A clinical study to compare the immunological response and safety of two Hepatitis B vaccines in healthy adult subjects
- Conditions
- Active immunization for the prevention of hepatitis B disease caused by hepatitis B virusEncounter for immunization,
- Registration Number
- CTRI/2018/08/015476
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
This is a randomized, single blind, parallel group, multicentre, non-inferiority phase II/III clinical trial to evaluate the immunogenicity and safety of Hepatitis B vaccine of M/s. Cadila Healthcare Ltd. [Test vaccine] as compared to Engerix-B (Hepatitis B vaccine) of M/s. GlaxoSmithKline Biologicals [Reference vaccine] in healthy adult subjects of 20-50 years of age. A minimum of 238 subjects will be enrolled in this study and they will be allocated to receive the either study vaccine as per the central computer generated randomization plan. Two blood samples will be collected; once pre-vaccination (upto day -14; screening) & another post-vaccination (day 90; end of study) to assess the anti-HBs antibody titre through Chemiluminescent Microparticle ImmunoAssay (CMIA) method. The primary immunogenicity endpoint of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for the proportion of subjects achieving seroprotective titres of anti-HBs antibodies (≥10 mIU/ml) post-vaccination. In addition, proportion of subjects achieving anti-HBs antibody titre of ≥100 mIU/ml (high-responders) at the end of study and geometric mean titre of anti-HBs antibodies at the screening and at the end of study will also be calculated for both the study groups. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 238
1.Healthy adult subjects of either gender between 20-50 years 2.Subjects willing to give written informed consent 3.Subjects literate enough to fill the diary card 4.Subjects negative for serological markers for Hepatitis B (HBsAg, anti-HBs and anti-HBc).
1.History of known or suspected allergy to any of the vaccine components 2.History of Hepatitis B vaccination 3.History of Hepatitis B infection or carrier state 4.Known history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy 5.Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy 6.Clinically significant systemic disorder such as hepatic, cardiovascular, respiratory, neurologic, gastrointestinal, renal, endocrine, hematological or immunological disorder 7.History of any acute illness within the last 1 week 8.Subjects with febrile illness (temperature ≥38 oC) at the time of presentation 9.Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study 10.Any vaccine administration within the last 30 days 11.Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) 12.Subjects with history of alcohol or drug abuse in the past one year.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with sero-protective levels of anti-HBs antibodies at the end of study Day 90 (30 days after third dose of vaccine)
- Secondary Outcome Measures
Name Time Method Geometric mean titre of anti-HBs antibodies at baseline and at the end of study Day 0 and Day 90 (30 days after third dose of vaccine) Proportion of subjects with anti-HBs antibody titre ≥100 mIU/ml (high-responders) at the end of study Day 90 (30 days after third dose of vaccine)
Trial Locations
- Locations (6)
Apex Hospitals Private Limited, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
Gandhi Medical College & Hospital, Secunderabad
🇮🇳Hyderabad, ANDHRA PRADESH, India
GCS Medical College, Hospital & Research Centre, Ahmedabad
🇮🇳Ahmadabad, GUJARAT, India
Government Medical College & Hospital, Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
IPGMER and SSKM Hospital, Kolkata
🇮🇳Kolkata, WEST BENGAL, India
King George’s Medical University, Lucknow
🇮🇳Lucknow, UTTAR PRADESH, India
Apex Hospitals Private Limited, Jaipur🇮🇳Jaipur, RAJASTHAN, IndiaDr Vipul KhandelwalPrincipal investigator9829193517dr.vipul@yahoo.co.in