26+gp140) (n = 9) or placebo (n = 6). Primary endpoints included safety and tolerability and secondary endpoints included HIV-specific binding and neutraNPJ vaccinesImmunogenicity of 2 therapeutic mosaic HIV-1 vaccine strategies in individuals with HIV-1 on antiretroviral therapy.PMC11116546R01 AI149670P01 AI177687AI149670AI169615AI164556AI128751U19 AI128751UM1 AI164556R01 AI138790Internal grantAI138790P01 AI169615AI177687Pattacini LWalker BDAnsel JLIlan SSchuitemaker HTomaka FJaegle KSeaman MSSpeidel TKanjilal DGWalsh SRvan Duijn JStieh DJWillems WBurgess EJulg BSabrina Tan CBartsch YBorducchi ENPau MGBarouch DHLavreys LYanosick KERobb MLNkolola JPSarnecki MMichael NLStephenson KEBraams EfalseImmunogenicity of 2 therapeutic mosaic HIV-1 vaccine strategies in individuals with HIV-1 on antiretroviral therapy.Mosaic HIV-1 vaccines have been shown to elicit robust humoral and cellular immune responses in people living with HIV-1 (PLWH), that had started antiretroviral therapy (ART) during acute infection. We evaluated the safety and immunogenicity of 2 mosaic vaccine regimens in virologically suppressed individuals that had initiated ART during the chronic phase of infection, exemplifying the majority of PLWH. In this double-blind, placebo-controlled phase 1 trial (IPCAVD013/HTX1002) 25 ART-suppressed PLWH were randomized to receive Ad26.Mos4.HIV/MVA-Mosaic (Ad26/MVA) (n = 10) or Ad26.Mos4.HIV/Ad26.Mos4.HIV plus adjuvanted gp140 protein (Ad26/Ad26+gp140) (n = 9) or placebo (n = 6). Primary endpoints included safety and tolerability and secondary endpoints included HIV-specific binding and neutra2024-01-01T00:00:00Z2024 May2026-07-15T09:24:46.994Z2026-07-02T03:11:20.484ZS-EPMC111165463878290210.1038/s41541-024-00876-2