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Impact of maternal diphtheria-tetanus-acellular pertussis vaccination on pertussis booster immune responses in toddlers: Follow-up of a randomized trial
F. Martinón-Torres, SA. Halperin, T. Nolan, B. Tapiéro, KP. Perrett, IS. de la Cueva, J. García-Sicilia, Z. Stranak, OG. Vanderkooi, P. Kosina, S. Rumlarova, M. Virta, JMM. Arribas, M. Miranda-Valdivieso, BA. Novas, J. Bozensky, MJC. Ortega, JTR....
Language English Country Netherlands
Document type 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
- Diphtheria * prevention & control MeSH
- Haemophilus Vaccines * MeSH
- Immunity MeSH
- Infant MeSH
- Vaccines, Combined MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Whooping Cough * prevention & control MeSH
- Poliovirus Vaccine, Inactivated MeSH
- Child, Preschool MeSH
- Antibodies, Bacterial MeSH
- Immunization, Secondary MeSH
- Pregnancy MeSH
- Tetanus * prevention & control MeSH
- Diphtheria-Tetanus-Pertussis Vaccine MeSH
- Diphtheria-Tetanus-acellular Pertussis Vaccines * MeSH
- Vaccination MeSH
- Check Tag
- Infant MeSH
- Humans MeSH
- Child, Preschool MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- Australia MeSH
- Europe MeSH
- Canada MeSH
BACKGROUND: Transplacentally transferred antibodies induced by maternal pertussis vaccination interfere with infant immune responses to pertussis primary vaccination. We evaluated whether this interference remains in toddlers after booster vaccination. METHODS: In a prior phase IV, observer-blind, placebo-controlled, randomized study (NCT02377349), pregnant women in Australia, Canada and Europe received intramuscular tetanus-reduced-antigen-content diphtheria-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) at 270/7-366/7 weeks' gestation, with crossover immunization postpartum. Their infants were primed (study NCT02422264) and boosted (at 11-18 months; current study NCT02853929) with diphtheria-tetanus-three-component acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b vaccine (DTaP-HepB-IPV/Hib) and 13-valent pneumococcal conjugate vaccine. Immunogenicity before and after booster vaccination, and reactogenicity and safety of the booster were evaluated descriptively. RESULTS: 263 (Tdap group) and 277 (control group) toddlers received a DTaP-HepB-IPV/Hib booster. Pre-booster vaccination, observed geometric mean concentrations (GMCs) for the three pertussis antigens and diphtheria were 1.4-1.5-fold higher in controls than in the Tdap group. No differences were observed for the other DTaP-HepB-IPV/Hib antigens. One month post-booster vaccination, booster response rates for pertussis antigens were ≥ 92.1% and seroprotection rates for the other DTaP-HepB-IPV/Hib antigens were ≥ 99.2% in both groups (primary objective). Higher post-booster GMCs were observed in controls versus the Tdap group for anti-filamentous hemagglutinin (1.2-fold), anti-pertussis toxoid (1.5-fold) and anti-diphtheria (1.4-fold). GMCs for the other DTaP-HepB-IPV/Hib antigens were similar between groups. Serious adverse events were reported for three toddlers (controls, not vaccination-related). One death occurred pre-booster (Tdap group, not vaccination-related). CONCLUSIONS: As a consequence of interference of maternal pertussis antibodies with infant immune responses to pertussis primary vaccination, pertussis antibody concentrations were still lower in toddlers from Tdap-vaccinated mothers before DTaP-HepB-IPV/Hib booster vaccination. After the booster, antibody concentrations were lower for filamentous hemagglutinin and pertussis toxoid but not for pertactin. The clinical significance of this interference requires further evaluation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02853929.
