CTRI/2021/08/035648尚未招募4 期
Comparison of reactogenicity and immunogenicity of heterologous prime-boost and heterologous boost of ChAdOx1 nCoV-19 (Covishield), BBV 152 (Covaxin), and other COVID vaccines with homologous administration of Covishield and Covaxin - MnM study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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