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

NCT04529720 | Completed DMC

• 1 other identifier: TDA202 5 year follow-up
• Study Type: observational
• Target: 159
• 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 vaccines) manufactured by BioNet-Asia Co., Ltd. (Bionet) and chemically-detoxified Adacel Tdap vaccine was conducted in Bangkok, Thailand in healthy participants aged 12-17 years (Protocol No. TDA202; http://clinicaltrials.in.th;Study ID:TCTR20150703002). A total of 450 participants 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 participants enrolled at each study site. During the study, the participants 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 participants 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-inactivated Tdap vaccine (Adacel) at 5 years after previously immunized in the TDA202 study.

Conditions

Pertussis

Keywords

TDA202; acellular pertussis vaccine; antibody persistence at 5 years after vaccination; Pertagen; Boostagen; aP vaccine

Outcome Measures

Primary Outcomes (5)

• Anti-PT and Anti-FHA GMTs (IU/ml) changed from baseline at 5 Years After Vaccination in All Evaluable Participants by Vaccine Groups

  Anti-PT and anti-FHA GMTs (IU/mL) at baseline and 5 years after vaccination as assess by ELISA in all evaluable participants by vaccine groups.

  5 years after vaccination ± 56 days

• Anti-Tetanus and Anti-Diphtheria GMTs (IU/mL) changed from baseline at 5 Years After Vaccination in All Evaluable Participants in Boostagen (BioNet TdaP BioNet) and Adacel Vaccine Groups

  Anti-Tetanus and anti-Diphtheria GMTs (IU/mL) between baseline and 5 years after vaccination as assessed by ELISA in all evaluable participants in Boostagen (BioNet TdaP BioNet) and Adacel vaccine groups

  5 years after vaccination ± 56 days

• Seroconversion Rates as Defined by the Proportion of Participants With Booster Response in Anti-PT and Anti-FHA Antibody Titers at Day 28 and 5 Years After Vaccination Compared to Baseline in All Evaluable Participants 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

  5 years after vaccination ± 56 days

• PT Neutralizing GMTs (IU/mL) changed from baseline at 5 Year After Vaccination as Assessed in a Subset of Evaluable Participants by Vaccine Group

  PT neutralizing GMTs (IU/mL) between baseline and 5 year after vaccination as assessed by PT neutralizing assay in a subset of evaluable participants by vaccine group

  5 years after vaccination ± 56 days

• Seroconversion Rates Defined by Proportion of Participants With ≥ 4-fold Changed in PT Neutralizing Antibody Titers at Day 28, Day 336 and 5 Years After Vaccination Compared to Baseline in a Subset of Evaluable Participants

  Seroconversion rates as defined by the proportion of participants with ≥ 4-fold increase in PT neutralizing antibody titers at Day 28, Day 336 and 5 years after vaccination compared to baseline as assessed by PT neutralizing assay in a subset of evaluable participants by vaccine group

  Day 28, Day 336 and 5 years after vaccination ± 56 days

Study Arms (1)

acellular pertussis vaccine

Antibody persistence at 5 years after a single dose vaccination of acellular pertussis vaccines (Pertagen;Boostagen;Adacel)

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

Interventions

Biological/Vaccine: 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 participant will be received one intramuscular injection in the non-dominant deltoid region.

acellular pertussis vaccine

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

acellular pertussis vaccine

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

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 participants 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 the initial 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 participants aged ≥18 years, or written informed consent are obtained from participants aged \<18 years with their parents/legal guardians, co-signed prior to study entry;
• Healthy, as established by pertinent medical history and physical examination;
• Capable of complying with study procedures and willing to provide with a blood sample

You may not qualify if:

• \. Having received pertussis vaccine since TDA202 study

Sponsors & Collaborators

• Mahidol University: lead
• BioNet-Asia Co., Ltd.: collaborator

Study Sites (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol 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 ≤ -30 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

Biological Products

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complex Mixtures

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: August 20, 2020
• First Posted: August 28, 2020
• Study Start: August 24, 2020
• Primary Completion: September 2, 2020
• Study Completion: November 3, 2021
• Last Updated: January 5, 2022

Record last verified: 2022-01

Locations

TH (1)