Evaluating the safety of a new pertussis vaccine in adults

A Randomized, Observer-blind, Active-controlled Study to Describe the Safety of Recombinant Acellular Pertussis (aP) Vaccine When Administered to Healthy Adults Aged of 18-75 Years Old

This study is testing a new pertussis vaccine in healthy adults to see if it is safe for them.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: BioNet-Asia Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Thailand, Bangkok and 2 other locations)
• Trial ID: NCT06798831 on ClinicalTrials.gov

What this trial studies

This pivotal trial aims to assess the safety of the BioNet recombinant acellular pertussis vaccine (Pertagen®) in a larger adult population. The study will recruit 2400 healthy adults aged 18 to 75 years across three sites in Bangkok, Thailand, using a randomized, observer-blind, active-controlled design to minimize bias. Participants will be monitored for adverse drug reactions (ADRs) to provide robust safety data and evaluate lot-to-lot consistency of the vaccine. The goal is to ensure comprehensive safety characterization of the vaccine in this demographic.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 75 years who can provide informed consent.

Not a fit: Patients with significant medical illnesses or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical safety data that supports the use of the recombinant pertussis vaccine in adults, potentially leading to improved public health outcomes.

How similar studies have performed: Other studies evaluating the safety of vaccines have shown success, but this specific approach with the recombinant acellular pertussis vaccine is novel.

Eligibility criteria

Inclusion Criteria:

* An adult participant will be eligible for inclusion if ALL of the following criteria are met at the time of screening:

  1. Aged 18 to 75 years (less than 76 years full of age) on the day of inclusion;
  2. Can provide written informed consent;
  3. Healthy, as established by pertinent medical history and physical examination;
  4. Capable of complying with the study protocol and procedures;
  5. For women with childbearing potential (i.e., urine pregnancy test will not be performed in females who have undergone sterilization, hysterectomy or who are post-menopausal.), must have a negative urine pregnancy test at enrollment.

Exclusion Criteria:

* A participant with ANY of the following criteria at study entry will not be eligible for participation:

  1. History of significant medical illness such as but not limited to immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination. For those cases that are clinically stable, the investigator may include them as deemed per medical judgement.
  2. Breastfeeding women or female participants who intend to become pregnant during the study period;
  3. History of a severe allergic reaction to any vaccine (including its components);
  4. History of serious adverse event or neurological adverse event to any vaccination;
  5. Receipt of any investigational product or licensed vaccine within 30 days prior to enrollment (3 months for live-attenuated vaccines);
  6. Plan to receive tetanus, diphtheria or pertussis vaccine or plan to participate in other clinical trial during the study period;
  7. Having experienced physician-diagnosed pertussis within 5 year prior to enrollment;
  8. Receipt of diphtheria or tetanus or pertussis vaccine within 5 years prior to enrollment;
  9. Having any progressive or severe neurologic disorder, seizure disorder or recent history of Guillain-Barré syndrome;
  10. Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years);
  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. Suspected or known alcoholism and/or illicit drug abuse within the past 5 years;
  13. Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period;
  14. 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 study entry;
  15. Has any active clinically significant finding or life-threatening disease that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study.

Where this trial is running

Thailand, Bangkok and 2 other locations

• Chula Clinical Research Center (Chula CRC) — Thailand, Bangkok, Thailand (Recruiting)
• Queen Saovabha Memorial Institute, Thai Red Cross Society — Thailand, Bangkok, Thailand (Recruiting)
• Thai Red Cross AIDS and Infectious Diseases Research Centre — Thailand, Bangkok, Thailand (Recruiting)

Study contacts

• Study coordinator: Vilasinee Yuwaree, MSc.

Conditions Pertussis Vaccine; Recombinant Pertussis Vaccine