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CTRI Number  CTRI/2021/09/036379 [Registered on: 09/09/2021] Trial Registered Prospectively
Last Modified On: 22/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  
Safety and immunogenicity study of an mRNA based vaccine GEMCOVAC-19 for COVID19 in healthy adult participants. 
Scientific Title of Study
Modification(s)  
A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability and Immunogenicity of the candidate GEMCOVAC-19 (COVID-19 vaccine) in healthy subjects 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
GEMCOVAC-19 (COVID-19 vaccine) Version 5.0 Dated 05 May 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Address 




 
Phone    
Fax    
Email    
 
Details Contact Person
Scientific Query
 
Name  Dr Amit Saraf 
Address  Gennova Vaccine Formulation Centre and Research Laboratory, BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2, International Biotech Park, Phase II, MIDC Hinjawadi,

Pune
MAHARASHTRA
411057
India 
Phone  02039166300  
Fax    
Email  amit.saraf@gennova.co.in  
 
Details Contact Person
Public Query
 
Name  Dr Amit Saraf 
Address  Gennova Vaccine Formulation Centre and Research Laboratory, BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2, International Biotech Park, Phase II, MIDC Hinjawadi,


MAHARASHTRA
411057
India 
Phone  02039166300  
Fax    
Email  amit.saraf@gennova.co.in  
 
Source of Monetary or Material Support  
Gennova Biopharmaceuticals Limited, Block 1, Plot No. P-1 and P-2, ITBT Park, Phase-II, MIDC, Hinjawadi, Pune- 411057, Maharashtra 
 
Primary Sponsor  
Name  Gennova Biopharmaceuticals Limited 
Address  Gennova Vaccine Formulation Centre and Research Laboratory, BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2, International Biotech Park, Phase II, MIDC Hinjawadi, Pune, MAHARASHTRA 411057. India  
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 = 36  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Sabah Siddiqui  All India Institute of Medical Sciences (AIIMS)  G.E. Road, Tatibandh
Raipur
 
85188819110

dr.sabah@aiimsraipur.edu.in 
Dr Pankaj Bhardwaj  All India Institute of Medical Sciences (AIIMS)  Basni,
Jodhpur
 
8003996903

pankajbhardwajdr@gmail.com 
Dr Koradia Parshottam Govindbhai  BAPS Pramukh Swami Hospital  Shri Pramukh Swami Maharaj Marg, Adajan Char Rasta, Adajan
Surat
 
9825312027

purushottam_koradia@yahoo.co.in 
Dr Bhaskar Jedhe Deshmukh  Baramati Hospital  Behind Kavivarya Moropant Natyamandir Ringroad
Pune
 
9822402772

jedhedeshmukh.12@gmail.com 
Dr Sonali Palkar  Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital  Pune-Satara Road
Pune
 
9881009817

researchpedpune@gmail.com 
Dr Gagandeep Kwatra  Christian Medical College  Christian Medical College, Brown Road
Ludhiana
 
9815588600

gagandeep.kwatra@cmcludhiana.in 
Dr Krishna Giri  Dhadiwal Hospital  Opp. New CBS, Trimbak road
Nashik
 
9975753763

drkmgiri@gmail.com 
Dr Smit Shah  DHS Hospital, Ahmedabad  OPD 3, First Floor, DHS Multispecialty Hospital, Vastrapur, Lake-Himalaya Mall Link Road, Sunrise Park, Vastrapur, Ahmedabad-380054.
Ahmadabad
 
7405310006

dhsclinicalrnd@gmail.com 
Dr Swapnav Borthakur  Downtown Hospital  GS Rd, Bormotoria, Guwahati
Kamrup
 
9864038704

swapnav.borthakur@gmail.com 
Dr Prakash Shende  Dr D Y Patil Hospital, Pimpri, Pune  Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra.
Pune
 
9028300177

Prakash.shende@dpu.edu.in 
Dr Shrikant Despande  Dr. Deshpande’s Ashirwad Hospital and Research Centre  Near Jijamata Udhyan Maratha Section
Mumbai
 
9822017445

writetoshrikant@rediffmail.com 
Dr K Sunil Naik  Government Medical College & Government General Hospital   Shanti Nagar Colony, Balaga,
Srikakulam
 
