Novavax A/H5N1 avian influenza vaccine candidate has met safety and immunogenicity endpoints in two Phase 1 clinical trials.
The trials achieved the primary objectives by displaying the safety and immunogenicity of different doses of vaccine, with and without adjuvant, and manifesting statistically significant adjuvant effects on the immune responses.
The randomized, dose-ranging, placebo-controlled trials, conducted under the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) contract, observed no vaccine-related severe adverse events.
Novavax president and CEO Stanley Erck said the results demonstrate that the company can produce antigens from avian influenza strains that are as, or more, immunogenic than any other described in published results to date.
“Importantly, as we accelerate our development activities, these results give us tremendous flexibility for pursuing pandemic vaccine products, including vaccines directed at population segments that are sensitive to adjuvant use,” Erck added.
The hemagglutination inhibition assay responses against the vaccine virus at day 42 indicated that the adjuvanted vaccines stimulated strong immunogenicity at even the lowest (3.75µg) dose tested.
Both the trials fulfill CBER criteria for accelerated approval as the unadjuvanted vaccine elicited HAI titers = 40 in >82% of subjects at 45µg dose and even obtained HAI titers =40 in more than 52% of subjects against the drifted virus.
Novavax senior vice president and chief medical officer Gregory Glenn said, “We have reviewed the preliminary top-line results of these trials and believe that achieving similar immune responses to our vaccine in future clinical trials, regardless of which of the two adjuvants is used, if any, would meet the immunogenicity criteria for accelerated approval of a pandemic influenza vaccine set by CBER.”