Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: recombinant BCG vaccine, VPM1002: Dose : 0.1 ml, single dose of the reconstituted vaccine to be administered as an intradermal injection
Control Intervention1: Placebo, 0.9% sodium chlo
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of subjects with laboratory confirmed COVID-19 infection among HCWs 2.Number of subjects with laboratory confirmed COVID-19 infection among other high-risk subjects 3.Number of laboratory confirmed COVID-19 infection with severe, critical or life-threatening disease as assessed by Investigator among HCWs 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
| Measure | Time frame |
|---|---|
| 1.Duration of COVID-19 symptoms in HCWs 2.Duration of COVID-19 symptoms in other high-risk subjects 3.Severe Disease Outcomes in HCWs 4.Severe Disease Outcomes in other high-risk subjects 5.Severe Disease Outcomes among in elderly subjects (greater than or equal to 60 years) 6.Severe Disease Outcomes among subjects with Co-morbidities 7.Incidence of Adverse Events and Serious Adverse EventsTimepoint: up to 6 months (180 days) following vaccine administration | — |
Countries
India
Contacts
Public ContactDr Umesh Shaligram
Serum Institute Of India Pvt. Ltd.
Outcome results
None listed