2-year Follow-up After a Single Dose Acellular Pertussis Vaccination

NCT04113655 | Completed DMC

• 1 other identifier: TDA202 2 year follow-up
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

In July 2015-November 2016, a phase II/III randomized, observer-blind,controlled study of two acellular Pertussis vaccines (aP standalone and TdaP combined vaccined) manufactured by BioNet-Asia Co., Ltd. (Bionet) and chemically-detoxified Adacel Tdap vaccine was conducted in Bangkok, Thailand in healthy subjects aged 12-17 years (Protocol No. TDA202; http://clinicaltrials.in.th; Study ID:TCTR20150703002). A total of 450 subjects were enrolled into the study at 2 study sites (Site No.1:Faculty of Medicine Siriraj Hospital; Site No.2:Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University) with equal number of 225 subjects enrolled at each study site. During the study, the subjects had been randomized in a 1:1:1 ratio to received intramuscularly a booster dose (0.5 mL) of the study vaccines. In this current study, persistence of pertussis antibodies induced by a booster dose of recombinant acellular Pertussis based vaccines (Pertagen and Boostagen) manufactured by Bionet will be evaluated and compared to the conventional chemically-detoxified Tdap vaccine (Adacel) at 2 years after previously immunized in the TDA202 study.

Conditions

Pertussis

Keywords

TDA202; acellular pertussis vaccine; antibody persistence at 2 years after vaccination; Pertagen; Boostagen; aP vaccine

Outcome Measures

Primary Outcomes (10)

• Anti-PT GMTs (IU/mL) at 2 years after vaccination

  Assessed by ELISA in all evaluable subjects by vaccine groups

  2 years after vaccination ± 1 month

• Anti-FHA GMTs (IU/mL) at 2 years after vaccination

  Assessed by ELISA in all evaluable subjects by vaccine groups

  2 years after vaccination ± 1 month

• Anti-Tetanus GMTs (IU/mL) at 2 years after vaccination

  Assessed by ELISA in all evaluable subjects by vaccine groups

  2 years after vaccination ± 1 month

• Anti-Diphtheria GMTs (IU/mL) at 2 years after vaccination

  Assessed by ELISA in all evaluable subjects by vaccine groups

  2 years after vaccination ± 1 month

• Seroconversion rates of subjects with booster response in anti-PT antibody titers at Day 28 and 2 years after vaccination compared to baseline in all evaluable subjects by vaccine groups

  Booster response: * In initially seronegative subjects (baseline titer \< 5 IU/mL), post-vaccination antibody concentrations ≥ 20 IU/mL; * In initially seropositive subjects with baseline titer ≥ 5 IU/mL and \< 20 IU/mL, an increase of at least 4 times (≥ 4-fold) the baseline titer; * In initially seropositive subjects with baseline titer ≥ 20 IU/mL, an increase of at least 2 times (≥ 2-fold) the baseline titer

  2 years after vaccination ± 1 month

• Seroconversion rates of subjects with booster response in anti-FHA antibody titers at Day 28 and 2 years after vaccination compared to baseline in all evaluable subjects by vaccine groups

  Booster response: * In initially seronegative subjects (baseline titer \< 5 IU/mL), post-vaccination antibody concentrations ≥ 20 IU/mL; * In initially seropositive subjects with baseline titer ≥ 5 IU/mL and \< 20 IU/mL, an increase of at least 4 times (≥ 4-fold) the baseline titer; * In initially seropositive subjects with baseline titer ≥ 20 IU/mL, an increase of at least 2 times (≥ 2-fold) the baseline titer

  2 years after vaccination ± 1 month

• Seroconversion rates of subjects with > 0.1 IU/mL of anti-Tetanus at Day 28 and 2 years after vaccination compared to baseline in all evaluable subjects by vaccine groups

  Assessed by ELISA

  2 years after vaccination ± 1 month

• Seroconversion rates of subjects with > 0.1 IU/mL of anti-Diphtheria at Day 28 and 2 years after vaccination compared to baseline in all evaluable subjects by vaccine groups

  Assessed by ELISA

  2 years after vaccination ± 1 month

• PT neutralizing GMTs (IU/mL) at 2 year after vaccination

  PT neutralizing antibody assessed by Chinese Hamster Ovary (CHO) in subset of each vaccine group

  2 years after vaccination ± 1 month

• Seroconversion rate of PT neutralizing antibody increase ≥ 4-fold at 2 years after vaccination compared to baseline

  PT neutralizing antibody assessed by Chinese Hamster Ovary (CHO) in subset of each vaccine group

  2 years after vaccination ± 1 month

Study Arms (1)

acellular pertussis vaccine

Antibody persistence at 2 years after a single dose vaccination of Pertagen (aP BioNet), Boostagen (TdaP BioNet) and Adacel (comparator vaccine) administered in parent protocol TDA202

Biological: Pertagen (aP BioNet); Biological: Boostagen (TdaP BioNet); Biological: Adacel

Interventions

Pertagen (aP BioNet) BIOLOGICAL

Pertagen (aP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Pertagen (aP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation. The study vaccine was presented in a single-dose prefilled syringe. Each subject was received one intramuscular injection in the non-dominant deltoid region in parent protocol TDA202.

acellular pertussis vaccine

Boostagen (TdaP BioNet) BIOLOGICAL

Boostagen (TdaP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Boostagen (TdaP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation. TDaP dose additional contained at least 7.5 Lf tetanus toxoid and at least 2.0 Lf diphtheria toxoid. The study vaccine was presented in a single-dose prefilled syringe. Each subject was received one intramuscular injection in the non-dominant deltoid region in parent protocol TDA202.

acellular pertussis vaccine

Adacel BIOLOGICAL

Comparator vaccine, Adacel (Sanofi-Pasteur, North York, ON, Canada) was produced chemically inactivated pertussis toxin. Each 0.5 mL dose of Adacel (as comparator vaccine) contained 2.5 µg PTchem, 5 µg FHA, 3 µg pertactin, 5 µg fimbriae types 2 and 3, 5.0 Lf tetanus toxoid, 2.0 Lf diphtheria toxoid and 0.33 mg as aluminium cation. The study vaccine was presented in a single-dose prefilled syringe. Each subject was received one intramuscular injection in the non-dominant deltoid region in parent protocol TDA202

acellular pertussis vaccine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for this study is the group of subjects who had received one dose of acellular pertussis based vaccine in TDA202 trial at Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University and who had completed the study follow-up at 1 year after vaccination.

You may qualify if:

• Having participated in TDA202 study, received a single dose of one of the 3 study vaccines, and completed 1 year follow-up visit.
• Written informed consent is obtained for subjects aged ≥18 years, or written assent and written informed consent are obtained from subjects aged \<18 years and from their parent/legal guardian, respectively, prior to study entry.
• Capable to comply with study procedures and willing to provide with a blood sample.

You may not qualify if:

• Received lived attenuated vaccine within 3 months prior to participating in this study.
• Received vaccines other than lived attenuated vaccine within 28 days prior to participating in this study.
• History of receiving blood or blood component or immunoglobulin within 3 months prior recruitment
• 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 recruitment.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (2)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,

Bangkok, 10400, Thailand

Location

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,

Bangkok, 10400, Thailand

Location

Related Publications (1)

• Pitisuttithum P, Chokephaibulkit K, Sirivichayakul C, Sricharoenchai S, Dhitavat J, Pitisuthitham A, Phongsamart W, Boonnak K, Lapphra K, Sabmee Y, Wittawatmongkol O, Chauhan M, Wijagkanalan W, Hommalai G, Fortuna L, Chinwangso P, Poredi IK, van den Biggelaar AHJ, Pham HT, Viviani S. Antibody persistence after vaccination of adolescents with monovalent and combined acellular pertussis vaccines containing genetically inactivated pertussis toxin: a phase 2/3 randomised, controlled, non-inferiority trial. Lancet Infect Dis. 2018 Nov;18(11):1260-1268. doi: 10.1016/S1473-3099(18)30375-X. Epub 2018 Sep 25.

  PMID: 30266329 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Approximately 5 mL whole blood will be processed for serum preparation. Sera obtained will be aliquoted into storage tubes and stored ≤ -60 degree Celsius and shipped to Bionet Human Serology Laboratory. The collected sera will be used for immunogenicity assessment for antibody persistence.

MeSH Terms

Conditions

Whooping Cough

Interventions

adacel

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Punnee Pitisutthithum, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: June 20, 2017
• Primary Completion: July 4, 2017
• Study Completion: July 31, 2017
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

TH (2)