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CTRI Number  CTRI/2020/11/029234 [Registered on: 19/11/2020] Trial Registered Prospectively
Last Modified On: 30/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Multi-centre, phase II/III adaptive clinical trial to assess safety and immunogenicity of Gam-COVID-Vac combined vector vaccine 
Scientific Title of Study
Modification(s)  
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS- Cov-2 Infection in Indian Healthy Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RDI-GCV-001 V3.0 dated 19 Oct 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Agam Shah 
Designation  Lead, Clinical & Medical Operations 
Affiliation  Dr. Reddy’s Laboratories Limited 
Address  Integrated Product Development Office, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal, Malkajgiri District, Hyderabad – 500090, Telangana, India

Hyderabad
TELANGANA
500090
India 
Phone  9963164410  
Fax    
Email  agam.shah@drreddys.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Sonika Newar 
Designation  Deputy General Manager-Medical Monitoring and Safety  
Affiliation  JSS Medical Research Asia Pacific Private Limited 
Address  Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 , Sector 27 D, Near Sarai Khawaja Metro Station, Delhi Mathura Road, Faridabad -121003, Haryana, India

Faridabad
HARYANA
121003
India 
Phone  08800799887   
Fax    
Email  sonika.newar@jssresearch.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Shariq Anwar 
Designation  Head Operations - Monitoring & Site Management 
Affiliation  JSS Medical Research Asia Pacific Private Limited 
Address  Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 , Sector 27 D, Near Sarai Khawaja Metro Station, Delhi Mathura Road, Faridabad -121003, Haryana, India

Faridabad
HARYANA
121003
India 
Phone  9810979215  
Fax    
Email  shariq.anwar@jssresearch.com  
 
Source of Monetary or Material Support  
Dr. Reddy’s Laboratories Limited, Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal, Malkajgiri District, Hyderabad – 500090  
 
Primary Sponsor
Modification(s)  
Name  Human Vaccine LLC 
Address  Capital City, South Tower, 8, Building. 1, Floor 7, Room I, part of Room 3, workstation 7.31, Presnenskaya Naberezhnaya, 123112, Russia 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Dr Reddys Laboratories Limited   Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal, Malkajgiri District, Hyderabad – 500090 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 25  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr P Naveen Reddy   AIG Hospitals   AIG Hospitals, No. 136, Plot No 2/3/4/5 Survey, 1, Mindspace Rd, Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA 
919848045814

drnaveen.reddy@aighospitals.com 
Dr Sandeep Kumar Gupta  Atharva Multispecialty Hospital & Research  H-4/ Comm-2, Construction Div-21, UP Avas Vikas Parishad Sector E, Lucknow-226003
Lucknow
UTTAR PRADESH 
9336077839

atharva.hospital@gmail.com 
Dr Rohidas Borse  B. J. Government Medical College & Sassoon General Hospital  B. J. Government Medical College & Sassoon General Hospital, Department of Medicine, 3rd floor, B J Government Medical College & Sassoon General Hospital Jayaprakash Narayan Road, Near Railway Station, Pune - 411001, Maharashtra, India
Pune
MAHARASHTRA 
919923912525

bjmct2020@gmail.com 
Dr Parshottam Koradia   BAPS Pramukh Swami Hospital   BAPS Pramukh Swami Hospital Shri Pramukh Swami Maharaj Marg, Adajan Chaar rasta, Surat - 395009
Surat
GUJARAT 
919825312027

purushottam_koradia@yahoo.co.in 
Dr Suninder Singh Arora   Batra Hospital and Medical Research Centre   Room No 15, Block B, Department of Medicine and Critical Care Medicine, Batra Hospital and Medical Research Centre, 1 Tughlakabad Institutional Area Mehrauli-Badarpur Road, New Delhi-110062
South
DELHI 
919810113414

