At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,075 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.
A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa
In Brief
A Phase 2 clinical trial evaluating Ad26.ZEBOV, MVA-BN-Filo, and 1 other intervention for Hemorrhagic Fever, Ebola. Completed, enrolled 1,075 participants across 7 sites in 4 countries.
Detailed Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of three heterologous prime-boost regimens for Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo. The study will include healthy adults and elderly participants, HIV infected participants and healthy children in 2 age strata.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhagic Fever, Ebola
CountriesBurkina Faso, Côte d’Ivoire, Kenya, Uganda
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartNov 2015
Primary CompletionFeb 2019
TodayJul 2026
First PostedSep 30, 2015
Enrollment StartNov 6, 2015
Primary CompletionFeb 12, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.8 years ago
Interventions
Ad26.ZEBOVbiological
One 0.5 mL intramuscular (IM) injection of (5x10\*10 viral particles)
MVA-BN-Filobiological
One 0.5 mL IM injection of (1x10\*8 infectious units)
Placebobiological
One 0.5 mL IM injection of 0.9% saline