CTRI/2022/04/041880 [Registered on: 18/04/2022] Trial Registered Prospectively
Last Modified On:
21/09/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
Safety, Tolerability and
Immunogenicity of the candidate GEMCOVAC-19 (COVID-19
vaccine) in healthy pediatric subjects of 5 to less than 18 years
Scientific Title of Study
A Prospective, Multicentre, Randomized, 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 pediatric subjects of 5 to less than 18 years
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GBL/GEMCOVAC-19/2022/01 Version 3.0 Dated 10 Feb 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
Assistant General Manager (AGM)
Affiliation
Gennova Biopharmaceuticals Limited
Address
Clinical Research Department , 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
02035250000
Fax
Email
amit.saraf@gennova.co.in
Details of Contact Person Public Query
Name
Dr Amit Saraf
Designation
Assistant General Manager (AGM)
Affiliation
Gennova Biopharmaceuticals Limited
Address
Clinical Research Department , 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
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
Primary Sponsor
Name
Gennova Biopharmaceuticals Limited
Address
Gennova Biopharmaceuticals Limited, Block 1, Plot No. P-1 and P-2, ITBT Park, Phase-II, MIDC, Hinjawadi, Pune- 411057, Maharashtra
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 14
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Atul Jindal
All India Institute of Medical Sciences
All India Institute of Medical Sciences, Pediatric OPD, First Floor, B Block, Gate No. 04, G.E. Road, Tatibandh, 492099
Raipur CHHATTISGARH
8224014667
dratuljindal@gmail.com
Dr Jagdish Prasad Goyal
All India Institute of Medical Sciences
All India Institute of Medical Sciences, 1st Floor, Room Mo. 103, Aayush Building, Basni Industrial Area, MIA 2nd Phase, Basni, 342005,
Jodhpur RAJASTHAN
8475000270
jpgoyal@rediffmail.com
Dr Kiritkumar Jesabhai Sisodiya
BAPS Pramukh Swami Hospital
BAPS Pramukh Swami Hospital, Clinical Research Department, Ground Floor, Shri Pramukh Swami Maharaj Marg, Adajan Char Rasta, Adajan,395009 Surat GUJARAT
9879194433
kiritsisodiya@gmail.com
Dr Sharad Agarkhedkar
Dr. D. Y. Patil Medical College, Hospital & Research Centre
Dr. D Y Patil Medical College Hospital and Research Centre, 1st Floor, OPD Complex, Hightech Building, OPD No 12 (Department of Pediatrics), Sant Tukaram Nagar, Pimpri, 411018 Pune MAHARASHTRA
9822030122
agarkhedkar@gmail.com
Dr Shri Harsha Yandapally
Induss Hospital
Induss Hospital, Department of Pediatrics, Ground Floor, Block A, 13-23-93/1, Krishnaveni nagar, Near Gaddiannaram municipal office,
Saroornagar,500060
Hyderabad TELANGANA
8309060367
harshayandapally10@gmail.com
Dr Kheya Ghosh Uttam
Institute of Child Health
Institute of Child Health, Ground Floor, Room No. 113, Project Room, 11, Dr. Biresh Guha Street, 700017 Kolkata WEST BENGAL
9830297578
kheyauttam@yahoo.co.in
Dr M D Ravi
JSS Medical College and Hospital
JSS hospital, Department of Pediatrics, 2nd floor, Mahatma Gandhi road, Ramachandra Agrahara
570004 Mysore KARNATAKA
9880629506
ravimdped@gmail.com
Dr Amita Sapru
KEM Hospital Research Centre
Pediatric Research Unit, KEM Hospital Research Centre, TDH Building, 3rd Floor, Sardar Moodliar Road, Rasta Peth, 411011 Pune MAHARASHTRA
9822842094
a.sapru@kemhrcpune.org
Dr Vinay Kumar Gill
Maharaja Agrasen Superspeciality Hospital
Maharaja Agrasen Superspeciality Hospital, Basement, Clinical Research Department, Sector-7, Central Spine, Vidyadhar Nagar, 302039 Jaipur RAJASTHAN
