NCT02598388

Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo

A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 578 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.

Detailed description

This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, 2-part, Phase 2 study of Ad26.ZEBOV and MVA-BN-Filo in healthy and HIV infected adults. In part 1, dose 1 vaccination with MVA-Bn-Filo will be followed by dose 2 vaccination with Ad26 14 days later in the US. In part 2, two regimens will be investigated. The first regimen will be Ad26 dose 1 vaccination followed by MVA-BN-Filo dose 2, 28 days later and the second regimen will be MVA-BN-Filo dose 1 vaccination followed by Ad26.ZEBOV dose 2, 14 days later in Africa. The study consists of a Screening phase of up to 8 weeks (starting from the moment the participants signs the ICF), a Vaccination Phase, in which participants will be vaccinated at baseline (Day 1) followed by a dose 2 vaccination on Day 15 or 29, and a post-dose 2 follow-up phase of maximum 1 year post-dose 2 vaccination. Upon completion of 6-month post dose 2 visit those participants who received active vaccine will enter long-term follow-up until the 1 year post dose 2 vaccination visit to assess long-term safety and immunogenicity.

Conditions

• Hemorrhagic Fever, Ebola

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.ZEBOV	One 0.5 mL intramuscular (IM) injection of (5x10\*10 viral particles).
BIOLOGICAL	MVA-BN-Filo	One 0.5 mL IM injection of (1x10\*8 infectious units).
BIOLOGICAL	Placebo	One 0.5 mL IM injection of 0.9 percent (%) saline.

Timeline

• Start date: 2015-12-10
• Primary completion: 2018-12-12
• Completion: 2018-12-12
• First posted: 2015-11-05
• Last updated: 2025-02-04
• Results posted: 2022-02-18

Locations

7 sites across 6 countries: United States, Kenya, Mozambique, Nigeria, Tanzania, Uganda