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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...
Language English Country Netherlands
Document type Clinical Trial, Phase IV, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 2002-01-01 to 2 months ago
Nursing & Allied Health Database (ProQuest)
from 2002-01-01 to 2 months ago
Health & Medicine (ProQuest)
from 2002-01-01 to 2 months ago
Family Health Database (ProQuest)
from 2002-01-01 to 2 months ago
Health Management Database (ProQuest)
from 2002-01-01 to 2 months ago
Public Health Database (ProQuest)
from 2002-01-01 to 2 months ago
- MeSH
- Haemophilus Vaccines immunology MeSH
- Infant MeSH
- Vaccines, Combined immunology MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Pneumococcal Vaccines immunology MeSH
- Poliovirus Vaccine, Inactivated immunology MeSH
- Antibodies, Bacterial blood MeSH
- Pregnancy MeSH
- Diphtheria-Tetanus-Pertussis Vaccine immunology MeSH
- Hepatitis B Vaccines immunology MeSH
- Diphtheria-Tetanus-acellular Pertussis Vaccines administration & dosage MeSH
- Check Tag
- Infant MeSH
- Humans MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase IV MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial 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
References provided by Crossref.org
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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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