None listed
Conditions
Interventions
Intervention1: Covaxin followed by Covishield followed by booster Covaxin: 0.5 ml Intramuscular
Intervention2: Covishield followed by Covaxin followed by booster Covishield: 0.5 ml Intramuscular
Inter
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18+ years 2. No known immunodeficiency 3. History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects) 4. No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history 5. No acute infectious and/or respiratory diseases within at least 14 days before the enrolment.
Exclusion criteria
Exclusion criteria: 1. Previous receipt of any COVID vaccine (only for those who are in the prime and boost part of the study) 2. Any vaccination/immunization within 30 days before the enrolment 3. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrolment 4. Immunosuppressors therapy finished within 3 months before the enrolment 5. Pregnancy or breast-feeding 6. Acute coronary syndrome or stroke suffered less than one year before the enrolment 7. Tuberculosis, chronic systemic infections 8. Drug allergy â?? history of anaphylaxis, hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day 9. Subjects who are on drugs that could have potential drug interactions with the vaccines: A.drugs for multiple sclerosis (dimethyl fumarate, fingolimod, ozanimod, etc.), B. monoclonal antibodies, corticosteroids, corticotropin, C. antineoplastic drugs, cytostatic agents (platinum-based drugs, bleomycin, taxanes, methotrexate, melphalan, capecitabine, carmustine, vincristine, vinblastine, cyclophosphamide, cyclosporine, docetaxel, doxorubicin, daunorubicin, fluorouracil, etc.) and target drugs (dasatinib, lenalidomide, nilotinib, pemetrexed, everolimus, sirolimus, asparaginase, bortezomib, etc.), D. immunoglobulins, interleukins, X-ray contrast agents 10. Medical history of malignancy 11. Donated blood or plasma (450+ mL) within 2 months before the enrolment 12. Splenectomy in the medical history 13. Neutropenia (absolute neutrophil count 14. Known HIV positive 15. Local inflammation at injection site (deltoid muscle area), which does not allow assessing the local response to the vaccine administration 16. Alcohol or drug addiction in the medical history 17. Participation in any other interventional clinical trial within 1 month prior to the screening 17. Any other medical condition that would limit the participation of the subject as per Investigatorâ??s discretion 18. Subjects contraindicated for vaccination Temporary exclusion criteria: If at visit 1 screening/ vaccination the volunteer has any of the following, they will not be enrolled that day. 1. Acute respiratory illness (moderate or severe illness with or without fever) 2. Fever (oral temperature greater than 37.8°C) They may be considered for enrolment later in the trial; if they recover in sufficient time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity measured by anti spike immunoglobulins for SARS CoV 2Timepoint: Boost Only - Day 28 after the booster dose Prime/boost - Day 28 after the second dose of the 2 primary vaccine doses | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutralizing antibodies against SARS CoV 2, antinucleocapsid immunoglobulins, pseudoneutralising antibodies, cellular T cell and B cell immune responses. Timepoint: D1, D14, D28, D56, D84, D208, D365;Serious adverse events and adverse events of special interestTimepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactWinsley Rose
Christian Medical College
Outcome results
None listed