None listed
Conditions
Interventions
Intervention1: BBV152D: Whole Virion Inactivated SARS-CoV-2 vaccine (BBV152D) dose:0.1 ml route of administration:
intradermally , 1 x 0.1 mL for Arm 1 frequency:day 0 and 14.
Intervention2: BBV152D:
Sponsors
Bharat Biotech International limited
Bharat Biotech International limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to provide written informed consent. 2. Participants of either gender age between >=18 to 3. Participants of either gender age between >=12 to 4. Good general health as determined by the discretion of investigator (vital signs (Pulse rate >=60 to=90 mm Hg and Hg; diastolic >= 60 mm Hg and medical history, and physical examination). 5. Expressed interest and availability to fulfil the study requirements. 6. 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 4 weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period. 7. Sexually active men who are considered sexually fertile must agree to use a barrier method of contraception and agree to continue the use for at least 3 months following the last vaccination, or have a partner who is permanently sterile or is medically unable to become pregnant. 8. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination. 9. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination. 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
Exclusion criteria: 1. History of any other COVID-19 investigational vaccination. 2. Unacceptable laboratory abnormality from screening (before first vaccination) or safety testing as listed below. ï?? Hematology, Random blood sugar , Renal function test (Blood urea nitrogen (BUN) and Serum creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C, HIV antibody, and hepatitis B surface antigen. (Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody and 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. 4. Pregnancy, lactation or willingness/intention to become pregnant during the study 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 3 days before 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 experimental agent during the study period. 8. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies or anaphylaxis concerning vaccination in the past. 9. Receipt of immunoglobulin or other blood products or blood transfusions within the 3 months before vaccination in this study. 10. Either Immunosuppressant or Immunocompromised status, 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. 11. 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 6 months (nasal and topical steroids are allowed). 12. Any history of hereditary angioedema or idiopathic angioedema. 13. History of any cancer. 14. History of serious psychiatric conditions likely to affect participation in the study. 15. A bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding following venipuncture. 16. Any other serious chronic illness requiring hospital specialist supervision. 17. Chronic respiratory diseases (SARS), including mild asthma 18. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, an endocrine disorder, and neurological illness 19. Morbidly Obese (BMI>=35 kg/m2) or underweight (BMI 20. Living in the same household of any COVID-19 positive. 21. New onset of fever or a cough or shortness of breath or anosmia/ageusia since May 2020. Should a reliable test become available, these exclusion criteria will be replaced with seropositivity for COVID-19 before enrolment. 22. 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 th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 1. The occurrence of immediate adverse events within two hours of vaccination. 2. The occurrence of adverse events within seven days . 3. The occurrence of any adverse events throughout the study duration 4. The occurrence of serious adverse events (SAEs). Phase 2 1. To evaluate the immunogenicity in terms of four-fold seroconversion rate of SARSCoV- 2 virus neutralizing antibodies across the two dosage strengths of BBV152D.Timepoint: Phase 1 1.Time Frame: 2 hours. 2.Time Frame: 7 days 3. Time Frame: throughout the study duration 4.Time Frame: throughout the study duration. Phase 2 baseline to day 0, 14, 28, 42, 104 and 194. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 1. To evaluate the immunogenicity in terms of four-fold seroconversion rate across the two dosage strengths of BBV152D. Phase 2: The occurrence of adverse or serious adeverse eventsTimepoint: Phase 1 baseline to day 14, 28,42, 104 and 194. Phase 2 2hrs after vaccination,7 days post vaccination,through out study duration. | — |
Countries
India
Contacts
Public ContactDr Krishna Mohan
Bharat Biotech International limited
Outcome results
None listed