Safety and Immunogenicity of the ChAdOx1 nCov-19 (AZD11222) vaccine against SARS-Cov-2 in HIV infection: a single-arm substudy of a phase 2/3 clinical trial

June 18, 2021

Prof John Frater, PhD, Katie J Ewer, PhD, Ane, Ogbe, PhD, Matthew Pace, PhD, Sandra Adele, MSc, Emily Adland, DPhil, et al.

The Lancet

Researchers sought to understand the safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine in individuals with HIV on successful antiretroviral therapy (ART) in comparison to those without HIV. Participants were selected using the inclusion criteria of age (18-55 years old), positive HIV status with suppression of viral loads via ART, and a CD4 count of more than 350 cells per microliter. From Nov 5 - Nov 24, 2020, 54 male participants of predominantly White European decent received two doses of the vaccine 4-6 weeks apart. Results showed no serious adverse events and mild to moderate symptoms comparable to HIV negative individuals, including pain at vaccination site, headache, fatigue, chills, malaise, joint pain, malaise, muscle aches, and nausea. Additionally, antibody levels against the spike protein were the same in those with and without HIV at days 14 and 28 but were significantly higher for the HIV positive cohort at days 42 and 56. T-cell counts peaked at days 14 and 28 but no difference was found in ELISpot responses in HIV positive and negative individuals. Overall, these results show no significant difference in serological and cell-mediated response and a similar reactogenicity to the vaccine, signifying safe use of vaccines and no necessity for a dosage change in this population of individuals living with HIV.

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