What is Pertagen4 studying for pertussis?

Pertagen4 is being studied to see how its second booster dose compares to Adacel4 in immune response and safety when given 10 years after the first booster. This study, led by Mahidol University, focuses on antibody levels and vaccine safety in adults previously vaccinated in an earlier trial. Participants can expect careful monitoring and blood tests to assess immune protection.

Who may be eligible for this pertussis clinical trial?

Adults who took part in the initial TDA202 vaccine study, completed its 1-year follow-up, and are generally healthy may be eligible. This study welcomes all genders and requires willingness to provide blood samples and, for women of childbearing potential, use of birth control after vaccination. Please review eligibility criteria for more details.

Is there any cost to participate in this pertussis clinical trial?

Study-related care, including the booster vaccine and all study visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered. Participants should consider these factors when planning participation.

Actively Recruiting

Phase 4

All Genders

Healthy Volunteers

ID06803524

10-Year Follow-Up Study on Safety and Immune Response of a Second Booster Dose of Pertagen or Adacel Vaccines After Initial Acellular Pertussis Vaccination

Led by Mahidol University · Updated on 2025-06-11

126

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a phase IV, open-label, non-randomized study to compare the immune response and safety of a second booster dose of Pertagen4 vaccine with Adacel4 vaccine, given 10 years after the first booster. The study also aims to evaluate the long-term persistence of antibodies from BioNets recombinant aP Pertagen4 and TdaP Boostagen4 vaccines, alongside the chemically-detoxified Tdap vaccine Adacel4 in adults who participated in a prior phase IIIII trial TDA202. Participants who received one dose of Boostagen4, Pertagen4, or Adacel4 in the initial TDA202 study and completed a 1-year follow-up will be invited about 10 years later for this follow-up study. After consenting and screening for health status, participants will provide blood samples before and 28 days after receiving a second booster dose either Pertagen4 or Adacel4 administered by trained staff. The study will monitor immediate reactions for 30 minutes post-vaccination and collect diary records of side effects for 7 to 28 days. Participants will have assessments including medical history review, physical exams, and antibody testing via blood samples at enrollment and 28 days after vaccination. Safety monitoring will continue through the study, with phone check-ins to support diary completion. Blood samples will be analyzed to measure antibody levels against pertussis, tetanus, and diphtheria toxins to understand immune responses and vaccine safety over time.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Participated in the initial TDA202 study, received one dose of Boostagen4, Pertagen4, or Adacel4, and completed 1-year follow-up
Provided written informed consent before joining
Generally healthy based on medical history and physical exam
Able to follow study procedures and willing to give blood samples
For women who can have children, negative pregnancy test at enrollment and agreement to use reliable birth control for one month after vaccination

You will not qualify if you...

Received any pertussis vaccine since completing 1-year follow-up in the initial TDA202 study
Diagnosed with pertussis by a doctor since completing 1-year follow-up in the initial TDA202 study
Pregnant, breastfeeding, or planning pregnancy during the study period
History of serious medical illness affecting immune, psychiatric, blood, lung, heart, liver, kidney, endocrine, spleen, or thymus function
Allergy or hypersensitivity to any vaccine or its components
History of serious or neurological adverse events after vaccination
Received blood, blood components, or immunoglobulin within 3 months before enrollment
Used immunosuppressive drugs or systemic corticosteroids (over 0.5 mg/kg prednisolone for more than 14 days) within 3 months before enrollment
Received any other vaccines within 28 days before enrollment (3 months for live vaccines)
Plans to receive other vaccines or join another clinical trial with treatment during this study
Known bleeding disorders affecting intramuscular injection
Progressive or severe neurological disorders like seizure or Guillain-Barr�e9 syndrome
Any illness or condition that might affect study results or participant safety
Fever (body temperature 38�b0C or higher) at enrollment (temporary exclusion; rescreening possible)

Research Team

Punnee Pitisuttithum

Jittima Dhitavat

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10-Year Follow-Up Study on Safety and Immune Response of a Second Booster Dose of Pertagen or Adacel Vaccines After Initial Acellular Pertussis Vaccination

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria