Prime-boost Regimen of AstraZeneca COVID-19 Vaccine Safe and Effective in People with HIV

Pavankumar Kamat

Disclosures

June 24, 2021

Takeaway

  • The ChAdOx1 nCoV-19 (AZD1222) vaccine given as a prime-boost regimen was well tolerated and produced similar immune responses in individuals with human immunodeficiency virus (HIV) well controlled on antiretroviral therapy (ART) vs those without HIV.

Why this matters

  • Findings support the need for vaccination against SARS-CoV-2, without any dose adjustment of the ChAdOx1 nCoV-19 vaccine, in people with HIV.

Study details

  • This single-arm, open-label sub-study of the phase 2/3 COV002 trial included 54 patients (age, 18-55 years) with HIV who were stable on ART with plasma HIV viral load of <50 copies/mL and a CD4 count of >350 cells/µL.

  • Patients were administered a prime-boost regimen of ChAdOx1 nCoV-19 vaccine 4-6 weeks apart.

  • Funding: UK Research and Innovation, Engineering and Physical Sciences Research Council, Coalition for Epidemic Preparedness Innovations, National Institute for Health Research (NIHR), Thames Valley and South Midland’s NIHR Clinical Research Network, NIHR Oxford Biomedical Research Centre and AstraZeneca.

Key results

  • No serious adverse events were reported.

  • Local and systemic reactions after prime dose included pain at vaccination site (49%), headache (47%), fatigue (47%), chills (23%), joint pain (9%), malaise (34%), feverish (19%) and nausea (8%).

  • Antibodies against the SARS-CoV-2 spike protein peaked at day 42 (median, 1440 ELISA units [EUs]; interquartile range [IQR], 704-2728) and were sustained until day 56 (median, 941 EUs; IQR, 531-1445).

  • No correlation was observed between antibody response at day 56 and CD4 cell count (P=.93) or age (P=.48).

  • Patients with HIV vs those without had no difference in SARS-CoV-2 spike-specific serological or cellular immune responses (P>.05).

Limitations

  • Preliminary data.

  • Open-label, single-arm study.

  • Predominantly White male population.
     

 

Frater J, Ewer KJ, Ogbe A, Pace M, Adele S, Adland E, Alagaratnam J, Aley PK, Ali M, Ansari MA, Bara A, Bittaye M, Broadhead S, Brown A, Brown H, Cappuccini F, Cooney E, Dejnirattisai W, Dold C, Fairhead C, Fok H, Folegatti PM, Fowler J, Gibbs C, Goodman AL, Jenkin D, Jones M, Makinson R, Marchevsky NG, Mujadidi YF, Nguyen H, Parolini L, Petersen C, Plested E, Pollock KM, Ramasamy MN, Rhead S, Robinson H, Robinson N, Rongkard P, Ryan F, Serrano S, Tipoe T, Voysey M, Waters A, Zacharopoulou P, Barnes E, Dunachie S, Goulder P, Klenerman P, Screaton GR, Winston A, Hill AVS, Gilbert SC, Pollard AJ, Fidler S, Fox J, Lambe T. 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. Lancet HIV. 2021 Jun 18 [Epub ahead of print]. doi: 10.1016/S2352-3018(21)00103-X. PMID: 34153264.  View full text

This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.

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