CTRI/2021/08/036074 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On:
18/03/2022
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.
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
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"
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.