Ad26.ZEBOV/MVA-BN-Filo is a heterologous prime-boost Ebola vaccine regimen.
Ad26.ZEBOV is a monovalent vaccine designed to provide active specific acquired immunity to the Ebola virus. The vaccine is based on adenovirus type 26 (Ad26) vector expressing the glycoprotein (GP) of the Ebola virus Mayinga variant.
MVA-BN-Filo is a multivalent vaccine preparation designed to provide active acquired immunity to the Sudan virus, the Ebola virus, the Marburg virus, and the Tai Forest virus (formerly known as Côte d’Ivoire ebolavirus).
These two vaccines combine to make Ad26.ZEBOV/MVA-BN-Filo.
These vaccines both use a viral vector approach, where a virus is genetically modified so that it cannot replicate but is used to safely express key proteins of the target virus, in this case, Ebola virus.
Prime-boost vaccination is an established approach for the prevention of other infectious diseases.
Ad26.ZEBOV/MVA-BN-Filo is indicated to provide active acquired immunity Ebola virus.
These vaccine candidates are administered as an intramuscular (IM) injection.
November 7th, 2019: The Janssen division of Johnson & Johnson announced it had filed for two approvals from European Medicines Agency (EMA) for its 2-dose prime-boost Ebola Zaire protective vaccine regimen.
Clinical Trials NCT04028349: Ebola Vaccine Trial (Ad26.ZEBOV/MVA-BN-Filo) (Recruiting)
- This is an interventional, single-arm, open-label, non-randomized, phase II study to accumulate additional data on immunogenicity and safety of Ad26.ZEBOV/MVA-BN®-Filo against Ebola virus disease.
- It also has a qualitative component to better understand knowledge about Ebola virus disease and the perception and attitudes towards the vaccine amongst participants (Healthcare and Frontline workers).
Clinical Trial NCT02376426: A Phase 1 Study to Evaluate the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
- This is a randomized placebo-controlled, double-blind study evaluating the safety, tolerability, and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different sequences and schedules to healthy adult participants.
- The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at Baseline [Day 1] followed by a boost on Day 29 or 57 and a post-boost follow-up until all participants have had their 21-day post-boost visit (Day 50 or Day 78).
- The participants who received the active vaccine will enter a long-term follow-up.
- The total duration of the study will be about 1 year for participants who received the vaccine and about 3 months for participants who received a placebo. Immunogenicity and safety will be monitored during the study.
Clinical Trial NCT03929757: A Phase 2 Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants
- The purpose of this study is to assess the safety and reactogenicity of a heterologous 2-dose regimen utilizing Ad26.ZEBOV (first vaccination; Dose 1) and MVA-BN-Filo (second vaccination; Dose 2) administered intramuscularly (IM) on Days 1 and 57, respectively.
Clinical Trial NCT02543567: A Phase 3 Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA‐BN‐Filo in Healthy Adult Participants
- 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.