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Ebola

MVA-BN® Filo

PHASE 3


MVA-BN Filo is a multivalent vaccine candidate designed to provide protection against the most common causes of viral hemorrhagic fever; Ebola and Marburg virus. While several sub-types of Ebola are known, our vaccine is targeting the Zaire and Sudan strains, which are considered the most important from a public health perspective.

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 in a prime-boost vaccine regimen together with their adenovirus–based vaccine candidate, Ad26.ZEBOV.

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. While several other vaccine candidates have also shown promising efficacy signals, they lack the ability to provide long-term protection.

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.

Filoviruses belong to a virus family called Filoviridae and can cause severe hemorrhagic fever in humans and nonhuman primates. So far, only two members of this virus family have been identified: Marburg virus and Ebola virus. Ebola and Marburg hemorrhagic fevers are acute viral diseases that often lead to severe illness and death in humans and other primates. The infections typically affect multiple organs in the body and are often accompanied by hemorrhage (bleeding). Once the virus has been transmitted from an animal host to a human, it can then spread through person-to-person contact.

Both diseases are rare, but have a capacity to cause dramatic outbreaks with high fatality. Outbreaks of the diseases have been frequently reported since the discovery of the viruses in the 1960s and 1970s, mainly in Africa where the viruses have their origin.

The World Health Organization reports that viral hemorrhagic fever outbreaks (such as those resulting from Marburg and Ebola viruses) have a case fatality rate of up to 90%

Due to their severe fatality rate and ease of transmission, both viruses are considered potential biological weapons. The U.S. government has determined Ebola and Marburg are material threats to national security.  Currently, no standard treatment or vaccine exists against the diseases.

Capelle MAH, Babich L, van Deventer-Troost JPE, et al.
Stability and suitability for storage and distribution of Ad26.ZEBOV/MVA-BN®-Filo heterologous prime-boost Ebola vaccine

Eur J Pharm Biopharm. 2018 Aug;129:215-221. doi: 10.1016/j.ejpb.2018.06.001. Epub 2018 Jun 2

Callendret B, Vellinga J, Wunderlich K, et al.
A prophylactic multivalent vaccine against different filovirus species is immunogenic and provides protection from lethal infections with Ebolavirus and Marburgvirus species in non-human primates

PLoS One. 2018 Feb 20;13(2):e0192312.

Winslow RL, Milligan ID, Voysey M, et al.
Immune Responses to Novel Adenovirus Type 26 and Modified Vaccinia Virus Ankara–Vectored Ebola Vaccines at 1 Year

JAMA. 2017;317(10):1075-1077. doi:10.1001/jama.2016.20644

Milligan ID, Gibani MM, et al.
Safety and Immunogenicity of Novel Adenovirus Type 26- and Modified Vaccinia Ankara-Vectored Ebola Vaccines: A Randomized Clinical Trial.

JAMA. 2016 Apr 19;315(15):1610-23. doi: 10.1001/jama.2016.4218.

Tapia MD, Sow SO, et al.
Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-blind, placebo-controlled trial.

Lancet Infect Dis. 2016 Jan;16(1):31-42. doi: 10.1016/S1473-3099(15)00362-X. Epub 2015 Nov 4.

November 7, 2019
Bavarian Nordic Announces Submission of European Marketing Authorisation Applications for Investigational Ebola Vaccine Regimen
October 31, 2019
Investigational Ebola Vaccine from Janssen and Bavarian Nordic to Support Outbreak Response in Democratic Republic of the Congo
September 12, 2016
Bavarian Nordic Announces that Janssen has completed a Submission for Emergency Use Assessment and Listing for its Ebola Vaccine Regimen to the World Health Organization 
April 19, 2016
Bavarian Nordic Applauds Announcement of Positive Data for Ebola Vaccine Regimen Published in JAMA
October 09, 2015
Bavarian Nordic Announces Initiation of Safety and Immunogenicity Study of Ebola Vaccine Regimen in Sierra Leone
September 14, 2015
Bavarian Nordic Receives Contract Valued at USD 9 Million from Janssen as part of Advanced Development of Prime-Boost Ebola Vaccine Regimen
July 15, 2015
Bavarian Nordic Announces that the Oxford Vaccines Group has Initiated a Phase 2 Study of the Ebola Prime-Boost Vaccine Regimen Combining MVA-BN® Filo and Janssen’s AdVac® Technology
May 12, 2015
Bavarian Nordic Announces Presentation of Preliminary Phase 1 Results for the Ebola Prime-Boost Vaccine Regimen of MVA-BN® Filo and Janssen’s AdVac® technology
January 06, 2015
Bavarian Nordic Announces Initiation of Phase 1 Clinical Trial for the Ebola Vaccine Regimen of MVA-BN® Filo and Janssen’s AdVac® technology
October 22, 2014
Bavarian Nordic Enters Licensing and Supply Agreement with Janssen on MVA-BN® Ebola Vaccine