CTRI Number |
CTRI/2021/05/033665 [Registered on: 18/05/2021] Trial Registered Prospectively |
Last Modified On: |
18/11/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Vaccine |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A Clinical Study to Test the Side Effects and Antibody Levels after Hetero-COVID Vaccine in Healthy Adults |
Scientific Title of Study
|
A Prospective, Randomized, Interventional, Parallel, Multi-Center, Comparative Clinical Trial to Evaluate the Safety and Immunogenicity of COVID-Vac Combined Vector Vaccine (Manufactured by Hetero) in Healthy Adult Human Subjects. |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
HCR/III/SARSCOV2VAC/04/2021; Version 2.0 Dated 24/Apr/2021 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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Name |
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Designation |
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Affiliation |
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Address |
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Phone |
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Fax |
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Email |
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Details of Contact Person Scientific Query
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Name |
Dr Sreenivasa Chary S |
Designation |
General Manager |
Affiliation |
Hetero Labs Limited |
Address |
7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar
Hyderabad TELANGANA 500018 India |
Phone |
04023704923 |
Fax |
|
Email |
sreenivasa.chary@heterodrugs.com |
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Details of Contact Person Public Query
|
Name |
Dr Shubhadeep Sinha |
Designation |
Sr. Vice President |
Affiliation |
Hetero Labs Limited |
Address |
7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar
Hyderabad TELANGANA 500018 India |
Phone |
04023704923 |
Fax |
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Email |
sd.sinha@heterodrugs.com |
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Source of Monetary or Material Support
|
Hetero Biopharma Limited, H. No. 8-3-166/1,2, 105 to 108, 1st Floor, G Block, EastWing, Challa Estates, Erragadda, Hyderabad, Telangana, India, 500018. Tel No. & Fax No.: 914023810110 |
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Primary Sponsor
|
Name |
Hetero Biopharma Limited |
Address |
Hetero Biopharma Limited, H. No. 8-3-166/1,2, 105 to 108, 1st Floor, G Block, EastWing, Challa Estates, Erragadda, Hyderabad, Telangana, India, 500018. Tel No. & Fax No.: 914023810110 |
Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 7 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Naveen Chander Reddy |
AIG Hospitals |
Department of General Medicine, Mindspace Road,
Gachibowli, Hyderabad -500032, Telangana Hyderabad TELANGANA |
9848045814
drnaveen.reddy@aighospitals.com |
Dr Jayaprakash Appajigol |
KLES Dr Prabhakar Kore Hopsital & Medical Research Centre |
Department of General Medicine, Nehrunagar Belagavi-590010, Karnataka Belgaum KARNATAKA |
9844595659
jayaprakashappajigol@gmail.com |
Dr Prabhakar Reddy |
Nizam Institute of Medical Sciences |
Department of Clinical Pharmacology & Therapeutics, Punjagutta, Hyderabad-500088, Telangana Hyderabad TELANGANA |
7416512888
cptnims@gmail.com |
Dr Subhrojyoti Bhowmick |
Peerless Hospitex Hospital and Research Center Limited |
Department of Pharmacology, 360, Panchasayar, Kolkata - 700094, West Bengal Kolkata WEST BENGAL |
9830204863
drsubhro@gmail.com |
Dr Keyur Madan Brahme |
SSG Hospital |
Department of General Medicine, Medical College Baroda, Vadodara-390001, Gujarat Vadodara GUJARAT |
9727729105
keyurbramhe@gmail.com |
Dr A Venkateshwar Rao |
St, Theresa’s Hospital |
Department of General Medicine, Sanath Nagar, Hyderabad-500018, Telangana Hyderabad TELANGANA |
9440040662
drvenkateshwarraoavula@gmail.com |
Dr Akash Ashok kumar Khobragade |
St. George Hospital |
Department of Pharmacology, Grant Government Medical College, PD Mello Road, CST, Mumbai-400001, Maharashtra Mumbai MAHARASHTRA |
9702658822
prowesscrs@gmail.com |
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Details of Ethics Committee
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No of Ethics Committees= 7 |
Name of Committee |
Approval Status |
Ethics Committee, St Theresa Hospital, Sanath Nagar, Hyderabad-500018, ECR/230/Inst/AP/2013/RR-19 |
Submittted/Under Review |
Institutional Ethics Committee of Human Research, Sir Sayajirao General Hospital (SSG Hospital), Medical College Baroda, Maharaja Sayajirao University of Baroda, Jail Road (Indira Avenue) Anandpura, Vadodara, Gujarat-390001, ECR/85/Inst/GJ/2013/RR-19 |
Submittted/Under Review |
Institutional Ethics Committee, Department of Pharmacology, Grant Medical College & Sir J.J Group of Hospitals, Byculla, Mumbai-400008, Maharashtra, ECR/382/Inst/MH/2013/RR-19 |
