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.
-
Exclusive Write-ups & Webinars by KOLs
-
Daily Quiz by specialty
-
Paid Market Research Surveys
-
Case discussions, News & Journals' summaries