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CTRI Number  CTRI/2021/08/036074 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On: 15/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Biological E’s CORBEVAX vaccine clinical study for protection against Covid-19 disease.  
Scientific Title of Study   A Prospective, Single-blind, Randomized, Active-controlled Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Biological E’s CORBEVAX Vaccine for Protection Against COVID-19 Disease When Administered to RT-PCR Negative Adult Subjects. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT/COVID-19-PHASE-III/074 Ver:1.1 Dated:19.08.21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhash Thuluva 
Designation  Vice President - Clinical Development  
Affiliation  Biological E.Limited 
Address  Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216248   
Fax    
Email  subhash.thuluva@biologicale.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr TSA Kishore 
Designation  Associate Vice president - Clinical Development 
Affiliation  Biological E.Limited 
Address  Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216247   
Fax    
Email  kishore.turaga@biologicale.com  
 
Details of Contact Person
Public Query
 
Name  Subba Reddy GV 
Designation  General Manager- Clinical Development 
Affiliation  Biological E.Limited 
Address  Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216240  
Fax    
Email  subbareddy.gunneri@biologicale.com  
 
Source of Monetary or Material Support  
Biological E.Limited, 18/1&3, Azamabad, Hyderabad - 500020, Telangana, India.  
 
Primary Sponsor  
Name  Biological E Limited 
Address  18/1&3, Azamabad, Hyderabad - 500020, Telangana, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 30  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyotiranjan Sahoo  Institute of Medical Sciences & SUM Hospital,  Department of Community Medicine, 2nd Floor, K8 Lane 1, Kalinganagar, Bhubaneswar 751003
Debagarh
ORISSA 
08917209161

jyotiranjansahoo@soa.ac.in 
Dr JS Khushwaha  Prakhar Hospital  Department of General Medicine, 4th Floor, 8/219, Khalasi Line, Arya Nagar, Kanpur 208002
Kanpur Nagar
UTTAR PRADESH 
07905113329

prakharhospitalresearch@gmail.com 
Dr Shiva Narang  GTB Hospital  Department of General Medicine, 4th Floor, Tahirpur Rd, GTB Enclave, Dilshad Garden, Delhi 110095
North East
DELHI 
09899838807

shivanarang@gmail.com 
Dr Dinesh Jain  Dayanand Medical College & Hospital  Department of General Medicine, Dayanand Medical College & Hospital, 3rd Floor, Civil Lines, Tagore Nagar, Ludhiana 141001, Punjab
Ludhiana
PUNJAB 
09915664709

drjaindinesh@yahoo.co.in 
Dr Anil Kumar Pandey  ESIC Medical College & Hospital,  Department of Physiology, Room No. 440, 4th Floor, NH-3 behind BK Hospital New Industrial Town-121001
Faridabad
HARYANA 
07042918222

drpandeyak@yahoo.co.in 
Dr Indranil Basu  Shubham Sudbhawana Hospital  Department of General Medicine, 2nd Floor, B 31/80, 23B - Bhogabeer, Lanka, 221005
Varanasi
UTTAR PRADESH 
09935036063

dribasumd@yahoo.co.in 
Dr A Venkateshwara Rao  St.Theresas Hospital (STH)  Department of General Medicine, 1st Floor, Room No. 05, Erragadda Main Road, Czech Colony Sanath Nagar, 500038
Hyderabad
TELANGANA 
09440040662

drvenkateshwarraoavula@gmail.com 
Dr R Vasudev  King George Hospital  Department of General Medicine, 1st Floor, Room No. 09, Department of Paediatrics, Collectorate Junction, Maharani Peta, 530002,
Visakhapatnam
ANDHRA PRADESH 
09866739808

vasudev.kgh@gmail.com 
Dr Madhav Prabhu  KLES Dr. Prabhakar Kore Hospital & Medical Research Centre  Department of General Medicine, 2nd Floor,Department of Medicine, Nehru Nagar,590010,
Belgaum
KARNATAKA 
09738462380

