Actively Recruiting
Antibody Persistence and Safety and Immunogenicity of a Second Booster Dose 10 Years After a First Booster Vaccination With a Single Dose Vaccination of aP Vaccine in Adults: A Phase IV, Open-label, Non-randomized, Follow-up Study
Led by Mahidol University · Updated on 2025-06-11
126
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mahidol University
Lead Sponsor
B
BioNet-Asia Co., Ltd.
Collaborating Sponsor
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 BioNet's recombinant aP (Pertagen4) and TdaP (Boostagen4) vaccines, alongside the chemically-detoxified Tdap vaccine (Adacel4) in adults who participated in a prior phase II/III 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
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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and health assessment
Duration - 1 day
Participants receive a single intramuscular injection of a second booster dose of Pertagen® or Adacel® vaccine and provide a blood sample before vaccination.
1 visit (in-person) for vaccination and blood sample collection
Duration - 28 days
Participants are monitored for safety and reactogenicity, record symptoms in diary cards for 7 days, and report adverse events until 28 days after vaccination. A blood sample is collected 28 days after vaccination.
1 visit (in-person) at Day 28 and phone contact on Day 7
Trial Site Locations
Total: 2 locations
1
Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok Metropolis, Thailand, 10700
Actively Recruiting
2
Vaccine Trial Centre
Ratchathewi, Bangkok Metropolis, Thailand, 10400
Actively Recruiting
Research Team
P
Punnee Pitisuttithum
J
Jittima Dhitavat
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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