Novavax Announces Initiation of Ebola Vaccine Phase 1 Clinical Trial Supported by Non-Human Primate Challenge Data and Documented Rapid Manufacturing Capabilities
- Initiation of Enrollment of Phase 1 Clinical Trial of Ebola GP Vaccine
- Non-Human Primate Challenge Data Signal Breakthrough in
Ebola Vaccine Development
- Rapid Manufacturing Process of Ebola GP Vaccine Published in
The Ebola GP Vaccine clinical trial, which is being conducted in
The Phase 1 clinical trial initiation is supported by significant immunogenicity and efficacy data demonstrating that the Ebola GP Vaccine is the first subunit Ebola GP-based vaccine to provide protection in non-human primates. Non-human primates received two injections of a 5µg dose of the Ebola GP Vaccine with the Matrix-M adjuvant, and were challenged with a lethal dose of Ebola virus. As expected, the challenge was lethal for the control animal whereas, in sharp contrast, 100% of the immunized animals were protected. Additionally, the Ebola GP Vaccine induced Ebola Makona strain GP antibody titers of 106 (ELISA EC90) after two doses and 104, after a single dose, both results well above the range reported to provide protection in non-human primate models and reported in recent Ebola Phase 1 clinical trials.
"The strong immune responses observed in our animal immunogenicity models and the protection observed in the non-human primate challenge models, confirm that our Ebola GP Vaccine is an important candidate for consideration. The use of a sequence reflecting the current circulating Makona strain of Ebola virus, along with the observed dose-sparing and enhanced antibody quality by the addition of our Matrix-M adjuvant, compelled the company to move to clinical testing," said
The rapid progression to a Phase I clinical trial is further supported by
Ebola virus, formerly known as Ebola hemorrhagic fever, is a severe, often fatal illness in humans. Five strains of Ebola virus have been identified, the most recent of which, the 2014 Makona strain, is associated with a case fatality rate of between 50 and 90%. There are currently no licensed immunological or therapeutic treatments proven to neutralize the virus, although a range of blood, immunological vaccine and drug therapies are under development.
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Barclay A. PhillipsSVP, Chief Financial Officer and Treasurer Novavax, Inc.240-268-2000 David Schullor Andrea Flynn, Ph. D. Russo Partners, LLC212-845-4271 David.firstname.lastname@example.org Andrea.email@example.com