wiseman2380@yahoo.com 
Dr P Naveen Chander Reddy  AIG Hospital  Department of Cardiology, 4th floor, Plot No. 2/3/4/5, Survey No. 136/1, Mindspace Road, Gachibowli, 500032,
Hyderabad
TELANGANA 
09848045814

drnaveen.reddy@aighospitals.com 
Dr Rachgonda GViveki  Belgavi Institute of Medical Sciences  Department of Community Medicine, Dr B R Ambedkar Rd, Sadashiv Nagar, 2nd Floor, 590019
Belgaum
KARNATAKA 
08088193939

bimsclinicalresearch@gmail.com 
Dr Rajendra Dhar  National Institute of Medical Sciences ( NIMS)  Department of General Medicine, 3rd Floor, NH-11C, Delhi - Jaipur Expressway, Shobha Nagar, 303121
Jaipur
RAJASTHAN 
09082793230

Nims.clinical@gmail.com 
Dr R B Sudagar Singh  Sri Ramachandra Hospital  Department of General Medicine, No. 1, Ground Floor, Porur – 600116
Chennai
TAMIL NADU 
09003178899

srmcclinicalresearch@gmail.com 
Dr Uday Wasudevrao Narlawar  Govt Medical College  Department of General Medicine, 1st Floor, Hanuman Nagar, Ajani Rd, Medical Chowk, Ajni, 440003
Nagpur
MAHARASHTRA 
09823133423

udaycon1@rediffmail.com 
Dr Pravin Soni  Yashwantrao Chavan Memorial (YCM) Hospital  Department of General Medicine, 1st Floor, Sant Tukaram Nagar, Pimpri Colony -411018
Pune
MAHARASHTRA 
09822057511

pravinsoni809@gmail.com 
Dr Khobragade Akash Ashok Kumar  Grant Medical College & Sir J.J Hospital  Department of Clinical Pharmacology, 2nd Floor, J J Marg, Nagpada, Mumbai Central 400008
Mumbai
MAHARASHTRA 
09702658822

drakashk.research@gmail.com 
Dr Renuka Munshi  TN Medical College & BYL Nair Hospital  Department of Clinical Pharmacology, 1st Floor, Dr. A. L, Dr Anandrao Nair Marg, RTO Colony, Mumbai Central, 400008,
Mumbai
MAHARASHTRA 
09820377409

renuka.munshi@gmail.com 
Dr Veer Bhadur Singh  JLN Medical College  Department of General Medicine, 2nd Floor, Kala Bagh - 305001,
Ajmer
RAJASTHAN 
09414136888

clinical.jln@gmail.com 
Dr Clarence J Samuel  Christian Medical College & Hospital,  Department of Community Medicine, Ground Floor, Brown Rd, CMC Campus,141008
Ludhiana
PUNJAB 
09988099867

clarencejs@yahoo.com 
Dr Vipul Khandelwal  Apex Hospital  Department of General Medicine, 1st Floor,SP 4& 6 MIA Malviya Nagar near apex circle -302017
Jaipur
RAJASTHAN 
08290252034

dr.vipul@yahoo.co.in 
Dr Sushila Kataria  Medanta Institute of Education and Research  Department of Internal Medicine, 2nd Floor,Sector 38, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38 - 122018,
Gurgaon
HARYANA 
09971918887

drsushilakataria@gmail.com 
Dr Gauravi Mishra  Tata Memorial Centre  Department of Preventive Oncology, 3rd Floor, Parel East, Parel - 400012
Mumbai
MAHARASHTRA 
09975390980

gauravi2005@yahoo.co.in 
Dr Parshottam Koradia  BAPS Pramukh Swami Hospital  Department of Internal Medicine, Ground Floor, Shri Pramukh Swami Maharaj Marg, Adajanchar rasta. Adajan- 395009,
Surat
GUJARAT 
09825312027

