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

Launched by MAHIDOL UNIVERSITY · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term effects of pertussis vaccines, specifically comparing two types: Pertagen® and Adacel®. Researchers want to see how well a second booster dose of Pertagen® works and how safe it is, ten years after participants received their first booster shot. They will also check if the antibodies (the body's defense against infections) from the vaccines last over the years.

To be eligible for this study, participants must have taken part in an earlier trial where they received one of the vaccines and completed a follow-up visit a year later. Participants should be healthy, able to provide a blood sample, and for women who can get pregnant, they need to take a pregnancy test and use reliable birth control for one month after vaccination. During the trial, participants will receive a booster shot and will have some follow-up visits to monitor their health and the vaccine's effects. It's important to note that some individuals, such as those who have had recent vaccinations or certain health conditions, may not qualify for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A participant will be eligible for inclusion if ALL of the following apply at the time of screening:
• • 1. 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;
• • 2. Written informed consent is obtained prior to study entry;
• • 3. Healthy, as established by pertinent medical history and physical examination;
• • 4. Capable of complying with study procedures and willing to provide with a blood sample;
• • 5. 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.
• Exclusion Criteria:
• A participant with following criteria at screening will not be eligible for participation:
• • 1. Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study;
• • 2. Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment;
• • 3. Pregnant or breast-feeding women or female participants who intend to become pregnant during study period;
• • 4. 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;
• • 5. History of allergy or hypersensitivity to any vaccine (including its component);
• • 6. History of any serious adverse event or neurological adverse event after vaccination;
• • 7. History of receiving blood or blood component or immunoglobulin within 3 months prior to enrollment;
• • 8. 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;
• • 9. Having received any other vaccines within 28 days prior to enrollment (3 months for live- attenuated vaccines);
• • 10. Plan to receive any other vaccine or plan to participate in another clinical trial with intervention during the study period;
• • 11. A known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in a problem with intramuscular injection;
• • 12. Any progressive or severe neurological disorder such as seizure disorder or Guillain-Barré syndrome;
• • 13. 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
• • 14. Fever as defined by body temperature ≥ 38°C at the time of enrollment (This is a temporary exclusion criterion).
• • 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.