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

Pregnancy Related Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498300
• Other study ID #: SI 089/2018
• Status: Completed
• Phase: Early Phase 1
• Start date: May 9, 2018
• Est. completion date: April 13, 2019

Study information

• Verified date: March 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 13, 2019
• Est. primary completion date: April 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pertussis
• Pregnancy Related
• Whooping Cough

Intervention

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

Locations

Country	Name	City	State
Thailand	Nalat Sompagdee	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women	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.	Four months
Secondary	Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td		Eight months