purushottam_koradia@yahoo.co.in 
Dr Winsley Rose  Christian Medical College  Department of Paediatrics, Vellore, 5th Floor, IDA Scudder Rd, 632004,
Vellore
TAMIL NADU 
09698884466

winsleyrose@cmcvellore.ac.in 
Dr Shilpa Avarebeel  JSS Hospital  Department of Geriatrics, 1st Floor, Mahatma Gandhi Road, Fort Mohalla, 570004,
Mysore
KARNATAKA 
09880053998

shilpaavarebeel@gmail.com 
Dr Bishan Swarup Garg  Mahatma Gandhi Institute of Medical Sciences (MGIMS)  Department of Community Medicine, 1st Floor, Sewagram, 442102
Wardha
MAHARASHTRA 
09422141693

gargbs@gmail.com 
Dr VenkateshwaranR  Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER)  Department of General Medicine, 1st Floor, Dhanvantari Nagar -605006,
Pondicherry
PONDICHERRY 
09488505555

drvenks@gmail.com 
Dr Chandramani Singh  All India Institute of Medical Sciences (AIIMS)  Department of Community Medicine, 3rd Floor, OPD Building, Room No. 254 ,Department of Community & Family Medicine, Aurangabad Road, Phulwari Sharif, 801507
Patna
BIHAR 
07906261455

drcmsingh@yahoo.co.in 
Dr Monica Gupta   Samvedna Hospital  Department of General Medicine, 3rd Floor, B-27/88-G, New Colony, 221005,
Varanasi
UTTAR PRADESH 
09415336322

monicag4@yahoo.com 
Dr Rohidas Borse  B J Govt Medical College and Sassoon General Hospitals College  Department of General Medicine, 1st Floor, Jai Prakash Narayan Road, Near Pune Railway Station, 411001
Pune
MAHARASHTRA 
09923912525

rohidas_borse@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 30  
Name of Committee  Approval Status 
BAPS Hospital Institutional Ethics Committee  Approved 
Drug Trial Ethics Committee - Dayanand Medical College and Hospital,  Submittted/Under Review 
Ethics Committee - Guru Teg Bahadur Hospital  Approved 
Ethics Committee - St. Theresas Hospital  Approved 
IEC - BJ Medical College  Submittted/Under Review 
IEC - King George Hospital  Submittted/Under Review 
IEC - NIMS University  Approved 
IEC IMS and SUM Hospital  Submittted/Under Review 
IEC Intervention Studies - JIPMER  Submittted/Under Review 
IEC Prakhar Hospital Pvt Ltd  Approved 
IEC, Mahatma Gandi Institute Of Medical Sciences  Approved 
IEC-AIIMS-Patna,   Submittted/Under Review 
Institutional Ethics Committee - Apex Hospitals Private Limited  Approved 
Institutional Ethics Committee - Christian Medical College & Hospital  Submittted/Under Review 
Institutional Ethics Committee - Grant Medical College & Sir J.J Hospital  Approved 
Institutional Ethics Committee - Jawahar Lal Nehru Medical College  Submittted/Under Review 
Institutional Ethics Committee - JSS Medical College and Hospital  Submittted/Under Review 
Institutional Ethics Committee - KLE University  Submittted/Under Review 
Institutional Ethics Committee - TNMC Nair Hospital,  Submittted/Under Review 
Institutional Ethics Committee - Yashwantrao Chavan Memorial Hospital  Submittted/Under Review 
Institutional Ethics Committee -SRIHER  Submittted/Under Review 
Institutional Ethics Committee for ESIC Medical College And Hospital  Approved 
Institutional Ethics Committee III - Tata Memorial Centre ACTREC,  Submittted/Under Review 
Institutional Ethics Committee, Belagavi Institute Of Medical Sciences  Approved 
Institutional Ethics Committee- Asian Institute of Gastroenterology  Submittted/Under Review 
Institutional Ethics Committee- Government Medical College and Hospital,  Submittted/Under Review 
IRB Christian Medical college  Submittted/Under Review 
Medanta Institutional Ethics Committee  Submittted/Under Review 
Samvedna Hospital Ethics Committee  Submittted/Under Review 
Shubham Sudbhawana Superspeciality Hospital Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Active immunization for the prevention of COVID-19 disease  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biological E’s CORBEVAX Vaccine  Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28.  
Comparator Agent  Serum Institute of India Pvt. Ltd’s- COVISHIELD   Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Subject is seronegative to anti-SARS-CoV-2 IgG antibody prior to randomisation either into Group-1 and Group-2.
2. Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment in all groups.
3. Male or female subject between ≥ 18 to 80 years of age.
4. Subject is willing to provide a written informed consent for voluntary participation in the study.
5. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol.
6. Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment.
7. Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination.
8. Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study.
9. Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration.
10. Subject agrees not to participate in another clinical trial at any time during the total study period.
11. Subject agrees to refrain from blood donation during the course of the study.
12. Subject agrees to remain in the town where the study centre is located, for the entire duration of the study.
 
