None listed
Conditions
Interventions
Intervention1: BBV154 INTRANASAL
VACCINE
: Replication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) administered 0.5ml of vaccine on day 0 and
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to provide written informed consent. 2. Participants of either gender of age >=18 years. 3. Good general health as determined by the discretion of investigator (vital signs : (heart rate >=60 to=90 mm Hg and = 60 mm Hg and 4. Expressed interest and availability to fulfil 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. Participants must refrain from blood/plasma or any other bodily fluid donation from the time of first vaccination until 3 months after last vaccination 8. Agrees not to participate in another clinical trial at any time during the study period. 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.
Exclusion criteria
Exclusion criteria: 1. History of any other COVID-19 investigational/or licensed vaccination. 2. For women of child bearing potential, 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). 3. Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. 4. Medical problems because of alcohol or illicit drug use during the past 12 months. 5. 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. 6. Receipt of any licensed vaccine within four weeks before enrolment in this study. 7. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. 8. Receipt of immunoglobulin or other blood products within the three months prior to 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. 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). 11. Any history of anaphylaxis in relation to vaccination. 12. History of any cancer. 13. History of severe psychiatric conditions likely to affect participation in the study. 14. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture). 15. Any other serious chronic illness requiring immediate hospital specialist supervision. 16. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Geometric mean titres (GMTs) of Serum neutralising antibody titer (NAbâ??s) by neutralizing antibody assays. 2.The occurrence of solicited adverse events. 3. The occurrence of serious adverse events (SAEs) 4. The occurrence of any unsolicited adverse eventsTimepoint: 1. day 0, 28, 42, 90 and 180. 2.7 days. 3. Through out the study 4. Up to day 42 from 1st dose of vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Geometric mean titers of salivary IgA, Serum IgA and IgG binding antibody titer by ELISA assays. 2. Geometric mean titers of Serum neutralizing antibody titer by neutralizing antibody assays. 3. The occurrence of adverse event of special interest (AESI). 4. Vaccine-induced cell mediated immunogenicity and antigen specific T-cell and B-cell responses. 5. The occurrence of the vaccine induced thrombosis and thrombocytopenia in participants reporting the respective symptoms and signs. Timepoint: 1. Day 0, 28, 42, 90 and 180 2. Day 0, 28 and 42 3. Throughout the study | — |
Countries
India
Contacts
Public ContactDr Krishna Mohan
Bharat Biotech International Ltd
Outcome results
None listed