Health TrialsbyHealthPanel

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

ConditionPertussis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMahidol University

About this trial

This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II/III trial (Protocol No. TDA202).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 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;

Disqualifiers

Having received any pertussis vaccine since completion of 1-year follow-up visit in the initial TDA202 study;

Having experienced physician-diagnosed pertussis since completion of 1-year follow-up visit in the initial TDA202 study prior to enrollment;

Pregnant or breast-feeding women or female participants who intend to become pregnant during study period;

History of any significant medical illness such as, but not limited to, immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, or endocrine disorder, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination that may interfere with the participant's safety and evaluation of investigational vaccines in this study;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pertagen® vaccine

    Biological/Vaccine

    Pertagen® vaccine, manufactured by BioNet-Asia Co., Ltd., Bangkok, Thailand. The vaccine is presented in pre-filled syringe, each containing one human dose (0.5 mL) of aP vaccine.

  • Adacel® vaccine

    Biological/Vaccine

    Adacel® vaccine, manufactured by Sanofi Pasteur, Ltd, Toronto, Ontario, Canada. The vaccine is presented in a single-dose vial, each containing one human dose (0.5 mL) of Tdap vaccine.

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: Pertagen® vaccineExperimental treatment 1 intervention
Group B: Adacel® vaccineExperimental treatment 1 intervention
Group C: Boostagen® vaccineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To demonstrate superiority at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

Geometric mean concentration (GMC) of anti-PT and anti-FHA antibodies measured at baseline (before second booster vaccination) and 28 days following vaccination.

Time frame
Day 28

Secondary outcomes

1

Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

• GMC of PT neutralizing antibody (PTNA) measured at baseline (before second booster vaccination) and 28 days following vaccination.

Time frame
Day 28
2

Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

• Seroconversion rates as defined by proportion of participants with antibody concentrations ≥ 4-fold increase with respect to baseline (before first and second booster vaccination) of anti-PT and anti-FHA, and PT- neutralizing antibodies at 28 days after booster dose vaccination.

Time frame
Day 28
3

Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

• Seropositive rates as defined by proportion of participants with antibody concentrations \> 5 IU/mL for anti-PT and anti-FHA, and PT-neutralizing antibodies at baseline (before first and second booster vaccination) and 28 days after booster dose vaccination.

Time frame
Day 28
4

Immunogenicity endpoints at 28 days post-booster vaccination with one dose of Pertagen® as compared to Adacel®.

• Booster response rates as defined by proportion of participants with antibody concentrations \>20 IU/mL for anti-PT and anti-FHA, and PT-neutralizing antibodies at baseline (before first and second booster vaccination) and 28 days after booster dose vaccination.

Time frame
Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

BioNet-Asia Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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