Overview
A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Three Age
Sponser
Jansenn & Jansenn
Principal Investigator
Abstract
Primary Objective: To assess the safety and tolerability of heterologous prime-boost regimens utilizing MVA-BN-Filo at a dose of 1x108 TCID50 (50% Tissue Culture Infective Dose) and d26.ZEBOV at a dose of 5x1010 vp(viral particles).
To assess humoral and cellular immune responses to the EBOV GP of the various regimens tested, as measured by virus neutralization assay, enzyme-linked immunosorbent assay (ELISA) and enzymelinked immunospot (ELISpot) assay.
