{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T19:37:00Z","timestamp":1772221020589,"version":"3.50.1"},"reference-count":17,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2025,6,11]],"date-time":"2025-06-11T00:00:00Z","timestamp":1749600000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Fundacion Huesped"},{"name":"CanSino Biologics Inc."}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"\n Background<\/jats:title>\n Despite higher risk of poorer outcomes and potential sub-optimal vaccine effectiveness, people living with HIV (PLWH) are underrepresented in SARS-CoV-2 vaccine trials. We evaluated the safety and immunogenicity of the Ad5-nCoV vaccine (CanSino Biologics Inc.\/The Beijing Institute of Biotechnology) in PLWH.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n In this single arm, open-label Phase 2b trial, PLWH were enrolled in Argentina. Participants received two doses of Ad5-nCoV vaccine (intramuscular, dosage 5x10\n 10<\/jats:sup>\n viral particles) at days 0 and 56. The primary outcomes were safety as serious adverse events [SAE], solicited and unsolicited local and systemic adverse events, impact on HIV viral load and CD4 counts and immunogenicity measured by S-RBD IgG and pseudo-virus neutralizing antibodies (nAbs) up to 52 weeks (ClinicalTrials.gov:NCT05005156).\n <\/jats:p>\n <\/jats:sec>\n \n Findings<\/jats:title>\n Between June 2021-January 2022, 140 PLWH received at least one dose of Ad5-nCoV vaccine. At baseline, the majority were on antiretroviral therapy (99.3%), virologically suppressed (93.6%), with a median (IQR) CD4-cell count:736 (531\u2013946) cells\/ul. At baseline, 38 (27%) participants were seropositive for S-RBD antibodies, and 40 (28%) for nAbs. There were no SAEs related to the vaccine. Solicited AE within 7 days after first and second dose occurred in 93 (69%) and 75 (60%) participants, mostly grade 1, included pain, drowsiness and headache. The incidence of unsolicited AE within 28 days of vaccination was 10.7%. There were no significant changes in plasma viral load, CD4 count, CD4\/CD8 ratio and no new AIDS-defining illnesses were reported. There were significant increases in the geometric mean titers (GMT) of S-RBD and nAbs between baseline to week 52. Seroconversion rates 28 days after the first and second doses (day 84) were 80% and 94% for S-RBD, and 35% and 78% for nAbs.<\/jats:p>\n <\/jats:sec>\n \n Interpretation<\/jats:title>\n The Ad5-nCoV vaccine was safe and induced an adequate immune response in virologically suppressed PLWH, maintaining high antibody titers at least during the first year post-vaccination. No significant changes were observed in plasma viral load, CD4 count and CD4\/CD8 ratio<\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pone.0312893","type":"journal-article","created":{"date-parts":[[2025,6,11]],"date-time":"2025-06-11T13:44:17Z","timestamp":1749649457000},"page":"e0312893","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Immune response induced by the recombinant novel coronavirus vaccine (Adenovirus type 5 vector) (Ad5-nCoV) in persons living with HIV (PLWH)"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9381-1931","authenticated-orcid":true,"given":"Pedro","family":"Cahn","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luis","family":"Barreto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Ines","family":"Figueroa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valeria","family":"Fink","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Jose","family":"Rolon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gustavo","family":"Lopardo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabel","family":"Cassetti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariela","family":"Ceschel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Patterson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luciana","family":"Gambardella","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gissella","family":"Mernies","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Agustin","family":"Nava","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinbo","family":"Gou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4110-6552","authenticated-orcid":true,"given":"Ruijie","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tao","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott A.","family":"Halperin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,6,11]]},"reference":[{"key":"pone.0312893.ref001","author":"WHO"},{"issue":"5","key":"pone.0312893.ref002","doi-asserted-by":"crossref","DOI":"10.1016\/S2352-3018(21)00070-9","article-title":"Overview of SARS-CoV-2 infection in adults living with HIV","volume":"8","author":"J Ambrosioni","year":"2021","journal-title":"Lancet HIV"},{"issue":"1","key":"pone.0312893.ref003","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1186\/s12981-021-00427-y","article-title":"Outcomes