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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 randomized, double-blind, placebo-controlled, phase 1B/2A trial

The Lancet HIV Sep 05, 2021

Madhi SA, Koen AL, Izu A, et al. - In this ongoing, double-blind, placebo-controlled, phase 1B/2A trial (COV005), people with HIV showed good tolerability towards ChAdOx1 nCoV-19 (AZD1222) vaccine. The vaccine had favorable safety and immunogenicity with SARS-CoV-2 baseline-seropositive participants exhibiting heightened immunogenicity. Cross-reactive binding antibodies to the Beta variant and Asp614Gly wild-type were detected among people with HIV, and neutralization against beta retained among high responders.

  • Enrolled were 104 people with HIV and 70 HIV-negative individuals aged 18–65 years.

  • Participants were randomly allocated (1:1) to receive a prime-boost regimen of ChAdOx1 nCoV-19, with two doses given 28 days apart.

  • Vaccine-induced serum IgG responses against wild-type Wuhan-1 Asp614Gly (also known as D614G) developed among people with HIV and HIV-negative participants.

  • Higher antibody responses appeared after each vaccine dose among baseline SARS-CoV-2 seropositive people with HIV than those who were seronegative at baseline.

  • Regardless of HIV status, there was high-level binding antibody cross-reactivity for the full-length spike and receptor-binding domain of the beta variant (B.1.351).

  • Neutralizing activity against beta was retained in people with HIV who showed high titer responses; this was predominantly evident in those who were receptor-binding domain seropositive at enrolment.

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