Phase III 'Prepare' trial of ResVax fails

1 March 2019

US vaccine developer Novavax (Nasdaq: NVAX) saw its shares crater 66.9% to $0.71 by close of trading yesterday, after the company announced results from ‘Prepare’, a global Phase III clinical trial using ResVax, an aluminum adjuvanted respiratory syncytial virus (RSV) fusion (F) protein recombinant nanoparticle vaccine.

ResVax is being developed to protect infants via maternal immunization against RSV disease. In the Prepare trial, efficacy of ResVax against the primary and two secondary endpoints in per-protocol infants with RSV lower respiratory tract infection (LRTI) through 90 days of life was:

39% against medically significant RSV LRTI (97.5%CI, -1% to 64%)
44% against RSV LRTI hospitalizations (95%CI, 20% to 62%)
48% against RSV LRTI with severe hypoxemia (95%CI, -8% to 75%)

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