CTRI/2022/10/046475 [Registered on: 14/10/2022] Trial Registered Prospectively
Last Modified On:
03/04/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Safety, Tolerability and Immunogenicity of GEMCOVAC-OM as a booster in Subjects 18 years of age and older
Scientific Title of Study
A Prospective, Multi-centre, Open-labelled, Randomized, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability and Immunogenicity of GEMCOVAC-OM as a booster in Subjects 18 years of age and older
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GBL/GEMCOVAC-OM/2022/02 VERSION 4.0 Dated 03-10-2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Amit Saraf
Designation
Deputy General Manager (DGM)
Affiliation
Gennova Biopharmaceuticals Ltd
Address
Clinical Research Department , Gennova Vaccine Formulation Centre andResearch, Laboratory, BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2,International Biotech Park, Phase II, MIDC Hinjawadi.
Pune MAHARASHTRA 411057 India
Phone
02035250000
Fax
Email
amit.saraf@gennova.co.in
Details of Contact Person Public Query
Name
Dr Amit Saraf
Designation
Deputy General Manager (DGM)
Affiliation
Gennova Biopharmaceuticals Ltd
Address
Clinical Research Department , Gennova Vaccine Formulation Centre andResearch, Laboratory, BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2,International Biotech Park, Phase II, MIDC Hinjawadi.
Pune MAHARASHTRA 411057 India
Phone
02035250000
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
Block 1, Plot No. P-1 and P-2, ITBT Park, Phase-II, MIDC, Hinjawadi, Pune- 411057
S.no.32/2A, Gulawani Maharaj Road, Erandwane Pune MAHARASHTRA
09503939461
himanshupophale@yahoo.co.in
Dr Md Sabah Siddiqui
All India Institute of Medical Sciences (AIIMS)
Room No. 1111, First Floor, Medical College Building, Gate No. 5, All India Institute of Medical Sciences, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099 Raipur CHHATTISGARH
8518881911
drsabahsiddiqui@gmail.com
Dr Pankaj Bhardwaj
All India Institute of Medical Sciences (AIIMS)
Room No 103,First Floor Ayush Building,AIIMS,Jodhpur,Rajasthan-342005 Jodhpur RAJASTHAN
8003996903
bhardwajp@aiimsjodhpur.edu.in
Dr Shrikant Vishnu Deshpande
Ashirwad Hospital & Research Centre
Maratha section, Near Jijamata Udhyan, Ulhasnagar Thane MAHARASHTRA
9822017445
writetoshrikant@rediffmail.com
Dr Bhaskar Vilasrao JedheDeshmukh
Baramati Hospital Pvt. Ltd.
Behind kavivary moropant natyamandir , Ring road, Baramati Pune MAHARASHTRA
9822402772
bhaskar.jedhe@gmail.com
DrVijay Kumar Bhagwan Barge
Chatrapati Shahu Maharaj Government Medical College & Chatrapati Parmila Raje(RCSMGMC&CPR)Hospital
Dr. D. Y. Patil Medical College, Hospital & Research Centre
Clinical Trial Unit, 3rd Floor, Medical College Building,
Dr D Y Patil Medical College, Hospital & Research Centre,
Sant Tukaram Nagar, Pimpri, Pune 411018, Maharashtra, India
Pune MAHARASHTRA
9822148896
dr.vvikhe@gmail.com
Dr Manoja K Das
INCLEN/Shri Ram Murti Smarak Institute of Medical Sciences
COVISHIELD™ (manufactured by Serum Institute of India Pvt Ltd)
Dose:0.5mL
Frequency: 1 Dose on Day 1
Administration:
Intramuscular
Duration of the study: 6 Months
Comparator Agent
GEMCOVAC-19 [mRNA Vaccine for Injection (COVID-19)]
Dose: 0.5mL
Frequency: 1 Dose on Day 1
Administration:
Intramuscular
Duration of the study: 6 Months
Intervention
GEMCOVAC-OM (COVID-19 BOOSTER vaccine)
Dose:0.1mL
Frequency: 1 Dose on Day 1
Administration:
Intradermal
Duration of the study: 6 Months
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male and female aged greater than or equal to 18 years
2. Subject who had received primary vaccination (both doses completed) with either
a. COVAXIN™ OR
b. COVISHIELD™
Wherein last dose of primary vaccination taken at least 4 months prior to the screening visit
3. Subject or their legally acceptable representative (LAR) should be capable and willing to give voluntary written informed consent prior to inclusion in the study
4. Inclusion of subjects based on clinical judgment by the investigator
5. Subjects who had COVID-19 infection after primary vaccination, should have been asymptomatic or RT-PCR negative for at least 3 months
6. Consent for using effective methods of contraception during the entire study period
7. No medical history of pronounced vaccine-induced reactions or complications after receiving immunobiological products
8. No acute infectious and/or respiratory diseases within 14 days prior to screening
9. Subjects able to comprehend and comply with study requirements and procedures and willing to complete subject diary
ExclusionCriteria
Details
1. Prior receipt of any COVID-19 vaccine in less than 4 months of duration
2. Pregnant or lactating mothers
3. 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, haematological 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.
