Clinical-stage vaccine firm Novavax has presented positive top-line data from a Phase I clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M.
The company presented the results at the World Health Organisation’s (WHO) fifth teleconference on Ebola vaccine clinical trials.
According to the firm, the study showed that the Ebola GP Vaccine was extremely immunogenic, well-tolerated, and conjunction with company’s Matrix-M adjuvant resulted in significant antigen dose-sparing.
Novavax president Stanley Erck said: "These positive data represent the third time Novavax has leveraged the power of our platform technology to rapidly address an emerging threat.
"These Ebola GP Vaccine data, in combination with clinical data from our H7N9 VLP vaccine candidate and preclinical data from our vaccine candidate for Middle East Respiratory Syndrome coronavirus, provide additional validation of our nanoparticle vaccine platform."
The Ebola GP Vaccine clinical trial is a randomised, observer-blinded and dose-escalation trial, which is designed to assess the safety and immunogenicity of the vaccine with and without Matrix-M, in 230 healthy adults between 18 and 49 years of age.
In the trial, the subjects received either one or two intramuscular injections ranging from 6.5ug to 50ug of antigen between zero and 21 days.
The company evaluated immunogenicity at multiple time points, including days 28 and 35.
The adjuvanted Ebola GP Vaccine is said to be highly immunogenic at all dose levels, where adjuvanted two-dose regimens induced Ebola anti-GP antibody geometric mean responses between 45,000 and 70,000 ELISA units (GMEU), representing a 500 to 750-fold rise over baseline at day 35.
In addition, the adjuvanted single dose vaccine regimen induced GMEU between 1700 and 3400, representing a 21 to 27-fold rise over baseline at day 35.
Image: Electron micrograph of an Ebola virus virion. Photo: courtesy of CDC / Cynthia Goldsmith.