{"doi":"10.1038/s41541-024-00876-2","title":"Immunogenicity of 2 therapeutic mosaic HIV-1 vaccine strategies in individuals with HIV-1 on antiretroviral therapy","abstract":"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 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-γ 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.","journal":"npj Vaccines","year":2024,"id":454545,"datarank":0.32958368660043297,"base_score":2.1972245773362196,"endowment":2.1972245773362196,"self_citation_contribution":0.32958368660043297,"citation_network_contribution":0.0,"self_endowment_contribution":0.32958368660043297,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9483,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":242328,"name":"Kathryn E. Stephenson","orcid":"0000-0002-3440-4105","position":1,"is_corresponding":false},{"id":290304,"name":"Frank Tomaka","orcid":null,"position":2,"is_corresponding":false},{"id":3911,"name":"Stephen R. Walsh","orcid":"0000-0002-0817-9370","position":3,"is_corresponding":false},{"id":345903,"name":"Chen Sabrina Tan","orcid":"0000-0001-7604-0824","position":4,"is_corresponding":false},{"id":503684,"name":"Ludo Lavreys","orcid":null,"position":5,"is_corresponding":false},{"id":288611,"name":"Michal Sarnecki","orcid":"0000-0001-7035-0020","position":6,"is_corresponding":false},{"id":346718,"name":"Jessica L. Ansel","orcid":null,"position":7,"is_corresponding":false},{"id":345905,"name":"Diane G. Kanjilal","orcid":"0000-0001-7300-5556","position":8,"is_corresponding":false},{"id":346719,"name":"Kate Jaegle","orcid":null,"position":9,"is_corresponding":false},{"id":1162195,"name":"Tessa Speidel","orcid":"0009-0000-7590-4141","position":10,"is_corresponding":false},{"id":106501,"name":"Joseph P. Nkolola","orcid":"0000-0002-0678-9765","position":11,"is_corresponding":false},{"id":346720,"name":"Erica N. Borducchi","orcid":null,"position":12,"is_corresponding":false},{"id":1278477,"name":"Esmée Braams","orcid":null,"position":13,"is_corresponding":false},{"id":686503,"name":"Laura Pattacini","orcid":"0000-0003-1702-4781","position":14,"is_corresponding":false},{"id":1278045,"name":"Eleanor Burgess","orcid":"0009-0002-7007-4104","position":15,"is_corresponding":false},{"id":1278478,"name":"Shlomi Ilan","orcid":null,"position":16,"is_corresponding":false},{"id":108364,"name":"Yannic C. Bartsch","orcid":"0000-0002-3844-3056","position":17,"is_corresponding":false},{"id":346722,"name":"Katherine E. Yanosick","orcid":null,"position":18,"is_corresponding":false},{"id":16991,"name":"Michael S. Seaman","orcid":"0000-0001-6444-3562","position":19,"is_corresponding":false},{"id":288610,"name":"Daniel J Stieh","orcid":"0009-0003-8523-1528","position":20,"is_corresponding":false},{"id":1119750,"name":"Janine van Duijn","orcid":"0000-0002-5097-0713","position":21,"is_corresponding":false},{"id":1119751,"name":"Wouter Willems","orcid":"0009-0006-5831-3749","position":22,"is_corresponding":false},{"id":288619,"name":"Merlin L. Robb","orcid":"0000-0003-3949-9649","position":23,"is_corresponding":false},{"id":40990,"name":"Nelson L. Michael","orcid":"0000-0001-5882-5548","position":24,"is_corresponding":false},{"id":108341,"name":"Bruce D. Walker","orcid":"0000-0001-6122-9245","position":25,"is_corresponding":false},{"id":288615,"name":"Maria Grazia Pau","orcid":"0000-0002-8995-9693","position":26,"is_corresponding":false},{"id":40994,"name":"Hanneke Schuitemaker","orcid":"0000-0001-8563-2266","position":27,"is_corresponding":false},{"id":106527,"name":"Dan H. Barouch","orcid":"0000-0001-5127-4659","position":28,"is_corresponding":false},{"id":444560,"name":"Boris Jülg","orcid":null,"position":0,"is_corresponding":true}],"reference_count":28,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-19T02:03:12.720997Z","pmid":"38782902","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}