drssarora@gmail.com 
Dr Winsley Rose  Christian Medical College Vellore  Department of Pediatrics (Unit-3) ISSCC Building, Ida Scudder Road, Christian Medical College Vellore- 632004,
Vellore
TAMIL NADU 
09698884466

winsleyrose@cmcvellore.ac.in 
Dr Arindam Ray   College of Medicine & Sagore Dutta Hospital   College of Medicine & Sagore Dutta Hospital, 578, B.T. Road, Kamarhati, Kolkata-700058, West Bengal
Kolkata
WEST BENGAL 
916291141797

rayarindam09@gmail.com 
Dr Asim Das   ESIC Medical College and Hospital   NH-3, NIT Faridabad - 121001, Haryana
Faridabad
HARYANA 
07838182228

dean-faridabad@esic.nic.in 
Dr Saurabh Agarwal  GSVM Medical College  Post Graduate Department of Medicine GSVM Medical College, Swaroop Nagar, Kanpur - 208002, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH 
09415039582

dragarwalsaurabh@gmail.com 
Dr Sunil Kohli   Hamdard Institute of Medical Science & Research with Centre for Health Research and Development   Hamdard Institute of Medical Science & Research (HIMSR) with Centre for Health Research and Development – Society for Applied studies (CHRD-SAS) [HIMSR with CHRD-SAS] Guru Ravidas Marg, Hamdard Nagar, New Delhi – 110062
South
DELHI 
919873351206

drskohli.himsr@gmail.com 
Dr Viny Kantroo  Indraprastha Apollo Hospitals  Indraprastha Apollo Hospitals, Apollo Research and Innovation Nursing Hostel Complex, Basement Indraprastha Apollo Hospitals, Delhi Mathura Road Sarita Vihar, New Delhi 110076, India
New Delhi
DELHI 
919811120777

vinykantroo@gmail.com 
Dr Shilpa Avarebeel  JSS Hospital  Department of Geriatrics JSS Hospital, Mahatma Gandhi Road, Mysore-570004, Karnataka
Mysore
KARNATAKA 
09880053998

shilpaavarebeel@gmail.com 
Dr Anand Kawade  KEM Hospital Research Center  Vadu Rural Health Program, P. O. Vadu (Budruk), Taluka Shirur, Dist Pune – 412216, Maharashtra
Pune
MAHARASHTRA 
09850559983

anand.kawade@kemhrcvadu.org 
Dr Jayaprakash Appajigol  KLE’s Dr Prabhakar Kore Hospital and MRC  Department of Medicine KLEs Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belgavi-590010, Karnataka
Belgaum
KARNATAKA 
09844595659

jayaprakashappajigol@gmail.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspecialty Hospital  Central Spine, Agrasen Aspatal Marg, Sec 7 Vidyadhar Nagar, Jaipur - 302039
Jaipur
RAJASTHAN 
9414414834

doctormanishjain2@gmail.com 
Dr Anand Nikalje  MGM Medical College & Hospital   MGM Medical College & Hospital, N-6, CIDCO, Aurangabad – 431003, Maharashtra
Aurangabad
MAHARASHTRA 
919890840086

dranandnikalje68@gmail.com 
Dr Sidram Raut  Noble Hospitals Pvt. Ltd.  153, Magarpatta City Road, Hadapsar, Pune - 411013 Maharashtra India
Pune
MAHARASHTRA 
9423581029

skrcorporate@yahoo.co.uk 
Dr Subhrojyoti Bhowmick   Peerless Hospitex Hospital and Research Centre Ltd.   Peerless Hospitex Hospital and Research center Ltd, 360, Panchasayar, Kolkata-700094
Kolkata
WEST BENGAL 
919830204863

drsubhro@gmail.com 
Dr Anil Purty  Pondicherry Institute of Medical Sciences  Department of Community Medicine Pondicherry Institute of Medical Sciences (Unit of Madras Medical Mission), Basic Sciences Block, Village no. 20, Ganapathychettikulam, Kalapet - 605014, Puducherry
Pondicherry
PONDICHERRY 
09442233460

