COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59405

Winsley Rose

winsleyrose@cmcvellore.ac.in

2021-08-13

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

1. Males and females aged 18+ years <br/ >2. No known immunodeficiency <br/ >3. History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects) <br/ >4. No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history <br/ >5. No acute infectious and/or respiratory diseases within at least 14 days before the enrolment. <br/ >

1. Previous receipt of any COVID vaccine (only for those who are in the prime and boost part of the study) <br/ >2. Any vaccination/immunization within 30 days before the enrolment <br/ >3. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrolment <br/ >4. Immunosuppressors therapy finished within 3 months before the enrolment <br/ >5. Pregnancy or breast-feeding <br/ >6. Acute coronary syndrome or stroke suffered less than one year before the enrolment <br/ >7. Tuberculosis, chronic systemic infections <br/ >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 <br/ >9. Subjects who are on drugs that could have potential drug interactions with the vaccines: <br/ >A.drugs for multiple sclerosis (dimethyl fumarate, fingolimod, ozanimod, etc.), <br/ >B. monoclonal antibodies, corticosteroids, corticotropin, <br/ >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.), <br/ >D. immunoglobulins, interleukins, X-ray contrast agents <br/ >10. Medical history of malignancy <br/ >11. Donated blood or plasma (450+ mL) within 2 months before the enrolment <br/ >12. Splenectomy in the medical history <br/ >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 <br/ >14. Known HIV positive <br/ >15. Local inflammation at injection site (deltoid muscle area), which does not allow assessing the local response to the vaccine administration <br/ >16. Alcohol or drug addiction in the medical history <br/ >17. Participation in any other interventional clinical trial within 1 month prior to the screening <br/ >17. Any other medical condition that would limit the participation of the subject as per Investigatorâ??s discretion <br/ >18. Subjects contraindicated for vaccination <br/ > <br/ >Temporary exclusion criteria: <br/ > <br/ >If at visit 1 screening/ vaccination the volunteer has any of the following, they will not be enrolled that day. <br/ >1. Acute respiratory illness (moderate or severe illness with or without fever) <br/ >2. Fever (oral temperature greater than 37.8°C) <br/ >They may be considered for enrolment later in the trial, if they recover in sufficient time. <br/ >

12

Christian Medical College

18

99

India

Healthy volunteers

N/A

1100

Immunogenicity measured by anti spike immunoglobulins for SARS CoV 2Timepoint: Boost Only - Day 28 after the booster dose <br/ > <br/ >Prime/boost - Day 28 after the second dose of the 2 primary vaccine doses

| Declared number of arm (8.0) differs from found arms (9.0)

Phase 4

[{"arm_notes": "Covaxin booster to already Covaxin vaccinated with 2 doses", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Covaxin booster to already Covishield vaccinated with 2 doses\u00a0", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Covaxin followed by Covishield followed by booster Covaxin\u00a0", "treatment_id": 1898, "treatment_name": "Chadox1 ncov-19+covaxin", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Covaxin followed by Covishield followed by booster Covishield\u00a0", "treatment_id": 1898, "treatment_name": "Chadox1 ncov-19+covaxin", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Covishield booster to already Covaxin vaccinated with 2 doses\u00a0", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Covishield booster to already Covishield vaccinated with 2 doses\u00a0", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Covishield followed by Covaxin followed by booster Covaxin\u00a0", "treatment_id": 1898, "treatment_name": "Chadox1 ncov-19+covaxin", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Covishield followed by Covaxin followed by booster Covishield\u00a0", "treatment_id": 1898, "treatment_name": "Chadox1 ncov-19+covaxin", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous Covaxin 2 primary doses followed by booster Covaxin\u00a0", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous Covaxin 2 primary doses followed by booster Covishield\u00a0", "treatment_id": 1898, "treatment_name": "Chadox1 ncov-19+covaxin", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous Covishield 2 primary doses followed by booster Covaxin\u00a0", "treatment_id": 1898, "treatment_name": "Chadox1 ncov-19+covaxin", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Homologous Covishield 2 primary doses followed by booster Covishield\u00a0", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]