Phase 3
N=1,018
Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
Ebola Virus Disease
Bottom Line
View on ClinicalTrials.gov: NCT02509494 ↗Enrolled (actual)
1,018
Serious AEs
4.6%
Results posted
Jul 2022
Primary outcome: Primary: Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) — 12; 51; 17; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ad26.ZEBOV (Biological); MVA-BN-Filo (Biological); MenACWY (Biological); Placebo (Biological)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stages 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) (Day 8) |
12; 51; 17; 14; 3; 30 | — |
| PRIMARY Stages 1 and 2: Number of Participants With Solicited Local AEs (Day 64) |
6; 58; 8; 21; 1; 22 | — |
| PRIMARY Stage 1: Number of Participants With Solicited Local AEs (Day 738) |
5 | — |
| PRIMARY Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 8) |
18; 161; 51; 52; 14; 45 | — |
| PRIMARY Stages 1 and 2: Number of Participants With Solicited Systemic AEs (Day 64) |
17; 107; 39; 26; 6; 27 | — |
| PRIMARY Stage 1: Number of Participants With Solicited Systemic AEs (Day 738) |
9 | — |
| PRIMARY Stages 1: Number of Participants With Serious Adverse Events (SAEs) |
3 | — |
| PRIMARY Stages 2: Number of Participants With SAEs |
16; 4; 0; 1; 5; 0 | — |
| PRIMARY Stage 1: Number of Participants With Unsolicited AEs (Day 759) |
5 | — |
| PRIMARY Stage 1: Number of Participants With Unsolicited AEs (Day 29) |
17 | — |
| PRIMARY Stage 2: Number of Participants With Unsolicited AEs (Day 29) |
198; 65; 54; 20; 60; 18 | — |
| PRIMARY Stage 1: Number of Participants With Unsolicited AEs (Day 85) |
17 | — |
| PRIMARY Stage 2: Number of Participants With Unsolicited AEs (Day 85) |
145; 48; 49; 13; 46; 13 | — |
| PRIMARY Stage 1: Number of Participants With Deaths |
— | — |
| PRIMARY Stage 2: Number of Participants With Deaths (Children and Adolescents) |
0; 1; 0; 0; 1; 0 | — |
| PRIMARY Stage 2: Number of Participants With Deaths (Adults) |
1; 0 | — |
| PRIMARY Stage 1: Number of Participants With Immediate Reportable Event (IREs) |
— | — |
| PRIMARY Stage 2: Number of Participants With IREs (Children and Adolescents) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Stage 2: Number of Participants With IREs (Adults) |
0; 0 | — |
| SECONDARY Stages 1 and 2: Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Enzyme-linked Immunosorbent Assay (ELISA) |
4784; 3810; 50; 9929; 74; 10212 | — |
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.
Eligibility Criteria
Inclusion Criteria Stage 1 and 2:
- Documented community engagement from community leader and a signed inform consent form (ICF) from each participant must be available
- Participant Stage 1 must be 18 years or older at screening and be resident in selected study community with no intention to move from study area within the next 5 months
- Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before Dose 1 vaccination
- Female participants of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination
- Participant must pass the test of understanding (TOU)
Additional Inclusion criteria Stage 2:
- One year or older at screening (children of enrolled parents are eligible)
- Parent/legal guardian (for children) must pass the TOU before signing the ICF
- Subjects aged 7 years and older will be asked to give positive assent in the presence of a witness
Exclusion Criteria
- Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of >= 38 degree Celsius (fever)
- Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia)
- Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine
- Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before Dose 1 vaccination
- Treated with an immunosuppressive drug at the time of screening
Additional exclusion criteria:
- Children up to 5 years of age with severe malnutrition (underweight or Z-score weight <2)
Data sourced from ClinicalTrials.gov (NCT02509494). 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.