Barely a month after reporting promising Phase II results for its respiratory syncytial virus (RSV) jab and netting an $89 million Gates Foundation grant, Gaithersburg, MD-based Novavax ($NVAX) is going full steam ahead, initiating a Phase III trial for its RSV candidate.
The randomized, observer-blinded, placebo-controlled trial will enroll up to 11,850 older adults at 60 sites in the U.S., the company announced on Monday. The participants will be vaccinated ahead of the 2015-2016 RSV season, with top-line results expected in the second half of 2016.
The trial's objective is to prevent moderate-to-severe lower respiratory tract disease caused by RSV. The objectives and endpoints were designed based on FDA feedback from the End of Phase II meeting.
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| Novavax CEO Stanley Erck |
"The primary objective of this clinical trial captures moderate-severe RSV disease that drives an estimated annual economic burden of more than $24 billion in the United States alone," said Novavax CEO Stan Erck in a statement. "The Resolve trial takes Novavax one step closer to bringing this important vaccine to licensure, years ahead of other RSV vaccine development efforts."
Novavax's RSV jab was fast-tracked by the FDA in November 2014, and it has conducted clinical trials in vulnerable populations, including older adults and infants via maternal immunization.
The quest for a vaccine against RSV has been a priority for decades, with the likes of Bavarian Nordic and AstraZeneca's ($AZN) MedImmune racing to develop a vaccine. The former kicked off a Phase I trial for its RSV candidate in August, while the latter had its own candidate fast-tracked by the FDA in April. It is especially important for AstraZeneca to bridge this gap since its blockbuster Synagis, a monoclonal antibody for use in limited RSV cases, went off patent last month.
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