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CTRI Number  CTRI/2020/07/026300 [Registered on: 01/07/2020] Trial Registered Prospectively
Last Modified On: 17/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Volunteers 
Scientific Title of Study
Modification(s)  		 An Adaptive, Seamless Phase 1, Followed by Phase 2 Randomized, Double-blind, Multicenter Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Volunteers 
Trial Acronym  BBV152 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
BBIL/BBV152-A/2020; Version 3.0; Date 07-07-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Krishna Mohan  
Designation  Whole-time Director  
Affiliation  Bharat Biotech International Limited 
Address  Bharat Biotech International Ltd, Medical Affairs Department, Genome Valley, Shameerpet

Medchal
TELANGANA
500078
India 
Phone  04023480567   
Fax  04023480560   
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V Krishna Mohan  
Designation  Whole-time Director  
Affiliation  Bharat Biotech International Limited 
Address  Bharat Biotech International Ltd, Medical Affairs Department, Genome Valley, Shameerpet

Medchal
TELANGANA
500078
India 
Phone  04023480567   
Fax  04023480560   
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Public Query  
Name  Dr V Krishna Mohan  
Designation  Whole-time Director  
Affiliation  Bharat Biotech International Limited 
Address  Bharat Biotech International Ltd, Medical Affairs Department, Genome Valley, Shameerpet

Medchal
TELANGANA
500078
India 
Phone  04023480567   
Fax  04023480560   
Email  kmohan@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Ltd Genome Valley Shameerpet Hyderabad – 500 078 Telagana INDIA 
 
Primary Sponsor  
Name  Bharat Biotech International Limited  
Address  Bharat Biotech International Ltd, Medical Affairs department, Genome Valley, Shameerpet, Medchal, TELANGANA - 500078 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandramani Singh  All India Institute of Medical Sciences  Room No. 17 Department of Community & Family Medicine All India Institute of Medical Sciences, Aurangabad Road Phulwari Sharif
Patna
BIHAR 		 9931733280

drcmsingh@aiimspatna.org 
Dr Sanjay Kumar Rai   All India Institute of Medical Sciences  Room No. 29 Department of Center for Community Medicine All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI 		 09868397358

drsanjay.aiims@gmail.com 
Dr Chandrasekhar Gillurkar  Gillukar Multispeciality Hospital  20, Reshimbagh, Umred road, Nagpur - 440009 Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA 		 09890005678

cgillurkar@yahoo.com 
Dr Venkata rao   Institute of Medical Sciences and SUM Hospital   DEPARTMENT OF COMMUNITY MEDICINE, 3rd Floor, K-8, KALINGA NAGAR, GHATIKIA,
Jajapur
ORISSA 		 07853889552

e.venkata.rao@gmail.com 
Dr Amit Suresh Bhate   Jeevan Rekha Hospital  3rd Floor Room No. 2 Jeevan Rekha Hospital, Dr. B.R. Ambedkar Road Opposite Civil Hospital
Belgaum
KARNATAKA 		 9695237796

jrhclinicalresearch@gmail.com 
Dr R Vasudev   King George Hospital  Dept of Medicine, 1st floor, King george Hospital, Maharanipeta
Visakhapatnam
ANDHRA PRADESH 		 9866739808

vasudev.kgh@gmail.com 
Dr Prabhakar Reddy   Nizam’s Institute of Medical Sciences  NIMS Old Block,ward No 11,second floor, near ward no 11 opp NP@ Department of Clinical Pharmacology & Therapeutics, (CP&T)
Hyderabad
TELANGANA 		 7416512888

cptnims@gmail.com 
Dr Savita Verma   PGIMS  Room no 428,Department of Pharmacology Directorate Office Rothak,Pt BD SHARMA,PGIMS/UHS.
Rohtak
HARYANA 		 9812283746

verma.savi@gmail.com 
Dr Jitendra Kushwaha  Prakhar Hospital  4th Floor Research Room Prakhar Hospital Pvt Ltd. 8/219 Arya Nagar
Kanpur Nagar
UTTAR PRADESH 		 08448522450

