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CTRI Number  CTRI/2021/03/032051 [Registered on: 16/03/2021] Trial Registered Prospectively
Last Modified On: 30/03/2021
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Approved/Obtained 
 
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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   19/03/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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.    
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