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Completed

NCT Number: NCT03498300

Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women

This study evaluated the seroprevalence of Bordetella pertussis antibodies and anti-pertussis antibody response after a single dose of reduced-antigen, combined diphtheria, tetanus, and acellular pertussis vaccine (Tdap) in pregnant Thai women.

All seronegative participants received Tdap, while seropositive participants were equally randomized into 2 groups. Half of seropositive participants received Tdap and the other half received tetanus-diphtheria (Td) as standard protocol.

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Key information

Conditions

Pertussis Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Pregnancy Related Respiratory Tract Diseases Respiratory Tract Infections Whooping Cough

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Nalat Sompagdee

Bangkok Noi, Bangkok, 10700, Thailand

About this study

The primary objective of this study was to determine the seroprevalence of anti-pertussis toxin antibodies (anti-PT IgG) among pregnant Thai women. The secondary objectives were to evaluate antibody response after Tdap vaccination between seronegative and seropositive participants and to compare the different antibody titers at delivery among seropositive participants who received Tdap to those who received tetanus-diphtheria vaccine (Td). The sample size calculation was based on the primary objective. Randomized clinical trial was performed for the latter secondary objective.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Thai pregnant women age at least 18 years
  • No known underlying disease
  • Singleton pregnancy without maternal or fetal complications
  • Gestational age not more than 20 weeks at the time of recruitment
  • Desired for delivery at Siriraj Hospital

Exclusion criteria

  • Pregnant women who have any contraindication to Tdap vaccine including
  • History of serious allergic reaction to any components of Tdap vaccine
  • History of seizure or coma after receiving Tdap vaccine in childhood
  • Having an underlying disease involving central nervous system (e.g., epilepsy, Guillain-Barré syndrome)
  • History of serious reactions after receiving Tdap vaccine (e.g., severe pain, severe swelling at the injection site)
  • Recently had Tdap vaccine injection
  • Denied for Tdap vaccine injection

Treatment and study plan

Tdap vaccine

Biological

A single dose of Tdap vaccine at GA 27 - 36 weeks

Primary outcomes

  1. The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women

    Time frame: Four months

    Percentage of participants who were seropositive for anti-pertussis toxin antibodies (anti-PT IgG).

    The overall number of 129 participants is greater than the number of 42 participants include in the Particiant Flow Module because it was the sample size calculated based on the primary objective, which was the seroprevalence of anti-pertussis antibodies in pregnant Thai women. Randomized clinical trial on 42 seropositive participants was performed for one of the secondary objectives, which was to compare the different anti-PT IgG at delivery among seropositive participants who received Tdap to those who received Td.

Secondary outcomes

  1. Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td

    Time frame: Eight months

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Reduced-antigen, Combined Diphtheria, Tetanus, and Acellular Pertussis Vaccine (Tdap) in Pregnant Thai Women

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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