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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) (<jats:italic>n<\/jats:italic>\u2009=\u200910) or Ad26.Mos4.HIV\/Ad26.Mos4.HIV plus adjuvanted gp140 protein (Ad26\/Ad26+gp140) (<jats:italic>n<\/jats:italic>\u2009=\u20099) or placebo (<jats:italic>n<\/jats:italic>\u2009=\u20096). Primary endpoints included safety and tolerability and secondary endpoints included HIV-specific binding and neutralizing antibody titers and HIV-specific T cell responses. Both vaccine regimens were well tolerated with pain\/tenderness at the injection site and fatigue, myalgia\/chills and headache as the most commonly reported solicited local and grade 3 systemic adverse events, respectively. In the Ad26\/Ad26+gp140 group, Env-specific IFN-\u03b3 T cell responses showed a median 12-fold increase while responses to Gag and Pol increased 1.8 and 2.4-fold, respectively. The breadth of T cell responses to individual peptide subpools increased from 11.0 pre-vaccination to 26.0 in the Ad26\/Ad26+gp140 group and from 10.0 to 14.5 in the Ad26\/MVA group. Ad26\/Ad26+gp140 vaccination increased binding antibody titers against vaccine-matched clade C Env 5.5-fold as well as augmented neutralizing antibody titers against Clade C pseudovirus by 7.2-fold. Both vaccine regimens were immunogenic, while the addition of the protein boost resulted in additional T cell and augmented binding and neutralizing antibody titers. These data suggest that the Ad26\/Ad26+gp140 regimen should be tested further.<\/jats:p>","DOI":"10.1038\/s41541-024-00876-2","type":"journal-article","created":{"date-parts":[[2024,5,23]],"date-time":"2024-05-23T08:03:05Z","timestamp":1716451385000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Immunogenicity of 2 therapeutic mosaic HIV-1 vaccine strategies in individuals with HIV-1 on antiretroviral therapy"],"prefix":"10.1038","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4687-9626","authenticated-orcid":false,"given":"Boris","family":"Julg","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3440-4105","authenticated-orcid":false,"given":"Kathryn 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B.V. and D.H.B. is a coinventor on HIV-1 vaccine antigen patents that have been licensed to Janssen Vaccines & Prevention. B.V., F.T., M.S., E.B., L.P., D.J.S., J.D., W.W., M.G.P., and H.S. are\/were employees of Janssen, pharmaceutical companies of Johnson & Johnson. L.L. is a consultant to Janssen, pharmaceutical companies of Johnson & Johnson. S.R.W. has received institutional grants or contracts from Sanofi Pasteur, Janssen Vaccines\/Johnson & Johnson, Moderna, Pfizer, Vir Biotechnology, and Worcester HIV Vaccine; has participated on data safety monitoring or advisory boards for Janssen Vaccines\/Johnson & Johnson; and his spouse holds stock\/stock options in Regeneron Pharmaceuticals. B.J. is an employee and equity holder of Leyden Laboratories B.V., a company developing respiratory virus prevention therapeutics and his spouse is an employee of and holds stock\/stock options in Moderna Inc. All other authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"89"}}