9440828299

drsunilnaikggh@gmail.com 
Dr Gosavi Rajesh Vithal  Government Medical College (GMC)  Medicine Research Room, Besides Ward No.: 48, 2nd Floor, Government Medical College and Hospital, Medical College Square, Hanuman Nagar, Nagpur 440003, Maharashtra, India.
Nagpur
 
9923693949

gosavirv@hotmail.com 
Dr Maria Thomas  Gurbachan Memorial Hospital  Christian Medical College (Rural Branch) Lalton Kalan
Ludhiana
 
9780197490

mariathomas_85@yahoo.com 
Dr Abhishek Agarwal  Gurunanak Hospital / The INCLEN Trust International  Room no 18, Department of Medicine, Gurunanak Hospital, Shiv Colony, Opposite Pawal Bus Stand, Delhi-Mathura National Highway (NH2), Palwal- 121102, Haryana.
Faridabad
 
9582366630

abhishek.agarwal@inclentrust.org 
Dr Sunil Kohli  Hamdard Institute of Medical Sciences and Research (HIMSR)  B/40, Department of medicine, Hamdard Institute of Medical Sciences and Research (HIMSR), with Centre for Health Research and Development - Society for Applied Studies (CHRD-SAS) [HIMSR with CHRD-SAS], Hakeem Abdul Hameed Centenary Hospital (HAHCH), Guru Ravidas Marg, Hamdard Nagar, New Delhi – 110062.
New Delhi
 
9873351206

drskohli.himsr@gmail.com 
Dr Gouranga Sarkar  Health Point Hospital, Kolkata.  Research Room, Room Number 12, Health point Hospital, 21 Prannath Pandit Street, Lansdown, Padmapukur, Kolkata, 700025.
Kolkata
 
9830165760

drgscardio1981@gmail.com 
Dr Shanta Dutta  ICMR-NICED, Kolkata  P-33 CIT Road Scheme XM Beliaghata.
Kolkata
 
9830152971

drshantadutta@gmail.com 
Dr Venkat Reddu Tummuru  Induss Hospital  Krishnaveninagar, Gaddiannaram, Near Municipal Office, Saroornagar
Hyderabad
 
9440383778

drvenkat14@gmail.com 
Dr Mukta Wyawahare  Jawaharlal Institute of Postgraduate Medical Education and Research  Dhanavantri Nagar
Pondicherry
 
8903307660

mukta.w@jipmer.edu.in 
Dr Subhash Chandra B J  JSS Hospital Mysore  JSS hospital, 2nd floor, Room no: 2211, Dept of General Medicine, Mahatma Gandhi road, Ramachandra Agrahara, Mysuru, 570004.
Mysore
 
9845197851

bjsubhashchandra@jssuni.edu.in 
Dr Pradeep DCosta  KEM Hospital Research Center  315, Pediatric Research Department, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth, Pune 411011, Maharashtra
Pune
 
09822632812

pradeepdcosta@yahoo.co.in 
Dr Ashwin Kulkarni   M.S Ramaiah Medical College and Hospitals  M.S Ramaiah Nagar, MSRIT Post
Bangalore
 
9620186394

drashwinkulkarni@yahoo.co.in 
Dr Manish Jain  Maharaja Agrasen Superspeciality Hospital  Central Spine AgrasenAspatal Marg, Sector-7, VidyadharNagar
Jaipur
 
9414414834

doctormanishjain2@gmail.com 
Dr Pooja Sharma  Medanta Institute of Education & Research,   The Medicity, CH Bhaktawar Chowk,Sector
Gurgaon
 
9811535739

Pooja.sharma@medanta.org 
Dr Ajay Bulle  Meditrina Institute of Medical Sciences  278, central bazar road, Ramdaspeth
Nagpur
 
9921981109

researchngp@gmail.com 
Dr S K Raut  Noble Hospital, Pune  Noble Hospital Clinical Research Department, Room No.6, Basement, Noble Annex, Noble Hospital Pvt. Ltd. 153/A, Magarpatta city road, Hadapsar, Pune - 411013. Maharashtra, India.
Pune
 
9423581029

nhcrd09@gmail.com 
Dr Savita Verma  PGIMS   Room No. 428, Department of Pharmacology
Rohtak
 
9812283746

Savita_verma@hotmail.com 
Dr Vijay Kumar Patil  Prakash Institute of Medical Science & Research   Sangli Road Uran Islampur Walwa
Sangli
 
9371877555

mangovijay@gmail.com 
Dr Hemant Gupta  Priyadarshani Nursing Home  Department of Medicine, M. Baria Estate, Kargil Nagar Road, Virar East
Mumbai
 
