| CTRI Number |
CTRI/2025/12/099590 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Phase IV Multicentre Study on the Safety and Immunogenicity of Recombinant Hepatitis E Vaccine (E. coli) in Healthy Adults |
|
Scientific Title of Study
|
A Prospective, Multicentre, Single Arm, Phase-IV Study to evaluate the Safety and
Immunogenicity of Recombinant Hepatitis E Vaccine (E. Coli) in Healthy Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRNI/CTP/24/07 Version No. 2 dated 15-Oct-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shiva Narang |
| Designation |
Principal Investigator |
| Affiliation |
UCMS & GTB Hospital |
| Address |
Department of Medicine Room No. 605 UCMS & GTB Hospital Dilshad Garden Delhi-110095
New Delhi
DELHI
110095
India |
| Phone |
9899838807 |
| Fax |
|
| Email |
shivanarang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun Gupta |
| Designation |
Manager Medical service |
| Affiliation |
Urihk Pharmaceutical Private Limited (Subsidiary of Ureka Hong Kong) |
| Address |
Urihk Pharmaceutical Private Limited (Subsidiary of Ureka Hong Kong) 602 603, Sai Samarth Business Park, Near Wasan Motors, Deonar Village Road, Deonar, Govandi (East), Mumbai 400088, India
Mumbai
MAHARASHTRA
400088
India |
| Phone |
9324461446 |
| Fax |
|
| Email |
arjun@urihkpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Singh |
| Designation |
Head Clinical Operations |
| Affiliation |
Clinical Research Network India Pvt Ltd |
| Address |
B-806,807, Advant Navis Business Park #Plot #7, Noida-Greater Noida Expressway
Sector 142, Noida, Delhi-NCR
Gautam Buddha Nagar UTTAR PRADESH 201305 India
Gautam Buddha Nagar
UTTAR PRADESH
201305
India |
| Phone |
9695237796 |
| Fax |
|
| Email |
nidhisingh@crnindia.org |
|
|
Source of Monetary or Material Support
|
| Urihk Pharmaceutical Private Limited (Subsidiary of Ureka Hong Kong)
602 603, Sai Samarth Business Park, Near Wasan Motors, Deonar Village Road, Deonar, Govandi (East), Mumbai 400088, India |
|
|
Primary Sponsor
|
| Name |
Urihk Pharmaceutical Private Limited (Subsidiary of Ureka Hong Kong) |
| Address |
Urihk Pharmaceutical Private Limited (Subsidiary of Ureka Hong Kong)
602 603, Sai Samarth Business Park, Near Wasan Motors, Deonar Village Road, Deonar, Govandi (East), Mumbai 400088, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Clinical Research Network India Pvt Ltd |
B-806 and 807 Advant Navis Business Park Plot No 7 Noida Greater Noida
Expressway Sector 142 Noida Delhi NCR Uttar Pradesh 201305 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Pandey |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences, Department of Community Medicine 1st floor Patna Aurangabad Road Phulwari Sharif, Patna, Bihar-801507
Patna
BIHAR |
7783892746
Drsanjaypanday72@gmail.com |
| Dr Hari Shankar Joshi |
ICMR-RMRC |
ICMR-RMRC Department of Community Medicine Room No. 105 BRD Medical College Campus Gorakhpur U.P-273013 India
Gorakhpur
UTTAR PRADESH |
9415833751
drjoshiharish@gmail.com |
| Dr Pentakota Jagath Srinivas |
King George Hospital |
Department of Pediatrics, 1st floor collectorate junction Maharanipeta Visakhapatnam Andhrapradesh 530002
Visakhapatnam
ANDHRA PRADESH |
9949001578
pjsrinivas.kghamc@gmail.com |
| Dr Jitendra Singh Kushwaha |
Prakhar hospital Private Limited |
Department of Medicine 4th floor, 8/219 Arya Nagar, Kanpur Uttar Pradesh- 208002
Kanpur Nagar
UTTAR PRADESH |
9415040752
dr.jskushwahacr@gmail.com |
| Dr Shiva Narang |
UCMS & GTB Hospital |
Department of Medicine Room No. 605 UCMS & GTB Hospital Dilshad Garden Delhi-110095
New Delhi
DELHI |
9899838807
shivanarang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Guru Teg Bahadur Hospital Ethics Committee |
Approved |
| IEC King George Hospital |
Approved |
| IEC Prakhar Hospital Pvt Ltd |
Approved |
| IEC-AIIMS-P |
Approved |
| Institutional Human Ethical Committee ICMR RMRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Hepatitis E |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Single arm study, no comparator in the study. |
| Intervention |
Recombinant Hepatitis E Vaccine (E. Coli) |
Each dose of 0.5 ml to be administered from prefilled syringe.
