NCT02543567

A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate A Range of Dose Levels of a Heterologous Prime-Boost Regimen of Ad26.ZEBOV and MVA-BN®-Filo in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 525 (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 the non-inferiority of a heterologous prime-boost regimen using Ad26.ZEBOV as prime and MVA-BN-Filo as boost administered at different doses at a 56-day interval versus the same regimen with the recently released batches of Ad26.ZEBOV and MVA-BN-Filo in terms of humoral immune response against the Ebola virus (EBOV) GP (glycoprotein) as measured by enzyme-linked immunosorbent assay (ELISA) at 21 days post boost.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate safety and immunogenicity of Ad26.ZEBOV and MVA-BN-Filo at different dose levels, administered to healthy adults participants. The study consists of a Screening period of up to 6 weeks, vaccinations on Day 1 and Day 57, and a post-vaccination phase until the 6 months post-boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.ZEBOV 5*10^10 viral particles (vp)	Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
BIOLOGICAL	Ad26.ZEBOV 2*10^10 (vp)	Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2\*10\^10 viral particles on Day 1
BIOLOGICAL	Ad26.ZEBOV 0.8*10^10 (vp)	Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8\*10\^10 viral particles on Day 1
BIOLOGICAL	MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]	MVA-BN-Filo- live replication incompetent vaccine, IM injection of 1\*10\^8 Infectious Unit \[Inf. U.\] once on Day 57
BIOLOGICAL	MVA-BN-Filo 5*10^7 Inf. U.	MVA-BN-Filo- live replication incompetent vaccine, IM injection of 5\*10\^7 Inf. U. once on Day 57
BIOLOGICAL	Placebo	One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57

Timeline

• Start date: 2015-09-21
• Primary completion: 2016-06-07
• Completion: 2016-11-29
• First posted: 2015-09-07
• Last updated: 2025-05-25

Locations

6 sites across 1 country: United States