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CTRI Number  CTRI/2021/06/034014 [Registered on: 04/06/2021] Trial Registered Prospectively
Last Modified On: 09/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological
Preventive 
Study Design  Single Arm Trial 
Public Title of Study   Biological E’s CORBEVAX vaccine clinical study for protection against Covid-19 disease.  
Scientific Title of Study   A Prospective, multicentre, Phase II Seamlessly Followed by 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 COVID-19-Negative Adult Subjects. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT/COVID-19-PHASE-III/069 Ver: 2.1 dated:13.05.21  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  04027675309   
Email  subhash.thuluva@biologicale.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Subhash Thuluva 
Designation  Vice President - Clinical Development  
Affiliation  Biological E.Limited 
Address  Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills


TELANGANA
500033
India 
Phone  04071216248   
Fax  04027675309   
Email  subhash.thuluva@biologicale.com  
 
Details of Contact Person
Public 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  04027675309   
Email  kishore.turaga@biologicale.com  
 
Source of Monetary or Material Support  
Biological E.Limited, 18/1&3, Azamabad, Hyderabad - 500020, Telangana, India.  
 
Primary Sponsor  
Name  Biological ELimited 
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 = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravi B Nagarajaiah  Adichunchanagiri Hospital & Research Centre  Dept of General Medicine,1st floor,B G Nagara Nagamangala Taluk, Mandya-571448
Mandya
KARNATAKA 
9448323893

ravibn972@yahoo.com 
DrPNaveen Chander Reddy  AIG Hospital  4th floor, Plot No. 2/3/4/5, Survey No. 136/1, Mindspace Road, Gachibowli-500032,
Hyderabad
TELANGANA 
9848045814

drnaveen.reddy@aighospitals.com 
Dr Chandramani Singh   All India Institute of Medical Sciences   Room No. 17 Department of Community & Family Medicine, Aurangabad Road Phulwari Sharif, Patna 801507.
Aurangabad
BIHAR 
09931733280

cmaiims57@gmail.com 
Dr Swapnav Borthakur  Down Town Hospital  2nd floor of 3rd building, G. S. Road, Bormotoria, Dispur, Guwahati-781006
Dibrugarh
ASSAM 
9864038704

swapnav.bortharkar@gmail.com 
Dr Anil Kumar Pandey  ESIC Medical College and Hospital  Room No. 440, 4th Floor, NH-3 behind BK Hospital New Industrial Town-121001
Faridabad
HARYANA 
7042918222

drpandeyak@yahoo.co.in 
Dr Shiva Narang  Guru Teg Bahadur Hospital & UCMS  Department of Medicine, Dilshad Garden, Delhi-110095,
North East
DELHI 
9899838807

shivanarang@gmail.com 
Dr E Venkata Rao  Institute of Medical Sciences & SUM Hospital  Department of community Medicine, 3rd Floor,K-8, Kalinga Nagar, Ghatikia,Bhubaneswar-751003
Baleshwar
ORISSA 
9668443382

e.venkata.rao@gmail.com 
Dr Madhav Prabhu  KLES Dr. Prabhakar Kore Hospital and MRC  Department of Medicine, Nehru Nagar,Belgavi-590010
Belgaum
KARNATAKA 
9738462380

wiseman2380@yahoo.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  Department of Pulmonology, Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyanagar-302039
Jaipur
RAJASTHAN 
9414414834

doctormanishjain2@gmail.com 
Dr Pajanivel Ranganadin  Mahatma Gandhi Medical College& Research Institute  1st floor, I block, Pondicherry-Cuddalore Road, ECRMain Road, Pillayarkuppam-607402,
Pondicherry
PONDICHERRY 
9443493122

pajanivelr@mgmcri.ac.in 
Dr Maulesh Tailor  Pagarav Hospital & ICU  Basement, Plot No. 512/1, Nr. G-6 Circle, Opp. SBI Bank, Sector-23, Gandhinagar-382023
Gandhinagar
GUJARAT 
9979867922

drmauleshtailor@yahoo.com 
Dr Jitendra Singh Kushwaha  Prakhar Hospital Pvt. Ltd  Department of Medicine, 8/219, Arya Nagar Road, Khalasi Line, Arya Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH 
844852240

dr.jskushwahacr@gmail.com 
Dr Sanjay Kala  Sarojini Naidu Medical College  Ground floor, Transfusion medicine department, Moti Katra, Mantola, Agra-282003
Agra
UTTAR PRADESH 
9839210012

surgerygsvmmc@gmail.com 
Dr A Venkateshwar Rao  St.Theresas Hospital  Room No. 5, Department of Medicine, Sanathnagar-500018
Hyderabad
TELANGANA 
9440040662

drvenkateshwarraoavula@gmail.com 
Dr Sandeep Jain  Tagore Hospital and Research Centre  Ground floor,Tagore Lane, Sector-7, Shipra Path, Madhyam Marg, Mansarovar-302020
Jaipur
RAJASTHAN 
9414069583

