CTRI

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CTRI Number

CTRI/2020/11/029234 [Registered on: 19/11/2020] Trial Registered Prospectively

Last Modified On:

12/01/2022

Post Graduate Thesis

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
Modification(s)

Secondary ID	Identifier
RDI-GCV-001 Version 4.1 dated 15 Jun 2021	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

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).