CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 108 enrolled
Drug / intervention
Ad26.ZEBOV +2 morebiological
Likely dose
Ad26.ZEBOV 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/NCT03929757
NCT03929757Phase 2Completed
CompareCT.gov

A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV and MVA-BN®-Filo in Infants Aged 4-11 Months in Guinea and Sierra Leone

Janssen Vaccines & Prevention B.V.·interventional·Posted Apr 29, 2019·Updated May 25, 2025

In Brief

A Phase 2 clinical trial evaluating Ad26.ZEBOV, MVA-BN-Filo, and 1 other intervention for Ebola Virus Disease. Completed, enrolled 108 participants across 2 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively (Main Study) and also to provide the heterologous 2-dose vaccination regimen (Ad26.ZEBOV on Day 1 and MVABN-Filo on Day 57) to participants in the control arm of the main study (Extension Phase).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEbola Virus Disease
CountriesGuinea, Sierra Leone
CollaboratorsLondon School of Hygiene and Tropical Medicine, University of Sierra Leone, Institut National de la Santé Et de la Recherche Médicale, France

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 29, 2019
Enrollment StartAug 19, 2019
Primary CompletionAug 22, 2022
Study CompletionSep 28, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.2 years ago

Interventions

Ad26.ZEBOVbiological

Participants will receive 0.5 mL IM injection of Ad26.ZEBOV as first vaccination.

MVA-BN-Filobiological

Participants will receive 0.5 mL IM injection of MVA-BN-Filo as second vaccination.

MenACWYbiological

Participants will receive 0.5 mL IM injection of MenACWY.