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

NCT04102137 | Completed DMC

• 1 other identifier: TDA202 3 year follow-up
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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. This is further follow-up from TDA202 clinical trial, which was completed on 29 November 2016. Target population for this study is the group of subjects who had received one dose of one of the three study vaccines in the TDA202 trial at site VTC and who had completed the study follow-up at 1-year after vaccination (223 subjects). In this current study, the long-term 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 3 years after previously immunized in the TDA202 study.

Conditions

Pertussis

Keywords

TDA202; acellular pertussis vaccine; antibody persistence at 3 years after vaccination; Pertagen; Boostagen; aP vaccine

Outcome Measures

Primary Outcomes (14)

• Comparison of anti-PT GMTs (IU/mL) between baseline and 3 years after vaccination

  Assessed by ELISA in all evaluable subjects by vaccine groups

  3 years after vaccination ± 1 month

• Comparison of anti-FHA GMTs (IU/mL) between baseline and 3 years after vaccination

  Assessed by ELISA in all evaluable subjects by vaccine groups

  3 years after vaccination ± 1 month

• Comparison of anti-Tetanus GMTs (IU/mL) between Day 336 and 3 years after vaccination

  Assessed by ELISA in all evaluable subjects by vaccine groups

  3 years after vaccination ± 1 month

• Comparison of anti-Diphtheria GMTs (IU/mL) between Day 336 and 3 years after vaccination

  Assessed by ELISA in all evaluable subjects by vaccine groups

  3 years after vaccination ± 1 month

• Seroconversion rates of subjects with anti-PT antibody titers at 3 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

  3 years after vaccination ± 1 month

• Seroconversion rates of subjects with anti-FHA antibody titers at 3 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

  3 years after vaccination ± 1 month

• Seroconversion rates of subjects with ≥ 2-fold increase in anti-PT antibody titers at 3 years after vaccination compared to baseline, Day 336 and 2 years after vaccination in all evaluable subjects by vaccine groups

  by ELISA in all evaluable groups

  3 years after vaccination ± 1 month

• Seroconversion rates of subjects with ≥ 2-fold increase in anti-FHA antibody titers at 3 years after vaccination compared to baseline, Day 336 and 2 years after vaccination in all evaluable subjects by vaccine groups

  by ELISA in all evaluable groups

  3 years after vaccination ± 1 month

• Seroconversion rates of subjects with ≥ 4-fold increase in anti-PT antibody titers at 3 years after vaccination compared to baseline, Day 336 and 2 years after vaccination in all evaluable subjects by vaccine groups

  by ELISA in all evaluable groups

  3 years after vaccination ± 1 month

• Seroconversion rates of subjects with ≥ 4-fold increase in anti-FHA antibody titers at 3 years after vaccination compared to baseline, Day 336 and 2 years after vaccination in all evaluable subjects by vaccine groups

  by ELISA in all evaluable groups

  3 years after vaccination ± 1 month

• Seroconversion rates of subjects with > 0.1 IU/mL of anti-Tetanus at baseline and 3 years after vaccination compared to baseline in all evaluable subjects by vaccine groups

  Assessed by ELISA

  3 years after vaccination ± 1 month

• Seroconversion rates of subjects with > 0.1 IU/mL of anti-Diphtheria at baseline and 3 years after vaccination compared to baseline in all evaluable subjects by vaccine groups

  Assessed by ELISA

  3 years after vaccination ± 1 month

• Comparison of PT neutralizing GMTs (IU/mL) between baseline and 3 year after vaccination

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

  3 years after vaccination ± 1 month

• Seroconversion rates of PT neutralizing antibody increase ≥ 4-fold at 3 years after vaccination compared to baseline, Day 336 and 2 years after vaccination

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

  3 years after vaccination ± 1 month

Study Arms (1)

3

Antibody persistence at 3 years after a single dose vaccination of acellular pertussis vaccines

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 will be presented in a single-dose prefilled syringe. Each subject will be received one intramuscular injection in the non-dominant deltoid region.

3

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 will be presented in a single-dose prefilled syringe. Each subject will be received one intramuscular injection in the non-dominant deltoid region.

3

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 will be presented in a single-dose prefilled syringe. Each subject will be received one intramuscular injection in the non-dominant deltoid region.

3

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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

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 Pitisuttithum, MD

  VTC, Faculty of Tropical Medicine, 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: September 22, 2019
• First Posted: September 25, 2019
• Study Start: June 26, 2018
• Primary Completion: July 31, 2018
• Study Completion: August 27, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

TH (1)