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

Mahidol University

Status and phase

Completed

Early Phase 1

Conditions

Pregnancy Related

Pertussis

Treatments

Biological: Tdap vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT03498300

SI 089/2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment

129 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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
1. History of serious allergic reaction to any components of Tdap vaccine
2. History of seizure or coma after receiving Tdap vaccine in childhood
3. 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