CHU Sainte Justine Université de Montréal Montréal QC H3T 1C5 Canada
Dalhousie University Canadian Center for Vaccinology Halifax NS B3K 6R8 Canada
Departamento de Salud Pública y Materno Infantil Hospital Clínico San Carlos 28040 Madrid Spain
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico 20122 Milan Italy
GSK Vaccines 1300 Wavre Belgium
GSK Vaccines Bangalore 560001 India
Hospital de Antequera Servicio de Pediatría 29200 Antequera Spain
Hospital Quiron Malaga Departamento de Pediatría y Neonatología 29004 Malaga Spain
Hospital Universitario La Paz Servicio de Neonatologia 28046 Madrid Spain
Hospital Universitario Madrid Sanchinarro Servicio de Pediatría 28050 Madrid Spain
Hospital Universitario Puerta de Hierro Majadahonda Servicio de Pediatría 28222 Madrid Spain
Hospital Universitario Sanitas La Zarzuela Servicio de Pediatría 28023 Aravaca Spain
Institute for the Care of Mother and Child Neonatology Department 147 00 Prague Czech Republic
Instituto Hispalense de Pediatría Unidad de Investigación 41014 Seville Spain
Nuevo Hospital Universitario de Burgos Departamento de Pediatría 09006 Burgos Spain
Ospedale dei Bambini Vittore Buzzi and University of Milan 20154 Milan Italy
Tampere Vaccine Research Center Tampere University 33100 Tampere Finland
Thomayer Hospital Prague Department of Neonatology 140 59 Prague Czech Republic
Università degli Studi di Milano 20122 Milan Italy
University Hospital Department of Infectious Diseases 500 05 Hradec Kralove Czech Republic
Vitkovice Hospital Pediatrics Department 703 00 Ostrava Czech Republic
References provided by Crossref.org
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- $a BACKGROUND: Transplacentally transferred antibodies induced by maternal pertussis vaccination interfere with infant immune responses to pertussis primary vaccination. We evaluated whether this interference remains in toddlers after booster vaccination. METHODS: In a prior phase IV, observer-blind, placebo-controlled, randomized study (NCT02377349), pregnant women in Australia, Canada and Europe received intramuscular tetanus-reduced-antigen-content diphtheria-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) at 270/7-366/7 weeks' gestation, with crossover immunization postpartum. Their infants were primed (study NCT02422264) and boosted (at 11-18 months; current study NCT02853929) with diphtheria-tetanus-three-component acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b vaccine (DTaP-HepB-IPV/Hib) and 13-valent pneumococcal conjugate vaccine. Immunogenicity before and after booster vaccination, and reactogenicity and safety of the booster were evaluated descriptively. RESULTS: 263 (Tdap group) and 277 (control group) toddlers received a DTaP-HepB-IPV/Hib booster. Pre-booster vaccination, observed geometric mean concentrations (GMCs) for the three pertussis antigens and diphtheria were 1.4-1.5-fold higher in controls than in the Tdap group. No differences were observed for the other DTaP-HepB-IPV/Hib antigens. One month post-booster vaccination, booster response rates for pertussis antigens were ≥ 92.1% and seroprotection rates for the other DTaP-HepB-IPV/Hib antigens were ≥ 99.2% in both groups (primary objective). Higher post-booster GMCs were observed in controls versus the Tdap group for anti-filamentous hemagglutinin (1.2-fold), anti-pertussis toxoid (1.5-fold) and anti-diphtheria (1.4-fold). GMCs for the other DTaP-HepB-IPV/Hib antigens were similar between groups. Serious adverse events were reported for three toddlers (controls, not vaccination-related). One death occurred pre-booster (Tdap group, not vaccination-related). CONCLUSIONS: As a consequence of interference of maternal pertussis antibodies with infant immune responses to pertussis primary vaccination, pertussis antibody concentrations were still lower in toddlers from Tdap-vaccinated mothers before DTaP-HepB-IPV/Hib booster vaccination. After the booster, antibody concentrations were lower for filamentous hemagglutinin and pertussis toxoid but not for pertactin. The clinical significance of this interference requires further evaluation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02853929.
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