Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Volunteers

Phase 2

Completed

• Registration Number: CTRI/2021/04/032942
• Lead Sponsor: Bharat Biotech International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-16
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 375

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity in terms of GMT and four fold seroconversion rate of neutralizing antibodies NAbs across the two groups Vaccine and PlaceboTimepoint: baseline, 28 days 6 months

Secondary Outcome Measures

Name	Time	Method
1. The occurrence of immediate adverse events within two hours of vaccination [Time Frame: 2 hours]. <br/ ><br>2. The occurrence of adverse events within seven days of vaccination [Time Frame: 7 <br/ ><br>days]. <br/ ><br>3. The occurrence of any adverse events throughout the study duration [Time Frame: <br/ ><br>throughout the study duration]. <br/ ><br>4. The occurrence of serious adverse events (SAEs) [Time Frame: throughout the <br/ ><br>study duration].Timepoint: 7 days