| CTRI Number |
CTRI/2020/02/023128 [Registered on: 05/02/2020] Trial Registered Prospectively |
| Last Modified On: |
15/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the Immunogenicity and Safety of Inactivated Japanese encephalitis vaccine |
|
Scientific Title of Study
|
A Phase IV Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Japanese Encephalitis Vaccine in healthy volunteers. |
| Trial Acronym |
JENVAC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BBIL/JEV/IV-2/2018; version 1.2 dated 06.08.2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Krishna Mohan |
| Designation |
Executive Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Bharat Biotech International Limited
Genome Valley
Shameerpet
hyderabad
Hyderabad
TELANGANA
500078
India |
| Phone |
04027784084 |
| Fax |
04023480560 |
| Email |
kmohan@bharatbiotech.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Krishna Mohan |
| Designation |
Executive Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Bharat Biotech International Limited
Genome Valley
Shameerpet
hyderabad
TELANGANA
500078
India |
| Phone |
04027784084 |
| Fax |
04023480560 |
| Email |
kmohan@bharatbiotech.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Krishna Mohan |
| Designation |
Executive Director |
| Affiliation |
Bharat Biotech International Limited |
| Address |
Bharat Biotech International Limited
Genome Valley
Shameerpet
hyderabad
TELANGANA
500078
India |
| Phone |
04027784084 |
| Fax |
04023480560 |
| Email |
kmohan@bharatbiotech.com |
|
|
Source of Monetary or Material Support
|
| Bharat biotech international limited |
|
|
Primary Sponsor
|
| Name |
Bharat Biotech International Ltd |
| Address |
Genome valley
Shameerpet
Hyderabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Epari Venkata Rao |
IMS & SUM Hospital |
K-8, Kalinga Nagar
Ghatikia
Bhubaneshwar - 751003
Khordha
ORISSA |
7853889552
e.venkata.rao@gmail.com |
| Dr R Vasudev |
King George Hospital |
Maharanipeta
Near Collectors Office
Vishakapatnam-530002
Visakhapatnam
ANDHRA PRADESH |
9866739808
vasudev.kgh@gmail.com |
| Dr Debashish Baidya |
Marwari Hospital & Research center |
Room No. 8, 1st Floor,
S J Road
Athgoan
Guwahati-781008
Kamrup
ASSAM |
91-8723085653
drbaidyamdmed@gmail.com |
| Dr Savita Verma |
Post Graduate Institute of Medical Sciences |
Department of Pharmacology
Directorate Office
Rothak - 124001
Rohtak
HARYANA |
9812283746
savita_verma@hotmail.com |
| Dr Jitendra Singh Kushwaha |
Prakhar Hospital Pvt Ltd |
8/219
Arya Nagar
Kanpur - 208002
Kanpur Nagar
UTTAR PRADESH |
9415040752
principalinvestigator1177@gmail.com |
| Dr Manish Multani |
Rahate Surgical Hospital & ICU |
Near Telephone Exchange Square 517,
Juni Mangalwari
Central Avenue
Nagpur - 440 008
Nagpur
MAHARASHTRA |
8983178550
mkmultani@gmail.com |
| Dr Ajeet Pratap Singh |
Rana Hospital Pvt.Ltd and Trauma Center |
Room No-02, Department of Medicine,
Rail Vihar,
Medical College Road
Chargawa, Gorakhpur-273001
Gorakhpur
UTTAR PRADESH |
7652456810
ajeetpsingh1177@gmail.com |
| Dr Sagar Vivek Redkar |
Redkar Hospital & Research Center |
Oxelbag Village
Dhargal
Goa - 403513
North Goa
GOA |
7776084679
redkar.research@gmail.com |
| Dr Amulya yelamanchi |
Yalamanchi Hospitals and Research center |
D.No-29-7-44
Venkataratnam Street
Suryaraopet,
Vijayawada - 520002
Krishna
ANDHRA PRADESH |
9052511661
amulya.yalamanchi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee Marwari Hospital & Research Center |
Approved |
| Ethics Committee Prakhar Hospital |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee institutional Medical Sciences and SUM Hospital |
Approved |
| Institutional Ethics Committee King George Hopsital |
Approved |
| Institutional Ethics Committee PGIMS |
Approved |
| Institutional Ethics Committee Rahate Surgical Hospital |
Approved |
| Redkar Hospital Institutional Ethics Committee |
Approved |
| Yelamanchi Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
JE Infection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Japanese encephalitis Vaccine
(JENVAC) |
0.5ml of Jenvac administerd intramuscularly at Day 0 |
| Comparator Agent |
Typbar TCV and Flu Vaccines |
1.Typbar TCV® :Single dose of 0.5 mL of Typbar TCV®will be administered intramuscularly.
2.Flu vaccine: Commercially available in market
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of age 1 to ≤65 years without significant medical history or abnormal clinical findings.
2.Subject or Subject’s Legally Acceptable Representative (LAR) who has been explained about all risks and benefits of the study and is willing to provide written informed consent.
3.Agree to be available for all study related visits and procedures throughout the entire duration of the study.
4.Individuals who are in good health as determined by the outcome of medical history, physical examination and based on the clinical judgement of the Principal Investigator.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with age less than 1 year and more than 65 years.
2.Fever of any origin of duration more than 3 days within one month prior to screening or on the day of screening.
3.History of malaise, head ache, anorexia at the time of screening or of the vaccine under study.
4.Past history of JE vaccination.
5.Life threatening or serious cardiac (NYHA grades III-IV heart failure), respiratory gastrointestinal, Hepatic, renal, Endocrine, hematological or immune disorders.
6.Any confirmed or suspected immunosuppressive or Immunodeficient condition.
7.Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for JE or other vaccine in the past 2months.
8.Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
9.Previous history of hypersensitive reaction to vaccine or vaccine component.
10.Women who are pregnant or breast-feeding.
11.Married or sexually active participants who are not willing to follow effective birth control methods during the treatment period.
12.Individuals participating in any other clinical trial within one month prior to study participation or intent to participate in any other clinical trial during the conduct of the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To evaluate the immunogenicity of the Test vaccine in terms of Seroconversion, Seroprotection and Geometric Mean Titers (GMTs) of JEV neutralizing antibody four weeks post vaccination in Group I and Group II. |
1) day 0 and 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) To assess and evaluate the safety of the test vaccine in Group I and Group II. |
1) day 0 and 28 |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "500"
Final Enrollment numbers achieved (India)="500" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/02/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study, we are comparing test
(vaccine group) Vs. Control (non-vaccine group) to study seroprevalence and immunogenicity
in both endemic and non-endemic zones aged 1 to 65 years. The rationale for
including a control arm is to assess and compare seroprevalence rates for JE
between both groups. This would provide the investigators with increased
knowledge of how JENVAC can produce robust immune responses.
Control
vaccine administered will be Typbar-TCV (Typhoid conjugate vaccine) from 9
months to 45 years or seasonal flu vaccine for ages above 45 years. Both the
Indian Academy of Pediatricians and WHO have recommended Typbar-TCV to be
administered in typhoid endemic countries with a single dose. Since both
vaccines are not available in the National Immunization Program, potential
control participants in this study will receive the added benefit of protection
from both Typhoid Fever and Seasonal Influenza. Due to the study being
conducted in JE endemic settings, a month after receipt of these control
vaccines, participants will receive a dose of JENVAC which will offer
protection to JE. |