Assessments of different batches and dose levels of a two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen.

ABSTRACT: Two phase 3 clinical studies were conducted in the USA to bridge across different Ad26.ZEBOV manufacturing processes and sites, and to evaluate the immunogenicity of different dose levels of Ad26.ZEBOV and MVA-BN-Filo. Study 1 evaluated the immunological equivalence of three batches of Ad26.ZEBOV administered as dose 1, followed by one batch of MVA-BN-Filo as dose 2. In Study 2, immunogenic non-inferiority of intermediate (Ad26.ZEBOV: 2 × 10¹⁰ viral particles [vp], MVA-BN-Filo: 5 × 10⁷ infectious units [Inf.U]) and low (8 × 10⁹ vp, 5 × 10⁷ Inf.U) doses of Ad26.ZEBOV and MVA-BN-Filo were evaluated against the full clinical dose (5 × 10¹⁰ vp, 1 × 10⁸ Inf.U). In Study 1, equivalence was demonstrated for two of three batch compa

SUBMITTER: Bockstal V 

PROVIDER: S-EPMC8688528 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature