| CTRI Number |
CTRI/2021/04/032942 [Registered on: 19/04/2021] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| 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
|
|
|
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
|
|
|
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) |
Completed |
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 |
