None listed
Conditions
Interventions
Intervention1: BBV152B: 6 µg antigen with Algel-IMDG: Whole-Virion Inactivated SARS-CoV-2 vaccine (BBV152) will be administered as a two dose intramuscular injection 28 days apart.
Control Interventi
Sponsors
Bharat Biotech International Ltd
The Indian Council of Medical Research ICMR New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to provide written informed consent and availability to fulfill the study requirements. 2. Participants of either gender of aged 18 years and above. 3. Participants with good general health as determined by the discretion of the investigator, or participants with stable medical conditions. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization or worsening disease during the 3 months before enrolment. 4. 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 eight weeks after the last vaccination. 5. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner and to refrain from sperm donation from first vaccination until at least 3 months after the last vaccination. 6. Agrees not to participate in another clinical trial at any time during the study period. 7. Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study. 8. Agrees to remain in the study area for the entire duration of the study. 9. Willing to allow storage and future use of biological samples for future research.
Exclusion criteria
Exclusion criteria: 1. History of any other COVID-19 investigational or licensed vaccination. 2. Known history of SARS-CoV-2 infection, as declared by the subject. 3. For women, positive urine pregnancy test before the first dose of vaccination, or any time during the study period. 4. 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. 5. Resident of COVID-19 infection in same household. 6. Known case of HIV, hepatitis B, or hepatitis C infection. 7. Receipt of any licensed/experimental vaccine within four weeks before enrolment in this study. 8. Receipt of immunoglobulin or other blood products within the three months before vaccination in this study. 9. 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. 10. Immunoglobulins, anti-cytokine antibodies and blood products within 6 months prior to study vaccination, during and 21 days following last dose of vaccination. 11. Pregnancy, lactation, or willingness/intention to become pregnant during the first 6 months after enrolment. 12. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder,, and neurological illness (mild/moderate well-controlled comorbidities are allowed) Re-Vaccination Exclusion Criteria 13. Pregnancy. 14. History of virologically (RT-PCR) confirmed SARS-CoV-2 infection 15. Anaphylactic reaction following administration of the investigational vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of BBV152B to prevent symptomatic COVID-19(Virologically confirmed-(RT-PCR positive) which include any participant who meets the Case Definitions for Symptomatic Endpoint and Severe Symptomatic COVID-19Timepoint: Day 42 to Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| EFFICACY:To evaluate the efficacy of BBV152B to prevent- 1. COVID-19 based on the case definition for the secondary efficacy symptomatic endpoint. 2.COVID-19-Virologically confirmed (RT-PCR positive) severe cases of COVID19. 3.Any severity of COVID-19 by age. 4.Asymptomatic COVID-19. 5.COVID-19 regardless of symptomatology or severity 6.COVID-19 related deaths 7.Symptomatic COVID-19, regardless of the previous infectionTimepoint: 1.Day 42 to Month 12 2.Day 42 to Month 12. 3.Day 42 to Month 12 4.Month 2 to Month 12 5.Day 42 to Month 12 6.Day 42 to Month 12 7.Day 42 to Month 12;IMMUNOGENECITY To evaluate the immunogenicity of BBV152B 1.Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) 2.Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibody (nAb). 3.Geometric Mean Titer (GMT) of SARS-CoV-2 S1 protein-specific Binding Antibody (bAb). 4.Lot-to-Lot consistency will be assessed based on the neutralizing titer of the three consistent lots used in the trialTimepoint: 1.Month 0 to Month 12 2.Month 0 to Month 12 3.Month 0 to Month 12 4.Month 0 to Month 2;SAFETY To assess the safety of BBV152B 1.Serious Adverse Events occurring at any time 2.Solicited local and systemic adverse events (AEs). 3.Unsolicited AEs occurring between the vaccination and 28 days after the final vaccination. 4.Immediate AEs with 30 minutes of vaccination 5. Medically attended adverse events (MAAEs) or AEs leading to withdrawal 6.The occurrence of enhanced respiratory disease episodes reported by participant/documented in hospital records 7.AE of Special interestTimepoint: 1.Throughout the study period 2.Within 7 days post each vaccination 3.Till 28 days post second dose vaccination 4. Within 30 minutes post each vaccination 5.Throughout the study period 6.Throughout the study period 7.Throughout the study period | — |
Countries
India
Contacts
Public ContactDr Shashikanth Muni
Bharat Biotech International limited
Outcome results
None listed