A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants
Summary
The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response.
Timeline
- Start
- 2020-02-18
- Primary completion
- 2022-04-25
- Completion
- 2022-04-25
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (equivalence test); Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1) vs Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2); Ratio of GMCs 0.9 (95% CI 0.8 to 1.1) NCT04228783 ↗
registry analysis (equivalence test); Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2) vs Ad26.ZEBOV(Lot C), MVA-BN-Filo (Lot 3) (Group 3); Ratio of GMCs 1.0 (95% CI 0.9 to 1.2) NCT04228783 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad26.ZEBOV | Vaccine | 5e+10 unknown | Intramuscular |
| Subject | MVA-BN-Filo | Vaccine | 1e+08 unknown | Intramuscular |