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Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants.
Hammitt, Laura L; Dagan, Ron; Yuan, Yuan; Baca Cots, Manuel; Bosheva, Miroslava; Madhi, Shabir A; Muller, William J; Zar, Heather J; Brooks, Dennis; Grenham, Amy; Wählby Hamrén, Ulrika; Mankad, Vaishali S; Ren, Pin; Takas, Therese; Abram, Michael E; Leach, Amanda; Griffin, M Pamela; Villafana, Tonya.
  • Hammitt LL; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Dagan R; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Yuan Y; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Baca Cots M; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Bosheva M; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Madhi SA; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Muller WJ; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Zar HJ; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Brooks D; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Grenham A; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Wählby Hamrén U; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Mankad VS; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Ren P; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Takas T; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Abram ME; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Leach A; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Griffin MP; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
  • Villafana T; From the Department of International Health, Johns Hopkins University, Baltimore (L.L.H.), and AstraZeneca, Gaithersburg (Y.Y., D.B., A.G., P.R., T.T., M.E.A., A.L., M.P.G., T.V.) - both in Maryland; the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel (R.D.); Quiró
N Engl J Med ; 386(9): 837-846, 2022 03 03.
Article in English | MEDLINE | ID: covidwho-1721750
ABSTRACT

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 21 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.).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Infant, Premature / Respiratory Syncytial Virus Infections / Antibodies, Monoclonal, Humanized / Infant, Premature, Diseases Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Female / Humans / Infant / Male / Infant, Newborn Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antiviral Agents / Infant, Premature / Respiratory Syncytial Virus Infections / Antibodies, Monoclonal, Humanized / Infant, Premature, Diseases Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Female / Humans / Infant / Male / Infant, Newborn Language: English Journal: N Engl J Med Year: 2022 Document Type: Article