Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial |
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| Affiliation: | 1. Murdoch Children’s Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia;2. Dalhousie University, Canadian Center for Vaccinology, Halifax, Canada;3. Instituto Hispalense de Pediatría, Sevilla, Spain;4. Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela and Genetics, Vaccines and Pediatrics Research Group, University of Santiago de Compostela, Instituto de Investigación Sanitaria de Santiago de Compostela, Santiago de Compostela, Spain;5. Hospital Universitario Madrid Sanchinarro, Madrid, Spain;6. Tampere Vaccine Research Center, Tampere University, Tampere, Finland;7. Alberta Children''s Hospital, University of Calgary, Alberta, Calgary, Canada;8. Ospedale dei Bambini Vittore Buzzi, and University of Milan, Milan, Italy;9. Ospedale Ostetrico Ginecologico Sant''Anna, Turin, Italy and Department of Maternal-Infant -Pediatric Health, Hospital “Degli Infermi”, Biella, Italy;10. Modis, C/O GSK, Wavre, Belgium;11. GSK, Wavre, Belgium;12. GSK, Bangalore, India;13. Institute for the Care of Mother and Child, Prague, Czech Republic;14. Nuevo Hospital Universitario de Burgos, Burgos, Spain;15. Hospital Universitario Puerta de Hierro, Majadahonda, Majadahonda, Spain;p. Hospital de Antequera, Antequera, Málaga, Spain;q. Hospital La Zarzuela, Aravaca, Spain;r. Hospital Clínico San Carlos, Madrid, Spain;s. Neonatologia, Hospital La Paz, Madrid, Spain;t. Hospital Quiron Malaga, Andalucia, Malaga, Spain;u. Unità Pediatrica di Cure Altamente Intensive, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Lombardia, Milano, Italy |
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| Abstract: | BackgroundPertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization.MethodsThis phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6–14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (270/7–366/7 weeks’ gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination.Results601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5–77.1%) versus placebo (90.0–99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related.ConclusionsPertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant’s ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience.Clinical Trial Registration: ClinicalTrials.gov: NCT02422264. |
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| Keywords: | Tdap vaccine Pertussis Maternal immunization Blunting Infants AE" },{" #name" :" keyword" ," $" :{" id" :" k0035" }," $$" :[{" #name" :" text" ," _" :" adverse event ATP" },{" #name" :" keyword" ," $" :{" id" :" k0045" }," $$" :[{" #name" :" text" ," _" :" according-to-protocol CI" },{" #name" :" keyword" ," $" :{" id" :" k0055" }," $$" :[{" #name" :" text" ," _" :" confidence interval CPS" },{" #name" :" keyword" ," $" :{" id" :" k0065" }," $$" :[{" #name" :" text" ," _" :" capsular polysaccharide DTaP-HepB-IPV/Hib" },{" #name" :" keyword" ," $" :{" id" :" k0075" }," $$" :[{" #name" :" text" ," $$" :[{" #name" :" __text__" ," _" :" diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated poliovirus and " },{" #name" :" italic" ," _" :" Haemophilus influenzae" },{" #name" :" __text__" ," _" :" type b vaccine ECL" },{" #name" :" keyword" ," $" :{" id" :" k0085" }," $$" :[{" #name" :" text" ," _" :" electrochemiluminescence ELISA" },{" #name" :" keyword" ," $" :{" id" :" k0095" }," $$" :[{" #name" :" text" ," _" :" enzyme-linked immunosorbent assay FHA" },{" #name" :" keyword" ," $" :{" id" :" k0105" }," $$" :[{" #name" :" text" ," _" :" filamentous hemagglutinin HBs" },{" #name" :" keyword" ," $" :{" id" :" k0115" }," $$" :[{" #name" :" text" ," _" :" hepatitis B surface antigen GMC" },{" #name" :" keyword" ," $" :{" id" :" k0125" }," $$" :[{" #name" :" text" ," _" :" geometric mean concentration GMT" },{" #name" :" keyword" ," $" :{" id" :" k0135" }," $$" :[{" #name" :" text" ," _" :" geometric mean titer Hib" },{" #name" :" keyword" ," $" :{" id" :" k0145" }," $$" :[{" #name" :" text" ," $$" :[{" #name" :" italic" ," _" :" Haemophilus influenzae" },{" #name" :" __text__" ," _" :" type b LLoQ" },{" #name" :" keyword" ," $" :{" id" :" k0155" }," $$" :[{" #name" :" text" ," _" :" lower limit of quantitation PCV13" },{" #name" :" keyword" ," $" :{" id" :" k0165" }," $$" :[{" #name" :" text" ," _" :" 13-valent pneumococcal conjugate vaccine PRN" },{" #name" :" keyword" ," $" :{" id" :" k0175" }," $$" :[{" #name" :" text" ," _" :" pertactin PRP" },{" #name" :" keyword" ," $" :{" id" :" k0185" }," $$" :[{" #name" :" text" ," _" :" polyribosylribitol phosphate PT" },{" #name" :" keyword" ," $" :{" id" :" k0195" }," $$" :[{" #name" :" text" ," _" :" pertussis toxoid RCT" },{" #name" :" keyword" ," $" :{" id" :" k0205" }," $$" :[{" #name" :" text" ," _" :" randomized controlled trial SAE" },{" #name" :" keyword" ," $" :{" id" :" k0215" }," $$" :[{" #name" :" text" ," _" :" serious adverse event Tdap" },{" #name" :" keyword" ," $" :{" id" :" k0225" }," $$" :[{" #name" :" text" ," _" :" diphtheria-tetanus-acellular pertussis vaccine TVC" },{" #name" :" keyword" ," $" :{" id" :" k0235" }," $$" :[{" #name" :" text" ," _" :" total vaccinated cohort |
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