US-based biopharmaceutical company Novavax has begun enrolment in a second Phase 1 clinical trial of a vaccine that could prevent a potential bird flu pandemic.
The aim of the trial is to test the safety of the monovalent virus-like particle (VLP) vaccine, which Novavax is developing under a contract with the US Department of Health and Human Services's Biomedical Advanced Research and Development Authority.
The placebo-controlled, observer-blind trial will also determine the vaccine's immunogenicity, with and without the use of an undisclosed adjuvant.
Novavax is enrolling 333 healthy patients in the trial, each of whom will be randomised into one of six treatment groups, including varying doses of the A/H5N1 VLP vaccine, with or without an adjuvant, or a placebo.
Gregory Glenn, Novavax senior vice president and chief medical officer, commented on the news: "This second clinical trial is supporting our efforts to determine the most appropriate dose of our VLP A/H5N1 avian influenza vaccine candidate and which adjuvant, if any, will be used in our future clinical trials."
"Like the first A/H5N1 trial we initiated on 1 May, we believe this trial will provide the data to determine whether our vaccine will fulfil the criteria for an accelerated approval of a potential pandemic influenza vaccine set by the FDA's Center for Biologics Evaluation and Research."
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