A Placebo-Controlled Study to Evaluate the effect of the recombinant Bacillus Calmette–Guérin (BCG) vaccine VPM1002 on the Incidence or Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Participants in Australia

Phase 3

Withdrawn

• Conditions: COVID-19; Infection - Studies of infection and infectious agents; Infection - Other infectious diseases

• Registration Number: ACTRN12620000707965
• Lead Sponsor: Accelagen Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-29
• Last Update Posted: 14 September 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 3468

Inclusion Criteria

1. Male or Female participants >/= 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection
2. Participants with high-risk of infection to COVID-19 cases defined as:
• Health care workers (physicians, nurses, paramedical staff) working in direct contact with COVID-19 patients
• Other high-risk participants who are aged >/= 65 years or aged >/= 18 years with co-morbidities such as:
• Insulin dependent or non-insulin dependent diabetes mellitus
• Hypertension
• Past history of completed acute myocardial infarction
• Cardiac failure of NYHA class 2 and above
• Rheumatic heart disease
• Chronic obstructive pulmonary disease, bronchiectasis or emphysema
• Chronic suppurative lung disease
• Cystic fibrosis
• Pulmonary fibrosis
3. Negative screening for SARS-CoV-2 infection (using a validated and approved PCR or serology test method) at time of consent
4. Capable of giving informed consent

Exclusion Criteria

1. Known active Mycobacterium tuberculosis disease
2. Fever (greater than or equal to 38 ºC) or any other respiratory symptoms/illnesses within the past 14 days
3. BCG vaccination in the previous 12 months
4. Has any BCG vaccine contraindication/s
5. Confirmed existing or past COVID-19 infection by PCR or serology testing methods with or without symptoms
6. Pregnant or breastfeeding women
7. Women of child-bearing potential not agreeing to use adequate contraception
8. Current active viral or bacterial infection
9. Expected vaccination during the study period, independently of the type of vaccination
10. Severely immunocompromised participants. This exclusion category comprises
a) participants with known infection by the HIV;
b) participants with solid organ transplantation;
c) participants with bone marrow transplantation;
d) participants under chemotherapy/radiotherapy;
e) participants with primary immunodeficiency;
f) treatment with any anticytokine therapies.
g) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisolone or equivalent for longer than 3 months from the time of screening, or probable use of oral or intravenous steroids in the following four weeks
11. Active solid or non-solid malignancy or lymphoma within the prior two years
12. Individuals known to be hypersensitive to any component of the vaccine
13. Eczema or other significant skin lesion or infection at the site/s of injection.
14. Any other medical condition which in the opinion of the investigator may affect the participant’s safety or study participation and conduct.

Study & Design

• Study Type: Interventional
• Study Design: Not specified