Each dose would contain 30µg of purified recombinant Hepatitis E antigen (HEV239 protein) adsorbed on 0.8 mg aluminium hydroxide suspended in 0.5 ml buffered saline. Each dose to be administered intramuscularly over the deltoid.
3 doses of vaccination to be administered at Day 0, Day 30, and Day
180. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Indian adults of either gender aged 18-65 years (both ends inclusive) who are seronegative for anti-HEV IgG antibody (as per the cut off values specified in kit brochure).
2. Subjects who are apparently healthy or having a clinically stable medical condition/disorder that would not interfere with evaluation of study vaccine.
3. Subjects who are willing to be available during the entire study period.
4. Subjects who agree to comply with trial requirements and are willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to study vaccine or their constituents, kanamycin or any other aminoglycoside.
2. History of administration of any other vaccine or immunoglobulin in past 1 month or planned immunization of any
other vaccine in next 7 months.
3. Clinical or laboratory evidence of ongoing viral hepatitis.
4. History or evidence of uncontrolled epilepsy or any progressive neurological disorder in the subject or family.
5. History or evidence of thrombocytopenia, blood coagulation abnormality or concomitant administration of any anticoagulant drugs.
6. History or evidence of any congenital or acquired immunodeficiency viz. HIV infection and/or concomitant administration of immunosuppressive drugs.
7. History or evidence of acute infections, acute flare of chronic infections or fever at the time of administration of vaccine.
8. History or evidence of any significant cardiovascular, hepatic, renal, neurological or neoplastic disorder which preludes participation of subject into the trial as per investigator discretion.
9. Subject who is pregnant as confirmed by positive UPT, or lactating female.
10. Female of childbearing potential not willing to practice acceptable method of contraception during study period.
11. History or evidence of any chronic alcohol abuse / drug abuse.
12. Subject who has participated in any other clinical study in past 3 months.
13. Subject judged ineligible for the vaccination by the investigator for any other reason. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the safety of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) in healthy Indian adults of either gender aged 18-65 years assessed using solicited and unsolicited adverse events following immunization.
2. To evaluate the immunogenicity of 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) in healthy Indian adults of either gender aged 18-65 years assessed by seroconversion rate from baseline to 30 days after third dose of vaccine administration. |
SafetY
1. Incidence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following each of the three vaccine doses.
2. Incidence, severity and relationship of unsolicited AEs from the first dose administration till the end of study visit.
3. Incidence of SAE from the first dose administration till the end of study visit.
Immunogenicity
1. Proportion of subjects achieving seroconversion against Hepatitis E at one month after three dose vaccination.
2. Geometric mean concentrations (GMCs) for anti-Hepatitis E antibodies at one month after three dose vaccination. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To demonstrate safety and seroconversion with age and gender stratification (18 to 35 years, 36 to 50 years, and 51 to 65 years). |
1. Incidence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following each of the three vaccine doses in male and female subjects aged 18 to 35
years, 36 to 50 years, and 51 to 65 years.
2. Incidence, severity and relationship of unsolicited AEs from the first dose administration till the end of study visit in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years.
3. Incidence of SAE from the first dose administration till the end of study visit in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years.
4. Proportion of male and female subjects achieving seroconversion against Hepatitis E at one month after three dose vaccination aged 18 to 35 years, 36 to 50 years, and 51 to 65 years.
5. Geometric mean concentrations (GMCs) for anti-Hepatitis E antibodies at one month after three dose vaccination in male and female subjects aged 18 to 35 years, 36 to 50 years, and 51 to 65 years. |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a Prospective, Multicentre, Single Arm, Phase IV Study to evaluate the Safety and Immunogenicity of Recombinant Hepatitis E Vaccine (E. Coli) in Healthy Adults. The study will enrol 1000 healthy adults who will receive 3 doses of Recombinant Hepatitis E Vaccine (E. Coli) at Day 0, Day 30, and Day 180. Each dose to be administered intramuscularly over the deltoid. Written informed consent will be taken from subjects/LAR before participation in the study. A total of 5 scheduled visits are planned for the study. Though every effort will be made to adhere
to the schedule of visits, a window period will be permitted as mentioned below. The schedule of
visits will be as follows:
Visit 1: Screening within 14 days of First dose of vaccination (Screening visit), Visit 2 : Day 0, First Dose of Vaccination, Visit 3: Day 30 + 7,| Second dose of Vaccination, Visit 4: Day 180 + 14, Third dose of Vaccination, Visit 5: Day 210 + 14, End of Study
Note: A subject may come for an unscheduled visit in the event of any adverse events or any other
clinical condition. |