At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 578 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, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo
In Brief
A Phase 2 clinical trial evaluating Ad26.ZEBOV, MVA-BN-Filo, and 1 other intervention for Hemorrhagic Fever, Ebola. Completed, enrolled 578 participants across 7 sites in 6 countries.
Detailed Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhagic Fever, Ebola
CountriesKenya, Mozambique, Nigeria, Tanzania, Uganda, United States
CollaboratorsWalter Reed Army Institute of Research (WRAIR)
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartDec 2015
Primary CompletionDec 2018
TodayJul 2026
First PostedNov 5, 2015
Enrollment StartDec 10, 2015
Primary CompletionDec 12, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.7 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 percent (%) saline.