CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,023 enrolled
Drug / intervention
Ad26.ZEBOV +3 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/NCT02509494
NCT02509494Phase 3Completed
CompareCT.gov

A Staged Phase 3 Study, Including a Double-Blinded Controlled Stage to Evaluate the Safety and Immunogenicity of Ad26.ZEBOV and MVA-BN-Filo as Candidate Prophylactic Vaccines for Ebola

Janssen Vaccines & Prevention B.V.·interventional·Posted Jul 28, 2015·Updated Jul 18, 2022

In Brief

A Phase 3 clinical trial evaluating Ad26.ZEBOV, MVA-BN-Filo, and 2 other interventions for Ebola Virus Disease. Completed, enrolled 1,023 participants across 1 site.

Detailed Summary

The purpose of this study is the evaluation of the safety and immunogenicity of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a 2-dose heterologous regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEbola Virus Disease
CountriesSierra Leone
CollaboratorsLondon School of Hygiene and Tropical Medicine, Ministry of Health and Sanitation, Sierra Leone, University of Sierra Leone, University of Oxford, Institut National de la Santé Et de la Recherche Médicale, France, Grameen Foundation, World Vision, Ireland

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 28, 2015
Enrollment StartSep 30, 2015
Primary CompletionJun 28, 2019
Study CompletionJul 3, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.9 years ago

Interventions

Ad26.ZEBOVbiological

Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles.

MVA-BN-Filobiological

MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1\*10\^8 Infectious Unit (Inf. U.).

MenACWYbiological

MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.

Placebobiological

0.9% saline for injection.