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Clin Infect Dis. 2018 Sep 14;67(7):1063-1071. doi: 10.1093/cid/ciy244.

A Randomized Controlled Trial of the Safety and Immunogenicity of Tetanus, Diphtheria, and Acellular Pertussis Vaccine Immunization During Pregnancy and Subsequent Infant Immune Response.

Author information

1
Canadian Center for Vaccinology, Dalhousie University and the IWK Health Centre and Nova Scotia Health Authority, Halifax.
2
Department of Pediatrics, Dalhousie University and the IWK Health Centre and Nova Scotia Health Authority, Halifax.
3
Department of Microbiology and Immunology, Dalhousie University and the IWK Health Centre and Nova Scotia Health Authority, Halifax.
4
Department of Community Health and Epidemiology, Dalhousie University and the IWK Health Centre and Nova Scotia Health Authority, Halifax.
5
Department of Obstetrics and Gynaecology, Dalhousie University and the IWK Health Centre and Nova Scotia Health Authority, Halifax.
6
Department of Mathematics and Statistics, Dalhousie University and the IWK Health Centre and Nova Scotia Health Authority, Halifax.
7
School of Nursing, Dalhousie University and the IWK Health Centre and Nova Scotia Health Authority, Halifax.
8
Department of Medicine, Dalhousie University and the IWK Health Centre and Nova Scotia Health Authority, Halifax.
9
Departments of Paediatrics, Microbiology, Immunology and Infectious Diseases, Pathology, and Laboratory Medicine.
10
Alberta Children's Hospital Research Institute, Alberta Health Services.
11
Department of Obstetrics and Gynaecology, University of Calgary.
12
Department of Medical Genetics, Cumming School of Medicine, University of Calgary.
13
Centre Hospitalier Universitaire Sainte-Justine and University of Montreal.
14
Department of Pediatrics, University of Ottawa.
15
Department of Obstetrics and Gynaecology, University of Ottawa.
16
Department of Pediatrics, University of Alberta and the Women and Children's Health Research Institute, Edmonton.
17
Department of Obstetrics and Gynecology, University of Alberta and the Women and Children's Health Research Institute, Edmonton.
18
Department of Pediatrics, University of British Columbia, Vancouver, Canada.
19
Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, Canada.

Abstract

Background:

Immunization of pregnant women with tetanus-diphtheria-acellular pertussis vaccine (Tdap) provides protection against pertussis to the newborn infant.

Methods:

In a randomized, controlled, observer-blind, multicenter clinical trial, we measured the safety and immunogenicity of Tdap during pregnancy and the effect on the infant's immune response to primary vaccination at 2, 4, and 6 months and booster vaccination at 12 months of age. A total of 273 women received either Tdap or tetanus-diphtheria (Td) vaccine in the third trimester and provided information for the safety analysis and samples for the immunogenicity analyses; 261 infants provided serum for the immunogenicity analyses.

Results:

Rates of adverse events were similar in both groups. Infants of Tdap recipients had cord blood levels that were 21% higher than maternal levels for pertussis toxoid (PT), 13% higher for filamentous hemagglutinin (FHA), 4% higher for pertactin (PRN), and 7% higher for fimbriae (FIM). These infants had significantly higher PT antibody levels at birth and at 2 months and significantly higher FHA, PRN, and FIM antibodies at birth and 2 and 4 months, but significantly lower PT and FHA antibody levels at 6 and 7 months and significantly lower PRN and FIM antibody levels at 7 months than infants whose mothers received Td. Differences persisted prebooster at 12 months for all antigens and postbooster 1 month later for PT, FHA, and FIM.

Conclusions:

This study demonstrated that Tdap during pregnancy results in higher levels of antibodies early in infancy but lower levels after the primary vaccine series.

Clinical Trials Registration:

NCT00553228.

PMID:
30010773
DOI:
10.1093/cid/ciy244

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