Mixing of COVID vaccines study
- Registration Number
- CTRI/2021/08/035648
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 <1000 mm3, agranulocytosis, significant blood loss, severe anaemia (haemoglobin <80g/l) immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity measured by anti spike immunoglobulins for SARS CoV 2Timepoint: Boost Only - Day 28 after the booster dose <br/ ><br> <br/ ><br>Prime/boost - Day 28 after the second dose of the 2 primary vaccine doses
- Secondary Outcome Measures
Name Time Method eutralizing antibodies against SARS CoV 2, antinucleocapsid immunoglobulins, pseudoneutralising antibodies, cellular T cell and B cell immune responses. <br/ ><br>Timepoint: D1, D14, D28, D56, D84, D208, D365;Serious adverse events and adverse events of special interestTimepoint: Throughout the study period