anilpurty@hotmail.com 
Dr Nirav Bhalani   Rhythm Heart Institute   Rhythm Heart Institute Near Siddharth Bungalows, Sama Savli Road Vadodara 390022
Vadodara
GUJARAT 
918128995863

drniravbhalani@hotmail.com 
Dr Prabhat Kumar Agrawal   SN Medical College   SN Medical College, Central Library, Moti Katra, Mantola, Agra, Uttar Pradesh – 282-003
Agra
UTTAR PRADESH 
919319250485

ppagrawal120@gmail.com 
Dr Akash Khobragade  St. Georges Hospital  P D Mello Rd, opposite GPO, beside CST station, Chhatrapati Shivaji Terminus Area, Fort, Mumbai, Maharashtra 400001
Mumbai
MAHARASHTRA 
09702658822

drakashk.research@gmail.com 
Dr Arti Shah   Sumandeep Vidyapeeth an Institution Deemed to be University & Dhiraj Hospital   Sumandeep Vidyapeeth an Institution Deemed to be University & Dhiraj Hospital, At & Po Piparia, Ta. Waqhodia, Vadodara 391760
Vadodara
GUJARAT 
919925047880

artidhawal76@gmail.com 
Dr Abhishek Agarwal  The INCLEN Trust International Guru Nanak Hospital  The INCLEN Trust International, Guru Nanak Hospital, Opposite Palwal Bus Stand, Main Delhi Mathura Road, (National Highway 2) Palwal, Haryana - 121102
Faridabad
HARYANA 
919582366630

abhishek.agarwal@inclentrust.org 
Dr K Shantaraman  Tirunelveli Medical College  Tirunelveli Medical College, North Highground, Tirunelveli-627011, Tamilnadu, India
Tirunelveli
TAMIL NADU 
919443133898

shantaram_kal@tvmc.ac.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 25  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maharaja Agrasen Hospital, Jaipur  Approved 
Ethics Committee GSVM Medical College  Approved 
INCLEN Independent Ethical Committee  Approved 
Institutional Ethics Committee , Atharva Hospital  Approved 
Institutional Ethics Committee , Noble Hospital  Approved 
Institutional Ethics Committee , Sehgal Nursing Home  Approved 
Institutional Ethics Committee Asian Institute of Gastroenterology   Approved 
Institutional Ethics Committee –Clinical studies Indraprastha Apollo Hospitals  Approved 
Institutional Ethics Committee College of Medicine and Sagore Dutta Hospital   Approved 
Institutional Ethics Committee Grant Government Medical College & Sir J J Group of Hospitals   Approved 
Institutional Ethics committee of B.J.G.M.C.& Sassoon General Hospital  Approved 
Institutional Ethics Committee Tirunelveli Medical College  Approved 
Institutional Ethics Committee, BAPS Pramukh Swami Hospital   Approved 
Institutional Ethics Committee, KAHER JNMC Campus  Approved 
Institutional Ethics Committee, S. N. Medical College, Agra  Approved 
Institutional Ethics Committee. JSS Medical College & Hospital  Approved 
Institutional Review Board, Christian Medical College  Approved 
Jamia Hamdard Institutional Ethics Committee  Approved 
KEM Hospital Research Centre Ethics Committee  Approved 
Mahatma Gandhi Missions Ethics Committee for Research on Human Subject   Approved 
Peerless Hospitex Hospital and Research Center Limited Clinical Research Ethics Committee   Approved 
PIMS Institute Ethics Committee  Approved 
Rhythm Heart Institute Ethics Committee  Approved 
Scientific Research and Ethics Review Committee Batra Hospital and Medical Research Centre   Approved 
Sumandeep Vidyapeeth Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  COVID-19 negative 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Component I   Recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0 +/-0.5) х 10 raise to 11 particles per dose of 0.5 mL. 
Intervention  Component II   Recombinant adenovirus serotype 5 particles containing SARS-CoV-2 protein S gene, in the amount of (1.0 +/-0.5) х 10raise to 11 particles per dose of 0.5 mL  
Comparator Agent  Placebo Component I  Matching product without Recombinant adenovirus particles containing the SARS-CoV-2 protein S gene 
Comparator Agent  Placebo Component II  Matching product without Recombinant adenovirus particles containing the SARS-CoV-2 protein S gene 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Written informed consent of a subject to participate in the trial
2. Males and females aged 18+ years
3. Negative human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C test results
4. Negative immunoglobulin M (IgM) and immunoglobulin G (IgG) SARS-CoV-2 antibodies through enzyme immunoassay test result
5. Negative COVID-2019 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit (72 hours prior to Visit 1 [Day 1])
6. No COVID-2019 in the medical history
7. History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects)
8. Consent for using effective methods of contraception during the entire trial1
9. Negative urine pregnancy test at the screening visit (for child-bearing age women)
10. No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history
11. No acute infectious and/or respiratory diseases within at least 14 days before the enrolment.
 
