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Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial.
JAMA. 2014 May 07; 311(17):1760-9.JAMA

Abstract

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.

Authors+Show Affiliations

Department of Pediatrics, Baylor College of Medicine, Houston, Texas2Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas.Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas.Department of Pediatrics, Baylor College of Medicine, Houston, Texas3Woman's OB/GYN Specialists, Houston, Texas.Department of Pediatrics, Baylor College of Medicine, Houston, Texas3Woman's OB/GYN Specialists, Houston, Texas.Private obstetric practice, Houston, Texas.Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, North Carolina.Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.Group Health Research Institute, Seattle, Washington.Seattle Children's Research Institute, Department of Pediatrics, University of Washington, Seattle.Department of Pediatrics, Baylor College of Medicine, Houston, Texas.Department of Pediatrics, Baylor College of Medicine, Houston, Texas.EMMES Corporation, Rockville, Maryland.EMMES Corporation, Rockville, Maryland.EMMES Corporation, Rockville, Maryland.Department of Pediatrics, Baylor College of Medicine, Houston, Texas2Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas.

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

24794369

Citation

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, 2014, pp. 1760-9.
Munoz FM, Bond NH, Maccato 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. 2014;311(17):1760-9.
Munoz, F. M., Bond, N. H., Maccato, M., Pinell, P., Hammill, H. A., Swamy, G. K., Walter, E. B., Jackson, L. A., Englund, J. A., Edwards, M. S., Healy, C. M., Petrie, C. R., Ferreira, J., Goll, J. B., & 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), 1760-9. https://doi.org/10.1001/jama.2014.3633
Munoz FM, et al. 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):1760-9. PubMed PMID: 24794369.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. AU - Munoz,Flor M, AU - Bond,Nanette H, AU - Maccato,Maurizio, AU - Pinell,Phillip, AU - Hammill,Hunter A, AU - Swamy,Geeta K, AU - Walter,Emmanuel B, AU - Jackson,Lisa A, AU - Englund,Janet A, AU - Edwards,Morven S, AU - Healy,C Mary, AU - Petrie,Carey R, AU - Ferreira,Jennifer, AU - Goll,Johannes B, AU - Baker,Carol J, PY - 2014/5/6/entrez PY - 2014/5/6/pubmed PY - 2014/5/17/medline SP - 1760 EP - 9 JF - JAMA JO - JAMA VL - 311 IS - 17 N2 - 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/24794369/Safety_and_immunogenicity_of_tetanus_diphtheria_and_acellular_pertussis__Tdap__immunization_during_pregnancy_in_mothers_and_infants:_a_randomized_clinical_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2014.3633 DB - PRIME DP - Unbound Medicine ER -