Novavax has initiated patient enrolment for Phase I clinical trial to evaluate the safety, immunogenicity and tolerability of a vaccine candidate against respiratory syncytial virus.
The blinded, placebo-controlled and escalating-dose study will enrol 100 healthy adults aged 18 to 49, who will be grouped into four cohorts and randomised to receive either vaccine treatment or saline placebo in a 4:1 ratio.
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The interim top-line data from the trial is expected to be available in the third quarter of 2011.
Novavax President and CEO Dr Rahul Singhvi said the launch of the trial is timely because there are no vaccines currently approved to treat respiratory syncytial virus.
Respiratory syncytial virus is a major cause of lower respiratory tract infection in infants and children worldwide, and is estimated to cause 160,000 deaths a year worldwide.
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