 
ExclusionCriteria 
Details  1. Any vaccination/immunization within 30 days before the enrolment
2. Steroids (except hormonal contraceptives) and immunoglobulins or other blood products therapy not finished 30 days before the enrolment
3. Immunosuppressors therapy finished within 3 months before the enrolment
4. Pregnancy or breast-feeding
5. Acute coronary syndrome or stroke suffered less than one year before the enrolment
6. Tuberculosis, chronic systemic infections
7. Drug allergy (anaphylactic shock, Quincke edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day
8. Subjects who are on drugs that could have potential drug interactions with adenovirus vaccine
9. Medical history of malignancy
10. Donated blood or plasma (450+ mL) within 2 months before the enrolment
11. Splenectomy in the medical history
12. Neutropenia (absolute neutrophil count less than 1,000 mm3), agranulocytosis, significant blood loss, severe anaemia (haemoglobin less than 80 g/L), immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment
13. Active form of a disease caused by the HIV and hepatitis B or C
14. Anorexia, protein deficiency of any origin
15. Tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the IMP or placebo administration
16. Alcohol or drug addiction in the medical history.
17. Participation in any other interventional clinical trial within 1 month prior to the Screening
18. Any other medical condition that would limit the participation of the subject as per Investigator discretion
19. Study centre staff or other employees directly involved in the trial and their families
20. Subjects contraindicated for vaccination




 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Phase II-Incidence & severity of AEs,Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies
Phase III-Incidence of SAEs following vaccination during the study, GMT ratio of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group
 
Phase II-At day 28, Phase III-Entire study duration,At day42 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of AEs & SAEs, Clinically significant changes.
GMT & Seroconversion rate of SARS-CoV-2 glycoprotein-specific & SARS-CoV-2 VNA antibodies in immunogenicity.
Interferon gamma concentration in T-cells after restimulation with the SARS-CoV-2 glycoprotein in CMI, Number of proliferating CD4 and CD8 cells in response to mitogen stimulation & their ratios in CMI, % of subjects with antibodies to SARS-CoV-2 N-protein.Incidence of cases of Covid-19 developed 
Entire study duration, Baseline (GMT), Day21,28,90,180
Baseline,Day28,42,90,180, Day 42 and 180 
 
Target Sample Size   Total Sample Size="1600"
Sample Size from India="1600" 
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 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  
01/12/2020 
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="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.

The IMP/placebo will be administered intramuscularly during vaccination visits:

At the Visit 1 (Day 1) the subject will receive component I of the IMP/placebo from the bottle marked with the Roman number I. Component II of the IMP/placebo will be administered during the Visit 3 (Day 21±2) from the bottle marked with the Roman number II.

1600 subjects planned for this trial (100 in phase II and 1500 in phase III).


 
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