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

NCT ID: NCT03498300

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-09
• Study Completion Date: 2019-04-13

Brief Summary

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.

Detailed 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.

Conditions

Pertussis; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Tdap vaccine

Intervention Type: BIOLOGICAL

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

Active comparator

dT vaccine as standard protocol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tdap vaccine

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Nalat Sompagdee

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nalat Sompagdee, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Nalat Sompagdee

Bangkok Noi, Bangkok, Thailand

Countries

Thailand

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SI 089/2018

Identifier Type: -

Identifier Source: org_study_id