FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094477 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
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 of Biological Es Covid-19 vaccine in 18 to 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 JN.1-RBD subunit Covid-19 vaccine in 18-80 years old individuals. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT092/JN.1-Covid-19-Phase-III/CTP-02 Ver:2.0dated:11.06.25  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  Associate Vice President- Clinical Development 
Affiliation  Biological E.Limited 
Address  Clinical Development Dept, Room no:3,2nd 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, Biotech Park, Phase II, Kolthur Village, Shameerpet, Medchal-Malkajgiri District, Telangana, India -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 = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshith CS  BGS Global Institute of Medical Sciences  Department of General Medicine, No. 67,OPD Room No: 03, BGS Health and Education City, Uttarahalli Road, Kengeri -560060
Bangalore
KARNATAKA 		 09972539315

drharshithcs.research@gmail.com 
Dr Anil Samaria  JLN Medical College  Department of General Medicine, Ground floor OPD Room No: 36, Kala Bagh-305001
Ajmer
RAJASTHAN 		 09414008246

clinical.jln@gmail.com 
Dr P Jagath Srinivas   King George Hospital  Department of Community Medicine, OPD Room No: 06, Collectorate Junction, Maharanipeta– 530002
Visakhapatnam
ANDHRA PRADESH 		 09949001578

pjsrinivas.kghamc@gmail.com 
Dr Keyur Brahme  SSG General Hospital  Department of General Medicine, Medical College Building Ground floor, Jail Road, Indira Avenue-390001
Vadodara
GUJARAT 		 09727729105

keyurbrahme@gmail.com 
Dr A Venkateshwar Rao  St.Theresas Hospital   Department of General Medicine, OPD Room No: 05 Sanath Nagar-500018
Hyderabad
TELANGANA 		 09440040662

drvenkateshwarraoavula@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee, St Theresas Hospital  Approved 
IEC, King George Hospital  Approved 
Institutional Ethics Committee for Human Research, Govt. Medical College & SSG Hospital  Submittted/Under Review 
Institutional Ethics Committee, Jawahar Lal Nehru Medical College  Approved 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  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 
Comparator Agent  BE’s CORBEVAX vaccine  Single dose of 0.5 mL vaccine administered on Day 0. The preferred route of administration is intramuscular and the site for injection is in the deltoid muscle of the upper arm. The total study duration is 56 days. 
Intervention  BE’s SARS-CoV-2 (Covid-19) Vaccine (Adsorbed) (Variant JN.1)  Single dose of 0.5 mL vaccine administered on Day 0. The preferred route of administration is intramuscular and the site for injection is in the deltoid muscle of the upper arm. The total study duration is 56 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Subject has the ability to provide written informed consent and does so;
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 18 to 80 years at the time of vaccination;
4. Participants negative for SARS-CoV-2 infection as assessed by a nasopharygeal swab RT-PCR test prior to enrolment.
5. Participants who have completed primary immunization with any COVID-19 vaccine with atleast 6 months ago
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 agrees not to participate in another clinical trial at any time during the total study period.
8. Subject agrees to remain in the town where the study centre is located, for the entire duration of the study.
9. Negative urine pregnancy test for female subjects of childbearing potential at screening, has practiced adequate contraception for one month prior to study intervention administration and has agreed to continue adequate contraception during the entire treatment period and for one month after completion of the study intervention administration.
10. Female participants of non-childbearing potential.
11.No clinically significant abnormal laboratory parameters at baseline as judged by the investigator.
12. Subjects willing to avoid consumption (ingestion) of chronic herbal medication during the course of the study.
13. Subject willing to allow storage and future use of collected biological samples for future research in an anonymised form. 
 
ExclusionCriteria 
Details  1. Living in the same household as any COVID-19 positive person;
2. Those who have received any COVID-19 vaccine (s) during the last 6 months prior to enrolment
3. Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment;
4. 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);
5. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period
6. Current or planned participation in prophylactic or therapeutic drug trials for the duration of the study.
7. Positive test results of HIV 1 & 2, HBV and HCV infection in participants;
8. Body temperature of greater than 100.4°F (greater than 38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination;
9.History of severe psychiatric conditions likely to affect participation in the study;
10. History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
11. History of allergic disease or reactions likely to be exacerbated by any component of the Biological E’s test or control vaccine formulations;
12. Chronic respiratory disease, including asthma;
13. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness;
14. Any other serious chronic illness requiring hospital specialist supervision;
15. Chronic administration (defined as more than 14 days in total) of immunosuppressant 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. For corticosteroids, this will mean prednisolone greater than or equal to 0.5 mg kg day, or equivalent. Inhaled and topical steroids are allowed;
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. 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 
To assess immunogenic superiority of BE’s JN.1-RBD subunit Covid-19 vaccine against monovalent Corbevax vaccine in terms of GMTs of anti-JN.1 neutralizing antibodies  On Day 28 post booster dose 
 
Secondary Outcome  
Outcome  TimePoints 
Occurrence of any adverse reactions  Within 60 minutes of immediate post booster vaccination 
Occurrence of any solicited local and systemic adverse events  Within 7 consecutive days after booster vaccination 
Occurrence of any unsolicited adverse events (AEs), serious AEs (SAEs), medically attended AEs (MAAEs) or AEs of special interest (AESIs)  Until 28 days’ post booster vaccination 
To assess geometric mean concentration (GMC) of anti-JN.1-RBD-IgG and GMTs of PSVNT antibodies  at baseline and on Day 28 in both test (Group-1) and control (Group-2) groups 
To assess geometric mean fold rise (GMFR) in Anti-JN.1 RBD-IgG and PSVNT antibodies  At Day 28 from baseline 
Proportion of subjects with greater than or equal to 2- fold and greater than or equal to 4-fold rise in anti-JN.1 neutralizing antibody (nAb) titers  At day 28 post vaccination 
Proportion of subjects with greater than or equal to 2- fold and greater than or equal to 4-fold rise in anti-JN.1-RBD Ig G antibody concentration/titers  At day 28 post vaccination. 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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)   30/09/2025 
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)  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 a single booster dose of Biological E’s JN.1-RBD subunit vaccine, when administered to individuals 18 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.

Individuals of stable health aged between 18 to 80 years old adults of either gender that are nasopharyngeal swab SARS-CoV-2 RT-PCR negative at the time of screening will be enrolled.

A total of 270 subjects, aged 18 to 80 years, will be enrolled to either a test group (Group-1) or to a control group (Group-2) for immunogenicity and safety assessment.

The study will be conducted in compliance with New Drugs and Clinical Trials Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.

 
Close