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

NCT06798831 | Active Not Recruiting Phase 3

• 2 other identifiers: APV301BioNet-Asia.Co.,Ltd.
• Study Type: interventional
• Target: 2,399
• Locations: 1 country
• Sites: 3

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.

Conditions

Pertussis Vaccine

Keywords

Recombinant Pertussis Vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence, severity, and percentages of participants reporting adverse events (AEs)

  28 days following vaccination

• Incidence, severity, and percentages of participants reporting serious adverse events (SAEs)

  28 days after vaccination

• Duration of AEs, ADRs, and SAEs

  28 days after vaccination

• Categorization of ADRs by System Organ Class and Preferred Term

  28 days after vaccination

Other Outcomes (2)

• The frequency and characteristics of AEs and ADRs

  28 days after vaccination

• Incidence and characteristics of unsolicited AEs and ADRs

  28 days after vaccination

Study Arms (2)

Boostrix

ACTIVE COMPARATOR

Licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine

Biological: Pertussis containing vaccine

Recombinant acellular pertussis (aP) vaccine

EXPERIMENTAL

Licensed recombinant acellular pertussis (aP) vaccine (containing 5 µg of PTgen and 5 µg of FHA)

Biological: Pertussis containing vaccine

Interventions

Pertussis containing vaccine BIOLOGICAL

Recombinant acellular pertussis (aP) vaccine (containing 5 µg of geneticallydetoxified pertussis toxin (PTgen),

Boostrix; Recombinant acellular pertussis (aP) vaccine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Can provide written informed consent;
• Healthy, as established by pertinent medical history and physical examination;
• Capable of complying with the study protocol and procedures;
• 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.

You may not qualify if:

• A participant with ANY of the following criteria at study entry will not be eligible for participation:
• 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.
• Breastfeeding women or female participants who intend to become pregnant during the study period;
• History of a severe allergic reaction to any vaccine (including its components);
• History of serious adverse event or neurological adverse event to any vaccination;
• Receipt of any investigational product or licensed vaccine within 30 days prior to enrollment (3 months for live-attenuated vaccines);
• Plan to receive tetanus, diphtheria or pertussis vaccine or plan to participate in other clinical trial during the study period;
• Having experienced physician-diagnosed pertussis within 5 year prior to enrollment;
• Receipt of diphtheria or tetanus or pertussis vaccine within 5 years prior to enrollment;
• Having any progressive or severe neurologic disorder, seizure disorder or recent history of Guillain-Barré syndrome;
• Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years);
• A known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in a problem with intramuscular injection;
• Suspected or known alcoholism and/or illicit drug abuse within the past 5 years;
• Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period;
• 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;

Sponsors & Collaborators

• BioNet-Asia Co., Ltd.: lead

Study Sites (3)

Chula Clinical Research Center (Chula CRC)

Bangkok, Bangkok, 10330, Thailand

Location

Queen Saovabha Memorial Institute, Thai Red Cross Society

Bangkok, Bangkok, 10330, Thailand

Location

Thai Red Cross AIDS and Infectious Diseases Research Centre

Bangkok, Bangkok, 10330, Thailand

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: February 8, 2025
• Primary Completion: April 4, 2025
• Study Completion: October 31, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (3)