Novavax Announces Positive Top-Line Data From Phase 1 Ebola Vaccine Trial on WHO Teleconference
The Ebola GP Vaccine clinical trial is a randomized, observer-blinded, dose-escalation trial to evaluate the safety and immunogenicity of the vaccine, with and without Matrix-M, in 230 healthy adults between 18 and 49 years of age. Participants received either one or two intramuscular injections ranging from 6.5µg to 50µg of antigen on study days 0 and 21. Immunogenicity was assessed at multiple time points including days 28 and 35.
The adjuvanted Ebola GP Vaccine was highly immunogenic at all dose levels. The 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. The adjuvanted single dose vaccine regimen induced GMEU between 1700 and 3400, representing a 21 to 27-fold rise over baseline at day 35.
“We are pleased to have the opportunity to share these positive data with the WHO. Novavax’ recombinant nanoparticle technology and proprietary Matrix-M adjuvant differentiates our Ebola GP Vaccine. The Phase 1 clinical data show that our vaccine was well-tolerated and elicited very high Ebola antibody responses,” said
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