Vaccine Info

Ad26.ZEBOV/MVA-BN-Filo Ebola Vaccine

Ebola Vaccine Description

Ad26.ZEBOV/MVA-BN-Filo is a heterologous prime-boost Ebola vaccine regimen.

Developed by Janssen, 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. Janssen has rapidly advanced the development of the vaccine with multiple clinical Phase 1, 2 and 3 trials ongoing in parallel in healthy adults, children, elderly and immunocompromised populations across Europe, USA and Africa with the goal of ultimately registering the vaccine.

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). The initial development of the vaccine was sponsored by the U.S. National Institutes of Health and is now managed by Janssen, a Johnson & Johnson company, who licensed MVA-BN Filo for use from Bavarian Nordic in a prime-boost vaccine regimen together with their adenovirus–based vaccine candidate, Ad26.ZEBOV. The prime-boost vaccination is an established approach for the prevention of other infectious diseases.

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, the Ebola virus.

Global partners on the vaccine program also include the Biomedical Advanced Research and Development Authority and the National Institutes of Health.

As a result of these collaborations, more than 6,500 individuals have now participated in clinical studies for the Ebola vaccine across the U.S., Europe, and Africa. So far, the data from these studies suggest that the vaccine stimulates a robust immune response and has a favorable safety profile.

Janssen has also assembled a stockpile of 1.5 million vaccine regimens for potential use in public health emergencies.

Vaccine Indication

Ad26.ZEBOV/MVA-BN-Filo is indicated to provide an active acquired immunity Ebola virus. Clinical results so far reported indicate that Ad26.ZEBOV prime immunization readily induces an immune response which is enhanced further by MVA-BN-Filo boosting, inducing a durable immunity to Ebola Zaire, and that both the prime and boost are well tolerated with a good safety profile.

Vaccine Dosage

Heterologous 2-dose vaccination with Ad26.ZEBOV and MVA-BN-Filo against Ebola virus is well tolerated and immunogenic in healthy volunteers. The vaccine candidate is administered as an intramuscular (IM) injection.

Update

  • 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. In September 2019, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted an Accelerated Assessment for these applications.
  • October 31, 2019 - Bavarian Nordic A/S announced that its partner Janssen Pharmaceutical Companies of Johnson & Johnson will donate up to 500,000 doses of its investigational Ebola vaccine regimen to support vaccination efforts in the Democratic Republic of the Congo.
  • September 21, 2019 – Authorities in the Democratic Republic of Congo said ‘they plan to introduce a 2nd experimental vaccine to counter the ongoing Ebola Zaire outbreak.
  • April 19, 2029 - A phase 1 study of healthy volunteers, immunization with Ad26.ZEBOV or MVA-BN-Filo did not result in any vaccine-related serious adverse events. An immune response was observed after primary immunization with Ad26.ZEBOV; boosting by MVA-BN-Filo resulted in sustained elevation of specific immunity. 
  • September 12, 2016 – Bavarian Nordic A/S announced that Janssen Vaccines & Prevention B.V. (Janssen) has completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for its investigational preventive Ebola prime-boost vaccine regimen, which includes Bavarian Nordic’s MVA-BN® Filo vaccine. 
  • October 22, 2014 – Bavarian Nordic A/S announced a global license and supply agreement for its MVA-BN Filovirus (Ebola and Marburg) vaccine candidate with Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.   

Vaccine Clinical Trials

Clinical Trials NCT04028349Ebola 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 NCT02376426A 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 the 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.

Ebola vaccine news is published by Precision Vaccinations.com. 

 

Updated
01/15/2020 - 18:57