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CTRI Number  CTRI/2022/01/039366 [Registered on: 12/01/2022] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on Biological E’s CORBEVAX booster vaccine for those who are vaccinated with two doses of either Covishield or Covaxin initially. 
Scientific Title of Study   A Prospective double-blind randomised Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Single Booster dose of Biological E’s CORBEVAX vaccine when Administered to COVID-19-Negative Adult Volunteers Previously vaccinated with 2-doses of either Covishield or Covaxin. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT/COVID-19-PHASE-III/070 Ver:1.2 dated:29.12.21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhash Thuluva 
Designation  Sr.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
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr P Naveen Chander Reddy   AIG Hospital   Department of Cardiology, AIG Hospital, 4th floor, Plot No. 2/3/4/5, Survey No. 136/1, Mindspace Road, Gachibowli
Hyderabad
TELANGANA 		 09848045814

drnaveen.reddy@aighospitals.com 
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 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 Shiva Narang  Guru Teg Bahadur Hospital & UCMS  Department of General Medicine, 4th Floor, Tahirpur Rd, GTB Enclave, Dilshad Garden
North East
DELHI 		 09899838807

shivanarang@gmail.com 
Dr Chandran K Nair  Malabar Cancer Centre  Department of Clinical Hematology & Medical Oncology, Malabar Cancer Centre, 2nd Floor, Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery 670103
Kannur
KERALA 		 09496048808

cknair09@gmail.com 
Dr Indranil Basu  Shubham Sudbhawana Hospital  Department of General Medicine, Shubham Sudbhawana Hospital, 2nd Floor, B 31/80, 23B - Bhogabeer, Lanka
Lucknow
UTTAR PRADESH 		 09935036063

dribasumd@yahoo.co.in 
Dr Chitta Sitaram Anjaneylu  St.Theresas Hospital  Department of General Medicine, St.Theresas Hospital (STH), 1st Floor, Room No. 05, Erragadda Main Road, Czech Colony Sanath Nagar- 500038
Hyderabad
TELANGANA 		 09440978935

cpdstth@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee - Guru Teg Bahadur Hospital  Approved 
Ethics Committee-St.Theresas Hospital  Approved 
Institutional Ethics Committee - Grant Medical College & Sir J.J Hospital  Approved 
Institutional Ethics Committee for ESIC Medical College And Hospital   Approved 
Institutional Ethics Committee- Asian Institute of Gastroenterology  Approved 
Institutional Ethics Committee- Malabar Cancer Centre  Approved 
Shubham Sudbhawana Superspeciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Active immunization for the prevention of COVID-19 disease  
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biological E’s CORBEVAX Vaccine   Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Single dose booster at Day 0 along with subsequent follow-up on Day 28, Day 180 & Day 270.  
Comparator Agent  PLACEBO   Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Single dose booster at Day 0 along with subsequent follow-up on Day 28, Day 180 & Day 270. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Healthy and/or high risk individuals of either gender between 18 to 80 years of age at enrolment;
2. Have received two doses of Covishield OR two doses of Covaxin, with the most recent dose at least six or nine months prior to enrolment;
3. Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study;
4. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol;
5. Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment;
6. Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination;
7. 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;
8. 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;
9. Subject agrees not to participate in another clinical trial at any time during the total study period;
10. Subject agrees to refrain from blood donation during the course of the study;
11. Subject agrees to remain in the town where the study centre is located, for the entire duration of the study.
 
 
ExclusionCriteria 
Details  1. Subject living in the same household as that of any active COVID-19 positive individual at the time of enrolment;
2. Have previously already received one or two doses of any COVID-19 vaccine except Covishield or Covaxin;
3. Pregnant women, nursing women or women of childbearing potential who are or may not actively avoid pregnancy during the study period;
4. Hospitalized patients, patients who need intensive care and/or require a ventilator to help them breathe;
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. Subjects with history of Covid-19 infection after receiving primary vaccination.
7. Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study:
a)Severe psychiatric conditions;
b)Any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
c)Allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE’s CORBEVAX vaccine);
8. Individuals who report any medical condition, or as determined by a clinician, not suitable to receive protein based subunit COVID-19 vaccines, including but not limited to allergies to the active substance or other ingredients of the vaccine.
9. Neurological illness, and any other serious chronic illness requiring hospital specialist supervision.
10. Use of medication that impairs immune system in the last 6 months, except topical or inhaled steroids or short-term oral steroids (course lasting ≤14 days).
11. Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data.
12. Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment.
13. Current or planned participation in prophylactic drug trials for the duration of the study.
14. Individuals who are part of the study team or close family members of individuals conducting the study.
15. Any medical condition that in the judgment of the investigator would make study participation unsafe.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects achieving ≥2-fold increase in neutralizing antibodies after single booster dose of Corbevax   At day 28  
 
Secondary Outcome  
Outcome  TimePoints 
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 first 28 days and for further 6 and 9 months of safety follow up period 
Serious adverse events (SAEs), if any,   during the entire study period. 
Medically attended adverse events (MAAE), and adverse events of special interest (AESI)   during the entire study period. 
Geometric mean titre (GMT/C) of neutralising antibodies in both groups  28 days after single booster dose. 
GMC/T of anti-RBD IgG antibodies   at pre-booster and 28 days after booster 
GMFR in comparison to pre booster  28 days after booster  
Persistance of anti-SARS-CoV-2 IgG antibodies and virus neutralising antibodies (VNA) in terms of their geometric mean titres (GMT/C)  at 6 months post single booster dose in comparison with corresponding antibody levels and day 28 post booster dose.  
 
Target Sample Size   Total Sample Size="416"
Sample Size from India="416" 
Final Enrollment numbers achieved (Total)= "416"
Final Enrollment numbers achieved (India)="416" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/01/2022 
Date of Study Completion (India) 01/02/2024 
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   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This is a prospective, multicentre, double-blind, randomised phase III clinical study to evaluate the immunogenicity and safety of single booster dose of Biological E’s CORBEVAX vaccine, when administered to equal number of healthy and high risk or comorbid condition participants who are between 18 to 80 years of age previously vaccinated with 2-doses of either Covishield and Covaxin, with the most recent dose at least six months (+28 days time window) prior to enrolment in sub group-1 and at least 9 months (+28 days time window) prior to enrolment in subgroup-2 under each treatment arm/group.

Subjects must be RT-PCR negative to SARS-CoV-2 from nasopharyngeal sample prior to enrolment. A total of 416 subjects between 18 to 80 years of age, will be enrolled into the study.

All eligible subjects will be randomised by treatment planned and by age into respective arms.

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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