principalinvestigator1177@gmail.com 
Dr Ajeet Pratap Singh   Rana Hospital and Trauma Center  Room No. 7 Rana Hospital Pvt. Ltd. Rail Vihar Medical College Road Chargawa
Gorakhpur
UTTAR PRADESH 		 7652456810

ajeetpsingh1177@gmail.com 
Dr Sagar Vivek Redkar  Redkar Hospital and Research Centre  Room No. 11 Mumbai Goa Highway, Oshalbag Village Dhargal, Tal
North Goa
GOA 		 07776084679

redkar.research@gmail.com 
Dr Satyajit Mohapatra   SRM Hospital & Research center  Department of Pharmacology , SRM Medical College Hospital and Research Centre, Kattankulathur Campus
Kancheepuram
TAMIL NADU 		 09791161626

satyajitmp@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Ethics Committee, All India Institute of Medical Sciences, Delhi   Approved 
Ethics Committee, Prakhar Hospital Pvt Ltd,Kanpur   Approved 
Gillurkar Hospital Ethics Committee, Nagpur   Approved 
Institutional Ethics Committee, All India Institute of Medical Sciences, Patna   Approved 
Institutional Ethics Committee, IMS & SUM Hospital,odissha   Approved 
Institutional Ethics Committee, Jeevan Rekha Hospital, Belgavi   Approved 
Institutional Ethics Committee, PGIMS, Rohtak   Approved 
Institutional Ethics Committee, Rana Hospital Pvt Ltd, Gorakhpur  Approved 
Institutional Ethics Committee, SRM College Hospital and Research Centre,Tamil Nadu   Approved 
NIMS Institutional Ethics Committee, Hyderabad   Approved 
Redkar Hospital and Research Centre Institutional Ethics Committee, Goa  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 SARS-CoV-2 infection 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  BBV152A, BBV152B and BBV152C   Whole-Virion Inactivated SARS-CoV-2 vaccine (BBV152) with three formulations, BBV152A, BBV152B and BBV152C. Dose: 0.5ml, Route of administration:Intramuscular injection, Frequency: Two doses at Day 0 and Day 14  
Comparator Agent  Placebo  Placebo will be used as a control. Dose: 0.5ml Route of administration:Intramuscular injection, Frequency:Two doses at Day 0 and Day 14  
 
Inclusion Criteria
Modification(s)  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Phase 1
1. Ability to provide written informed consent (Audio video consent for vulnerable
subjects).
2. Participants of either gender of age between ≥18 to ≤55 years.
3. Good general health as determined by the discretion of investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and <140 mm
Hg; diastolic ≥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical
history, and physical examination).
4. Expressed interest and availability to fulfill the study requirements.
5. For a female participant of child-bearing potential, planning to avoid becoming
pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination
6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination
7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination
9. Agrees not to participate in another clinical trial at any time during the study period.
10. Agrees to remain in the study area for the entire duration of the study.
11. Willing to allow storage and future use of biological samples for future research.

Phase 2:
1. Ability to provide written informed consent (Audio video consent for vulnerable subjects).
2. Participants of either gender of age between ≥12 to ≤ 65 years.
3. Good general health as determined by the discretion of investigator (vital signs (heart rate ≥60 to≤100 bpm; blood pressure systolic ≥90 mm Hg and <140 mm
Hg; diastolic ≥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination).
4. Expressed interest and availability to fulfill the study requirements.
5. For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study
enrolment until at least four weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period.
6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination
7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination.
9. Agrees to remain in the study area for the entire duration of the study.
10. Willing to allow storage and future use of biological samples for future research.
 
