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Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected adults: A randomized, placebo-controlled phase 2 clinical trial in Africa

PLoS Medicine Nov 04, 2021

Barry H, Mutua G, Kibuuka H, et al. - The Ebola vaccination regimen consisting of Ad26.ZEBOV and MVA-BN-Filo is demonstrated as safe and immunogenic in healthy and HIV-infected adults. The regimen induces immune memory that can rapidly be reactivated.

  • The urgent medical need during the 2014 to 2016 outbreak led to the acceleration of the clinical development of the 2-dose vaccine regimen consisting of Ad26.ZEBOV and MVA-BN-Filo.

  • As part of this accelerated program, the phase 2 study was performed to determine the safety and immunogenicity of the 2-dose vaccine regimen in healthy and HIV-infected African adults, with 28-, 56-, and 84-day intervals between doses.

  • Safety and immunogenicity of a booster vaccination with Ad26.ZEBOV, administered nearly 1 year after the first vaccination, were evaluated in healthy adults in this amended study.

  • In this randomized trial, 668 healthy 18- to 70-year-olds and 142 HIV-infected 18- to 50-year-olds were randomized to receive intramuscular Ad26.ZEBOV followed by MVA-BN-Filo at 28-, 56-, or 84-day intervals, or saline.

  • Participants showed good tolerability towards the vaccine regimen.

  • The regimen induced marked immune responses.

  • The highest humoral responses were detected after vaccination with 56-day and 84-day intervals.

  • Receipt of Ad26.ZEBOV as booster at 1 year after the first dose was linked with induction of anamnestic responses in all healthy participants.

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