AstraZeneca COVID-19 Vaccine Safe for People with HIV on ART

People with HIV who are well-controlled using antiretroviral therapy (ART) can safely receive the AstraZeneca COVID-19 vaccine, according to a paper published in The Lancet HIV.

Investigators from the University of Oxford conducted a phase 2/3 trial of adults aged 18 to 55 years with HIV in order to understand and explore the safety and immunogenicity of the AstraZeneca AZD1222 (ChAdOx1) vaccine for people with HIV. The participants were eligible for the trial if they were on ART with undetectable plasma HIV viral loads, plus CD4 counts of more than 350 cells per μL between November 5 and 24, 2020. Then, the participants received 2 doses of the AstraZeneca COVID-19 vaccine, with the doses spaced 4 to 6 weeks apart. The investigators compared all outcomes to a control group with the same ages and dosing strategies as the HIV group.

All 54 of the study participants with HIV were male, the study authors noted, with most self-reporting as White. The median age was 42.5 years.

The HIV-negative cohort included 50 participants (26 males, 24 females), and the median age was 38.5 years. A majority of the HIV-negative cohort also self-reported as White, the study authors reported.

The study authors reported no serious adverse events among the participants, though local and systemic reactions occurred during the first 7 days after the first dose, including pain at the injection site, fatigue, headache, malaise, chills, muscle ache, joint pain, and nausea. The frequencies of these side effects occurred similarly between the HIV and non-HIV group, the study authors reported.

Antibodies against COVID-19 spike protein peaked at Day 42, according to the study authors, and were sustained until Day 56, which was 2 weeks after the second dose. The study authors added that they observed no correlation between the magnitude of the anti-spike IgG response at Day 56 and the CD4 cell count or age.

At Days 14 and 28, the study authors found no difference in response among the HIV-negative cohort, but said that the responses of HIV-positive patients were significantly higher by Days 42 and 56. Additionally, at Day 56, the study authors observed no correlation with antibody response and CD4 count or age, they said.

“These preliminary data show that the ChAdOx1 nCoV-19 vaccine given as prime-boost dosing given 4–6 weeks apart was well tolerated and produced equivalent immune responses in people living with HIV who are well controlled on ART compared with a similar adult population without HIV,” the study authors concluded, while noting that the study is ongoing. “These findings suggest that no dose adjustment in the vaccine is needed for people with HIV on ART with CD4 counts of more than 350 cells per μL.”

The study authors also noted that their sample size (54 participants with HIV) was too small to report protection from infection. However, the measured immunological response they observed matched the measured response to similar, larger studies of HIV-negative participants. And, in those larger studies, evidence has been mounting that vaccination leads to a reduction in symptomatic cases and hospital admissions, even among COVID-19 variants, they wrote.

“Our findings of robust immune responses to the ChAdOx1 nCoV-19 vaccine, irrespective of HIV status, are encouraging, and reinforce the message that people living with HIV should be supported to receive vaccination.”