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A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA‐BN‐Filo in Healthy Adult Participants

2015-09-09 01:23:23 | BioPortfolio

Summary

The purpose of this study is to demonstrate that 3 different batches of Ad26.ZEBOV as prime and a single batch of MVA‐BN‐Filo as boost at a 56 day interval induce an equivalent humoral immune response, in terms of humoral immune response against the Ebola virus (EBOV) GP (Glycoprotein) as measured by Enzyme‐linked Immunosorbent Assay (ELISA) at 21 days post‐boost.

Description

This is a randomized, double‐blind, placebo‐controlled, parallel‐group, multicenter, Phase 3 study to evaluate the immunogenic equivalence of a heterologous prime‐boost regimen using 3 different batches of Ad26.ZEBOV as prime and a single batch of MVA‐BN‐Filo as boost at a 56‐day interval in healthy adult participants. The study consists of a screening period of up to 6 weeks, a vaccination period in which participants will be vaccinated at baseline (Day 1), followed by a boost vaccination on Day 57, and a post-vaccination phase until the 42 day post‐boost visit (Day 99). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Ebola Vaccine

Intervention

Ad26.ZEBOV‐Batch #1, Ad26.ZEBOV‐Batch #2, Ad26.ZEBOV‐Batch #3, MVA‐BN‐Filo, Placebo

Location

Huntsville
Alabama
United States

Status

Not yet recruiting

Source

Crucell Holland BV

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-09T01:23:23-0400

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