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Preliminary Communication |

Safety and Immunogenicity of Tetanus Diphtheria and Acellular Pertussis (Tdap) Immunization During Pregnancy in Mothers and Infants:  A Randomized Clinical Trial

Flor M. Munoz, MD1,2; Nanette H. Bond, PAC2; Maurizio Maccato, MD1,3; Phillip Pinell, MD1,3; Hunter A. Hammill, MD4; Geeta K. Swamy, MD5; Emmanuel B. Walter, MD6; Lisa A. Jackson, MD7; Janet A. Englund, MD8; Morven S. Edwards, MD1; C. Mary Healy, MD1; Carey R. Petrie, PhD9; Jennifer Ferreira, ScM9; Johannes B. Goll, MS9; Carol J. Baker, MD1,2
[+] Author Affiliations
1Department of Pediatrics, Baylor College of Medicine, Houston, Texas
2Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas
3Woman’s OB/GYN Specialists, Houston, Texas
4Private obstetric practice, Houston, Texas
5Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, North Carolina
6Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina
7Group Health Research Institute, Seattle, Washington
8Seattle Children’s Research Institute, Department of Pediatrics, University of Washington, Seattle
9EMMES Corporation, Rockville, Maryland
JAMA. 2014;311(17):1760-1769. doi:10.1001/jama.2014.3633.
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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

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Figure.
Consort Flow Diagram

Tdap indicates tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis.aParticipants who did not meet more than 1 eligibility criterion are categorized by the first criterion met.bReceived pharmacy stock vaccine, not study vaccine; included in analysis.

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