Pertussis Clinical Trial
Official title:
Antibody Persistence at 2 Years After a Single Dose Vaccination of Acellular Pertussis Vaccines Among Thai Adolescents
Verified date | October 2019 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | July 31, 2017 |
Est. primary completion date | July 4, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Having participated in TDA202 study, received a single dose of one of the 3 study vaccines, and completed 1 year follow-up visit. 2. 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. 3. Capable to comply with study procedures and willing to provide with a blood sample. Exclusion Criteria: 1. Received lived attenuated vaccine within 3 months prior to participating in this study. 2. Received vaccines other than lived attenuated vaccine within 28 days prior to participating in this study. 3. History of receiving blood or blood component or immunoglobulin within 3 months prior recruitment 4. 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. 5. Received diphtheria or tetanus or pertussis vaccine within 1 year prior to inclusion in the present study. |
Country | Name | City | State |
---|---|---|---|
Thailand | Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, | Bangkok | |
Thailand | Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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