NCT02543268

A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of a Heterologous Prime-Boost Regimen Using Three Different Batches of Ad26.ZEBOV and a Single Batch of MVA-BN®-Filo in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the humoral immune response induced by 3 different batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.

Detailed description

This is a randomized, double - blind, placebo - controlled, parallel - group, multicenter, Phase 3 study to evaluate the immunogenic equivalence of a heterologous prime - boost regimen using 3 different batches of Ad26.ZEBOV in healthy adult participants. The study consists of a screening period of up to 6 weeks, a vaccination period in which participants will be vaccinated at baseline (Day 1), followed by a boost vaccination on Day 57, and a post-vaccination phase until 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-Batch #1	Ad26.ZEBOV - Batch #1, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
BIOLOGICAL	Ad26.ZEBOV-Batch #2	Ad26.ZEBOV - Batch #2, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
BIOLOGICAL	Ad26.ZEBOV-Batch #3	Ad26.ZEBOV - Batch #3, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
BIOLOGICAL	MVA-BN-Filo	MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1\*10\^8 Infectious Unit \[Inf. U.\] once on Day 57.
BIOLOGICAL	Placebo	One 0.5 ml IM injection of 0.9% saline once on Day 1 and Day 57.

Timeline

• Start date: 2015-09-21
• Primary completion: 2016-01-22
• Completion: 2016-07-20
• First posted: 2015-09-07
• Last updated: 2025-06-22

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study