| CTRI Number |
CTRI/2023/02/049637 [Registered on: 10/02/2023] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate immune response and safety of Hepatitis E Vaccine in healthy subjects |
|
Scientific Title of Study
|
A prospective, randomized, two-arm, parallel, placebo-controlled, multicentre, superiority,
phase II clinical trial to evaluate the immunogenicity and safety of Recombinant Hepatitis E Vaccine (Adsorbed) of M/s. Zydus Lifesciences Limited in healthy subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 22-06, Version no. 01, Date: 07/10/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Zydus Lifesciences Limited |
| Address |
Zydus Lifesciences Limited
(Formerly known as Cadila Healthcare Limited),
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
S.G. Highway
Ahmadabad
GUJARAT
382481
India |
| Phone |
|
| Fax |
|
| Email |
r.mittal@zyduslife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Zydus Lifesciences Limited |
| Address |
Zydus Lifesciences Limited
(Formerly known as Cadila Healthcare Limited),
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
S.G. Highway
GUJARAT
382481
India |
| Phone |
|
| Fax |
|
| Email |
r.mittal@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavankumar Daultani |
| Designation |
DGM – Medical & Regulatory Affairs |
| Affiliation |
Zydus Lifesciences Limited |
| Address |
Zydus Lifesciences Limited
(Formerly known as Cadila Healthcare Limited),
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
S.G. Highway
Ahmadabad
GUJARAT
382481
India |
| Phone |
|
| Fax |
|
| Email |
pavankumar.daultani@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences Limited
(Formerly known as Cadila Healthcare Limited),
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
S.G. Highway, Ahmedabad – 382481,
Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences Limited |
| Address |
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad – 382481, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chintan Patel |
Aatman Hospital |
Clinical Research Room, Ground Floor, Aatman Hospital, 5, Anveshan Row House, Opp. Bopal Garn BRTS, Bopal-Ghuma Road, Bopal, Ahmedabad - 380058, Gujarat
Ahmadabad
GUJARAT |
9825182251
chintanpatel7691@gmail.com |
| Dr SK Mahiuddin Ahammed |
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital |
Department of Hepatology,
School of Digestive & Liver Diseases, Institute of Post Graduate Medical Education and Research (IPGMER) and Seth Sukhlal Karnani Memorial (SSKM) Hospital, 244, A.J.C. Bose Road, Kolkata – 700020, West Bengal
D
Kolkata
WEST BENGAL |
9051157404
skmahiuddinahammed@gmail.com |
| Dr Pazhanivel Mohan |
Jawaharlal Institute of Postgraduate Medical Education and Research |
4th Floor,Department of Gastroenterology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Puducherry - 605006
Pondicherry
PONDICHERRY |
9840612324
dr.pazhani@gmail.com |
| Dr Prabhat Kumar Sharma |
Maharaja Agrasen Superspeciality Hospital |
Basement 01, Maharaja Agrasen Superspeciality Hospital, Central Spine, Agrasen Aspatal Marg, Sector No. 7, Vidhyadhar Nagar, Jaipur - 302039, Rajasthan
Jaipur
RAJASTHAN |
9983995050
pksharma.clinical@gmail.com |
| Dr Amit Goel |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
4th Floor, Department of Gastroenterology,
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS),
Raebareli Road, Lucknow - 226014, Uttar Pradesh
Lucknow
UTTAR PRADESH |
8765974037
agoel.ag@gmail.com |
| Dr Abhishek M Karmalkar |
Vedant Multispeciality Hospital |
Ground Floor, Vedant Multispeciality Hospital, GP 83, Opp. Rotary Club, Sambhaji nagar, MIDC, Chinchwad, Pune – 411019, Maharashtra
Pune
MAHARASHTRA |
9970004295
drkarmalkar.vedant@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Intervention Studies, JIPMER, Puducherry |
Approved |
| Institutional Ethics Committee, Aatman Hospital, Ahmedabad, Gujarat |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspecialty Hospital, Jaipur, Rajasthan |
Approved |
| Institutional Ethics Committee, SGPGIMS, Lucknow, UP |
Approved |
| Institutional Ethics Committee, Vedant Multispeciality Hospital, Pune, Maharashtra |
Approved |
| IPGMER Research Oversight Committee, IPGMER, Kolkata, WB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo-Hepatitis B Vaccine (rDNA) of M/s.
