BCG and Plasma Amyloid in Non-Demented Adults (NCT04449926) | Clinical Trial Compass
CompletedPhase 2
BCG and Plasma Amyloid in Non-Demented Adults
United States49 participantsStarted 2020-11-09
Plain-language summary
BCG vaccination, the most widely used vaccination in the world, is used to reduce risk of tuberculosis infection; it is used for other mycobacterial infections as well, benefiting leprosy and Buruli ulcer. BCG has "heterologous" effects that aids in an array of non-mycobacterial and viral infections as well as bladder cancer. It is the heterologous effect, sometimes called the "off-target" effect that may offer benefit in Alzheimer's disease. Population studies and studies of adults receiving BCG show a lessened risk of Alzheimer's disease. The study will see if BCG vaccination will alter a plasma test for amyloid, a biomarker for cerebral amyloid.
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion Criteria:
* BCG naive
* Ability to read, understand and sign consent form
Exclusion Criteria:
* Known allergy to (components of) the BCG vaccine or serious adverse events to prior vaccine administration
* Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history of - or a suspicion of M. tuberculosis infection.
* Fever (\>38 C) within the past 24 hours.
* Suspicion of active viral or bacterial infection.
* Vaccination in the past 4 weeks or expected vaccination during the study period, independent of the type of vaccination.
* Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks.
* Active solid or non-solid malignancy or lymphoma within the prior two years.