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news.US-based clinical-stage vaccine company Novavax has reported positive top-line data from a Phase I clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M.
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The results were presented at the World Health Organization’s (WHO) fifth teleconference on Ebola vaccine clinical trials.
The results showed that the Ebola GP Vaccine was highly immunogenic, well-tolerated and, in conjunction with the company’s Matrix-M adjuvant, resulted in significant antigen dose-sparing.
Novavax Research and Development senior vice-president Gregory Glenn said: "Novavax’ recombinant nanoparticle technology and proprietary Matrix-M adjuvant differentiates our Ebola GP Vaccine.
"The Phase I clinical data show that our vaccine was well-tolerated and elicited very high Ebola antibody responses.
"These data, together with two positive challenge studies in non-human primates, suggest that the Ebola GP Vaccine would be protective in humans."
Around 230 healthy adults between 18 and 49 years of age are involved in this randomized, observer-blinded and dose-escalation trial, which is designed to evaluate the safety and immunogenicity of the vaccine with and without Matrix-M.
During the trial, the patients 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.
Additionally, the adjuvanted single dose vaccine regimen induced GMEU between 1700 and 3400, representing a 21 to 27-fold rise over baseline at day 35.