Novavax Announces Topline Results from Phase 3 PrepareTM Trial of ResVax™ for Prevention of RSV Disease in Infants via Maternal Immunization
- Trial did not meet primary objective of prevention of medically significant RSV LRTI
- Trial did show efficacy against secondary objective (RSV LRTI hospitalization); first RSV vaccine to show Phase 3 efficacy
- Other pre-specified exploratory endpoints and post-hoc analyses highlight potential to improve global health against RSV disease
- Favorable safety and tolerability data
- Next step to meet with key regulatory authorities to discuss licensure pathways
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- 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%)
Pre-specified exploratory analyses of these same vaccine efficacy endpoints, which include additional data ascertained from hospitalization records, were:
- 41% against medically significant RSV LRTI (95%CI, 16% to 58%)
- 42% against RSV LRTI hospitalizations (95%CI, 17% to 59%)
- 60% against RSV LRTI with severe hypoxemia (95%CI, 32% to 76%)
“Pneumonia stubbornly remains the leading killer of children under the age of five worldwide. The new maternal vaccine from
“Importantly, while this study did not meet the pre-specified success criterion for the primary clinical endpoint of this trial, the data indicate that ResVax protects infants from some of the most serious consequences of RSV, including RSV LRTI hospitalizations and RSV LRTI with severe hypoxemia,” said
Other observations from the Prepare trial:
- Reduction in all-cause LRTI hospitalizations (25%) and all-cause LRTI severe hypoxemia (39%) in infants observed through the first 180 days of life
- Mothers vaccinated from 28 up to < 33 weeks of pregnancy, showed vaccine efficacy rates against RSV LRTI hospitalization of 53% and severe RSV hypoxemia of 70% through the first 90 days of their infants’ lives, compared with 26% and 44% for mothers vaccinated ≥ 33 weeks of pregnancy
- Over 90% of RSV LRTI hospitalizations and RSV LRTI severe hypoxemia in the placebo group occurred in the first 90 days of life
- 99% of vaccinated mothers had measurable antibody responses to the vaccine, with ≥100% transplacental transfer for all antibody types measured
- ResVax appears safe in mothers and their infants through 180 days post-delivery
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About RSV in Infants
Globally, RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children.1 It is the second leading cause of death in children under one year of age.2 Estimated annual hospitalizations of 1.4 million and an estimated 27,300 in-hospital deaths were due to RSV acute lower respiratory infection in children under six months of age.3 RSV results in a total global economic burden of
In the U.S., RSV is the leading cause of hospitalization of infants, with estimated annual hospitalizations of up to 76,000.4,5,6 While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year RSV infections occur before six months.7 In the U.S., the total economic burden is
About ResVax™
ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. ResVax is being evaluated in Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom received the vaccine, and their infants. Prepare is supported by an
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1 Nair, H., et al. (2010) Lancet. 375:1545-1555
2 Losano R., et al. (2012/Dec15) Lancet. 380: 2095
3 Ting S/Nair H. Lancet. (2017). Sep2;390:946
4 Leader S., et al. (2003) J Pediatr. 143: S127
5 Hall CB. N Engl J Med (2009). 360:588
6 CDC-Stockman LJ. Pediatr Infect Dis J (2012). 31:5
7 Hall CB. (2013) Pediatrics. 132:e341
Source: Novavax, Inc.