9820098763

drhemantgupta@gmail.com 
Dr Vijaykumar B Barge  Rajashree Chhatrapati Shahu Maharaj Govt. Medical College  Room no 7, Research department, Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Dasara Chowk, Town hall, Bhausingji Road, Kolhapur, Maharashtra 416002.
Kolhapur
 
09011066766

drvijaybarge12@gmail.com 
Dr Atul Joshi  Sahyadri Hospital, Pune  Sahayadri super speciality hospital, Ground floor hospital building, 30-C Karve road, Erandwane, Pune Maharashtra India 411004 .
Pune
 
02025449117

aj@sahyadrihospitals.com 
Dr Satyajit Mohapatra  SRM Medical College Hospital & Research Centre  SRM Nagar, Kattankulathur- 603 203, Chengalpattu,
Kancheepuram
 
9791161626

satyajitmp@gmail.com 
Dr Venkateshwar Rao  St.Theresas Hospital  Sanathnagar, Hyderabad
Hyderabad
 
9440010662
-
drvenkateshwarraoavula@gmail.com 
Dr Manoj Lahoti  Suyash Hospital   Gudhiyari Road, near Avinash lifestyle tower, behind Hotel Piccadily, Kota
Raipur
 
09926386660

manojlahoti@gmail.com 
Dr Abhishek Karmalkar  Vedant Multispeciality Hospital  GP 83, Opp Rotary Club, Sambhaji Nagar, MIDC, Chinchwad
Pune
 
9850337271

drkarmalkar@icloud.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 36  
Name of Committee  Approval Status 
Ashirwad Ethics Committee, Ulhasnagar  Approved 
BAPS Pramukh Swami Hospital Institutional Ethics Committee, Surat  Approved 
Ethics Committee downtown hospital  Approved 
Ethics Committee of Baramati Hospital Pvt. Ltd  Approved 
Ethics Committee, Dr. D. Y. Patil Vidyapeeth Pimpri, Pune  Approved 
Ethics Committee, M S Ramaiah Medical College and Hospitals Bengaluru   Approved 
ETHICS COMMITTEE, ST.THERESAS HOSPITAL , Hyderabad  Approved 
Health Point Ethics Committee, Kolkata   Approved 
IEC Intervention Studies JIPMER  Approved 
IEC of New Health Care Nursing Home New Health Care Nursing Home  Approved 
IEC, ICMR-NICED ICMR-NICED, Kolkata  Approved 
IEC, Maharaja Agrasen Hospital, Jaipur  Approved 
IEC-Vedant Multispeciality Hospital, Pune  Approved 
INCLEN Independent Ethics Committee, New Delhi  Approved 
INSTITUTE ETHICS COMMITTEE, AIIMS RAIPUR  Approved 
Institutional Ethics Committee BVDU Bharati Hospital and Research Centre, Pune  Approved 
Institutional Ethics Committee Christian Medical College & Hospital, Ludhiana  Approved 
Institutional Ethics Committee Christian Medical College & Hospital, Ludhiana  Approved 
Institutional Ethics Committee Govt. Medical College Govt.General Hospital Srikakulam  Approved 
Institutional Ethics Committee Induss Hospital, Hyderabad  Approved 
Institutional Ethics Committee JSS Medical College, Mysore   Approved 
INSTITUTIONAL ETHICS COMMITTEE SRM INSTITUTES FOR MEDICAL SCIENCE, Kattankulathur  Approved 
Institutional Ethics Committee, GMC, Nagpur  Approved 
Institutional Ethics Committee, PGIMS UHS Rohtak  Approved 
Institutional Human Ethics Committee,. All India Institute of Medical Sciences,. Basni, Jodhpur  Approved 
Jamia Hamdard Institutional Ethics Committee, South Delhi  Approved 
KEM Hospital Research Centre Ethics Committee, Pune  Approved 
Medanta Institutional Ethics Committee. Medanta, Gurugram  Approved 
Meditrina Institute Ethics Committee   Approved 
Noble Hospital Institutional Ethics Committee, Noble Hospitals Pvt. Pune  Approved 
Prakash Medical College IEC, Islampur,Sangli  Approved 
RCSMGMCIEC2 RCSMGMC and CPR Hospital , Kolhapur   Approved 
Sahyadri Hospitals Ltd. Ethics committee, Pune.  Approved 
Sangini Hospital Ethics Committee, Ahmedabad  Approved 
Shreeji Institutional Ethics Committee, Nashik  Approved 
SUYASH HOSPITAL INSTITUTIONAL ETHICS COMMITTEE , Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Active immunization for the prevention of SARS-CoV-2 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  COVISHIELD (SII-ChAdOx1 nCoV-19)  COVISHIELD will be administered as a 2 dose schedule on Days 1 and 29 as 0.5 mL intramuscularly 
Intervention  GEMCOVAC-19  GEMCOVAC-19 will be administered as a 2 dose schedule on Days 1 and 29 as 0.5 mL intramuscularly 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Male and female subjects’ 18- 80 years (both inclusive) for Phase II and > 18 (inclusive) years for Phase III. 2.Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. 3. Subject should be capable and willing to give voluntary written informed consent prior to inclusion in the study. 4. Subject is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. 5. Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2. 6. Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child bearing potential should be willing to follow effective birth control methods for duration of the study. 
 
