COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59772

Subba Reddy GV

kishore.turaga@biologicale.com

2021-08-31

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Subject is seronegative to anti-SARS-CoV-2 IgG antibody prior to randomisation either into Group-1 and Group-2. <br/ >2. Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment in all groups. <br/ >3. Male or female subject between â?¥ 18 to 80 years of age. <br/ >4. Subject is willing to provide a written informed consent for voluntary participation in the study. <br/ >5. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ >6. Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >7. Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination. <br/ >8. Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study. <br/ >9. Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration. <br/ >10. Subject agrees not to participate in another clinical trial at any time during the total study period. <br/ >11. Subject agrees to refrain from blood donation during the course of the study. <br/ >12. Subject agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ >

1. History of vaccination with any investigational or approved vaccine against COVID-19 disease. <br/ >2. Subject living in the same household as that of any active COVID-19 positive individual. <br/ >3. History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines), <br/ >4. Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator. <br/ >5. Subjects with Body temperature of �100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination. <br/ >6. Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study. <br/ >7. Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: <br/ >8. severe psychiatric conditions, <br/ >9. any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >10. allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE SARS-CoV-2 COVID-19 vaccine), <br/ >11. neurological illness, and any other serious chronic illness requiring hospital specialist supervision. <br/ >12. Subjects requiring chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. <br/ >13. For corticosteroids, this will mean prednisone �0.5 mg/kg/day, or equivalent. <br/ >14. Inhaled and topical steroids are allowed. <br/ >15. Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data. <br/ >16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). <br/ >17. Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >18. Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment. <br/ >19. Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >20. Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >

2

Biological E Limited

18

80

India

Healthy volunteers

N/A

2140

1.Immune response measured after completion of 2-dose immunization schedule; as determined by geometric mean titres (GMT/C) of SARS-CoV-2 specific neutralising antibodies to evaluate immunogenic superiorityTimepoint: 1. After 14 days

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "0,5ml;2;Days0-28;IM", "treatment_id": 1896, "treatment_name": "Corbevax", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0,5ml;2;Days0-28;IM", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]