Trial reportPloS one2025
Immune response induced by the recombinant novel coronavirus vaccine (Adenovirus type 5 vector) (Ad5-nCoV) in persons living with HIV (PLWH).
Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05005156 (A Phase IIb Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Two Doses of Recombinant Novel Coronavirus Vaccine), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Phase IIb Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Two Doses of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Adults 18 Years of Age and Older, Living With HIV.
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Authors and funding
16 authors.
Funding
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Abstract
backgroundDespite 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.
methodsIn this single arm, open-label Phase 2b trial, PLWH were enrolled in Argentina. Participants received two doses of Ad5-nCoV vaccine (intramuscular, dosage 5x1010 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).
findingsBetween 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 (531-946) 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.
interpretationThe 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.
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