Submittted/Under Review |
Institutional Ethics Committee, KLE Universitys KLE PK Hospital, Nehrunagar, Belagavi, ECR/211/Inst/KA/2013/RR-19 |
Submittted/Under Review |
Institutional Ethics Committee-AIG(IEC-AIG), 6-3-661, Somajiguda, Hyderabad, Telangana-500082, ECR/346/Inst/AP/2013/RR-19 |
Approved |
NIMS Institutional Ethics Committee, Punjagutta, Hyderabad-500082, ECR/303/Inst/AP/2013/RR-19 |
Submittted/Under Review |
Peerless Hospitex Hospital and Research Center Ltd. Clinical Research Ethics Committee 360, Panchasayar, Kolkata-700094, ECR/232/Inst/WB/2013/RR-19 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
COVID-VAC Combined Vector Vaccine for SARS CoV2 Infection Prophylaxis |
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Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
COVID-Vac Combined Vector Vaccine (manufactured by Hetero)
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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 power 11 particles per dose of 0.5 mL||
Component II: Recombinant adenovirus serotype 5 particles containing SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 10 power 11 particles per dose of 0.5 mL||
Component I and Component II will be given with a gap of 21 Days |
Comparator Agent |
Gam-COVID-Vac (Sputnik V – Manufactured for RDIF, Russia) |
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 power 11 particles per dose of 0.5 mL|| Component II: Recombinant adenovirus serotype 5 particles containing SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 10 power 11 particles per dose of 0.5 mL|| Component I and Component II will be given with a gap of 21 Days |
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Inclusion Criteria
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Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Adult male or female volunteers aged 18-65 years (inclusive of both) who are not vaccinated for COVID-19/Influenza and willing to give written, signed and dated informed consent to participate in the study
2. Negative immunoglobulin M (IgM) SARS-CoV-2 antibodies through enzyme immunoassay test result
3. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit
4. No acute infections and/or respiratory diseases within 14 days before enrollment
5. Negative human immunodeficiency virus (HIV 1 & 2), Syphilis, Hepatitis B and C test results |
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ExclusionCriteria |
Details |
1. Any vaccination/immunization within 30 days before the enrollment
2. Usage of Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before the enrollment
3. Immunosuppressive therapy within 3 months before the enrollment
4. Donated blood or plasma within 3 months before enrollment
5. Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past 6 months before enrollment
6. Participation in any other interventional clinical trial within 3 months
7. Volunteer is pregnant or breast-feeding
8. History or evidence of Tuberculosis or chronic systemic infections |
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
Method of Concealment
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On-site computer system |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Geometric Mean Titre (GMT) Ratio of SARS-CoV-2 glycoprotein-specific antibodies |
Day 28 and Day 42 |
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Secondary Outcome
|
Outcome |
TimePoints |
Incidence of AEs and SAEs following vaccination during the study |
All Visits |
GMT ratio of SARS-CoV-2 glycoprotein-specific antibodies |
Day 21 |
Number of proliferating CD4 and CD8 cells in response to mitogen stimulation and their ratios in cell mediated immunogenicity (T-cell mediated immunity) |
Day 21, Day 28 and Day 42 |
Incidence of cases of Covid-19 |
Day 21 and Day 42 |
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Target Sample Size
|
Total Sample Size="228" Sample Size from India="228"
Final Enrollment numbers achieved (Total)= "227"
Final Enrollment numbers achieved (India)="227" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
24/05/2021 |
Date of Study Completion (India) |
02/09/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not Applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This study is a prospective, randomized, interventional, double blind, active controlled, parallel group bridging clinical study to evaluate the safety and immunogenicity of Hetero-COVID-Vac Combined Vector Vaccine compared to Gam-COVID-Vac (Sputnik V - Manufactured for RDIF, Russia) in healthy adult human subjects. All subjects will be administered 2 doses of Hetero-COVID-Vac Combined Vector Vaccine (Component I & Component II) or Gam-COVID-Vac (Sputnik V) (Component I & Component II) with 21 days gap followed by assessments on Day 28 and 42. |