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CTRI Number  CTRI/2020/07/026352 [Registered on: 04/07/2020] Trial Registered Prospectively
Last Modified On: 31/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   Novel Corona Virus-2019-nCov vaccine by intradermal route in healthy subjects.  
Scientific Title of Study   A prospective, randomized, adaptive, phase I/II clinical study to evaluate the safety and immunogenicity 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 
NCOV 1002 Version 02 dated 02 July 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravindra Mittal 
Designation  Senior Vice President 
Affiliation  Cadila Healthcare Limited 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway.

Ahmadabad
GUJARAT
382481
India 
Phone  07948040000  
Fax    
Email  r.mittal@zyduscadila.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kevinkumar Kansagra 
Designation  Deputy General Manager 
Affiliation  Cadila Healthcare Limited 
Address  Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya, Ahmedabad - 382213

Ahmadabad
GUJARAT
382213
India 
Phone  02717665555  
Fax    
Email  kevinkumarkansagra@zyduscadila.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ravindra Mittal 
Designation  Senior Vice President 
Affiliation  Cadila Healthcare Limited 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway

Ahmadabad
GUJARAT
382481
India 
Phone  07948040000  
Fax    
Email  r.mittal@zyduscadila.com  
 
Source of Monetary or Material Support  
Cadila Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, S-G Highway, Ahmedabad  
 
Primary Sponsor  
Name  Cadila Healthcare Ltd  
Address  Zydus Corporate Park, 3rd Floor B Wing (NPD), Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, S-G Highway, Ahmedabad – 382 481,  
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 = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hari Shankar Gupta  VIMS Hospital  Kamptee Rd, LIC Square, Mohan Nagar, Nagpur, Maharashtra 440001
Nagpur
MAHARASHTRA 
9890924509

drhari_gupta@yahoo.com 
Dr Parshottam Koradia  BAPS Pramukh Swami Hospital  Shri Pramukh Swami Maharaj Marg, Adajan char rasta. Adajan. Surat - 395 009 Gujarat, India
Surat
GUJARAT 
9825312027

purushottam_koradia@yahoo.co.in 
Dr Vipul Prajapati  GCS Medical College, Hospital & Research Centre  Opposite DRM office, Near Chamunda Bridge, Naroda Road, Ahmedabad – 380025, Gujarat
Ahmadabad
GUJARAT 
9909912551

Prajapativipul1983@gmail.com 
Dr Suresh Bhate  Jeevan Rekha Hospital  Dr. B.R. Ambedkar Road, Opp. Civil Hospital, Belagavi (Belgaum), Karnataka – 590002
Belgaum
KARNATAKA 
9845273830

drsureshgbhate@gmail.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  Central Spine Agrasen Aspatal Marg, Sector No. - 7 Vidhyadhar Nagar, Jaipur, Rajasthan -302039
Jaipur
RAJASTHAN 
9414414834

doctormanishjain2@gmail.com 
Dr Virendra Nath Tripathi  Prakhar Hospital Pvt. Ltd.  8/219, Arya Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH 
9415050777

principalinvestigator1177@gmail.com 
Dr Ajeet Pratap Singh  Rana Hospital Pvt. Ltd.  Rail Vihar, Medical College Road, Chargawa, Gorakhpur, Uttar Pradesh 273001
Gorakhpur
UTTAR PRADESH 
7652456810

ajeetpsingh1177@gmail.com 
Dr Talati Kalpesh Chimanlal  Zydus Hospitals and Healthcare Research Pvt Ltd.  Zydus Hospitals Road, S.G. Highway, Thaltej, Ahmedabad, Gujarat 380054
Ahmadabad
GUJARAT 
9824014187

KALPESHTALATI@zydushospitals.com 
Dr Taufik Momin   Zydus Research Centre   Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad 382213, Gujarat, India Ahmadabad GUJARAT
Ahmadabad
GUJARAT 
02717665555

