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

Launched by MAHIDOL UNIVERSITY · Apr 7, 2018

Keywords

ClinConnect Summary

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.

Gender

FEMALE

Eligibility criteria

• 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