PMID- 32571718 OWN - NLM STAT- MEDLINE DCOM- 20210427 LR - 20240124 IS - 1873-2518 (Electronic) IS - 0264-410X (Print) IS - 0264-410X (Linking) VI - 38 IP - 33 DP - 2020 Jul 14 TI - Safety and immunogenicity of three seasonal inactivated influenza vaccines among pregnant women and antibody persistence in their infants. PG - 5355-5363 LID - S0264-410X(20)30704-0 [pii] LID - 10.1016/j.vaccine.2020.05.059 [doi] AB - OBJECTIVE: Inactivated influenza virus vaccines (IIVs) are recommended for all pregnant women in the United States. We conducted a prospective, randomized, double blind study of three licensed seasonal trivalent IIVs (IIV3s) to assess their safety and immunogenicity in pregnant women and determine the level and persistence of passively transferred maternal antibody in infants. STUDY DESIGN: 139 pregnant women ages 18-39 years and 14-33 weeks' gestation, and 44 non-pregnant women, were randomized 1:1:1 to receive a single intramuscular dose of one of three licensed IIV3s (Agriflu(R), Fluzone(R), or Fluarix(R)) prior to the 2010-2011 influenza season. Reactogenicity, adverse events (AEs) and pregnancy outcomes were documented. Serum samples for hemagglutination inhibition (HAI) and neutralization antibody assays were collected prior to and 28 and 180 days after immunization. Maternal sera and cord blood were collected at the time of delivery and sera were obtained from 44 infants at 6 weeks of age. RESULTS: Pregnant and non-pregnant women experienced similar frequency of injection site (92% and 86%, respectively) and systemic (95% and 87%, respectively) reactions, the majority of which were mild. There were no vaccine-associated maternal or infant serious AEs. Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women. The ratios of cord blood (infant) to maternal HAI antibody titers at delivery ranged between 1.1 and 1.7 for each of the vaccine antigens. Influenza antibody concentrations in infants were 70-40% of the birth titer by 6 weeks of age. CONCLUSIONS: The three IIV3s were well tolerated in pregnant women. Antibody responses were comparable in pregnant and non-pregnant women, and after second or third trimester vaccination. Transplacental transfer of maternal antibodies to the infant was efficient. However, antibody titers decline rapidly in the first 6 weeks of life. CI - Copyright (c) 2020 Elsevier Ltd. All rights reserved. FAU - Munoz, Flor M AU - Munoz FM AD - Department of Pediatrics, Houston, TX, United States; Department of Molecular Virology and Microbiology, Houston, TX, United States. Electronic address: florm@bcm.edu. FAU - Patel, Shital M AU - Patel SM AD - Department of Molecular Virology and Microbiology, Houston, TX, United States; Department of Medicine, Baylor College of Medicine, Houston, TX, United States. FAU - Jackson, Lisa A AU - Jackson LA AD - Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States. FAU - Swamy, Geeta K AU - Swamy GK AD - Department of Obstetrics & Gynecology, Duke University, Durham, NC, United States. FAU - Edwards, Kathryn M AU - Edwards KM AD - Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, TN, United States. FAU - Frey, Sharon E AU - Frey SE AD - Saint Louis University School of Medicine, St. Louis, MO, United States. FAU - Petrie, Carey R AU - Petrie CR AD - The EMMES Company, LLC, Rockville, MD, United States. FAU - Sendra, Eli A AU - Sendra EA AD - The EMMES Company, LLC, Rockville, MD, United States. FAU - Keitel, Wendy A AU - Keitel WA AD - Department of Molecular Virology and Microbiology, Houston, TX, United States; Department of Medicine, Baylor College of Medicine, Houston, TX, United States. LA - eng GR - N01AI25465/AI/NIAID NIH HHS/United States GR - HHSN272200800057C/AI/NIAID NIH HHS/United States GR - HHSN272200800002C/AI/NIAID NIH HHS/United States GR - HHSN272201300023C/AI/NIAID NIH HHS/United States GR - HHSN27220130021I/AI/NIAID NIH HHS/United States GR - HHSN272200800003C/AI/NIAID NIH HHS/United States GR - HHSN272201300015I/AI/NIAID NIH HHS/United States GR - HHSN272201500002C/AI/NIAID NIH HHS/United States GR - HHSN272201300019C/AI/NIAID NIH HHS/United States GR - HHSN272201300019I/AI/NIAID NIH HHS/United States GR - HHSN272200800007C/AI/NIAID NIH HHS/United States GR - HHSN272201300017C/AI/NIAID NIH HHS/United States GR - HHSN272201300015C/AI/NIAID NIH HHS/United States GR - HHSN272201300017I/AI/NIAID NIH HHS/United States GR - HHSN272201300023I/AI/NIAID NIH HHS/United States GR - HHSN272200800004C/AI/NIAID NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial DEP - 20200619 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Viral) RN - 0 (Influenza Vaccines) RN - 0 (Vaccines, Inactivated) SB - IM MH - Adolescent MH - Adult MH - Antibodies, Viral MH - Female MH - Hemagglutination Inhibition Tests MH - Humans MH - Infant MH - *Influenza Vaccines/adverse effects MH - *Influenza, Human/prevention & control MH - Pregnancy MH - Pregnant Women MH - Prospective Studies MH - Seasons MH - Vaccines, Inactivated/adverse effects MH - Young Adult PMC - PMC10803065 MID - NIHMS1598041 OTO - NOTNLM OT - Antibody persistence OT - IIV3 OT - Infant OT - Influenza vaccine OT - Maternal immunization OT - Passive antibody transfer OT - Pregnant women COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Declaration of Competing Interest FMM received funding for unrelated research from the following: Centers for Disease Control and Prevention, Bill and Melinda Gates Foundation, the Brighton Collaboration, Novavax, Regeneron, Janssen; serves in Data Safety Monitoring Boards (DSMB) for the National Institutes of Health, Moderna, and Pfizer; and is an author and editor for UpToDate. GKS serves received unrelated research funding from the Centers for Disease Control and Prevention and Novavax, and serves as chair of Independent Data Monitoring Committee (IDMC) for RSV vaccines in pregnant women for GlaxoSmithKline and for Group B streptococcus vaccines in non-pregnant and pregnant women for Pfizer. KME serves as an advisor for Bio-Net, IBM, and Merck and on Data Safety and Monitoring Boards for Sanofi, X-4 Pharma, Seqirus, Moderna, and Pfizer. The following authors report no financial conflicts: SMP, LAJ, SEF, CRP, EAS, WAK. EDAT- 2020/06/24 06:00 MHDA- 2021/04/28 06:00 PMCR- 2024/01/22 CRDT- 2020/06/24 06:00 PHST- 2020/02/03 00:00 [received] PHST- 2020/05/10 00:00 [revised] PHST- 2020/05/16 00:00 [accepted] PHST- 2020/06/24 06:00 [pubmed] PHST- 2021/04/28 06:00 [medline] PHST- 2020/06/24 06:00 [entrez] PHST- 2024/01/22 00:00 [pmc-release] AID - S0264-410X(20)30704-0 [pii] AID - 10.1016/j.vaccine.2020.05.059 [doi] PST - ppublish SO - Vaccine. 2020 Jul 14;38(33):5355-5363. doi: 10.1016/j.vaccine.2020.05.059. Epub 2020 Jun 19.