| CTRI Number |
CTRI/2021/08/035344 [Registered on: 02/08/2021] Trial Registered Prospectively |
| Last Modified On: |
23/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prevention of Cholera from the use of experimental oral cholera vaccine (Euvichol-Plus) |
|
Scientific Title of Study
|
A Phase III, open label, multicenter, parallel group, randomized Clinical Study to compare the Immunogenicity and Safety of Euvichol-Plus vaccine with Oral Cholera Vaccine Shanchol in healthy adults and children above age of one year |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay K Rai |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Centre for Community Medicine, AIIMS,
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
011265923233 |
| Fax |
|
| Email |
drsanjay.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Singh |
| Designation |
Head Clinical operations |
| Affiliation |
Clinical Research Network India |
| Address |
B-812, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi NCR
Gautam Buddha Nagar
UTTAR PRADESH
201305
India |
| Phone |
9695237796 |
| Fax |
|
| Email |
nidhisingh@crnindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Singh |
| Designation |
Head Clinical operations |
| Affiliation |
Clinical Research Network India |
| Address |
B-812, Advant Navis Business Park, Plot #7, Noida-Greater Noida Expressway, Sector 142, Noida, Delhi NCR
Gautam Buddha Nagar
UTTAR PRADESH
201305
India |
| Phone |
9695237796 |
| Fax |
|
| Email |
nidhisingh@crnindia.org |
|
|
Source of Monetary or Material Support
|
| Techinvention lifecare Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Techinvention lifecare Pvt Ltd |
| Address |
1004, The summit business park,
Off WEH metro station, Andheri kurla road
Andheri east Mumbai 400093. INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Clinical Research Network India CRO |
B-812, Advant Navis Business Park, Plot #7,
Noida-Greater Noida Expressway, Sector 142,
Noida, Delhi-NCR, Uttar Pradesh 201305
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jinen Mukeshbhai Shah |
Aartham Multi Super Specialty Hospital |
Aartham Multi Super Specialty Hospital,
Opp. Polytechnic, NR. Panjarapole cross road, Ambawadi, Ahmedabad
Ahmadabad
GUJARAT |
9724440891
jinenshah@gmail.com |
| Dr Chintan B Patel |
Aatman Hospital |
5, Anveshan Row House, Opp Umiya Mata Mandir Bopal-Ghuma Road, Bopal Ghuma, Ahmedabad - 380058
Ahmadabad
GUJARAT |
9825182251
chintanpatel7691@gmail.com |
| Dr Chandramani Singh |
All India Institute of Medical Sciences Patna |
All India Institute of Medical Sciences,
Dept. of Community & Family Medicine,
Patna, Bihar
Patna
BIHAR |
9931733280
cmaiims57@gmail.com |
| Dr Sanjay K Rai |
All India Institute of Medical Sciences Delhi |
Centre for Community Medicine, AIIMS,
New Delhi-110029
New Delhi
DELHI |
011265923233
drsanjay.aiims@gmail.com |
| Dr Rambha Pathak |
Government Institute of Medical Sciences |
Department of Community Medicine, Government Institute of Medical Sciences,
King’s George Medical University, Greater Noida,
Gautam Budh Nagar, UP
Gautam Buddha Nagar
UTTAR PRADESH |
01202341738
rambha_p@yahoo.com |
| Dr Abhishek T Chavan |
Jeevan Rekha Hospital |
Jeevan Rekha Hospital,
Dr. B R Ambedkar Road, Belagavi, Karnataka
Belgaum
KARNATAKA |
9900291629
dr.abhishektchavan@gmail.com |
| Dr N Ravi Kumar |
Niloufer Hospital |
Niloufer Hospital,
Dept. of Pediatrics,
Red Hills, Lakdikapool,
Hyderabad
Hyderabad
TELANGANA |
9490919293
ravik1961@yahoo.com |
| Dr Amit Chawla |
Prakhar Hospital |
Prakhar Hospital Pvt Ltd,
8/219 Arya Nagar,
Kanpur, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH |
9839217288
Dr.amitchawlacr@gmail.com |
| Dr Vinod Chayal |
Pt. B D Sharma PGIMS, Rohtak |
Department of Community Medicine Room number 405 PGIMS Rohtak Haryana Rohtak HARYANA 124001
Rohtak
HARYANA |
9355001856
drvinodchayal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences Patna |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences Delhi |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics Committee at Jeevan Rekha Hospital Belagavi |
Approved |
| Institutional Ethics Committee at Osmania Medical College Koti Hyderabad |
Approved |
| Institutional Ethics Committee Prakhar Hospital Kanpur |
Approved |
| Institutional Ethics Committee Pt. B.D. sharma post graduate institute of medical sciences Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of Cholera caused by Vibrio cholerae |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Euvichol-Plus vaccine |
Euvichol-Plus vaccine is a bivalent (O1 and O139) inactivated whole cell Oral Cholera Vaccine (OCV) containing killed whole cells of Vibrio cholerae O1 and Vibrio cholerae O139. A two-dose regimen of this vaccine was shown to be well-tolerated and immunogenic against Vibrio cholerae. |
| Comparator Agent |
Shanchol vaccine |
