Clinical Trial: Safety, Tolerability and Immunogenicity Study of 2 Prime-boost Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief 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 heterologous prime-boost regimens in healthy and in HIV-infected adults.

Detailed Summary: This is a randomized, observer-blind, placebo-controlled, parallel-group, multicenter, 2-part, Phase 2 study Ad26.ZEBOV and MVA-BN-Filo in healthy and HIV infected adults. In part 1, prime vaccination with MVA-Bn-Filo will be followed by boost vaccination with Ad26 14 days later in the US. In part 2, two regimens will be investigated. The first regimen will be Ad26 prime vaccination followed by MVA-BN-Filo boost 28 days later and the second regimen will be MVA-BN-Filo prime vaccination followed by MVA-BN-Filo boost 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 boost vaccination on Day 15 or 29, and a post-boost follow-up phase of maximum 1 year post-boost vaccination. Upon completion of 6-month post boost visit those participants who received active vaccine will enter long-term follow-up until the 1 year post boost vaccination visit to assess long-term safety and immunogenicity.
Sponsor: Janssen Vaccines & Prevention B.V.

Current Primary Outcome:

  • Number of Participants With Adverse Events [ Time Frame: Up to Day 42 post-boost visit ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Continuous throughout the duration of the study (up to 1 year post boost visit +/- 1 month) ]
  • Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: Up to 7 days after each study vaccination ]
  • Antibody levels against the ebola virus glycoprotein (EBOV GP) measured by an enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Up to day 21 after boost vaccination ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Comparison of Safety and Tolerability of Ad26.ZEBOV/MVA-BN-Filo and MVA-BN- Filo/Ad26.ZEBOV Regimens Between Healthy and HIV-Infected Adults [ Time Frame: Up to 1 year post boost ]

The comparison will be made on the basis of treatment emergent adverse events as well as comparison of the solicited local and systemic adverse events for tolerability.


Original Secondary Outcome:

  • Immune Responses to study vaccine regimens as measured by a virus neutralization assay against ebola virus glycoprotein (EBOV GP) [ Time Frame: Day 21, 42, Month 6 and 1 year post boost ]
  • Number of interferon-gamma producing T Cells measured by an enzyme-linked immunospot (ELISpot) assay [ Time Frame: Day 21, 42, Month 6 and 1 year post boost ]


Information By: Janssen Vaccines & Prevention B.V.

Dates:
Date Received: November 4, 2015
Date Started: December 10, 2015
Date Completion: November 26, 2018
Last Updated: March 22, 2017
Last Verified: March 2017