of patients with HIV and COVID-19 co-infection: a systematic review and meta-analysis","volume":"19","author":"C Danwang","year":"2022","journal-title":"AIDS Res Ther"},{"issue":"12","key":"pone.0312893.ref004","article-title":"Efficacy and safety of COVID-19 vaccines","volume":"12","author":"C Gra\u00f1a","year":"2022","journal-title":"Cochrane Database Syst Rev"},{"issue":"1","key":"pone.0312893.ref005","doi-asserted-by":"crossref","first-page":"200","DOI":"10.1186\/s12916-022-02397-y","article-title":"Effectiveness of COVID-19 vaccines against SARS-CoV-2 variants of concern: a systematic review and meta-analysis","volume":"20","author":"B Zeng","year":"2022","journal-title":"BMC Med"},{"issue":"2","key":"pone.0312893.ref006","doi-asserted-by":"crossref","first-page":"184","DOI":"10.1038\/s41423-023-01087-w","article-title":"The immune response to SARS-CoV-2 in people with HIV","volume":"21","author":"MA H\u00f6ft","year":"2024","journal-title":"Cell Mol Immunol"},{"issue":"8","key":"pone.0312893.ref007","doi-asserted-by":"crossref","DOI":"10.1016\/S2352-3018(21)00103-X","article-title":"Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in HIV infection: a single-arm substudy of a phase 2\/3 clinical trial","volume":"8","author":"J Frater","year":"2021","journal-title":"Lancet HIV"},{"issue":"9","key":"pone.0312893.ref008","doi-asserted-by":"crossref","DOI":"10.1016\/S2352-3018(21)00157-0","article-title":"Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B\/2A trial","volume":"8","author":"SA Madhi","year":"2021","journal-title":"Lancet HIV"},{"issue":"5","key":"pone.0312893.ref009","doi-asserted-by":"crossref","DOI":"10.1016\/S2352-3018(22)00041-8","article-title":"Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A\/2B trial","volume":"9","author":"SA Madhi","year":"2022","journal-title":"Lancet HIV"},{"issue":"10260","key":"pone.0312893.ref010","doi-asserted-by":"crossref","DOI":"10.1016\/S0140-6736(20)32156-5","article-title":"Use of adenovirus type-5 vectored vaccines: a cautionary tale","volume":"396","author":"SP Buchbinder","year":"2020","journal-title":"Lancet"},{"issue":"6","key":"pone.0312893.ref011","doi-asserted-by":"crossref","first-page":"765","DOI":"10.1093\/infdis\/jiq114","article-title":"An Ad5-vectored HIV-1 vaccine elicits cell-mediated immunity but does not affect disease progression in HIV-1-infected male subjects: results from a randomized placebo-controlled trial (the Step study)","volume":"203","author":"DW Fitzgerald","year":"2011","journal-title":"J Infect Dis"},{"issue":"10321","key":"pone.0312893.ref012","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1016\/S0140-6736(21)02753-7","article-title":"Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial","volume":"399","author":"SA Halperin","year":"2022","journal-title":"Lancet"},{"key":"pone.0312893.ref013","author":"R Foundation for Statistical Computing R"},{"key":"pone.0312893.ref014","doi-asserted-by":"crossref","first-page":"107065","DOI":"10.1016\/j.ijid.2024.107065","article-title":"SARS-CoV-2 mRNA vaccination and short-term changes in viral load and CD4\/CD8 T-cell counts in people living with HIV","volume":"144","author":"A Vergori","year":"2024","journal-title":"Int J Infect Dis"},{"issue":"1","key":"pone.0312893.ref015","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1111\/hiv.13537","article-title":"SARS-CoV-2 vaccine immunogenicity for people living with HIV: A systematic review and meta-analysis","volume":"25","author":"MH S\u00f8ndergaard","year":"2024","journal-title":"HIV Med"},{"issue":"9","key":"pone.0312893.ref016","doi-asserted-by":"crossref","first-page":"1569","DOI":"10.3390\/vaccines10091569","article-title":"Immunogenicity and Safety of COVID-19 Vaccines among People Living with HIV: A Systematic Review and Meta-Analysis","volume":"10","author":"L Kang","year":"2022","journal-title":"Vaccines (Basel)"},{"issue":"2","key":"pone.0312893.ref017","doi-asserted-by":"crossref","first-page":"381","DOI":"10.3201\/eid2902.221422","article-title":"Correlates of Protection, Thresholds of Protection, and Immunobridging among Persons with SARS-CoV-2 Infection","volume":"29","author":"DS Khoury","year":"2023","journal-title":"Emerg Infect Dis"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0312893","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,11]],"date-time":"2025-06-11T13:44:21Z","timestamp":1749649461000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0312893"}},"subtitle":[],"editor":[{"given":"Juan P.","family":"Jaworski","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,6,11]]},"references-count":17,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2025,6,11]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0312893","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2024.10.17.24315660","asserted-by":"object"}]},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,11]]}}}