Phase 2
N=4,786
Partnership for Research on Ebola VACcinations
Ebola Virus Disease
Bottom Line
View on ClinicalTrials.gov: NCT02876328 ↗Enrolled (actual)
4,786
Serious AEs
2.2%
Results posted
Sep 2022
Primary outcome: Primary: Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response — 40.9; 75.7; 81.1; 2.7 percentage of participants — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ad26.ZEBOV (Biological); MVA-BN-Filo (Biological); rVSVΔG-ZEBOV-GP (Biological); Placebo (Biological); rVSV boost (Biological)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response |
40.9; 75.7; 81.1; 2.7; 78.5; 87.3 | <.001 sig |
| SECONDARY Frequency of Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Number of Participants With Ebola Virus Glycoprotein (GP-EBOV) Antibody Response |
— | — |
Summary
The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.
Eligibility Criteria
Inclusion Criteria
- Informed consent/assent
- Age greater than or equal to 1 year
- Planned residency in the area of the study site for the next 12 months
- Willingness to comply with the protocol requirements
Exclusion Criteria
- Fever greater than 38º Celsius
- History of EVD (self-report)
- Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
- Positive HIV test for participants less than 18 years of age
- Reported current breast-feeding
- Prior vaccination against Ebola (self-report)
- Any vaccination in the past 28 days or planned within the 28 days after randomization (initial vaccination)
- In the judgement of the clinician, any clinically significant acute/chronic condition that would limit the ability of the participant to meet the requirements of the study protocol
Inclusion Criteria for Revaccination Post 12 Month Visit:
- Participants who received the placebo
- Participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy
Temporary Exclusion Criteria for Revaccination Post 12 Month Visit:
- Fever greater than 38º Celsius
- Pregnancy (a negative urine pregnancy test is required for females of child-bearing potential, i.e., females who have experienced menarche or who are aged 14 years and older)
- Reported current breast-feeding (self-report)
- Any vaccination in the past 28 days or planned within the 28 days after trial vaccination
Exclusion Criteria for Revaccination Post 12 Month Visit:
- EVD notified in the electronic case report form
- For minor participants: change in HIV status since enrollment (self-report)
- Previous Ebola vaccination outside of the study including incomplete vaccine strategies
- Known medical history or significant risk factors for a thrombotic and/or thrombocytopenic event (for participants who will receive the Ad26.ZEBOV or MVA-BN-Filo vaccine)
Data sourced from ClinicalTrials.gov (NCT02876328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.