Serum Institute of India Pvt. Ltd. |
Subjects will be administered hepatitis B vaccine (rDNA) of
M/s. Serum Institute of India Pvt. Ltd. (placebo) as per their allocated study group. The dose of hepatitis B vaccine will be based on the age of the
subject; subject aged ≥20 years at enrollment will be administered 1.0 ml dose
containing 20 mcg of Hepatitis B surface antigen while the subject of 16 to 19 years
of age will be administered 0.5 ml dose containing 10 mcg of hepatitis B surface
antigen. The study vaccines will be administered as intramuscular (IM) injection in
the upper arm taking aseptic precautions. |
| Intervention |
Recombinant Hepatitis E Vaccine
(Adsorbed) of M/s. Zydus Lifesciences Ltd |
Subjects will be administered recombinant hepatitis E vaccine
(adsorbed) of M/s. Zydus Lifesciences Ltd. (test) as per their allocated study group.
The study vaccine will be administered thrice in this study at day 0 (visit 1), day 30 (visit 3) and day 180 (visit 6). Each dose of recombinant hepatitis E vaccine (adsorbed) of 0.5 ml contains ≥30 mcg of hepatitis E antigen. The study vaccines will be administered as intramuscular (IM) injection in the upper arm taking aseptic precautions. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subjects of either gender between 16 to 65 years of age (both inclusive) at the time of enrollment
2. Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator
3. No previous history of vaccination with any licensed or investigational Hepatitis E Vaccine
4. Informed consent from the adult subjects or from the parents of adolescent subjects (<18 years). Additionally, assent from adolescent subjects
5. Adult subjects or parents of adolescent subjects literate enough to fill the diary card
6. Adult subjects or adolescent subjects and parents likely to be available for follow-up for entire duration of the study |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity reaction or serious adverse event to any component of the vaccine
2. History of laboratory confirmed or suspected hepatitis / jaundice in the past
3. Fever of any origin or infectious disorder of 3 days or more within past one month
4. History of vaccination against Hepatitis B within past 10 years
5. Subjects with febrile illness (body temperature ≥37.5°C) at the time of enrollment
6. History of any vaccination within past one month
7. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
8. Any confirmed or suspected immunosuppressive or immunodeficiency disorder (based on medical history); or subjects who have used any immunosuppressive or immunostimulant therapy in past 1 month
9. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
10. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
11. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
12. Subject participated in another clinical study in the past 3 months or subject intends to participate in another clinical study during the study period
13. Subject with history of alcohol or drug abuse in the past one year
14. Any other reason for which the investigator feels that subject should not participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with seroconversion for anti-HEV IgG antibodies |
At Day 210 (End of the study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with seroconversion for anti-HEV IgG antibodies |
At Day 30 and Day 60 |
| Geometric mean titre of anti-HEV IgG antibodies |
At Day 0, Day 30, Day 60 and Day 210 |
| Local and systemic adverse events reported |
Throughout the study duration |
| Serious adverse events reported |
Throughout the study duration |
|
|
Target Sample Size
|
Total Sample Size="304"
Sample Size from India="304"
Final Enrollment numbers achieved (Total)= "304"
Final Enrollment numbers achieved (India)="304" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2023 |
| Date of Study Completion (India) |
01/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a randomized, two-arm, single-blind, parallel, placebo-controlled, multicentre clinical study planned to evaluate the immunogenicity and safety of the hepatitis E vaccine administered to healthy subjects of 16 to 65 years of age. Hepatitis B vaccine of M/s. Serum Institute of India Pvt. Ltd. which is marketed in the country for past several decades and recommended for administration through the same 3-dose schedule will be used as placebo in this study. The randomized subjects will be enrolled in either study group as per their randomization number and will be followed up in a parallel manner till the completion of the study. Immunogenicity will be evaluated at day 0 (pre-vaccination), day 30, day 60, day 180 and day 210. Safety will be evaluated by recording the adverse events occurring during the course of the study. |