A Staged Phase 3 Study, Including a Double-blind controlled stage to evaluate the safety and immunogenicity of Ad26 ZEBOV and MVA-BN-Filo as candidate prophylactic vaccines for Ebola

Janssen Vaccines and Prevention B.V.0 个研究点目标入组 1,020 人开始时间: 2015年5月25日最近更新: 2023年5月29日

适应症

试验速览

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•Inclusion criteria Stage 1 and 2
•- Documented community engagement from community leader and a signed inform consent form (ICF) from each participant must be available - Participant must be 18 years or older at screening and be resident in selected study community with no intention to move from study area within the next 5 months (or during the entire study duration for stage 2)
•- Participant must be healthy with no abnormalities in laboratory screening tests within 28 days before prime vaccination
•- Female subjects of childbearing potential must use adequate birth control measures and must have a negative pregnancy test at screening and immediately prior to each study vaccination
•- Participant must pass the test of understanding (TOU) Additional Inclusion criteria Stage 2
•- One year or older at screening (children of enrolled parents are eligible)
•- Parent/legal guardian (for children) must pass the TOU before signing the ICF
•- Subjects aged 7 years and older will be asked to give positive assent in the presence of a witness

•Exclusion criteria Stage 1 and 2
•- Diagnosed with EVD or under quarantine/exposed to Ebola or body temperature equal of greater than 38.00C (fever)
•- Having an acute illness (mild in nature that can be treated at home) or any clinically significant acute/chronic medical condition or having a decreased number of red blood cells/hemoglobin in the blood (anemia)
•- Previously participated in another Ebola interventional study or received any Ad26/MVA-based candidate vaccine
•- Vaccinated with live attenuated vaccines within 30 days or with inactivated vaccines 15 days before prime vaccination
•- Treated with an immunosuppressive drug at the time of screening
•Additional exclusion criteria for stage 2
•-Children up to 5 years of age with severe malnutrition (underweight or Z-score weight <2)

发起方

Janssen Vaccines and Prevention B.V.