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A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

2015-04-13 09:55:17 | BioPortfolio

Summary

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult participants.

Description

This study consists of 2 parts: a) First part with standard doses and b) Second part with higher doses. Both parts are randomized, placebo-controlled, observer-blind study to evaluate the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different doses, sequences and schedules to healthy adult participants. The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29, or 57, and a post-boost follow-up period until all participants have had their 21-day post-boost visit (Day 36, Day 50, or Day 78). The total duration of the study will be about 1 year for participants who received vaccine and about 3 months for participants who received placebo. Safety will be monitored during the study.

Study Design

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

Conditions

Healthy

Intervention

MVA-BN-filo, Ad26. ZEBOV, Placebo

Location

Rockville
Maryland
United States

Status

Recruiting

Source

Crucell Holland BV

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-04-13T09:55:17-0400

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