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Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial
KP. Perrett, SA. Halperin, T. Nolan, A. Carmona Martínez, F. Martinón-Torres, J. García-Sicilia, M. Virta, OG. Vanderkooi, GV. Zuccotti, P. Manzoni, L. Kostanyan, N. Meyer, MA. Ceregido, B. Cheuvart, SO. Kuriyakose, Z. Stranak, JM. Merino...
Jazyk angličtina Země Nizozemsko
Typ dokumentu klinické zkoušky, fáze IV, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
NLK
ProQuest Central
od 2002-01-01 do Před 2 měsíci
Nursing & Allied Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Health & Medicine (ProQuest)
od 2002-01-01 do Před 2 měsíci
Family Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Health Management Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Public Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
- MeSH
- hemofilové vakcíny imunologie MeSH
- kojenec MeSH
- kombinované vakcíny imunologie MeSH
- lidé MeSH
- následné studie MeSH
- pneumokokové vakcíny imunologie MeSH
- poliovirová vakcína inaktivovaná imunologie MeSH
- protilátky bakteriální krev MeSH
- těhotenství MeSH
- vakcína proti diftérii, tetanu a pertusi imunologie MeSH
- vakcína proti hepatitidě B imunologie MeSH
- vakcína proti záškrtu, tetanu a černému kašli aplikace a dávkování MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. METHODS: This 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. RESULTS: 601 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. CONCLUSIONS: Pertussis 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.
Alberta Children's Hospital University of Calgary Alberta Calgary Canada
Dalhousie University Canadian Center for Vaccinology Halifax Canada
Hospital Clínico San Carlos Madrid Spain
Hospital de Antequera Antequera Málaga Spain
Hospital La Zarzuela Aravaca Spain
Hospital Quiron Malaga Andalucia Malaga Spain
Hospital Universitario Madrid Sanchinarro Madrid Spain
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Spain
Institute for the Care of Mother and Child Prague Czech Republic
Instituto Hispalense de Pediatría Sevilla Spain
Neonatologia Hospital La Paz Madrid Spain
Nuevo Hospital Universitario de Burgos Burgos Spain
Ospedale dei Bambini Vittore Buzzi and University of Milan Milan Italy
Tampere Vaccine Research Center Tampere University Tampere Finland
Citace poskytuje Crossref.org
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- $a Perrett, Kirsten P $u 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
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- $a Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial / $c KP. Perrett, SA. Halperin, T. Nolan, A. Carmona Martínez, F. Martinón-Torres, J. García-Sicilia, M. Virta, OG. Vanderkooi, GV. Zuccotti, P. Manzoni, L. Kostanyan, N. Meyer, MA. Ceregido, B. Cheuvart, SO. Kuriyakose, Z. Stranak, JM. Merino Arribas, MJ. Cilleruelo Ortega, M. Miranda-Valdivieso, B. Arias Novas, JT. Ramos Amador, F. Omeñaca, M. Baca, PG. Marchisio, N. Mesaros
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- $a BACKGROUND: Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. METHODS: This 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. RESULTS: 601 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. CONCLUSIONS: Pertussis 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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- $a Halperin, Scott A $u Dalhousie University, Canadian Center for Vaccinology, Halifax, Canada. Electronic address: scott.halperin@dal.ca
- 700 1_
- $a Nolan, Terry $u 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
- 700 1_
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- 700 1_
- $a Martinón-Torres, Federico $u 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. Electronic address: federico.martinon.torres@sergas.es
- 700 1_
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- 700 1_
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- 700 1_
- $a Vanderkooi, Otto G $u Alberta Children's Hospital, University of Calgary, Alberta, Calgary, Canada. Electronic address: ovanderk@ucalgary.ca
- 700 1_
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- 700 1_
- $a Kostanyan, Lusine $u Modis, C/O GSK, Wavre, Belgium. Electronic address: lusine.x.kostanyan@gsk.com
- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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