CTRI/2018/08/015476 [Registered on: 27/08/2018] Trial Registered Prospectively
Last Modified On:
31/12/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to compare the immunological response and safety of two Hepatitis B vaccines in healthy adult subjects
Scientific Title of Study
A prospective, randomized, two-arm, parallel, single-blind, active-controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Hepatitis B Vaccine (rDNA) of M/s Cadila Healthcare Limited compared to Engerix-B of M/s GlaxoSmithKline Biologicals in healthy adult subjects
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
15-05; Version No. 01; Dated 27/12/2017
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ravindra Mittal
Designation
Medical Advisor & Head - Regulatory Affairs
Affiliation
Cadila Healthcare Ltd
Address
Cadila Healthcare Ltd,
Sigma CommerZone,
Near ISCON Temple & Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad,
Gujarat, India
Ahmadabad GUJARAT 380015 India
Phone
079-26868926
Fax
079-26868910
Email
r.mittal@zyduscadila.com
Details of Contact Person Scientific Query
Name
Dr Ravindra Mittal
Designation
Medical Advisor & Head - Regulatory Affairs
Affiliation
Cadila Healthcare Ltd
Address
Cadila Healthcare Ltd,
Sigma CommerZone,
Near ISCON Temple & Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad,
Gujarat, India
Ahmadabad GUJARAT 380015 India
Phone
079-26868926
Fax
079-26868910
Email
r.mittal@zyduscadila.com
Details of Contact Person Public Query
Name
Dr Pavankumar Daultani
Designation
Senior Manager – Medical & Regulatory Affairs
Affiliation
Cadila Healthcare Ltd
Address
Cadila Healthcare Ltd,
Sigma CommerZone,
Near ISCON Temple & Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad,
Gujarat, India
Ahmadabad GUJARAT 380015 India
Phone
079-26868937
Fax
079-26868910
Email
pavankumar.daultani@zyduscadila.com
Source of Monetary or Material Support
Cadila Healthcare Ltd., Sigma CommerZone, Near ISCON Temple & Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad – 380015, Gujarat, India
Primary Sponsor
Name
Cadila Healthcare Ltd
Address
Sigma CommerZone, Near ISCON Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad – 380015, Gujarat, India
In-patient block, 2nd floor, Hospital building, Department of Medicine, Gandhi Medical College & Hospital, Musheerabad, Secunderabad - 500003, Telangana Hyderabad ANDHRA PRADESH
9160860777
thrilokchander73@gmail.com
Dr Vipul Prajapati
GCS Medical College, Hospital & Research Centre, Ahmedabad
Room No. 13, Medicine OPD, Department of Medicine, GCS Medical College, Hospital & Research Centre, Opp. DRM Office, Near Chamunda Bridge, Naroda Road, Ahmedabad – 380025, Gujarat Ahmadabad GUJARAT
9909912551
prajapativipul1983@gmail.com
Dr Dipti A Chand
Government Medical College & Hospital, Nagpur
Ward No. 49, Hospital building, Department of Medicine, Government Medical College and Hospital, Medical College Square, Hanuman Nagar, Nagpur – 440003, Maharashtra Nagpur MAHARASHTRA
9823257601
dachand.ngp@gmail.com
Dr Anupam Mandal
IPGMER and SSKM Hospital, Kolkata
Arsenic Clinic, 4th floor, Ronald Ross building, Department of Medicine, Institute of Post Graduate Medical Education & Research and Seth Sukhlal Karnani Memorial Hospital, 244, Acharya JC Bose Road, Kolkata - 700020, West Bengal Kolkata WEST BENGAL
9434120356
mandalanupam75@gmail.com
Dr Vivek Kumar
King George’s Medical University, Lucknow
Room No. 505, 5th floor, Kalam Centre, Department of Medicine, King George’s Medical University, Chowk, Lucknow – 226003, Uttar Pradesh Lucknow UTTAR PRADESH
Ethics Committee, IPGME&R Research Oversight Committee, Institute of Post Graduate Medical Education & Research, Office of the Dean, 5th floor, College Building, 244, Acharya JC Bose Road, Kolkata - 700020, West Bengal
Institutional Ethics Committee, Gandhi Medical College & Hospital, Musheerabad, Secunderabad - 500003, Telangana
Approved
Institutional Ethics Committee, GCS Medical College, Hospital & Research Centre, Opp. DRM office, Nr. Chamunda Bridge, Naroda Road, Ahmedabad - 380025, Gujarat
Approved
Institutional Ethics Committee, Government Medical College, Nagpur – 440003, Maharashtra
Approved
Institutional Ethics Committee, Office of Research Cell, Administrative Block, King George’s Medical University, Chowk, Lucknow – 226003, Uttar Pradesh
Active immunization for the prevention of hepatitis B disease caused by hepatitis B virus
Patients
(1) ICD-10 Condition: Z23||Encounter for immunization,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Engerix-B of M/s GlaxoSmithKline Biologicals
Subjects will receive three doses (1 ml each) of the vaccine on day 0, day 30 and day 60 respectively. The vaccine will be administered as intramuscular injection in the deltoid muscle in the upper arm taking aseptic precautions
Intervention
Hepatitis B vaccine (rDNA) I.P. of M/s Cadila Healthcare Ltd.
Subjects will receive three doses (1 ml each) of the vaccine on day 0, day 30 and day 60 respectively. The vaccine will be administered as intramuscular injection in the deltoid muscle in the upper arm taking aseptic precautions
Inclusion Criteria
Age From
20.00 Year(s)
Age To
50.00 Year(s)
Gender
Both
Details
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)
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
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
Outcome
TimePoints
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)
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)
Target Sample Size
Total Sample Size="238" Sample Size from India="238" Final Enrollment numbers achieved (Total)= "238" Final Enrollment numbers achieved (India)="238"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.