9252101110
drvinaykgill@gmail.com
Dr Sanjay Mankar
Mankar Hospital
Mankar Hospital, Ground Floor, Research Room,
Plot no-4, Swaroop Housing Society, Plot No 19, Narveer Tanaji Malusare Road, Anandnagar, 411051, Pune MAHARASHTRA
9422078779
drsanjaym.mankarhospital@gmail.com
Dr Sandeep Mogre
Meditrina Institute of Medical Sciences
Meditrina Institute of Medical Sciences, Department of Pediatrics, Room No. 7, 1st Floor,
278, Central Bazar Road, Ramdaspeth, 440010 Nagpur MAHARASHTRA
9822201872
mogre91@gmail.com
Dr Vinky Mohanlal Rughwani
Rughwani Child Care Centre and Hospital
Thalassemia and Sickle Cell Centre, Thalassemia Society of Central India, Rughwani Child Care Centre and Hospital, Research Room, Ground Floor, 22 Sindhu Nagar Society, Mohanlal Rughwani Marg, Jaripatka, 440014 Nagpur MAHARASHTRA
9370388915
Dr.vinky@yahoo.com
Dr Sunil Karande
Seth G. S. Medical College and KEM Hospital
Seth G. S. Medical College and KEM Hospital, Department of Pediatrics, Hospital Building, Ground floor, KEM Hospital, 400012 Mumbai MAHARASHTRA
9322934309
karandesunil@yahoo.com
Dr Sathya Moorthy Mani
SRM Medical College Hospital & Research Centre
3rd Floor, Centre for Clinical Trials and Research, SRM Medical College Hospital and Research Centre, SRM Nagar, Kattankulathur-603203, Chengalpattu Kancheepuram TAMIL NADU
Institutional Ethics Committee JSS Medical College
Approved
INSTITUTIONAL ETHICS COMMITTEE SRM INSTITUTES FOR MEDICAL SCIENCE
Approved
Institutional Ethics Committee, Seth GS Medical College and KEM Hospital, Mumbai
Submittted/Under Review
Institutional Human Ethics Committee , AIIMS , Jodhpur
Submittted/Under Review
KEM Hospital Research Centre Ethics Committee
Approved
Meditrina Institute Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Active immunization to develop immunological protection for prevention of severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
COVAXIN®
COVAXIN® will be administered as a 2 dose schedule on Days 1 and 29 as 0.5 mL intramuscularly (In 12 to less than 18 years)
Intervention
GEMCOVAC-19 (COVID-19 vaccine)
In 12 to less than 18 years, GEMCOVAC-19 will be administered as a 2 dose schedule on Day 1 and 29 at 10 micrograms intramuscularly.
In 5-11 years , GEMCOVAC-19 will be assesseed in Phase II at 5 and 10 micrograms as a 2 dose regimen intramuscularly. In phase IIII(In 5-11 years), one dose will be selected to be administered as a 2 dose schedule intramuscularly.
The study in each age group will last for 9 months
Comparator Agent
Placebo
0.9% NaCl will be administered as a 2 dose schedule on Days 1 and 29 as 0.5 mL intramuscularly (In 5 to 11 years)
Inclusion Criteria
Age From
5.00 Year(s)
Age To
17.00 Year(s)
Gender
Both
Details
Inclusion Criteria for Phase II:
1.Male and female subjects’ 5- <18 years.
2.Healthy as judged by medical history, physical and other examination or screening laboratory assessments or other investigations and in the clinical opinion of the Investigator.
3.Age group 12 - <18 years:
Subject’s parent should be capable and willing to give voluntary written informed consent and subject should be capable and willing to give voluntary assent prior to inclusion in the study.
4.Age group: 5 - 11 years:
Subject’s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study
5.Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2
6.Subject/ subject’s parent is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
Inclusion Criteria for Phase III:
1.Male and female subjects’ 5 - <18 years.
2.Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator.
