COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48329

DrTSA Kishore

subhash.thuluva@biologicale.com

2020-11-10

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

1.Ability and willingness to provide written or thumb printed informed consent prior to performing any study specific procedure. <br/ >2.Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ >3.Participants of either gender between �18 to �55 years of age at phase-I and �18 to �65 years of age at phase-II at the time of 1st vaccination. <br/ >4.Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment. <br/ >5.Participants seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital signs defined as pulse rate of �60 to �100 bpm, blood pressure systolic of �90 mm Hg and <140 mm Hg, diastolic � 60 mm Hg and <90 mm Hg, body temperature <100.4ºF prior to enrolment]. <br/ >7.Female participants of child bearing potential negative to urine pregnancy test 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, <br/ >8.Agrees not to participate in another clinical trial at any time during the total study period. <br/ >9.Agrees to refrain from blood donation during the course of the study. <br/ >10.Agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ >11.Willing to allow storage and future use of collected biological samples for future research in an anonymised form. <br/ >

1.History of vaccination with any investigational vaccine against COVID-19 disease, <br/ >2.Seropositive to IgG antibodies against SARS CoV-2 <br/ >3.Living in the same household of any COVID-19 positive person, <br/ >4.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during clinical trials, <br/ >5.Seriously overweight (BMI â?¥ 40 Kg/m2), <br/ >6.Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment, <br/ >7.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/ >8.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >9.Any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator, <br/ >10.Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination, <br/ >11.History of severe psychiatric conditions likely to affect participation in the study, <br/ >12.History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >13.History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s four COVID-19 vaccine formulations, <br/ >14.Chronic respiratory diseases, including asthma, <br/ >15.Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, <br/ >16.Any other serious chronic illness requiring hospital specialist supervision, <br/ >17.Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week for at least one year, <br/ >18.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. For corticosteroids, this will mean prednisone â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed, <br/ >19.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), <br/ >20.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >21.Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >

2

Biological ELimited

18

65

India

Healthy volunteers

N/A

360

Phase-I <br/ >1.any adverse reactions <br/ >2.any solicited symptoms <br/ >3.any unsolicited adverse events <br/ >4.Serious and other medically attended adverse events <br/ >Phase-II <br/ >1.Virus neutralizing antibody (NAb) assay against SARS-CoV-2 virus <br/ >2.Seroconversion rates in terms of proportion of subjects with â?¥4-fold increase in neutralizing antibodies <br/ >3.Geometric mean titres and Geometric mean fold rise in neutralizing antibodies <br/ >Timepoint: Phase-I <br/ >1.within 2 hours of immediate post vaccination period; <br/ >2.within 7 consecutive days after each dose captured through subject diary; <br/ >3.at 6 months and 12 months post 2nd dose. <br/ >4.at 6 months and 12 months post 2nd dose <br/ > <br/ >Phase-II <br/ >1.at baseline; 28; 42; 56 days and again at 6 months and 12 months post 2nd dose. <br/ >2.from baseline <br/ >3.from baseline <br/ >

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

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "2 (day0-28)", "treatment_id": 190, "treatment_name": "Becov2", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]