COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55080

Dr V Krishna Mohan

kmohan@bharatbiotech.com

2021-04-19

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Phase 1 (Completed) <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable <br/ >subjects). <br/ >2. Participants of either gender of age between �18 to �55 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical <br/ >history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, planning to avoid becoming <br/ >pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination <br/ >9. Agrees not to participate in another clinical trial at any time during the study period. <br/ >10. Agrees to remain in the study area for the entire duration of the study. <br/ >11. Willing to allow storage and future use of biological samples for future research. <br/ > <br/ >Phase 2: <br/ >1. Ability to provide written informed consent (Audio video consent for vulnerable subjects). <br/ >2. Participants of either gender of age between �12 to � 65 years. <br/ >3. Good general health as determined by the discretion of investigator (vital signs (heart rate �60 to�100 bpm, blood pressure systolic �90 mm Hg and <140 mm <br/ >Hg, diastolic � 60 mm Hg and <90 mm Hg, oral temperature <100.4ºF), medical history, and physical examination). <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study <br/ >enrolment until at least four weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period. <br/ >6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ >7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ >8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination. <br/ >9. Agrees to remain in the study area for the entire duration of the study. <br/ >10. Willing to allow storage and future use of biological samples for future research. <br/ >Phase 2 Extension: <br/ >The participants enrolled in Phase 2 part of the study and received two doses of the <br/ >BBV152 (6μg) vaccine are eligible. <br/ >

Phase 1: <br/ >1. History of any other COVID-19 investigational vaccination. <br/ >2. Unacceptable laboratory abnormality from screening (prior to first vaccination) <br/ >or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen]. <br/ >(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary <br/ >care provider for follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA method. <br/ >4. Health care workers. <br/ >5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine). <br/ >6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness <br/ >such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >7. Medical problems as a result of alcohol or illicit drug use during the past 12 months. <br/ >8. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. <br/ >9. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >12. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ >13. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ >14. Any history of hereditary angioedema or idiopathic angioedema. <br/ >15. Any history of anaphylaxis in relation to vaccination. <br/ >16. Any history of albumin-intolerance. <br/ >17. Pregnancy, lactation, or willingness/intention to become pregnant during the study. <br/ >18. History of any cancer. <br/ >19. History of psychiatric severe conditions likely to affect participation in the study. <br/ >20. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ >21. Any other serious chronic illness requiring hospital specialist supervision. <br/ >22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma. <br/ >23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness <br/ >24. Morbidly obese (BMI�35 kg/m2) or underweight (BMI �18 kg/m2). <br/ >25. Living in the same household of any COVID-19 positive person. <br/ >26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights

2

Bharat Biotech International Limited

12

65

India

Healthy volunteers

N/A

190

To evaluate the immunogenicity in terms of GMT and four fold seroconversion rate of neutralizing antibodies NAbs across the two groups Vaccine and PlaceboTimepoint: baseline; 28 days 6 months

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

Phase 2

[{"arm_notes": "", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]