ExclusionCriteria 
Details  1. Subject with a recent history of COVID-19 infection within 3 months from Screening.
2. Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection.
3. Any clinically significant laboratory values (Only Phase II).
4. Any significant illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.
5. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
6. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature > 38°C or > 100.4 °F (inclusive) or its equivalent for axillary and tympanic) within 48 hours prior to vaccination.
7. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease.
8. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study.
9. Prior major surgery or any radiation therapy within 4 weeks of Screening visit.
10. Positive serologic test for HIV 1 and 2, HBsAg or HCV.
11. Current (within 14 days prior to Screening visit) or anticipated concomitant immune-modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
12. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
13. Eczema or other significant skin lesion or infection at the site of vaccination.
14. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
15. Bleeding diathesis or condition associated with prolonged bleeding.
16. Subjects with a history of thromboembolic events.
17. History of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome
18. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate.
19. Any other condition which in the opinion of the Investigator may affect subject’s safety or participation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Safety (Only Phase II)
Occurrence and severity of local and systemic reactogenicity adverse events, unsolicited events and serious adverse events (SAE)

Immunogenicity (Phase II and III)
Geometric mean titer (GMT) as measured by IgG-ELISA against SARS-CoV-2 Spike protein.
 
Safety
Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study.

Immunogenicity
Immunogenicity at 43 day (14 days post dose 2) for Phase II and III
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Cellular Immunity (Phase II and III)
Cell mediated immunity assessment in terms of cytokine expression
 
Cellular Immunity
Day 29, 43 and 119.
 
Immunogenicity (Phase II and III)
1. Anti-Spike IgG GMT
2. GMFR in Anti-Spike IgG
3. Proportion of subjects seroconverted in terms of 2-fold rise (inclusive) in anti-spike IgG titer in seropositive subjects and 4-fold rise (inclusive) in anti-spike 
1. Anti-spike IgG GMT at day 29, 119 and 209.
2. GMFR in anti-spike IgG GMT at day 29 and 43.
3. Proportion of subjects seroconverted at day 43.
 
Neutralization
Phase II - cPASS and PRNT assay
Phase III - cPASS, PRNT and pseudovirus assay 
cPASS on Day 29, 43, 119 and 209
PRNT on day Day 29 and 43
Pseudovirus assay on Day 29, 43 and 119
 
Safety (Phase III)
Occurrence and severity of local and systemic reactogenicity adverse events, unsolicited events and serious adverse events (SAE)
 
Safety (Phase III)
Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study.
 
 
Target Sample Size   Total Sample Size="4400"
Sample Size from India="4400" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)
Modification(s)  
16/09/2021 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Brief Summary
Modification(s)  
This is a randomized, observer-blind, active controlled, seamless, Phase II/III study. Phase II part will be conducted in 400 healthy subjects while Phase III part of the study will enroll 4000 healthy subjects. Phase II of the study will enroll subjects in 1:1 randomization scheme to receive either GEMCOVAC-19 (10 microgram) or COVISHIELD™ while Phase III will enroll subjects in ratio 3:1 (GEMCOVAC-19: COVISHIELD™). Thus, 4000 randomized subjects in Phase III study with 3000 randomized to GEMCOVAC-19 arm and 1000 randomized to COVISHIELD™ arm will make ‘Safety Cohort’ of the study. A subset of these subjects will constitute the immunogenicity cohort. 

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