10-year Follow-up After a Single Dose Acellular Pertussis Vaccination

NCT06803524 | Recruiting Phase 4 DMC

• 1 other identifier: TDA 202 10-year follow-up
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II/III trial (Protocol No. TDA202).

Conditions

Pertussis

Keywords

TDA202; acellular pertussis vaccine; a second booster dose of Pertagen® as compared to Adacel®; antibody persistence at 10 years after vaccination; Pertagen; Boostagen; aP vaccine

Outcome Measures

Primary Outcomes (1)

• To demonstrate superiority at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

  Geometric mean concentration (GMC) of anti-PT and anti-FHA antibodies measured at baseline (before second booster vaccination) and 28 days following vaccination.

  Day 28

Secondary Outcomes (14)

• Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

  Day 28

• Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

  Day 28

• Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

  Day 28

• Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

  Day 28

• Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

  Day 28

Study Arms (3)

Pertagen® vaccine

EXPERIMENTAL

Pertagen® vaccine, manufactured by BioNet-Asia Co., Ltd., Bangkok, Thailand. The vaccine is presented in pre-filled syringe, each containing one human dose (0.5 mL) of aP vaccine.

Biological: Pertagen® vaccine

Adacel® vaccine

EXPERIMENTAL

Adacel® vaccine, manufactured by Sanofi Pasteur, Ltd, Toronto, Ontario, Canada. The vaccine is presented in a single-dose vial, each containing one human dose (0.5 mL) of Tdap vaccine.

Biological: Adacel® vaccine

Boostagen® vaccine

EXPERIMENTAL

BIoNet Recombinant TdaP, each 0.5 mL dose of Boostagen (TdaP BioNet) contained 5 μg PTgen, 5 μg FHA, and 0.3 mg as aluminium cation.

Biological: Pertagen® vaccine

Interventions

Pertagen® vaccine BIOLOGICAL

Pertagen® vaccine, manufactured by BioNet-Asia Co., Ltd., Bangkok, Thailand. The vaccine is presented in pre-filled syringe, each containing one human dose (0.5 mL) of aP vaccine.

Boostagen® vaccine; Pertagen® vaccine

Adacel® vaccine BIOLOGICAL

Adacel® vaccine, manufactured by Sanofi Pasteur, Ltd, Toronto, Ontario, Canada. The vaccine is presented in a single-dose vial, each containing one human dose (0.5 mL) of Tdap vaccine.

Adacel® vaccine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having participated in the initial TDA202 study, received a single dose of one of the 3 study vaccines, and completed 1-year follow-up visit;
• Written informed consent is obtained prior to study entry;
• Healthy, as established by pertinent medical history and physical examination;
• Capable of complying with study procedures and willing to provide with a blood sample;
• For women with childbearing potential (i.e., urine pregnancy test will not be performed in females who have undergone sterilisation, hysterectomy or who are post-menopausal), must have a negative urine pregnancy test at enrollment and willing to take reliable birth control measures for one month following vaccination.

You may not qualify if:

• A participant with following criteria at screening will not be eligible for participation:
• Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study;
• Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment;
• Pregnant or breast-feeding women or female participants who intend to become pregnant during study period;
• History of any significant medical illness such as, but not limited to, immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, or endocrine disorder, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination that may interfere with the participant's safety and evaluation of investigational vaccines in this study;
• History of allergy or hypersensitivity to any vaccine (including its component);
• History of any serious adverse event or neurological adverse event after vaccination;
• History of receiving blood or blood component or immunoglobulin within 3 months prior to enrollment;
• History of receiving immunosuppressive drugs or systemic corticosteroid (\>0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to enrollment;
• Having received any other vaccines within 28 days prior to enrollment (3 months for live- attenuated vaccines);
• Plan to receive any other vaccine or plan to participate in another clinical trial with intervention during the study period;
• A known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in a problem with intramuscular injection;
• Any progressive or severe neurological disorder such as seizure disorder or Guillain-Barré syndrome;
• History of any illness or clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the volunteers due to participation in the study
• Remark: If fever occurs at screening visit, the participant may be rescreened and enrolled at a later date at the discretion of the investigator, or withdrawn at the discretion of the investigator.

Sponsors & Collaborators

• Mahidol University: lead
• BioNet-Asia Co., Ltd.: collaborator

Study Sites (2)

Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok Metropolis, 10700, Thailand

RECRUITING

Vaccine Trial Centre

Ratchathewi, Bangkok Metropolis, 10400, Thailand

RECRUITING

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

Study Officials

• Punnee Pitisuttithum

  Vaccine trial Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Punnee Pitisuttithum

CONTACT

0818294906; punnee.pit@mahidol.ac.th

Jittima Dhitavat

CONTACT

0875921777; ่jittima_pu@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: May 13, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)