| CTRI Number |
CTRI/2024/11/077489 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to evaluate the Safety and Immunogenicity of Japanese Encephalitis Vaccine of HBI in Healthy Male Subjects |
|
Scientific Title of Study
|
An Open Label Single Centric Phase I Clinical Trial to evaluate the Safety and Immunogenicity of Japanese Encephalitis Vaccine Inactivated (Adsorbed, Human) I.P. of HBI when administered in two groups of Healthy Male Subjects |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| HBI/JE1/24/02.1.3 Version 01; Amend 03 Dated: 26 Feb 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Krishna |
| Designation |
GM Medical Veterinary services |
| Affiliation |
Human Biologicals Institute |
| Address |
Medical and Veterinary Services department Human Biologicals institute A division of Indian Immunologicals Limited
Rakshapuram Gachibowli Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8187836444 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sai Krishna |
| Designation |
GM Medical Veterinary services |
| Affiliation |
Human Biologicals Institute |
| Address |
Medical and Veterinary Services department Human Biologicals institute A division of Indian Immunologicals Limited
Rakshapuram Gachibowli Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8187836444 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Krishna |
| Designation |
GM Medical Veterinary services |
| Affiliation |
Human Biologicals Institute |
| Address |
Medical and Veterinary Services department Human Biologicals institute A division of Indian Immunologicals Limited
Rakshapuram Gachibowli Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8187836444 |
| Fax |
|
| Email |
s.saikrishna@indimmune.com |
|
|
Source of Monetary or Material Support
|
| Human Biologicals Institute
Rakshapuram Gachibowli
Hyderabad 500032 |
|
|
Primary Sponsor
|
| Name |
Human Biologicals Institute |
| Address |
Human Biologicals Institute (A division of Indian Immunologicals Limited) Rakshapuram, Gachibowli Hyderabad – 500 032, Telangana |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayesh Sanmukhani |
Health 1 Super Speciality Hospital |
Near Venitian Villa Shilaj Circle S.P. Ring Rd, Thaltej Ahmedabad- 380059, Gujarat,India.
Ahmadabad
GUJARAT |
7600012192
drjayesh@clinexcelresearch.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Health 1 Super Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Japanese Encephalitis infection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Japanese Encephalitis Vaccine Inactivated (Adsorbed, Human) I.P. of HBI |
Group A(18 to 49 years of age)
Group B(12 to below 18 years of age) will be administered Two doses (of 0.5 ml each) at 4 weeks interval by intramuscular route at the deltoid.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Male |
| Details |
Healthy male subjects of 18 to 49 years and 12 to below18 years of age.
Judged to be in good health based on reported medical history physical examination and clinical judgement of the investigator
Subject or Parent or LAR is literate and has understood and signed the written informed consent prior to the study inclusion. Subjects of 12 to below 18 years of age have provided Assent
Plans to remain in the study area for the entire length of the trial
|
|
| ExclusionCriteria |
| Details |
Past history of Japanese Encephalitis or Dengue infection
History of receipt of licensed or experimental Japanese Encephalitis or Yellow Fever or Dengue vaccine
Participation in another clinical trial in the four weeks preceding the trial vaccination
Planned participation or planning to participate in any other clinical trial during the present trial period
Subject who has a known history of allergy to any component of the vaccine
Known or suspected primary or acquired disease of the immune system
Allergy immunotherapy or receiving immunosuppressive therapy except for using
topical steroids
Subjects on treatment with any hepatotoxic drug before receiving the vaccine during
the last 90 days
History of any significant underlying disease including but not limited to malignancy cardiopulmonary disease renal endocrinologic hematologic or hepatic dysfunction
Having diabetes mellitus type I or II
Known or suspected acute respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea new cough pharyngitis and respiratory problems eg wheezing and shortness of breath
Asthma that is unstable or required emergent care urgent care hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids
Any fever with axillary temperature greater than equals to 38 Celsius 100 4 Fahrenheit in last 3 days
Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms
History of recent contact with any confirmed case of COVID 19 or having tested positive for COVID 19 since less than a month
Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days
Any known history of thrombocytopenia or a bleeding disorder
History or suspicion of HIV HCV or Hepatitis B
Any history of receipt of blood products in last 3 months
Any condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety
Solicited/unsolicited local adverse events after each dose of vaccination and during the 4-6 weeks follow-up period in each age group.
Solicited/unsolicited systemic adverse events after each dose of vaccination and during the 4-6 weeks follow-up period in each age group.
Number of serious adverse events during the study period in each age group.
|
4-6 weeks after second dose of vaccination. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Immunogenicity
Seroprotection seroconversion rate in each group 4 to 6 weeks after the second dose of vaccination
Geometric mean titres of antibodies in each age group 4 to 6 weeks after the second dose of vaccination
|
4 to 6 weeks after second dose of vaccination |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
09/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An Open Label Single Centric Phase I Clinical Trial to evaluate the
Safety and Immunogenicity of Japanese Encephalitis Vaccine Inactivated
(Adsorbed, Human) I.P. of HBI administered in two groups of Healthy Male
Subjects of 18 to 49 years and 12 to below 18 years of age. The primary objectives
are to evaluate the safety of Japanese Encephalitis Vaccine in two groups of healthy male subjects, proportion of
the subjects experiencing local and/or systemic adverse events during follow up
period in each age group and number of serious adverse events occurring during
follow up period in each age group.
The secondary objective is to determine the Immunogenicity i.e. the
humoral immune response after each dose of vaccination of Japanese Encephalitis
Vaccine of HBI in two groups of Healthy male subjects of 18 to 49 years and 12
to below 18 years of age. Blood samples will be collected before the first dose
of vaccination and 4-6 weeks after the second dose vaccination. The samples
will be sent to central lab for analysis. The study will be conducted at one site. |