Clinical trial NCT06798831: Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pertussis Vaccine
Keywords: Recombinant Pertussis Vaccine
Lead sponsor: BioNet-Asia Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Incidence and percentages of participants reporting any adverse drug reactions (ADRs)
timeFrame: 28 days after vaccination
Secondary outcomes:
measure: Incidence, severity, and percentages of participants reporting adverse events (AEs)
timeFrame: 28 days following vaccination
measure: Incidence, severity, and percentages of participants reporting serious adverse events (SAEs)
timeFrame: 28 days after vaccination
measure: Duration of AEs, ADRs, and SAEs
timeFrame: 28 days after vaccination
measure: Categorization of ADRs by System Organ Class and Preferred Term
timeFrame: 28 days after vaccination
Other outcomes:
measure: The frequency and characteristics of AEs and ADRs
timeFrame: 28 days after vaccination
measure: Incidence and characteristics of unsolicited AEs and ADRs
timeFrame: 28 days after vaccination
Locations:
city: Thailand
country: Thailand
facility: Chula Clinical Research Center (Chula CRC)
state: Bangkok
city: Thailand
country: Thailand
facility: Queen Saovabha Memorial Institute, Thai Red Cross Society
state: Bangkok
city: Thailand
country: Thailand
facility: Thai Red Cross AIDS and Infectious Diseases Research Centre
state: Bangkok
Study officials:
References: