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

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

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.

Study Overview

• Status: Completed
• Conditions: Pertussis; Pregnancy Related
• Intervention / Treatment: Biological: Tdap vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Nalat Sompagdee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; A single dose of Tdap vaccine at GA 27 - 36 weeks	Biological: Tdap vaccine; A single dose of Tdap vaccine at GA 27 - 36 weeks
No Intervention: Active comparator; dT vaccine as standard protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td	Eight months

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Nalat Sompagdee, MD, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2018
• Primary Completion (Actual): April 13, 2019
• Study Completion (Actual): April 13, 2019

Study Registration Dates

• First Submitted: April 7, 2018
• First Submitted That Met QC Criteria: April 7, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Whooping Cough
• Other Study ID Numbers: SI 089/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes