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CTRI Number  CTRI/2021/04/032942 [Registered on: 19/04/2021] Trial Registered Prospectively
Last Modified On: 14/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Volunteers  
Scientific Title of Study   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. 
Secondary IDs if Any  
Secondary ID  Registry 
BBIL/BBV152-A/2020 version 6.0 dated 31.03.2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Krishna Mohan 
Address  Bharat Biotech International Limited Genome Valley Shmaeerpet
Bharat Biotech International Limited Genome Valley Shmaeerpet
Hyderabad
TELANGANA
500078
India 
Phone  04023480567  
Fax  04023480560  
Email  kmohan@bharatbiotech.com  
 
Details Contact Person
Scientific Query
 
Name  Dr V Krishna Mohan 
Address  Bharat Biotech International Limited Genome Valley Shmaeerpet
Bharat Biotech International Limited Genome Valley Shmaeerpet

TELANGANA
500078
India 
Phone  04023480567  
Fax  04023480560  
Email  kmohan@bharatbiotech.com  
 
Details Contact Person
Public Query
 
Name  Dr V Krishna Mohan 
Address  Bharat Biotech International Limited Genome Valley Shmaeerpet
Bharat Biotech International Limited Genome Valley Shmaeerpet

TELANGANA
500078
India 
Phone  04023480567  
Fax  04023480560  
Email  kmohan@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Limited 
 
Primary Sponsor  
Name  Bharat Biotech International Limited 
Address  Genome Valley Shameerpet Hyderabad 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 9  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandramani Singh  All India Institute of Medical Sciences Patna  Room No. 17 Department of Community & Family Medicine All India Institute of Medical Sciences, Aurangabad Road Phulwari Sharif Patna
Patna
 
9931733280

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

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

cgillurkur@yahoo.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
Belgaum
 
9695237796

jrhclinicalresearch@gmail.com 
Dr Prabhakar Reddy  Nizams 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
Hyderabad
 
7416512888

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

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

principalinvestigator1177@gmail.com 
Dr Sagar Vivek Redkar   Redkar Hospital and Research center  Room No. 11 Mumbai Goa Highway, Oshalbag Village Dhargal, Tal North Goa
North Goa
 
07776084679

redkar.research@gmail.com 
Dr Satyajit Mohapatra  SRM hospital and Research Center  Department of Pharmacology , SRM Medical College Hospital and Research Centre, Kattankulathur Campus Kancheepuram
Chennai
 
09791161626

satyajitmp@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee of the Prakhar Hospital  Approved 
Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved 
Gillurkur Hospital Ethics Committee Nagpur  Approved 
Institutional Ethics Committe, All India Institute of Medical Sciences, Patna  Approved 
Institutional Ethics Committe, Jeevan Rekha Hospital, belgaum  Approved 
Institutional Ethics Committee PGIMS Rothak  Approved 
Institutional Ethics Committee SRM College Hospital and Research center Tamilnadu  Approved 
NIMS Institutional Ethics Committee Hyderabad  Approved 
Redkar Hospital and Research center Institutional Ethics Committee Goa  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 SARS-CoV-2 infection  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BBV152B  Whole-Virion Inactivated SARS-CoV-2 vaccine (BBV152B) Dose: 0.5ml, Route of administration:Intramuscular injection  
Comparator Agent  Placebo  Placebo will be used as a control. Dose: 0.5ml Route of administration:Intramuscular injection 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Phase 1 (Completed)
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.
Phase 2 Extension:
The participants enrolled in Phase 2 part of the study and received two doses of the
BBV152 (6μg) vaccine are eligible.
 
 
ExclusionCriteria 
Details  Phase 1:
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   Double Blind Double Dummy 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To evaluate the immunogenicity in terms of GMT and four fold seroconversion rate of neutralizing antibodies NAbs across the two groups Vaccine and Placebo  baseline, 28 days 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. The occurrence of immediate adverse events within two hours of vaccination [Time Frame: 2 hours].
2. The occurrence of adverse events within seven days of vaccination [Time Frame: 7
days].
3. The occurrence of any adverse events throughout the study duration [Time Frame:
throughout the study duration].
4. The occurrence of serious adverse events (SAEs) [Time Frame: throughout the
study duration]. 
7 days 
 
Target Sample Size   Total Sample Size="190"
Sample Size from India="190" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
27/05/2021 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
No 
Brief Summary  

The purpose of this study is to evaluate the immunogenicity, safety, reactogenicity, tolerability of the booster dose of whole-virion inactivated SARS-CoV-2 vaccine, BBV152.

In this study, participants who were already vaccinated with BBV152B (as part of the phase 2 trial) will visit the site (one week after 6 months visit). On this visit, consent will re-obtained for Arm 2 participants and they will be randomized to receive either vaccine or placebo. All these participants will be followed up for 6 months after the third dose for their safety and immunogenicity 

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