Ad26.ZEBOV 5*10^10 viral particles (vp)
BiologicalAd26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5*10^10 viral particles on Day 1
NCT Number: NCT02543567
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 3
Huntsville, Alabama, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5*10^10 viral particles on Day 1
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2*10^10 viral particles on Day 1
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8*10^10 viral particles on Day 1
MVA-BN-Filo- live replication incompetent vaccine, IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57
MVA-BN-Filo- live replication incompetent vaccine, IM injection of 5*10^7 Inf. U. once on Day 57
One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57
Time frame: At 21 days post boost vaccination
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
Time frame: 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
Time frame: Up to 7 days after each vaccination
Time frame: Up to 42 days post boost vaccination
Time frame: Continuous throughout the duration of study (Up to Day 237)
Janssen Vaccines & Prevention B.V.
Industry
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate A Range of Dose Levels of a Heterologous Prime-Boost Regimen of Ad26.ZEBOV and MVA-BN®-Filo in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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