• DOI:10.1056/NEJMoa2110275
• Corpus ID: 247220023

Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants.

@article{Hammitt2022NirsevimabFP,
  title={Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants.},
  author={Laura L. Hammitt and Ron Dagan and Yuan Yuan and Manuel Baca Cots and Miroslava N. Bosheva and Shabir Ahmed Madhi and William J Muller and Heather J. Zar and Dennis Brooks and Amy Grenham and Ulrika W{\"a}hlby Hamr{\'e}n and Vaishali S. Mankad and Pin Ren and Therese Takas and Michael E. Abram and Amanda Jane Leach and M. Pamela Griffin and Tonya Villafana},
  journal={The New England journal of medicine},
  year={2022},
  volume={386 9},
  pages={
          837-846
        }
}

• L. Hammitt, R. Dagan, +15 authors T. Villafana
• Published 3 March 2022
• Medicine
• The New England journal of medicine

BACKGROUND
Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infection and hospitalization in infants. Nirsevimab is a monoclonal antibody to the RSV fusion protein that has an extended half-life. The efficacy and safety of nirsevimab in healthy late-preterm and term infants are uncertain.

METHODS
We randomly assigned, in a 2:1 ratio, infants who had been born at a gestational age of at least 35 weeks to receive a single intramuscular injection of nirsevimab or placebo before the start of an RSV season. The primary efficacy end point was medically attended RSV-associated lower respiratory tract infection through 150 days after the injection. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after the injection.

RESULTS
A total of 1490 infants underwent randomization: 994 were assigned to the nirsevimab group and 496 to the placebo group. Medically attended RSV-associated lower respiratory tract infection occurred in 12 infants (1.2%) in the nirsevimab group and in 25 infants (5.0%) in the placebo group; these findings correspond to an efficacy of 74.5% (95% confidence interval [CI], 49.6 to 87.1; P<0.001) for nirsevimab. Hospitalization for RSV-associated lower respiratory tract infection occurred in 6 infants (0.6%) in the nirsevimab group and in 8 infants (1.6%) in the placebo group (efficacy, 62.1%; 95% CI, -8.6 to 86.8; P = 0.07). Among infants with data available to day 361, antidrug antibodies after baseline were detected in 58 of 951 (6.1%) in the nirsevimab group and in 5 of 473 (1.1%) in the placebo group. Serious adverse events were reported in 67 of 987 infants (6.8%) who received nirsevimab and in 36 of 491 infants (7.3%) who received placebo.

CONCLUSIONS
A single injection of nirsevimab administered before the RSV season protected healthy late-preterm and term infants from medically attended RSV-associated lower respiratory tract infection. (Funded by MedImmune/AstraZeneca and Sanofi; MELODY ClinicalTrials.gov number, NCT03979313.).