Study to Evaluate the Efficacy of Recombinant BCG VPM1002 in Reducing Infection Incidence and Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Subjects
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: Z23- Encounter for immunization
- Registration Number
- CTRI/2020/04/024749
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6041
1.Male or Female subjects = 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection
2.Test negative for SARS-CoV-2 infection (RT-PCR test) at screening
3.Capable of giving informed consent
1.Previous history of Tuberculosis or known active Mycobacterium tuberculosis infection
2.Received BCG vaccine within one year prior to screening
3.Fever (greater than or equal to 38 ºC/100.4°F) or any other respiratory symptoms/illnesses within the past 14 days
4.Pregnant or lactating women
5.Women of child-bearing potential not agreeing to use adequate contraception
6.Current active viral or bacterial infection
7.Expected vaccination during the study period, independently of the type of vaccination
8.Severely immunocompromised subjects.
9.Active solid or non-solid malignancy or lymphoma within the prior two years
10.Individuals known to be hypersensitive to any component of the vaccine
11.Eczema or other significant skin lesion or infection at the site/s of injection.
12.Any other medical condition which in the opinion of the investigator may affect the subject’s safety or study participation and conduct
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Number of subjects with laboratory confirmed COVID-19 infection among HCWs <br/ ><br>2.Number of subjects with laboratory confirmed COVID-19 infection among other high-risk subjects <br/ ><br>3.Number of laboratory confirmed COVID-19 infection with severe, critical or life-threatening disease as assessed by Investigator among HCWs <br/ ><br>4.Number of laboratory confirmed COVID-19 infection with severe, critical or life-threatening disease as assessed by Investigator among other high-risk subjectsTimepoint: up to 6 months (180 days) following vaccine administration
- Secondary Outcome Measures
Name Time Method 1.Duration of COVID-19 symptoms in HCWs <br/ ><br>2.Duration of COVID-19 symptoms in other high-risk subjects <br/ ><br>3.Severe Disease Outcomes in HCWs <br/ ><br>4.Severe Disease Outcomes in other high-risk subjects <br/ ><br>5.Severe Disease Outcomes among in elderly subjects (greater than or equal to 60 years) <br/ ><br>6.Severe Disease Outcomes among subjects with Co-morbidities <br/ ><br>7.Incidence of Adverse Events and Serious Adverse EventsTimepoint: up to 6 months (180 days) following vaccine administration