Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults

Last updated: February 17, 2025
Sponsor: BioNet-Asia Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Pertussis (Whooping Cough)

Treatment

Pertussis containing vaccine

Clinical Study ID

NCT06798831
APV301
BioNet-Asia.Co.,Ltd.
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This pivotal safety trial aims to extend the safety database for BioNet recombinant acellular pertussis (aP) vaccine (Pertagen®) in a larger population of adults and evaluate the incidence and characteristics of adverse drug reactions (ADRs), including uncommon events, to provide robust safety data. The study focuses on identifying and describing all ADRs following vaccination with BioNet recombinant acellular pertussis (aP) vaccine, ensuring the vaccine's safety is well-characterized in a large population. This study will also describe the lot-to-lot consistency between three lots of BioNet recombinant acellular pertussis (aP) vaccine across safety outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • An adult participant will be eligible for inclusion if ALL of the following criteriaare 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 beperformed in females who have undergone sterilization, hysterectomy or who arepost-menopausal.), must have a negative urine pregnancy test at enrollment.

Exclusion

Exclusion Criteria:

  • A participant with ANY of the following criteria at study entry will not be eligiblefor participation:
  1. History of significant medical illness such as but not limited to immunedeficiency, clinically significant psychiatric, hematologic, pulmonary,cardiovascular, or hepatic, renal, splenic or thymic functional abnormality asdetermined by the investigator based on medical history and physicalexamination. For those cases that are clinically stable, the investigator mayinclude them as deemed per medical judgement.

  2. Breastfeeding women or female participants who intend to become pregnant duringthe study period;

  3. History of a severe allergic reaction to any vaccine (including itscomponents);

  4. History of serious adverse event or neurological adverse event to anyvaccination;

  5. Receipt of any investigational product or licensed vaccine within 30 days priorto enrollment (3 months for live-attenuated vaccines);

  6. Plan to receive tetanus, diphtheria or pertussis vaccine or plan to participatein other clinical trial during the study period;

  7. Having experienced physician-diagnosed pertussis within 5 year prior toenrollment;

  8. Receipt of diphtheria or tetanus or pertussis vaccine within 5 years prior toenrollment;

  9. Having any progressive or severe neurologic disorder, seizure disorder orrecent 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 aprolonged bleeding time resulting in a problem with intramuscular injection;

  12. Suspected or known alcoholism and/or illicit drug abuse within the past 5years;

  13. Administration of immunoglobulins and/or any blood products within 3 monthspreceding study entry or planned administration during the study period;

  14. History of receiving immunosuppressive drugs or systemic corticosteroid (>0.5mg/kg of prednisolone or equivalent for more than 14 days) within 3 monthsprior 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'shaving an adverse outcome by participating in this study.

Study Design

Total Participants: 2400
Treatment Group(s): 1
Primary Treatment: Pertussis containing vaccine
Phase: 3
Study Start date:
February 08, 2025
Estimated Completion Date:
April 30, 2025

Study Description

This is a pivotal, multi-site, observer-blind, randomized, active-controlled vaccine trial in which 2400 healthy adults aged 18 to 75 years will be recruited at approximately 7:1 ratio from three sites in Bangkok, Thailand. As the aim of this trial is to extend the safety database for recombinant acellular pertussis (aP) vaccine in a larger population of adults, the active-controlled arm is added mainly to reduce selection and measurement bias through randomization and blinding methods.

Connect with a study center

  • Chula Clinical Research Center (Chula CRC)

    Thailand, Bangkok 10330
    Thailand

    Active - Recruiting

  • Queen Saovabha Memorial Institute, Thai Red Cross Society

    Thailand, Bangkok 10330
    Thailand

    Active - Recruiting

  • Thai Red Cross AIDS and Infectious Diseases Research Centre

    Thailand, Bangkok 10330
    Thailand

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.