Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in children and adolescents in Africa: A randomized, placebo-controlled, multicenter phase 2 clinical trial

PLoS MedicineAnywaine Z, Barry H, Anzala O, et al. | January 13, 2022

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Researchers herein evaluated the safety, tolerability, and immunogenicity of the 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination regimen in healthy African children.

  • In this randomized, placebo-controlled, phase 2 clinical trial, researchers enrolled 131 adolescents (12 to 17 years old) and 132 children (4 to 11 years old) and randomized them 5:1 to receive study vaccines or placebo.

  • There was no report of any vaccine-related serious adverse event, and both adolescents and children showed induction of robust immune responses after receiving the active 2-dose regimen.

  • Per these findings, African adolescents and children at risk of Ebola infection should be administered the Ad26.ZEBOV, MVA-BN-Filo vaccination regimen.

  • Although protection against EVD was identified in a shorter time frame in correlation with receiving vaccination according to a 28-day regimen, vaccination according to a 56-day regimen induced higher EBOV GP binding and neutralizing antibody responses.

  • The finding that there was no impact of Ad26 preexisting immunity in the majority of participants on their EBOV GP-specific antibody responses post vaccination supports the use of this vaccine regimen even in regions with a high prevalence of preexisting Ad26 seropositivity.

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