Brief Title
3-year Follow-up After a Single Dose Acellular Pertussis Vaccination
Official Title
Antibody Persistence at 3 Years After a Single Dose Vaccination of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin
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.
Detailed Description
The study population will included all subjects who participated in the TDA202 study at the
Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University, Bangkok.
The subjects who had received a single dose of one of the 3 study vaccines and completed
1-year follow-up visit at Day 336±28 during the TDA202 study will be called in for consent
process at 3 years after vaccination based on Vaccination Date in TDA202 study within ±1
month window period. Subjects aged ≥ 18 years who have signed the written informed consent
form or subjects aged < 18 years who have signed the assent form with their parent/legal
guardian's given written informed consent will be screened for general health status and
those who fulfill all inclusion and exclusion criteria will be enrolled into the study.
Once enrolled, blood sample (approximately 5 mL) will be taken from all subjects. After blood
collection, vaccination with a licensed influenza vaccine will be offered to all
subjects.Blood samples will be processed for serum separation and shipped to Bionet Human
Serology Laboratory where immunogenicity testing (ELISA antibodies against tetanus (TT),
diphtheria(DT), Pertussis Toxin (PT) and Filamentous hemagglutinin (FHA) and PT neutralizing
antibody by Chinese Hamster Ovary (CHO cell assay) will be performed . ELISA testing to
detect antibodies against tetanus, diphtheria, and pertussis antigens (PT and FHA) will be
performed for all enrolled subjects while CHO cell assay to detect PT neutralizing antibody
will be performed only in the same subset of 75 subjects (25 subjects in each vaccine group)
who had been selected for PT neutralizing antibody assessment in the previous TDA202 study.
The knowledge from this long-term 3-year antibody persistence study will provide supportive
data to identify the best alternative acellular pertussis vaccines to conventional
chemically-detoxified vaccines for controlling the resurgence of pertussis disease.
Data management and statistical analysis will be performed by Center of Excellence for
Biomedical and Public Health Informatics (BIOPHICS), Bangkok, Thailand.
Study Type
Observational
Primary Outcome
Comparison of anti-PT GMTs (IU/mL) between baseline and 3 years after vaccination
Condition
Pertussis
Intervention
Pertagen (aP BioNet)
Study Arms / Comparison Groups
3
Description: Antibody persistence at 3 years after a single dose vaccination of acellular pertussis vaccines
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
181
Start Date
June 26, 2018
Completion Date
August 27, 2018
Primary Completion Date
July 31, 2018
Eligibility Criteria
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:
No exclusion criteria for this study. Subjects will be eligible for participation if all
inclusion criteria are met.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Punnee Pitisuttithum, MD, ,
Location Countries
Thailand
Location Countries
Thailand
Administrative Informations
NCT ID
NCT04102137
Organization ID
TDA202 3 year follow-up
Responsible Party
Principal Investigator
Study Sponsor
Mahidol University
Study Sponsor
Punnee Pitisuttithum, MD, Principal Investigator, VTC, Faculty of Tropical Medicine, Mahidol University
Verification Date
September 2019