Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Health Network, Toronto
With
Serum Institute of India Pvt. Ltd.
Max Planck Institute for Infection Biology
Verity Pharmaceuticals Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Eighteen years of age or older
Employee/member of: municipal or provincial police service, emergency medical services, fire services, public transport service, health service, food manufacturing facility
You may not be if
Prior intravesical BCG or intradermal BCG, with the exception of tuberculosis vaccination in childhood.
Previous known history of latent or active tuberculosis
Known kidney, liver or blood disorders which impairs organ and marrow function
Chronic administration of steroids (\>10 mg prednisone) at the time of randomization
Current or planned concomitant biologic therapy in the next 7 months.
Known hypersensitivity or allergy to components of VPM1002
Pregnant or planning to become pregnant in the future 7 months.
Breastfeeding.
Current suspected viral or bacterial infection.
Body temperature \> 38° C
Participation in another interventional study with potentially conflicting medication within 30 days before screening.
The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-TNF therapy, methotrexate, azathioprine, antimalarials).
Active malignancy requiring treatment.
Known positive HIV serology.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine.
Previous positive COVID-19 confirmed infection.
Uncontrolled intercurrent illness.
Psychiatric illness/social situations that would limit compliance with study requirements.