Shanchol vaccine contains Killed bivalent (O1 & O139 strains) whole cell oral cholera vaccine. The recommended dose of the vaccine (1.5 mL) is to be administered orally. Shanchol is indicated for active immunization against Vibrio cholerae. The primary immunization schedule consists of two doses given at an interval of at least two weeks. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged 1 year to 60 years both inclusive
2. Voluntary written informed consent form for study participation provided by an individual or his/her legally acceptable representative. Subjects aged 12 to <18 years, must sign an assent for the study and a parent or a legal guardian have to sign the informed consent. Subject aged 7 to 11 years need to provide an oral consent/assent and the consent form must be signed by parent/legally acceptable representative. Less than 7 years no need of assent, LAR can give consent
3. An individual who can be followed up during the study period and is capable of complying with the study requirements.
4. Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator
|
|
| ExclusionCriteria |
| Details |
1. History of cholera vaccinations or history of cholera.
2. History of hypersensitivity reactions to other preventative vaccinations.
3. Immune function disorders including immunodeficiency diseases.
4. 38℃ or higher body temperature measured prior to investigational product dosing.
5. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation. Also, administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
6. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
7. Pregnant or lactating women should be excluded by performing urine pregnancy test during screening.
8. Children vaccinated within 1 month prior to study initiation or planned vaccination during the study.
9. Participants in another clinical trial with investigational product dosing within 6 months prior to study initiation.
10. An individual thought to have difficulty in participating the study due to severe chronic diseases, based on the judgment of the investigator.
11. An individual thought to have difficulty in participating the study due to other reasons, based on the judgment of the investigator
12. If female patient will get pregnant after first vaccination
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of seroconversion rate :The proportion of subjects with at least 4 times higher anti-V. cholerae O1 Ogawa and Inaba antibody titer |
2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of seroconversion rate: The proportion of subjects with at least 4 times higher anti-V. cholerae O139 antibody titer |
2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1) |
| • Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by anti-V. Cholerae O1 Ogawa and Inaba antibody titer |
2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1). |
| • Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by anti-V. Cholerae O139 antibody titer |
2 Weeks after the second dose (Visit 3) as compared to baseline titers prior to investigational product dosing (Visit 1). |
|
|
Target Sample Size
|
Total Sample Size="416"
Sample Size from India="416"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="416" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/08/2021 |
| Date of Study Completion (India) |
11/12/2021 |
| 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
Modification(s)
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Cholera is a significant public health problem in many developing countries. The WHO recommends immunization with cholera vaccines as the complementary management strategy. This study is related to a bivalent (O1 and O139) inactivated whole cell Oral Cholera Vaccine (OCV) containing killed whole cells of Vibrio cholerae O1 and Vibrio cholerae O139. A two-dose regimen of this vaccine was shown to be well-tolerated and immunogenic against Vibrio cholerae. This will be carried out in healthy adults and children. Randomization will be stratified according to age 18 years to 60 years, 1 to <18 years. According to the pre-generated randomization table, the subjects will be randomized to the test and comparator groups (Visit 1) and will be given either the test vaccine or the comparator vaccine. For immunogenicity assessment, the blood sample will be taken at Visit 1 (prior to investigational product dosing), Visit 2 (prior to investigational product dosing), and Visit 3 (after two weeks of the second dose). At both follow up telephonic visits after vaccination, the appointed field officer will contact subjects via telephone for 3 consecutive days after the dosing of the vaccine. For safety assessment, the subjects and/or parents/legally acceptable representatives will be instructed to record on the subject diaries adverse events that occur after investigational product dosing. |