CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 423 enrolled
Drug / intervention
MVA-BN-Filo +2 morebiological
Likely dose
MVA-BN-Filo 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02416453
NCT02416453Phase 2Completed

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 in Europe

Janssen Vaccines & Prevention B.V.·interventional·Posted Apr 15, 2015·Updated Feb 8, 2021

In Brief

A Phase 2 clinical trial evaluating MVA-BN-Filo, Ad26.ZEBOV, and 1 other intervention for Ebola Viral Disease. Completed, enrolled 423 participants across 11 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, United Kingdom

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 15, 2015
Enrollment StartJun 15, 2015
Primary CompletionJan 19, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.2 years ago

Interventions

MVA-BN-Filobiological

One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit \[Inf. U.\] on Day 29, 57, or 85.

Ad26.ZEBOVbiological

One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.

Placebobiological

One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.