 
ExclusionCriteria 
Details  Phase 2:
1. History of any other COVID-19 investigational vaccination.
2. Unacceptable laboratory abnormality from screening (prior to first vaccination)
or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen].
(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary
care provider for follow up of these abnormal laboratory tests.)
3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA method.
4. Health care workers.
5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness
such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
7. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
8. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period.
9. Receipt of any licensed vaccine within four weeks before enrolment in this study.
10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
12. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
13. Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed).
14. Any history of hereditary angioedema or idiopathic angioedema.
15. Any history of anaphylaxis in relation to vaccination.
16. Any history of albumin-intolerance.
17. Pregnancy, lactation, or willingness/intention to become pregnant during the study.
18. History of any cancer.
19. History of psychiatric severe conditions likely to affect participation in the study.
20. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
21. Any other serious chronic illness requiring hospital specialist supervision.
22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma.
23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness
24. Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
25. Living in the same household of any COVID-19 positive person.
26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
Re-Vaccination Exclusion Criteria
27. Pregnancy.
28. Anaphylactic reaction following administration of the investigational vaccine.
29. Virologically confirmed cases of COVID-19

Phase 2:
1. History of any other COVID-19 investigational vaccination.
2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and /or ELISA method.
3. Health care workers.
4. Positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
5. Temperature > 38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
6. Medical problems as a result of alcohol or illicit drug use during the past 12 months.
7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrolment or expects to receive an investigational agent during the study period.
8. Receipt of any licensed vaccine within four weeks before enrolment in this study.
9. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
10. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
11. Immunosuppression as a result of an underlying illness or treatment with
immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or
radiation therapy within the preceding 36 months.
12. Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or
high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed).
13. Any history of hereditary angioedema or idiopathic angioedema.
14. Any history of anaphylaxis in relation to vaccination.
15. Any history of albumin-intolerance.
16. Pregnancy, lactation, or willingness/intention to become pregnant during the
study.
17. History of any cancer.
18. History of psychiatric severe conditions likely to affect participation in the study.
19. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or
venepuncture.
20. Any other serious chronic illness requiring hospital specialist supervision.
21. Chronic respiratory diseases like severe acute respiratory syndrome (SARS),
including mild asthma.
22. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal
disease, endocrine disorder, and neurological illness
23. Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2).
24. Living in the same household of any COVID-19 positive person.
25. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the
subject unable to comply with the protocol.
Re-Vaccination Exclusion Criteria
26. Pregnancy.
27. Anaphylactic reaction following administration of the investigational vaccine.
28. Virologically confirmed cases of COVID-19.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Phase 1:
1. The occurrence of immediate adverse events within two hours of vaccination 2. The occurrence of adverse events within 7 days of vaccination.3. The occurrence of any adverse events throughout the study duration 4. The occurrence of serious adverse events (SAEs)
Phase 2:
Primary
1. To evaluate the immunogenicity in terms of GMT and four-fold seroconversion
rate amongst the two selected BBV152 vaccine formulations 		 Phase 1:
Occurrence of Adverse events within 2hrs, at Day 7 and through out the study duration

Phase 2:
Day 0, Day 14, Day 28, Day 42 Day 104 and Day 194 in two cohorts  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Phase 1
To evaluate the immunogenicity in terms of GMT and four-fold seroconversion rate
of neutralizing antibodies (NAbs) across the three formulations of BBV152 in
comparison with control group.
Phase 2
The occurrence of immediate adverse events within two hours of vaccination.2. The occurrence of adverse events within seven days of vaccination 3. The occurrence of any adverse events throughout the study duration 4. The occurrence of serious adverse events (SAEs).  		 Phase 1:
Day 0, Day 14, Day 28, Day 42 Day 104 and Day 194 in two cohorts.
Phase 2:
Occurrence of Adverse events within 2hrs, at Day 7 and through out the study duration 
 
Target Sample Size   Total Sample Size="1125"
Sample Size from India="1125" 
Final Enrollment numbers achieved (Total)= "755"
Final Enrollment numbers achieved (India)="755" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   13/07/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
This is a phase 1 to be followed by phase 2 randomized, double-blind, multicenter study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers. 
The study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of three groups of healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations. A total sample size of 1125 healthy volunteers, with 375 volunteers in the phase 1 study and 750 volunteers in phase 2 study (4:1 test and control).

 
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