Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis

Juan C Vargas-Zambrano; Liana R Clark; David R Johnson; Celine Monfredo; Vitali Pool; Lin Li; Paul-Edouard Bouvet; Yoann Blangero; Denis Macina

doi:10.1016/j.vaccine.2023.03.048

Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis

Vaccine. 2023 May 2;41(18):2968-2975. doi: 10.1016/j.vaccine.2023.03.048. Epub 2023 Apr 7.

Authors

Juan C Vargas-Zambrano¹, Liana R Clark², David R Johnson², Celine Monfredo³, Vitali Pool⁴, Lin Li⁵, Paul-Edouard Bouvet⁶, Yoann Blangero⁶, Denis Macina⁷

Affiliations

¹ Global Medical Evidence Generation, Sanofi, Lyon, France. Electronic address: juan.vargas@sanofi.com.
² Global Medical, Sanofi, Swiftwater, PA, USA.
³ Biostatistical Sciences, Sanofi, Marcy l'Etoile, France.
⁴ US Medical, Sanofi, Swiftwater, PA, USA.
⁵ Epidemiology and Benefit Risk, Sanofi, Bridgewater, NJ, USA.
⁶ Soladis, Lyon, France.
⁷ Global Medical Evidence Generation, Sanofi, Lyon, France.

PMID: 37032227
DOI: 10.1016/j.vaccine.2023.03.048

Abstract

Objective: To evaluate the effectiveness of the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine containing five pertussis components (Tdap5; Adacel®, Sanofi) when given during pregnancy at preventing pertussis in infants less than 2 months of age.

Methods: The US Centers for Disease Control and Prevention (CDC), in collaboration with the Emerging Infections Program (EIP) Network, undertook a case-control study evaluating the effectiveness of Tdap vaccination in pregnancy against pertussis in infants less than 2 months of age based on data collected by the EIP Network from 2011 through 2014. The dataset from the CDC/EIP Network study was used to conduct this product-specific vaccine effectiveness analysis of Tdap5 vaccination in pregnancy to prevent disease in young infants. The main outcome of interest was vaccine effectiveness in infants whose pregnant parents were vaccinated with Tdap5 between 27 and 36 weeks' gestation, in accordance with the ideal timing for Tdap vaccination in pregnancy recommended by the US Advisory Committee on Immunization Practices. Odd ratios (ORs) and 95 % confidence intervals (CIs) were estimated using conditional logistic regression, and vaccine effectiveness was calculated as (1-OR) × 100 %.

Results: There were 160 infant pertussis cases and 302 matched controls included in this Tdap5-specific study. Tdap5 effectiveness in preventing pertussis in infants whose pregnant parents were vaccinated between 27 and 36 weeks' gestation was 92.5 % (95 % CI, 38.5 %-99.1 %). Effectiveness of Tdap5 against pertussis-related hospitalization in infants whose pregnant parents were vaccinated between 27 and 36 weeks' gestation could not be calculated due to lack of discordance among matched cases and controls. Vaccination of the parents after pregnancy or less than 14 days before delivery did not protect infants from pertussis.

Conclusions: Tdap5 vaccination in pregnancy between 27 and 36 weeks' gestation is highly effective at protecting young infants from pertussis.

Study registration: ClinicalTrials.gov, NCT05040802.

Keywords: Adacel; Hospitalization; Infant; Pertussis; Pregnancy; Tdap; Vaccination.

Publication types

Evaluation Study
Research Support, Non-U.S. Gov't

MeSH terms

Case-Control Studies
Diphtheria* / prevention & control
Diphtheria-Tetanus-acellular Pertussis Vaccines*
Female
Humans
Infant
Pregnancy
Tetanus* / prevention & control
Vaccination
Vaccine Efficacy
Whooping Cough* / prevention & control

Substances

Diphtheria-Tetanus-acellular Pertussis Vaccines

Associated data

ClinicalTrials.gov/NCT05040802