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

NCT03498300 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: SI 089/2018
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Pertussis; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td

  Eight months

Study Arms (2)

Experimental

EXPERIMENTAL

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

Biological: Tdap vaccine

Active comparator

NO INTERVENTION

dT vaccine as standard protocol

Interventions

Tdap vaccine BIOLOGICAL

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women who have any contraindication to Tdap vaccine including
• History of serious allergic reaction to any components of Tdap vaccine
• History of seizure or coma after receiving Tdap vaccine in childhood
• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Nalat Sompagdee

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Nalat Sompagdee
• Organization: Faculty of Medicine Siriraj Hospital, Mahidol University

pear_nalat@hotmail.com

+6687-008-7100

Study Officials

• Nalat Sompagdee, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 13, 2018
• Study Start: May 9, 2018
• Primary Completion: April 13, 2019
• Study Completion: April 13, 2019
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Locations

TH (1)