 
ExclusionCriteria 
Details  1. History of vaccination with any investigational or approved vaccine against COVID-19 disease.
2. Subject living in the same household as that of any active COVID-19 positive individual.
3. History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines);
4. Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator.
5. Subjects with Body temperature of ≥100.4°F (>38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination.
6. Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study.
7. Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study:
8. severe psychiatric conditions;
9. any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
10. allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE SARS-CoV-2 COVID-19 vaccine);
11. neurological illness, and any other serious chronic illness requiring hospital specialist supervision.
12. Subjects requiring chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products.
13. For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day, or equivalent.
14. Inhaled and topical steroids are allowed.
15. Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data.
16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
17. Any medical condition that in the judgment of the investigator would make study participation unsafe.
18. Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment.
19. Current or planned participation in prophylactic drug trials for the duration of the study.
20. Individuals who are part of the study team or close family members of individuals conducting the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Immune response measured after completion of 2-dose immunization schedule, as determined by geometric mean titres (GMT/C) of SARS-CoV-2 specific neutralising antibodies to evaluate immunogenic superiority   1. After 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Immune response measured after completion of 2-dose immunization schedule, as determined by geometric mean titres (GMT/C) of SARS-CoV-2 specific neutralising antibodies to evaluate immunogenic non-inferiority   After 14 days 
Immune response against Beta and Delta variants in terms of geometric mean virus neutralising antibody (VNA) titre and Fold Reduction of VNA titer from Wuhan strain to Beta or Delta strain. Geometric Mean Fold Reduction will be calculated   At Day 42  
Occurrence and severity of any adverse reactions   Within 60 minutes of post vaccination  
Occurrence and severity of any solicited symptoms   Within 7 consecutive days  
Occurrence and severity of any unsolicited adverse events   Till 28 days’ post vaccination period 
Occurrence and severity of any SAEs or medically attended AEs or AEs of special interest (AESIs)  Until 6 months post 2nd dose 
 
Target Sample Size   Total Sample Size="2140"
Sample Size from India="2140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   03/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a prospective, multicentre single-blind, randomized, active-controlled phase III clinical study. A total of 2140 eligible volunteers of either gender, aged 18 to 80 years, will be enrolled in this Phase III study. All the subjects enrolled into the trial will be assessed for overall safety, reactogenicity and tolerability at each of the protocol specified visits till end of the study.

The immunogenicity assessment would be to demonstrate immunogenicity in terms of both neutralising and IgG ELISA antibody titres of Test vaccine and their comparability with Comparator vaccine in the immunogenicity population.

The study will be conducted in compliance with GSR 227(E), ICH and Indian good clinical practice guidelines in force at the time of study conduct.


 
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