A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants
- Conditions
- Healthy
- Interventions
- Biological: Ad26.ZEBOV 2*10^10 (vp)Biological: Ad26.ZEBOV 0.8*10^10 (vp)Biological: Ad26.ZEBOV 5*10^10 viral particles (vp)Biological: PlaceboBiological: MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]Biological: MVA-BN-Filo 5*10^7 Inf. U.
- Registration Number
- NCT02543567
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 525
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] Ad26.ZEBOV 5\*10\^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 1\*10\^8 Infectious Unit \[Inf. U.\] single dose IM injection on Day 57 Group 2 Ad26.ZEBOV 2*10^10 (vp) Ad26.ZEBOV 2\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U single dose IM injection on Day 57 Group 3 MVA-BN-Filo 5*10^7 Inf. U. Ad26.ZEBOV 0.8\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U. single dose IM injection on Day 57 Group 3 Ad26.ZEBOV 0.8*10^10 (vp) Ad26.ZEBOV 0.8\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U. single dose IM injection on Day 57 Group 2 MVA-BN-Filo 5*10^7 Inf. U. Ad26.ZEBOV 2\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U single dose IM injection on Day 57 Group 1 Ad26.ZEBOV 5*10^10 viral particles (vp) Ad26.ZEBOV 5\*10\^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 1\*10\^8 Infectious Unit \[Inf. U.\] single dose IM injection on Day 57 Group 4 Placebo Participants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57
- Primary Outcome Measures
Name Time Method Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA) At 21 days post boost vaccination The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
- Secondary Outcome Measures
Name Time Method Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Up to 7 days after each vaccination Number of Participants with Serious Adverse Events (SAEs) Continuous throughout the duration of study (Up to Day 237) Number of Participants with Adverse Events (AEs) Up to 42 days post boost vaccination Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA) At Days 1, 29, 57 post prime dose and at days 42, and 180 post boost vaccination The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody