PMID- 31776029 OWN - NLM STAT- MEDLINE DCOM- 20210317 LR - 20210317 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 38 IP - 8 DP - 2020 Feb 18 TI - Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial. PG - 2095-2104 LID - S0264-410X(19)31507-5 [pii] LID - 10.1016/j.vaccine.2019.10.105 [doi] AB - BACKGROUND: Pertussis immunization during pregnancy is recommended in many countries. Data from large randomized controlled trials are needed to assess the immunogenicity, reactogenicity and safety of this approach. METHODS: This phase IV, observer-blind, randomized, placebo-controlled, multicenter trial assessed immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety of a reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap) during pregnancy. Women received Tdap or placebo at 27-36 weeks' gestation with crossover /= 1.5. Solicited and unsolicited adverse events (AEs) and pregnancy-/neonate-related AEs of interest were recorded. RESULTS: 687 pregnant women were vaccinated (Tdap: N = 341 control: N = 346). Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5-19.2) for anti-filamentous hemagglutinin, 20.7 (15.9-26.9) for anti-pertactin and 8.5 (7.0-10.2) for anti-pertussis toxoid. Rates of pregnancy-/neonate-related AEs of interest, solicited general and unsolicited AEs were similar between groups. None of the serious AEs reported throughout the study were considered related to maternal Tdap vaccination. CONCLUSIONS: Tdap vaccination during pregnancy resulted in high levels of pertussis antibodies in cord blood, was well tolerated and had an acceptable safety profile. This supports the recommendation of Tdap vaccination during pregnancy to prevent early-infant pertussis disease. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02377349. CI - Copyright (c) 2019. Published by Elsevier Ltd. FAU - Perrett, Kirsten P AU - Perrett KP AD - Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: kirsten.perrett@rch.org.au. FAU - Halperin, Scott A AU - Halperin SA AD - Dalhousie University, Canadian Center for Vaccinology, Halifax, Canada. Electronic address: scott.halperin@dal.ca. FAU - Nolan, Terry AU - Nolan T AD - Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: t.nolan@unimelb.edu.au. FAU - Martinez Pancorbo, Cristina AU - Martinez Pancorbo C AD - Instituto Sevillano de la Mujer-Instituto Hispalense de Pediatria, Seville, Spain. FAU - Tapiero, Bruce AU - Tapiero B AD - CHU Sainte Justine, Universite de Montreal, Montreal, Canada. Electronic address: b.tapiero@umontreal.ca. FAU - Martinon-Torres, Federico AU - Martinon-Torres F AD - Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clinico Universitario de Santiago de Compostela and Genetics, Vaccines and Pediatrics Research Group, University of Santiago de Compostela, Instituto de Investigacion Sanitaria de Santiago de Compostela, Santiago de Compostela, Spain. Electronic address: federico.martinon.torres@sergas.es. FAU - Stranak, Zbynek AU - Stranak Z AD - Institute for the Care of Mother and Child, Prague, Czech Republic. Electronic address: z.stranak@seznam.cz. FAU - Virta, Miia AU - Virta M AD - Tampere Vaccine Research Center, Tampere University, Tampere, Finland. Electronic address: miia.virta@staff.uta.fi. FAU - Vanderkooi, Otto G AU - Vanderkooi OG AD - Alberta Children's Hospital, University of Calgary, Alberta, Calgary, Canada. Electronic address: ovanderk@ucalgary.ca. FAU - Kosina, Pavel AU - Kosina P AD - University Hospital, Hradec Kralove, Czech Republic. Electronic address: kosinpav@seznam.cz. FAU - Encinas Pardilla, Maria Begona AU - Encinas Pardilla MB AD - Hospital Universitario Puerta de Hierro, Majadahonda, Spain. FAU - Cristobal Garcia, Ignacio AU - Cristobal Garcia I AD - Universidad Francisco de Vitoria, Madrid, Spain. Electronic address: icristobalg@sego.es. FAU - Zuccotti, Gian Vincenzo AU - Zuccotti GV AD - Ospedale dei Bambini Vittore Buzzi and University of Milan, Milan, Italy. Electronic address: gianvincenzo.zuccotti@unimi.it. FAU - Kostanyan, Lusine AU - Kostanyan L AD - Modis, C/O GSK, Wavre, Belgium. Electronic address: lusine.x.kostanyan@gsk.com. FAU - Meyer, Nadia AU - Meyer N AD - GSK, Wavre, Belgium. Electronic address: nadia.x.meyer@gsk.com. FAU - Ceregido, Maria Angeles AU - Ceregido MA AD - GSK, Wavre, Belgium. Electronic address: maria-angeles.x.ceregido@gsk.com. FAU - Cheuvart, Brigitte AU - Cheuvart B AD - GSK, Wavre, Belgium. Electronic address: brigitte.cheuvart@gsk.com. FAU - Kuriyakose, Sherine O AU - Kuriyakose SO AD - GSK, Bangalore, India. Electronic address: sherine.o.kuriyakose@gsk.com. FAU - Marcos Fernandez, Manuel AU - Marcos Fernandez M AD - Hospital Monteprincipe, Boadilla del Monte, Spain. Electronic address: mmarcos@egom.es. FAU - Rodriguez Zambrano, Miguel Angel AU - Rodriguez Zambrano MA AD - Hospital HM Puerta del Sur, Mostoles, Spain. FAU - Martin Garcia, Adrian AU - Martin Garcia A AD - Nuevo Hospital Universitario de Burgos, Burgos, Spain. FAU - Asenjo de la Fuente, Juan Eloy AU - Asenjo de la Fuente JE AD - Hospital Clinico San Carlos, Madrid, Spain. Electronic address: eloyasenjo@telefonica.net. FAU - Camacho Marin, Maria Dolores AU - Camacho Marin MD AD - Hospital Clinico San Carlos, Madrid, Spain. FAU - de la Calle Fernandez-Miranda, Maria AU - de la Calle Fernandez-Miranda M AD - Hospital La Paz, Madrid, Spain. FAU - Romero Espinar, Yolanda AU - Romero Espinar Y AD - Hospital Quironsalud Malaga, Malaga, Spain. FAU - Marchisio, Paola Giovanna AU - Marchisio PG AD - Universita degli Studi di Milano, Milan, Italy. Electronic address: paola.marchisio@unimi.it. FAU - Manzoni, Paolo AU - Manzoni P AD - Ospedale Ostetrico Ginecologico Sant'Anna, Turin, Italy and Department of Maternal-Infant-Pediatric Health, Degli Infermi Hospital, Biella, Italy. FAU - Mesaros, Narcisa AU - Mesaros N AD - GSK, Wavre, Belgium. Electronic address: narcisa.x.mesaros@gsk.com. LA - eng SI - ClinicalTrials.gov/NCT02377349 PT - Clinical Trial, Phase IV PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20191124 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Bacterial) RN - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines) SB - IM MH - Antibodies, Bacterial/*blood MH - Diphtheria-Tetanus-acellular Pertussis Vaccines/*administration & dosage/adverse effects MH - Female MH - Humans MH - *Immunity, Maternally-Acquired MH - Infant, Newborn MH - *Maternal Exposure MH - Pregnancy MH - Single-Blind Method MH - Vaccination MH - *Whooping Cough/prevention & control OTO - NOTNLM OT - Adult formulation acellular pertussis vaccine OT - Maternal immunization OT - Tdap COIS- Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: BC, MAC, NMes, NMey and SOK are employees of the GSK group of companies (GSK), and BC and NMes own GSK restricted shares. BT, MBEP, OGV, SAH and TN's institutions received grants from GSK during the conduct of the study. KPP received grants from the National Health and Medical Research Council during the conduct of the study, and from MedImmune, Novavax and Pfizer outside the submitted work. FMT's institution received financial support from GSK during the conduct of the study, as well as financial and non-financial support outside the submitted work; he also received personal fees from Pfizer, Novavax, MSD and Sanofi Pasteur; his institution also received financial support as trial fees from Ablynx, Jansen, Regeneron, Medimmune, Pfizer, MSD, Sanofi Pasteur, Novavax and Novartis, as well as non-financial support from Pfizer and MSD and grants from MSD and Astra Zeneca. LK is working as consultant for GSK. SAH is member of ad-hoc advisory committees for GSK and Sanofi Pasteur and he has a patent for novel triple adjuvant issued. AMG, CMP, GVZ, ICG, JEAF, MARZ, MCFM, MDCM, MMF, MV, PGM, PK, PM, YRE and ZS declare no conflicts of interest. EDAT- 2019/11/30 06:00 MHDA- 2021/03/18 06:00 CRDT- 2019/11/29 06:00 PHST- 2019/07/30 00:00 [received] PHST- 2019/10/30 00:00 [revised] PHST- 2019/10/31 00:00 [accepted] PHST- 2019/11/30 06:00 [pubmed] PHST- 2021/03/18 06:00 [medline] PHST- 2019/11/29 06:00 [entrez] AID - S0264-410X(19)31507-5 [pii] AID - 10.1016/j.vaccine.2019.10.105 [doi] PST - ppublish SO - Vaccine. 2020 Feb 18;38(8):2095-2104. doi: 10.1016/j.vaccine.2019.10.105. Epub 2019 Nov 24.