Skip to main content
Journal cover image

Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial.

Publication ,  Journal Article
Munoz, FM; Bond, NH; Maccato, M; Pinell, P; Hammill, HA; Swamy, GK; Walter, EB; Jackson, LA; Englund, JA; Edwards, MS; Healy, CM; Petrie, CR ...
Published in: JAMA
May 7, 2014

IMPORTANCE: Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine could prevent infant pertussis. OBJECTIVE: To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine. DESIGN, SETTING, AND PARTICIPANTS: Phase 1-2, randomized, double-blind, placebo-controlled, clinical trial conducted from 2008 to 2012. Forty-eight pregnant women aged 18 to 45 years received Tdap (n = 33) or placebo (n = 15) at 30 to 32 weeks' gestation, with crossover immunization postpartum. INTERVENTIONS: Tdap vaccination at 30 to 32 weeks' gestation or postpartum. MAIN OUTCOMES AND MEASURES: Primary outcomes were maternal and infant adverse events, pertussis illness, and infant growth and development until age 13 months. Secondary outcomes were antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo, at delivery and 2 months' postpartum, and in infants at birth, at 2 months, and after the third and fourth doses of DTaP. RESULTS: No Tdap-associated serious adverse events occurred in women or infants. Injection site reactions after Tdap immunization were reported in 26 (78.8% [95% CI, 61.1%-91.0%]) and 12 (80% [95% CI, 51.9%-95.7%]) pregnant and postpartum women, respectively (P > .99). Systemic symptoms were reported in 12 (36.4% [ 95% CI, 20.4%-54.9%]) and 11 (73.3% [95% CI, 44.9%-92.2%]) pregnant and postpartum women, respectively (P = .03). Growth and development were similar in both infant groups. No cases of pertussis occurred. Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum (eg, pertussis toxin antibodies: 51.0 EU/mL [95% CI, 37.1-70.1] and 9.1 EU/mL [95% CI, 4.6-17.8], respectively; P < .001) and in their infants at birth (68.8 EU/mL [95% CI, 52.1-90.8] and 14.0 EU/mL [95% CI, 7.3-26.9], respectively; P < .001) and at age 2 months (20.6 EU/mL [95% CI, 14.4-29.6] and 5.3 EU/mL [95% CI, 3.0-9.4], respectively; P < .001). Antibody responses in infants born to women receiving Tdap during pregnancy were not different following the fourth dose of DTaP. CONCLUSIONS AND RELEVANCE: This preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants. For secondary outcomes, maternal immunization with Tdap resulted in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00707148.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

May 7, 2014

Volume

311

Issue

17

Start / End Page

1760 / 1769

Location

United States

Related Subject Headings

  • Young Adult
  • Whooping Cough
  • Pregnancy Trimester, Third
  • Pregnancy
  • Postpartum Period
  • Infant, Newborn
  • Infant
  • Immunization
  • Humans
  • General & Internal Medicine
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Munoz, F. M., Bond, N. H., Maccato, M., Pinell, P., Hammill, H. A., Swamy, G. K., … Baker, C. J. (2014). Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA, 311(17), 1760–1769. https://doi.org/10.1001/jama.2014.3633
Munoz, Flor M., Nanette H. Bond, Maurizio Maccato, Phillip Pinell, Hunter A. Hammill, Geeta K. Swamy, Emmanuel B. Walter, et al. “Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial.JAMA 311, no. 17 (May 7, 2014): 1760–69. https://doi.org/10.1001/jama.2014.3633.
Munoz, Flor M., et al. “Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial.JAMA, vol. 311, no. 17, May 2014, pp. 1760–69. Pubmed, doi:10.1001/jama.2014.3633.
Munoz FM, Bond NH, Maccato M, Pinell P, Hammill HA, Swamy GK, Walter EB, Jackson LA, Englund JA, Edwards MS, Healy CM, Petrie CR, Ferreira J, Goll JB, Baker CJ. Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA. 2014 May 7;311(17):1760–1769.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

May 7, 2014

Volume

311

Issue

17

Start / End Page

1760 / 1769

Location

United States

Related Subject Headings

  • Young Adult
  • Whooping Cough
  • Pregnancy Trimester, Third
  • Pregnancy
  • Postpartum Period
  • Infant, Newborn
  • Infant
  • Immunization
  • Humans
  • General & Internal Medicine