COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
BBV152, COVID-19 vaccine, inactivated vaccine
Brief summary
Double blind, Multi-Centre study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of three investigational vaccine groups and one placebo group in healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations and placebo. A total sample size of 755 healthy volunteers, with 375 and 380 volunteers in phase 1 and 2 studies, respectively. A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or placebo.
Detailed description
Phase 1 study The study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Four arms of healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations or Placebo. A total no of 375 subjects will be enrolled in 4:1 ratio. This study will be conducted in a dose escalatory manner with a two-dose regimen fourteen days apart. Phase 2 study The study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of two arms of healthy volunteers who will receive two intramuscular doses of BBV152 vaccine formulations (BBV152-A & BBV152-B) in a 1:1 ratio with dosage schedule on Day 0 and Day 28. A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or placebo. The investigator, participant and Sponsor were blinded to the allocation.
Interventions
BIOLOGICALBBV152A - Phase I
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
BIOLOGICALBBV152B - Phase I
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
BIOLOGICALBBV152C - Phase I
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
BIOLOGICALPlacebo - Phase I
0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14
BIOLOGICALBBV152A - Phase II
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
BIOLOGICALBBV152B - Phase II
0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
Sponsors
Indian Council of Medical Research
Bharat Biotech International Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Phase 1: Inclusion Criteria 1. Ability to provide written informed consent. 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.
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Occurrence of adverse events and Serious Adverse events | Through study completion, an average of 6 months | Safety |
| Phase 2: Evaluation of Neutralizing Antibody Titers | Through study completion, an average of 6 months | Pre- and Post-vaccination immune response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Evaluation of Neutralizing Antibody Titers | Through study completion, an average of 6 months | Pre- and Post-vaccination immune response |
| Phase 2: Occurrence of adverse events and Serious Adverse events | Through study completion, an average of 6 months | Safety |
| Phase 2: Evaluation of Neutralizing Antibody Titers | Through study completion, an average of 6 months | Post-vaccination immune responses comparing two-dose and three dose regimens |
Countries
India
Outcome results
None listed