3.Age group 12 - <18 years:
Subject’s parent should be capable and willing to give voluntary written informed consent and subject’s should be capable and willing to give voluntary assent form prior to inclusion in the study.
4.Age group: 5 - 11 years:
Subject’s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study.
5.Subject’s parent/subjects is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
ExclusionCriteria
Details
Exclusion Criteria for Phase II:
1.Subject with a recent history of COVID-19 infection within 3 months of Screening.
2.Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection.
3.Protocol defined laboratory assessments outside the range/limit defined in Appendix 2. Any other laboratory value if ≥ Grade 2 as per DAIDs* criteria
* Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health
4.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
5.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.
6.History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
7.Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F or its equivalent for axillary and tympanic) within 48 hours prior to vaccination.
8.History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease.
9.Subjects willing to get married and planning for pregnancy within 4 months of study participation (only applicable for participants of 15 - (smaller than)18 years age).
10.Prior major surgery or any radiation therapy within 4 weeks of Screening visit.
11.Positive serologic test for HIV 1 and 2, HBsAg and HCV.
12.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).
13.Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
14.Eczema or other significant skin lesion or infection at the site of vaccination.
15.Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
16.Bleeding diathesis or condition associated with prolonged bleeding.
17.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.
18.Any other condition which in the opinion of the Investigator may affect subject’s safety or participation.
Exclusion Criteria for Phase III:
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 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 allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
5.Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F or its equivalent for axillary and tympanic) within 48 hours prior to vaccination.
6.History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease.
7.Subjects who are planning to get married and get pregnant in next 4 months (only applicable for participants of 15 - (smaller than)18 years age).
8.Prior major surgery or any radiation therapy within 4 weeks of Screening visit.
9.A known case of HIV 1 and 2, HBsAg and HCV.
10.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).
11.Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
12.Eczema or other significant skin lesion or infection at the site of vaccination.
13.Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
14.Bleeding diathesis or condition associated with prolonged bleeding.
15.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.
16.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 (Phase II )
Occurrence and severity of local and systemic reactogenicity adverse events,
unsolicited events and serious adverse events (SAE)
Immunogenicity (Phase II and III)
Age group: 12 - Less than 18 years
Geometric mean titer (GMT) of SARS-CoV-2 specific serum neutralizing antibody levels using live virus [Plaque Reduction Neutralization Test (PRNT)]
Immunogenicity (Phase II and III)
Age group: 5 - 11 years
GMT as measured by IgG-ELISA against SARS-CoV-2 Spike protein
Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study.
At Day 57.
At Day 43.
Secondary Outcome
Outcome
TimePoints
Age Group 12 to less than 18
(Phase II and III)
GMT of anti-spike IgG
GMFR in anti-spike IgG
Proportion seroconverted
Neutralization using cPASS Assay
Cellular Immune Response
Phase III only
Safety, Tolerability and Immunogenicity
At Day 57 (28 days post Dose 2), Day 119 and Day 209
At Baseline and Day 57
At Day 57
At Day 57, Day 119 and Day 209 visit
At Day 119 and Day 209 visit
Entire duration of study
Age Group 5 to 11 year old
(Phase II and III)
GMFR in anti-spike IgG
Proportion seroconverted
Neutralization using PRNT and Cpass
Phase III only
Safety, Tolerability and Immunogenicity
Day 43
Day 43
Day 43
Entire duration of study
Target Sample Size
Total Sample Size="800" Sample Size from India="800" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
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 30-04-2023 and end date provided 30-04-2026? Response - Beginning 9 months and ending 36 months following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
The current study is designed as a prospective, randomized, Phase II study seamlessly followed by a Phase III study in two age groups-12 - <18 years and 5 - 11 years. The study is an active-controlled study with COVAXIN® as the comparator vaccine for age group 12 - <18 years whereas the study is a placebo-controlled study for age group 5 - 11 years. The study will be conducted in 4 parts: Part 1: Phase II in 12 - <18 years age group, Part 2: Phase III in 12 - <18 age group, Part 3: Phase II in 5 - 11 years age group, Part 4: Phase III in 5 - 11 years age group.