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CTRI Number  CTRI/2024/01/061423 [Registered on: 12/01/2024] Trial Registered Prospectively
Last Modified On: 17/05/2024
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   A study to assess safety and immunogenicity of Biological E’s Covid-19 vaccine in 5-80 year old people. 
Scientific Title of Study   A prospective single-blind randomized phase-III comparative study to evaluate immunogenicity and safety of Biological E’s XBB.1.5-RBD subunit Covid-19 vaccine in 5-80 years old individuals. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT083/XBB-Covid-19-Phase-III/CTP-01Ver:1.1 dated: 20.12.23  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, Room no:5,2nd 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 Subhash Thuluva 
Designation  Sr. Vice President- Clinical development 
Affiliation  Biological E.Limited 
Address  Clinical Development Dept, Room no:5,2nd floor, Road No.35,Jubilee Hills


TELANGANA
500033
India 
Phone  04071216248  
Fax    
Email  subhash.thuluva@biologicale.com  
 
Details of Contact Person
Public Query  
Name  Mr Subba Reddy GV 
Designation  General Manager- Clinical Development 
Affiliation  Biological E.Limited 
Address  Clinical Development Dept, Room no:2,2nd 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  Plot No 1, Phase II, Biotech Park, Kolthur Village,Shameerpet manadal, Medchal, Malkajgiri District, Telangana-500 078  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parshottam Govindbhai Koradia  BAPS Pramukh Swami Hospital  Department of Paediatrics, Ground Floor, Shri Pramukh Swami Maharaj Marg, Adajanchar rasta. Adajan -395 009
Surat
GUJARAT 		 09825312027

purushottam_koradia@yahoo.co.in 
Dr Pradeep Nanjappa  Cheluvamba Hospital  Department of Paediatric, 2nd Floor, Irwin Rd, Devraj Mohalla-570001
Mysore
KARNATAKA 		 09611898080

drpradeepn80@yahoo.com 
Dr Anil Kumar Pandey  ESIC Medical College & Hospital,   Department of Physiology, Room No. 4007, 4th Floor, NH-3 behind BK Hospital New Industrial Town -121001
Faridabad
HARYANA 		 07042918222

drpandeyak@yahoo.co.in 
Dr Chandrashekhar S Gillurkar  Gillurkar Multispeciality Hospital  Department of Internal Medicine, 3rd Floor, 20, Reshimbag, Umred Road, Sakkardara- 440009
Nagpur
MAHARASHTRA 		 09890005678

cgillurkar@yahoo.com 
Dr Manish Narang  GTB Hospital  Department of Paediatrics, 4th Floor, Tahirpur Rd, GTB Enclave, Dilshad Garden-110095
North East
DELHI 		 09811036569

manish_2710@yahoo.com 
Dr Sachin Kisan Shivnitwar  Lifepoint Multispecialty Hospital  Department of General Medicine, 2nd Floor, No. 145, Sr, 1, Mumbai Pune Bypass Rd, near Sayaji Hotel, Wakad- 411057
Pune
MAHARASHTRA 		 08999285166

sachinshivnitwar94@gmail.com 
Dr A Venkateshwara Rao  St.Theresas Hospital   Department of General Medicine, 1st Floor, Room No. 05, Erragadda Main Road, Czech Colony Sanath Nagar,
Hyderabad
TELANGANA 		 09440040662

drvenkateshwarraoavula@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
BAPS Hospital Institutional Ethics Committee  Approved 
Ethics Committee - St. Theresas Hospital,   Approved 
Gullurkar Hospital Ethics Committee  Approved 
Guru Teg Bahadur Hospital Ethics Committee  Approved 
IEC-Mysore Medical College and Research & Associated Hospital,  Submittted/Under Review 
Institutional Ethics Committee for ESIC   Approved 
Lifepoint Research- Ethics Committee  Approved 
 
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  
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Biological Es Monovalent Corbevax vaccine   Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses 1st at Day 0 and the 2nd dose at Day 28. 
Intervention  Biological Es XBB.1.5 RBD subunit vaccine   Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses 1st at Day 0 and the 2nd dose at Day 28. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Ability to provide written informed consent and by the subjects or their parents or legally acceptable representative and also an assent by the children aged between 7 to 18 years
2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol
3. Participants of either gender, aged between 5 to 80 years on the day of screening
4. Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR prior to enrolment.
5.Participants who have not received any COVID-19 related vaccine(s), during the last six months prior to enrolment
6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital sign as defined in the protocol.
7. Subject or his or her LAR agrees not to participate in another clinical trial at any time during the total study period.
8.Subject or his or her LAR willing to allow storage and future use of collected biological samples for future research in an anonymised form.
9.Subject or his or her LAR agrees to remain in the town where the study centre is located, for the entire duration of the study.  
 
ExclusionCriteria 
Details  1. Living in the same household of any COVID-19 positive person;
2. Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to 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. Current or planned participation in prophylactic or therapeutic drug trials for the duration of the study.
5.Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment.;
6. Pregnant women, nursing women or women of childbearing potential who are or may not actively avoid pregnancy during the study period;
7. Chronic respiratory disease, including asthma;
8. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness;
9. Individuals who are part of the study team or close family members of individuals conducting the study.
10. Anaphylactic reaction following administration of the investigational vaccine.
11. History of severe psychiatric conditions likely to affect participation in the study;
12. History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
13. History of allergic disease or reactions likely to be exacerbated by any component of the Biological E’s test or control vaccine formulations;



 
 
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 as determined by geometric mean titre (GMT) of anti-XBB.1.5.RBD neutralizing antibodies  1. At day 28 and at day 42 in cohorts under Group-1 (test) and Group-2 (control)  
 
Secondary Outcome  
Outcome  TimePoints 
Occurrence of any adverse reactions   Within 60 minutes of immediate post vaccination period  
Occurrence of any solicited adverse events  Within 7 consecutive days after each dose 
Occurrence of any unsolicited adverse events (AEs), serious AEs (SAEs), medically attended AEs (MAAEs) or AEs of special interest (AESIs) in all study participants   until 28 days’ post vaccination period 
To assess geometric mean titre (GMT) of, Anti-XBB.1.5-RBD-IgG and PSVNT antibodies  At baseline, Day-28 and Day-42 time-points in both test (Group-1) and control (Group-2) groups 
To assess geometric mean fold rise (GMFR) in Anti-XBB-1.5 RBD-IgG and PSVNT antibodies   From baseline at day 28 and again at day 42 in both test (Group-1) and control (Group-2) groups 
Proportion of subjects with ≥2-fold and ≥4-fold rise   At day 28 and day 42  
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
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)   31/01/2024 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This will be a prospective, multicentre, single-blind, randomised, comparative phase III clinical study to evaluate the immunogenicity and safety of two booster doses of Biological E’s XBB.1.5-RBD subunit vaccine, when administered in to individuals ≥5 to ≤80 years of age previously vaccinated with any existing COVID-19 vaccine either as primary series or booster dose with the most recent dose at least six months prior to enrolment.

A total of 360 subjects, aged 5 to 80 years, will be enrolled to either test group (Group-1) or to control group (Group-2) for immunogenicity and safety assessment.

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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