| CTRI Number |
CTRI/2021/03/032051 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
21/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Trial to evaluate 3mg dose of Covid Vaccine of Cadila healthcare Limited |
|
Scientific Title of Study
|
A prospective, randomized, phase I/II clinical study to evaluate the safety and immunogenicity of 3mg dose of Novel Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No. 21-01; Version No. 01 Dated 17-02-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
079-48041430 |
| Fax |
|
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Deputy General Manager - New Product Development |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
jayeshsanmukhani@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Deputy General Manager - New Product Development |
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad
GUJARAT
382481
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
jayeshsanmukhani@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Limited |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Limited |
| Address |
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jinen Mukeshbhai Shah |
Aartham Multi Super Speciality Hospital |
Clinical Research Room - Basement 2;
Aartham Hospital, Opp. Polytechnic, Nr. Panjarapole
cross road, Ambawadi
Ahmadabad
GUJARAT |
9724440891
jinenshah@gmail.com |
| Dr Abhishek Pande |
Axon Multispeciality Hospital Rukhmini Complex |
Research Room, Axon hospital, Hingna Rd, near Mascott Honda, Bansi Nagar
Nagpur
MAHARASHTRA |
8793653698
dr_abhishekpande@yahoo.com |
| Dr Chandra Prakash Suthar |
Dana Shivam Heart & Superspeciality Hospital |
Clinical Research Room, Basement, Dana Shivam hospital, Plot No:2, Opp. Times Square, Sector 2, Vijay Bari,
Vidyadhar Nagar
Jaipur
RAJASTHAN |
9413861322
danashivam.cr@gmail.com |
| Dr Amit Bhate |
Jeevan Rekha Hospital |
Clinical Research Department, Second Floor,
Jeevan Rekha Hospital,
Dr. B.R. Ambedkar Road Opp Civil Hospital
Belagavi (Belgaum)
Belgaum
KARNATAKA |
9695237796
dr.amitsureshbhate@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC Maharaja Agrasen Hospital |
Approved |
| Institutional Ethics Committee Jeevan Rekha Hospital |
Approved |
| Institutional Ethics Committee of Vidharbha Institute of Medical Sciences |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Novel Corona Virus-2019-nCov vaccine of M/s. Cadila Healthcare Limited (ZyCoVD) |
3 mg dose (0.1ml dose at three sites) to be given twice at day 0 and 28 |
| Comparator Agent |
Placebo |
0.1ml dose at three sites to be given twice at day 0 and 28 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subject of either gender 18 to 60 years of age
2. Informed consent from the subjects (Audio video recording in case of vulnerable subject)
3. Adult subjects literate enough to fill the diary card
4. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the follow-up visit and males who agree to use contraception
|
|
| ExclusionCriteria |
| Details |
1. Febrile illness (temperature ≥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment
2. History or laboratory evidence of confirmed SARS-CoV-2 positive
3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
4. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test / RTPCR positive at the time of screening
5. History of SARS/ MERS infection
6. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine
7. Past history of hypersensitivity reaction or any serious adverse event after any vaccination
8. Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder
11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
12. Any other vaccine administration within the last 30 days or planned to be administered during the study period
13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
14. Participation in another clinical trial in the past 3 months
15. History of drug / alcohol abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Adverse events (solicited, unsolicited and SAEs) reported during the study in the two groups
Seroconversion rate based on IgG antibodies against S1 antigen (by ELISA) at Day 56.
|
Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Seroconversion rate based on of IgG antibodies against S1 antigen (by ELISA) |
Day 28 and 42 |
| Geometric Mean Titre and Geometric Mean Fold Rise |
Day 28, 42 and 56 |
| Neutralizing antibody assay |
Day 42 and 56 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
19/03/2021 |
| Date of Study Completion (India) |
27/05/2021 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
current study is being planned as a proof of concept study to evaluate the
effect of 2 doses of 3mg given by Pharmajet at interval of 28 days. healthy subjects will be screened as per inclusion and exclusion criteria and will be randomized in 2:1 ratio to receive either the vaccine or placebo. Randomized subjects will be
given two doses of vaccine / placebo at an interval of 28 days. Each dose of vaccine / placebo comprises of 3mg (0.3 ml) Novel Corona Virus-2019-nCov vaccine / placebo. The vaccine / placebo
will be given as 3 shots of 0.1ml each via intradermal route using Pharmajet
Tropis device at three different sites on the upper arm. Subjects will be followed for 28 days after last dose of vaccine. Blood samples will be taken at Day 0, 28, 42 and 56 for immunogenicity analysis. |