drsandeeprjain@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Ethical Committee, Mahatma Gandhi Medical College and Research Institute  Submittted/Under Review 
Ethics Committee downtown hospital  Submittted/Under Review 
Ethics Committee, St. Theresa’s Hospital  Approved 
Guru Teg Bahadur Hospital Ethics Committee  Approved 
IEC ESIC Medical College and Hospital,  Approved 
IEC Prakhar Hospital Pvt Ltd  Approved 
IEC, All India Institute of Medical Sciences, Patna   Submittted/Under Review 
IEC, Maharaja Agrasen Hospital  Approved 
Institutional Ethics Committee of AH and RC Adichunchanagiri Hospital and Research Center   Submittted/Under Review 
Institutional Ethics Committee S.N Medical college  Submittted/Under Review 
Institutional Ethics Committee, IMS & SUM Hospital  Submittted/Under Review 
Institutional Ethics committee, KLES Dr. Prabhakar Kore Hospital   Submittted/Under Review 
Institutional Ethics Committee- AIG Hospital  Submittted/Under Review 
Pagarav Ethics committee  Submittted/Under Review 
Tagore 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 SARS-CoV-2 (COVID-19)Vaccine- CORBEVAX   Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28.  
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion Criteria ONLY for Phase II:
1.Male or female (non-pregnant) subject between ≥ 18 to 55 years of age.
2.Subject seronegative to anti-SARS-CoV-2 antibody prior to enrolment.
Inclusion Criteria ONLY for Phase III:
1.Male or female subject between ≥ 18 to 80 years of age.
Inclusion Criteria for Phase II and Phase III:
1.Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study.
2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol.
3.Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment.
4.Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment.
5.Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination.
6.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.
7.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.
8.Subject agrees not to participate in another clinical trial at any time during the total study period.
9.Subject agrees to refrain from blood donation during the course of the study.
10.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 at the time of enrolment.
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:
i.severe psychiatric conditions;
ii.any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
iii.allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE CORBEVAX vaccine);
iv.neurological illness, and any other serious chronic illness requiring hospital specialist supervision.
8.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.
i.For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day, or equivalent.
ii.Inhaled and topical steroids are allowed.
iii.Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data.
9.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
10.Any medical condition that in the judgment of the investigator would make study participation unsafe.
11.Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment.
12.Current or planned participation in prophylactic drug trials for the duration of the study.
13.Individuals who are part of the study team or close family members of individuals conducting the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Proportion of subjects with solicited adverse reactions/symptoms
2.Proportion of subjects with unsolicited adverse events (AEs)
3.SAEs & MAAE in all subjects.
1.Anti-RBD IgG antibodies in terms of ratio of IgG1 to IgG4 anti-RBD titres.
2.Neutralizing antibody titre
3.Immunogenicity in terms of GMC/T
4.Proportion of subjects seroconverted in terms of ≥2-fold & ≥4-fold rise
5.Cell mediated immunity assessment in terms of cytokine expression from stimulated PBMCs (INF-γ, IL-4)
 
1.during first 60 minutes of post vaccination and subsequent 7 days.
2.28-day follow-up period after each dose.
3.At 6 and 12months post 2nd dose.
1.at day 42 vs baseline.
2.at baseline and again at day 42.
3.at baseline and again at day 42.
4.in baseline seronegative subjects and ≥2-fold rise in baseline seropositive subjects along with their GMFR at day 42
5.at baseline and at day 42  
 
Secondary Outcome  
Outcome  TimePoints 
At Phase-II:
Anti-RBD IgG concentrations (GMC, Fold Rise, GMFR)  
At baseline, day 28, 42 and 56 and at 6 and 12 months post second dose. 
Anti-RBD IgG subclass assessment in terms of ratio of IgG1 to IgG4 titres   At day 42 & day 56. 
Neutralizing antibody titre   At baseline, day 28, 42, 56 and at 6 and 12 months post second dose. 
Cell mediated immunity assessment in terms of cytokine expression from stimulated PBMCs (INF-γ, IL-4)   At baseline and at day 42  
At Phase-III:
Proportion of subjects with solicited adverse reactions/symptoms  
During first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days  
Proportion of subjects with unsolicited adverse events (AEs)  During the 28-day follow up period after each dose 
SAEs and MAAES  During the entire study period 
Safety follow-up visit   At 6 and12 months post 2nd dose 
 
Target Sample Size   Total Sample Size="1268"
Sample Size from India="1268" 
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 2/ Phase 3 
Date of First Enrollment (India)   07/06/2021 
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="1"
Months="2"
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, open-label, single arm, phase II seamlessly followed by Phase III clinical study design to evaluate the immunogenicity and safety of CORBEVAX vaccine for Protection Against COVID-19 Disease When administered to COVID-19-Negative Adult Subjects between18-80 years of age.

A total of 1268 male and non-pregnant female adult, from moderate to high-risk population with and without comorbidities will be enrolled across both phases of the study. Subjects must be RT-PCR negative to SARS-CoV-2 antigen. A total of 100 subjects, aged 18 to 55 years, will be enrolled in Phase II for safety assessment and a total of 1168 subjects, aged 18 to 80 years, will be enrolled in Phase III to receive BioE’s SARS-CoV-2 vaccine (CORBEVAX).

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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