4. History of chronic infections in immunocompromised subjects
5. History of chronic immune disease, Splenectomy or systemic collagenosis
6. Subjects with oncological disease within 5 years prior to inclusion into the study
7. History of the human immunodeficiency virus, syphilis, hepatitis B, or C
8. Acute Kidney injury or dialysis, had transplant and on immunosuppressive therapy
9. Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements
10. Receipt of steroids and/or immunoglobulins or other blood products within 30 days prior to randomization
11. Tattoos or scars at the injection site, which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration
12. Participation in other interventional clinical trial within the previous 90 days prior to randomization and over duration of the trial
13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Phase II
Immunogenicity:
Comparison of anti-Spike IgG Antibodies
Safety:
Occurrence and severity of local and systemic reactogenicity AE
Occurrence of unsolicited AE
Occurrence of related unsolicited related AE
Occurrence of SAE
Phase III
Immunogenicity:
Comparison of neutralizing antibody titers against SARS-CoV-2 using PRNT assay by non-inferiority
Comparison of seroconversion rates as assessed by greater than or equal to 2-fold rise in neutralizing antibodies using PRNT assay
Phase II
Immunogenicity: Day 29
Safety:
Day 7 (Local and Systemic reactogenicity)
Day 29 (Unsolicited AE)
Day 180 (SAE and related unsolicited AE throughout the duration of the study)
Phase III
Immunogenicity: Day 29
Secondary Outcome
Outcome
TimePoints
Phase II
Immunogenicity:
Comparison of seroconversion rates as assessed by more than or equal to 2- fold rise in antibody titers
Comparison of neutralizing antibodies against SARS-CoV-2 using a surrogate virus assay (cPASS™)
Cell mediated immunity assessment by cytokine expression from stimulated PBMCs
Immunogenicity:
Day 29
Phase III
Immunogenicity:
Comparison of anti-Spike IgG antibodies (GMT) by non-inferiority
Comparison of seroconversion rates as assessed by greater than or equal to 2- fold rise in IgG antibody titers by non-inferiority
Comparison of neutralizing antibodies against SARS-CoV-2 using a surrogate virus assay (cPASS)
Assessment of cellular immune responses from stimulated PBMCs
Safety:
Occurrence and severity of local and systemic reactogenicity AEs
Occurrence of unsolicited AE
Occurrence of related unsolicited AE
Occurrence of SAEs
Immunogenicity:
Day 29
Safety:
Day 7 (Local and Systemic reactogenicity)
Day 29 (Unsolicited AE)
Day 180 (SAE and related unsolicited AE throughout the duration of the study)
Target Sample Size
Total Sample Size="3280" Sample Size from India="3280" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="3280"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study Protocol
Who will be able to view these files? Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
For what types of analyses will this data be available? Response - For individual participant data meta-analysis.
By what mechanism will data be made available? Response - Proposals should be directed to [sanjay.singh@gennova.co.in].
For how long will this data be available start date provided 01-03-2023 and end date provided 28-02-2028? Response - Beginning 3 months and ending 5 years following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
This is a Phase II study seamlessly followed by Phase III study to evaluate the immunogenicity and safety of a booster dose of the mRNA vaccine – GEMCOVAC-OM. The study participants will be adult subjects who are fully vaccinated against COVID-19 with either COVAXIN™ or COVISHIELD™ and received last dose of primary vaccination at least 4 months prior to screening. This booster dose of GEMCOVAC-OM is based on the sequence of Omicron variant of SARS-CoV-2. The study will be conducted in two parts:
Phase II
Approximately 140 subjects will be randomized in 1:1 ratio to receive either booster dose of the mRNA vaccine GEMCOVAC-OM (intradermal) or a booster dose of GEMCOVAC-19 (intramuscular).
Phase III
Approximately 3140 subjects will be randomized, and the enrolment will be competitive. The subjects will be randomized into two arms:
Arm I: 3000 Subjects who have received either COVAXIN™ or COVISHIELD™ as primary vaccination (both doses) will receive a booster dose of GEMCOVAC-OM.
Arm II: 140 Subjects who have received COVISHIELD™ as primary vaccination (both doses) will receive a booster dose of COVISHIELD™.