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
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
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
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
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"
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.
