Study 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 Ebola Ad26.ZEBOV and MVA-BN-Filo (VAC52150EBL2003)
Sponsor Name: Janssen Vaccines & Prevention B.V
Application Number: TFDA0016/CTR/0001, Date Received: 18/01/2016
Principal Investigator: Dr. Nyanda Elias Ntinginya NIMR - MMRC P.O. Box 2410, Mbeya, Tanzania
Intervention Medicinal Product Status of IMP
Ad26.ZEBOV and MVA-BN-Filo Unregistered
Primary Disease: Ebola
Trial Site: NIMR-Mbeya Medical Research Centre (MMRC) P.O. Box 2410, Mbeya, Tanzania
Start / Approval Date: 04th March 2017, Status / Approval Remark: Approved
Primary Purpose: 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.
Study Phase: Phase II
Study Type: Interventional
Expected Completion Date: 18 April 2019
Target Sample Size: 575
Recruitment Status: Recruitment ended
Outcome:
Primary Outcome Measures:
1. Number of Participants With Adverse Events [ Time Frame: Up to Day 42 post-boost visit ]
2. 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) ]
3. Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: Up to 7 days after each study vaccination ]
4. 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 ]

Secondary Outcome Measures:
1 .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.