NCT04228783

A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, Reactogenicity, and Consistency of a Heterologous 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN®-Filo in Adult Participants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 974 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ebola

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.ZEBOV	Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).
BIOLOGICAL	MVA-BN-Filo	Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.
BIOLOGICAL	Placebo	Participants will receive IM injection (0.5 mL) of placebo (0.9 % saline) as Dose 1 on Day 1, followed by placebo as Dose 2 on Day 57 (Groups 4 and 6) and a booster of matching placebo on Day 177 (Group 6).

Timeline

• Start date: 2020-02-18
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2020-01-14
• Last updated: 2025-05-25
• Results posted: 2023-05-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study