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Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants.

Publication ,  Journal Article
Kampmann, B; Madhi, SA; Munjal, I; Simões, EAF; Pahud, BA; Llapur, C; Baker, J; Pérez Marc, G; Radley, D; Shittu, E; Glanternik, J; Snaggs, H ...
Published in: N Engl J Med
April 20, 2023

BACKGROUND: Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain. METHODS: In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestation to receive a single intramuscular injection of 120 μg of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine or placebo. The two primary efficacy end points were medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth. A lower boundary of the confidence interval for vaccine efficacy (99.5% confidence interval [CI] at 90 days; 97.58% CI at later intervals) greater than 20% was considered to meet the success criterion for vaccine efficacy with respect to the primary end points. RESULTS: At this prespecified interim analysis, the success criterion for vaccine efficacy was met with respect to one primary end point. Overall, 3682 maternal participants received vaccine and 3676 received placebo; 3570 and 3558 infants, respectively, were evaluated. Medically attended severe lower respiratory tract illness occurred within 90 days after birth in 6 infants of women in the vaccine group and 33 infants of women in the placebo group (vaccine efficacy, 81.8%; 99.5% CI, 40.6 to 96.3); 19 cases and 62 cases, respectively, occurred within 180 days after birth (vaccine efficacy, 69.4%; 97.58% CI, 44.3 to 84.1). Medically attended RSV-associated lower respiratory tract illness occurred within 90 days after birth in 24 infants of women in the vaccine group and 56 infants of women in the placebo group (vaccine efficacy, 57.1%; 99.5% CI, 14.7 to 79.8); these results did not meet the statistical success criterion. No safety signals were detected in maternal participants or in infants and toddlers up to 24 months of age. The incidences of adverse events reported within 1 month after injection or within 1 month after birth were similar in the vaccine group (13.8% of women and 37.1% of infants) and the placebo group (13.1% and 34.5%, respectively). CONCLUSIONS: RSVpreF vaccine administered during pregnancy was effective against medically attended severe RSV-associated lower respiratory tract illness in infants, and no safety concerns were identified. (Funded by Pfizer; MATISSE ClinicalTrials.gov number, NCT04424316.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 20, 2023

Volume

388

Issue

16

Start / End Page

1451 / 1464

Location

United States

Related Subject Headings

  • Vaccines, Combined
  • Vaccine Efficacy
  • Vaccination
  • Treatment Outcome
  • Respiratory Tract Infections
  • Respiratory Syncytial Viruses
  • Respiratory Syncytial Virus Vaccines
  • Respiratory Syncytial Virus Infections
  • Pregnancy
  • Injections, Intramuscular
 

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Kampmann, B., Madhi, S. A., Munjal, I., Simões, E. A. F., Pahud, B. A., Llapur, C., … MATISSE Study Group. (2023). Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med, 388(16), 1451–1464. https://doi.org/10.1056/NEJMoa2216480
Kampmann, Beate, Shabir A. Madhi, Iona Munjal, Eric A. F. Simões, Barbara A. Pahud, Conrado Llapur, Jeffrey Baker, et al. “Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants.N Engl J Med 388, no. 16 (April 20, 2023): 1451–64. https://doi.org/10.1056/NEJMoa2216480.
Kampmann B, Madhi SA, Munjal I, Simões EAF, Pahud BA, Llapur C, et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med. 2023 Apr 20;388(16):1451–64.
Kampmann, Beate, et al. “Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants.N Engl J Med, vol. 388, no. 16, Apr. 2023, pp. 1451–64. Pubmed, doi:10.1056/NEJMoa2216480.
Kampmann B, Madhi SA, Munjal I, Simões EAF, Pahud BA, Llapur C, Baker J, Pérez Marc G, Radley D, Shittu E, Glanternik J, Snaggs H, Baber J, Zachariah P, Barnabas SL, Fausett M, Adam T, Perreras N, Van Houten MA, Kantele A, Huang L-M, Bont LJ, Otsuki T, Vargas SL, Gullam J, Tapiero B, Stein RT, Polack FP, Zar HJ, Staerke NB, Duron Padilla M, Richmond PC, Koury K, Schneider K, Kalinina EV, Cooper D, Jansen KU, Anderson AS, Swanson KA, Gruber WC, Gurtman A, MATISSE Study Group. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med. 2023 Apr 20;388(16):1451–1464.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 20, 2023

Volume

388

Issue

16

Start / End Page

1451 / 1464

Location

United States

Related Subject Headings

  • Vaccines, Combined
  • Vaccine Efficacy
  • Vaccination
  • Treatment Outcome
  • Respiratory Tract Infections
  • Respiratory Syncytial Viruses
  • Respiratory Syncytial Virus Vaccines
  • Respiratory Syncytial Virus Infections
  • Pregnancy
  • Injections, Intramuscular