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

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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pertussis Vaccine
• Intervention / Treatment: Biological: Pertussis containing vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 2399
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10330
      • Chula Clinical Research Center (Chula CRC)
    • Bangkok, Bangkok, Thailand, 10330
      • Queen Saovabha Memorial Institute, Thai Red Cross Society
    • Bangkok, Bangkok, Thailand, 10330
      • Thai Red Cross AIDS and Infectious Diseases Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Boostrix; Licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine	Biological: Pertussis containing vaccine; Recombinant acellular pertussis (aP) vaccine (containing 5 µg of geneticallydetoxified pertussis toxin (PTgen),
Experimental: Recombinant acellular pertussis (aP) vaccine; Licensed recombinant acellular pertussis (aP) vaccine (containing 5 µg of PTgen and 5 µg of FHA)	Biological: Pertussis containing vaccine; Recombinant acellular pertussis (aP) vaccine (containing 5 µg of geneticallydetoxified pertussis toxin (PTgen),

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and percentages of participants reporting any adverse drug reactions (ADRs)	Incidence and percentages of participants reporting any adverse drug reactions (ADRs) within 28 days following a single booster dose of recombinant acellular pertussis (aP) vaccine.	28 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, severity, and percentages of participants reporting adverse events (AEs)	Incidence, severity, and percentages of participants reporting adverse events (AEs) during 28 days following vaccination	28 days following vaccination
Incidence, severity, and percentages of participants reporting serious adverse events (SAEs)	Incidence, severity, and percentages of participants reporting serious adverse events (SAEs) during the study period.	28 days after vaccination
Duration of AEs, ADRs, and SAEs	Duration of AEs, ADRs, and SAEs, categorized by severity and MedDRA System Organ Class.	28 days after vaccination
Categorization of ADRs by System Organ Class and Preferred Term	Categorization of ADRs by System Organ Class and Preferred Term, based on MedDRA coding.	28 days after vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency and characteristics of AEs and ADRs	The frequency and characteristics of AEs and ADRs across three lots of recombinant acellular pertussis (aP) vaccine.	28 days after vaccination
Incidence and characteristics of unsolicited AEs and ADRs	Incidence and characteristics of unsolicited AEs and ADRs pooled from all randomized controlled trials with aP vaccine including APV301, TDA206 TDA202, TDA207, PertaPrime and any relevant studies.	28 days after vaccination

Collaborators and Investigators

• Sponsor: BioNet-Asia Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2025
• Primary Completion (Actual): April 4, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Recombinant Pertussis Vaccine
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Bordetella Infections; Whooping Cough
• Other Study ID Numbers: APV301; BioNet-Asia.Co.,Ltd. (Other Identifier: BioNet-Asia.Co.,Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No