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Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants.

ABSTRACT: BACKGROUND:Respiratory syncytial virus (RSV) is the dominant cause of severe lower respiratory tract infection in infants, with the most severe cases concentrated among younger infants. METHODS:Healthy pregnant women, at 28 weeks 0 days through 36 weeks 0 days of gestation, with an expected delivery date near the start of the RSV season, were randomly assigned in an overall ratio of approximately 2:1 to receive a single intramuscular dose of RSV fusion (F) protein nanoparticle vaccine or placebo. Infants were followed for 180 days to assess outcomes related to lower respiratory tract infection and for 364 days to assess safety. The primary end point was RSV-associated, medically significant lower respiratory tract infection up to 90 days of life, and the primary analysis of vaccine efficacy against the primary end point was performed in the per-protocol population of infants (prespecified criterion for success, lower bound of the 97.52% confidence interval [CI] of ?30%). RESULTS:A total of 4636 women underwent randomization, and there were 4579 live births. During the first 90 days of life, the percentage of infants with RSV-associated, medically significant lower respiratory tract infection was 1.5% in the vaccine group and 2.4% in the placebo group (vaccine efficacy, 39.4%; 97.52% CI, -1.0 to 63.7; 95% CI, 5.3 to 61.2). The corresponding percentages for RSV-associated lower respiratory tract infection with severe hypoxemia were 0.5% and 1.0% (vaccine efficacy, 48.3%; 95% CI, -8.2 to 75.3), and the percentages for hospitalization for RSV-associated lower respiratory tract infection were 2.1% and 3.7% (vaccine efficacy, 44.4%; 95% CI, 19.6 to 61.5). Local injection-site reactions among the women were more common with vaccine than with placebo (40.7% vs. 9.9%), but the percentages of participants who had other adverse events were similar in the two groups. CONCLUSIONS:RSV F protein nanoparticle vaccination in pregnant women did not meet the prespecified success criterion for efficacy against RSV-associated, medically significant lower respiratory tract infection in infants up to 90 days of life. The suggestion of a possible benefit with respect to other end-point events involving RSV-associated respiratory disease in infants warrants further study. (Funded by Novavax and the Bill and Melinda Gates Foundation; ClinicalTrials.gov NCT02624947.).

SUBMITTER: Madhi SA

PROVIDER: S-EPMC7299433 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants.

Madhi Shabir A SA Polack Fernando P FP Piedra Pedro A PA Munoz Flor M FM Trenholme Adrian A AA Simões Eric A F EAF Swamy Geeta K GK Agrawal Sapeckshita S Ahmed Khatija K August Allison A Baqui Abdullah H AH Calvert Anna A Chen Janice J Cho Iksung I Cotton Mark F MF Cutland Clare L CL Englund Janet A JA Fix Amy A Gonik Bernard B Hammitt Laura L Heath Paul T PT de Jesus Joanne N JN Jones Christine E CE Khalil Asma A Kimberlin David W DW Libster Romina R Llapur Conrado J CJ Lucero Marilla M Pérez Marc Gonzalo G Marshall Helen S HS Masenya Masebole S MS Martinón-Torres Federico F Meece Jennifer K JK Nolan Terry M TM Osman Ayman A Perrett Kirsten P KP Plested Joyce S JS Richmond Peter C PC Snape Matthew D MD Shakib Julie H JH Shinde Vivek V Stoney Tanya T Thomas D Nigel DN Tita Alan T AT Varner Michael W MW Vatish Manu M Vrbicky Keith K Wen Judy J Zaman Khalequ K Zar Heather J HJ Glenn Gregory M GM Fries Louis F LF

The New England journal of medicine 20200701 5

<h4>Background</h4>Respiratory syncytial virus (RSV) is the dominant cause of severe lower respiratory tract infection in infants, with the most severe cases concentrated among younger infants.<h4>Methods</h4>Healthy pregnant women, at 28 weeks 0 days through 36 weeks 0 days of gestation, with an expected delivery date near the start of the RSV season, were randomly assigned in an overall ratio of approximately 2:1 to receive a single intramuscular dose of RSV fusion (F) protein nanoparticle vac ...[more]

PMID: 32726529

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Project description:ImportanceA nonadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF [Pfizer]) protein subunit vaccine was newly approved and recommended for pregnant individuals at 32 0/7 to 36 6/7 weeks' gestation during the 2023 to 2024 RSV season; however, clinical vaccine data are lacking.ObjectiveTo evaluate the association between prenatal RSV vaccination status and perinatal outcomes among patients who delivered during the vaccination season.Design, setting, and participantsThis retrospective observational cohort study was conducted at 2 New York City hospitals within 1 health care system among patients who gave birth to singleton gestations at 32 weeks' gestation or later from September 22, 2023, to January 31, 2024.ExposurePrenatal RSV vaccination with the RSVpreF vaccine captured from the health system's electronic health records.Main outcome and measuresThe primary outcome is preterm birth (PTB), defined as less than 37 weeks' gestation. Secondary outcomes included hypertensive disorders of pregnancy (HDP), stillbirth, small-for-gestational age birth weight, neonatal intensive care unit (NICU) admission, neonatal respiratory distress with NICU admission, neonatal jaundice or hyperbilirubinemia, neonatal hypoglycemia, and neonatal sepsis. Logistic regression models were used to estimate odds ratios (ORs), and multivariable logistic regression models and time-dependent covariate Cox regression models were performed.ResultsOf 2973 pregnant individuals (median [IQR] age, 34.9 [32.4-37.7] years), 1026 (34.5%) received prenatal RSVpreF vaccination. Fifteen patients inappropriately received the vaccine at 37 weeks' gestation or later and were included in the nonvaccinated group. During the study period, 60 patients who had evidence of prenatal vaccination (5.9%) experienced PTB vs 131 of those who did not (6.7%). Prenatal vaccination was not associated with an increased risk for PTB after adjusting for potential confounders (adjusted OR, 0.87; 95% CI, 0.62-1.20) and addressing immortal time bias (hazard ratio [HR], 0.93; 95% CI, 0.64-1.34). There were no significant differences in pregnancy and neonatal outcomes based on vaccination status in the logistic regression models, but an increased risk of HDP in the time-dependent model was seen (HR, 1.43; 95% CI, 1.16-1.77).Conclusions and relevanceIn this cohort study of pregnant individuals who delivered at 32 weeks' gestation or later, the RSVpreF vaccine was not associated with an increased risk of PTB and perinatal outcomes. These data support the safety of prenatal RSVpreF vaccination, but further investigation into the risk of HDP is warranted.

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Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants.

Publications

Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants.

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