Taufik.Momin@zyduscadila.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
BAPS Pramukh Swami Hospital Ethics Committee, BAPS Pramukh Swami Hospital, Adajan Cross Road. Adajan. Surat-395009  Approved 
Ethics Committee Prakhar Hospital Pvt Ltd. Prakhar Hospital Pvt. Ltd. 8/219, Arya Nagar, Kanpur, Uttar Pradesh 208002  Approved 
IEC Maharaja Agrasen Hospital, Maharaja Agrasen Superspeciality Hospital, Central Spine, Agrasen Aspatal Marg, Sector No. - 7 Vidhyadhar Nagar, Jaipur, Rajasthan -302039  Approved 
Instituional Ethics Committee Jeevan Rekha Hospital Dr. B R Ambedkar Road Belgavi-590002  Approved 
Institutional Ethics Committee of VIMS, Mohan nagar, LIC Square, Kamptee Road, Nagpur 440001, Maharastra India.  Approved 
Institutional Ethics Committee Rana Hospital Pvt. Ltd., Rail Vihar Medical College Road, Chargawa Gorakhpur-273001  Approved 
Institutional Ethics Committee, GCS Medical College, Hospital and Research Centre, Opp DRM Office, Nr Chamunda Bridge, Naroda Road, Ahmedabad-380025  Approved 
Sangini Hospital Ethics Committee,C/o Sangini Hospital, First Floor,Santorini Square, b/h Abhishree Complex, Opp. Star Bazar, Nr. Jodhpur Cross Roads, Satellite, Ahmedabad-380015, Gujarat,India   Approved 
Zydus Hospital Ethics Commitee Zydus Hospitals and Healthcare Research Pvt Ltd., Zydus Hospitals Road, S.G. Highway, Thaltej, Ahmedabad, Gujarat 380054  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nCov Vaccine  1)Dose:-0.1 ml.(2)Frequency:-single time at day 0 day 28 and day 56.(3)Route: Intradermal  
Comparator Agent  Placebo  1)Dose:-0.1 ml.(2)Frequency:-single time at day 0(3)Route: Intradermal  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Healthy male and non-pregnant, non-lactating female subjects between 18-55 years of age (both inclusive)
2.Body weight > 50 kg for male and > 45 kg for female and BMI within the range 18.5 - 29.9 kg/m2 (Both inclusive)
3.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study
4.Subjects who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator, including the following parameters: haematology, serum biochemistry, urinalysis, and serology
5.Subjects who can comply with trial procedures and who are available for the duration of follow up
6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of last study vaccine.

For Phase II:-
1.Healthy subject of either gender ≥12 years of age
2.Informed consent from the adult subjects or from the parents of paediatric subjects. Additionally, assent from paediatric subjects (Audio video recording in case of vulnerable subject)
3.Adult subjects or parents of paediatric subjects literate enough to fill the diary card
4.Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit and males will agree to use contraception.

 
 
ExclusionCriteria 
Details  For Phase I
1.Febrile illness (temperature ≥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment
2.History of confirmed SARS-CoV-2 positive
3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
4.History of SARS/ MERS infection
5.Subjects positive for antibody and antigen against SARS-CoV-2.
6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine
7.Any clinically significant laboratory or ECG findings during screening or check-in
8.History or presence of significant smoking (10 cigarettes per day)
9.Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg.
10.History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II

For Phase II
1.Febrile illness (temperature ≥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment
2.History of confirmed SARS-CoV-2 positive
3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
4.History of SARS/ MERS infection
5.Subjects positive for antibodies against SARS-CoV-2 on antibody detection test at the time of screening
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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Phase I:-To evaluate the safety of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects.

Phase II:-To evaluate the immunogenicity of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects compared to placebo. 
Phase I: Day 0 and Day 84
Phase II: Day 0 and Day 224 
 
Secondary Outcome  
Outcome  TimePoints 
Phase I:-1)To evaluate the safety of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects.
Phase II:-1)To evaluate the safety of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects compared to placebo.
 
Phase I: Day 0 and Day 84
Phase II: Day 0 and Day 224 
 
Target Sample Size   Total Sample Size="1048"
Sample Size from India="1048" 
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)   13/07/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Brief Summary  

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first reported in January, 2020. The virus is highly transmissible between humans and has spread rapidly, causing the COVID-19 pandemic. Patients infected with SARS-CoV-2, especially older patients and those with pre-existing respiratory or cardiovascular conditions are at greater risk for severe complications, including severe pneumonia, acute respiratory distress syndrome, multiple organ failure, and in some cases, death.

In the absence of effective prevention measures, current management to control the epidemic is the enforcement of quarantine, isolation, and physical distancing. Effective vaccines against COVID-19 are urgently needed to reduce the enormous burden of mortality and morbidity associated with SARS-CoV-2 infection. 
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