FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/SARSCOV2VAC/04/2021; Version 2.0 Dated 24/Apr/2021  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 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  
 
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    
Email  sd.sinha@heterodrugs.com  
 
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 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Details of Ethics Committee  
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 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  COVID-VAC Combined Vector Vaccine for SARS CoV2 Infection Prophylaxis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  COVID-Vac Combined Vector Vaccine (manufactured by Hetero)   Component I: Recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) Ñ… 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) Ñ… 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) Ñ… 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) Ñ… 10 power 11 particles per dose of 0.5 mL|| Component I and Component II will be given with a gap of 21 Days 
 
Inclusion Criteria  
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 
 
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 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   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 
 
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 
 
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
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. 
Close