COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46312

Dr Krishna Mohan

kmohan@bharatbiotech.com

2020-09-08

Not recruiting

RCT

Randomized

Adaptive

Not reported

multi-center

Prevention

1. Ability to provide written informed consent. <br/ >2. Participants of either gender age between �18 to �55 years. (Phase 1) <br/ >3. Participants of either gender age between �12 to �65 years. (Phase2) <br/ >4. Good general health as determined by the discretion of investigator (vital signs <br/ >(Pulse 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), <br/ >medical history, and physical examination). <br/ >5. Expressed interest and availability to fulfil the study requirements. <br/ >6. For a female participant of child-bearing potential, avoid becoming pregnant <br/ >(use of an effective method of contraception or abstinence) from the time of <br/ >study enrolment until at least 4 weeks after the last vaccination and agrees not <br/ >to participate in another clinical trial at any time during the study period. <br/ >7. Sexually active men who are considered sexually fertile must agree to use a <br/ >barrier method of contraception and agree to continue the use for at least 3 <br/ >months following the last vaccination, or have a partner who is permanently <br/ >sterile or is medically unable to become pregnant. <br/ >8. Male subjects agree to refrain from sperm donation from the time of first <br/ >vaccination until 3 months after last vaccination. <br/ >9. Participants must refrain from blood or plasma donation from the time of first <br/ >vaccination until 3 months after last vaccination. <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 <br/ >research. <br/ >

1. History of any other COVID-19 investigational vaccination. <br/ >2. Unacceptable laboratory abnormality from screening (before first vaccination) <br/ >or safety testing as listed below. <br/ >ï?? Hematology, Random blood sugar , Renal function test (Blood urea nitrogen <br/ >(BUN) and Serum creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C, HIV antibody, and hepatitis B surface antigen. (Subjects will <br/ >be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody and <br/ >hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for <br/ >follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA. <br/ >4. Pregnancy, lactation or willingness/intention to become pregnant during the <br/ >study <br/ >5. 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 3 days before <br/ >each dose of vaccine. <br/ >6. Medical, problems as a result of alcohol or illicit drug use during the past 12 <br/ >months. <br/ >7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days <br/ >before enrolment or expects to receive an experimental agent during the study <br/ >period. <br/ >8. Known sensitivity to any ingredient of the study vaccines, or a more severe <br/ >allergic reaction and history of allergies or anaphylaxis concerning vaccination <br/ >in the past. <br/ >9. Receipt of immunoglobulin or other blood products or blood transfusions <br/ >within the 3 months before vaccination in this study. <br/ >10. Either Immunosuppressant or Immunocompromised status, as a result of an <br/ >underlying illness or treatment with immunosuppressive or cytotoxic drugs, or <br/ >use of anticancer chemotherapy or radiation therapy within the preceding 36 <br/ >months. <br/ >11. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids), or <br/ >high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or <br/ >equivalent) within the preceding 6 months (nasal and topical steroids are <br/ >allowed). <br/ >12. Any history of hereditary angioedema or idiopathic angioedema. <br/ >13. History of any cancer. <br/ >14. History of serious psychiatric conditions likely to affect participation in the <br/ >study. <br/ >15. A bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), <br/ >or prior history of significant bleeding following venipuncture. <br/ >16. Any other serious chronic illness requiring hospital specialist supervision. <br/ >17. Chronic respiratory diseases (SARS), including mild asthma <br/ >18. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal <br/ >disease, an endocrine disorder, and neurological illness <br/ >19. Morbidly Obese (BMIâ?¥35 kg/m2) or underweight (BMI â?¤18 kg/m2). <br/ >20. Living in the same household of any COVID-19 positive. <br/ >21. New onset of fever or a cough or shortness of breath or anosmia/ageusia since <br/ >May 2020. Should a reliable test become available, these exclusion criteria will <br/ >be replaced with seropositivity for COVID-19 before enrolment. <br/ >22. Any other condition that in the opinion of the investigator would jeopardize the <br/ >safety or rights of a volunteer participating in the trial or would render th

2

Bharat Biotech International limited

12

65

India

Healthy volunteers

N/A

124

Phase 1 <br/ >1. The occurrence of immediate adverse events within two hours of vaccination. <br/ >2. The occurrence of adverse events within seven days . <br/ >3. The occurrence of any adverse events throughout the study duration <br/ > 4. The occurrence of serious adverse events (SAEs). <br/ > <br/ >Phase 2 <br/ >1. To evaluate the immunogenicity in terms of four-fold seroconversion rate of SARSCoV- <br/ >2 virus neutralizing antibodies across the two dosage strengths of BBV152D.Timepoint: Phase 1 <br/ > <br/ >1.Time Frame: 2 hours. <br/ >2.Time Frame: 7 <br/ >days <br/ >3. Time Frame: throughout the study duration <br/ >4.Time Frame: throughout the <br/ >study duration. <br/ > <br/ >Phase 2 <br/ >baseline to day 0; 14; 28; 42; 104 and 194.

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

Phase 1/Phase 2

[{"arm_notes": "0,1ml;1; \u226518 to \u226455 yo and \u226512 to \u226465", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0,1ml;2; \u226518 to \u226455 yo and \u226512 to \u226465", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]