BCG and Plasma Amyloid in Non-Demented Adults
Alzheimer Disease, Late Onset
About this trial
This is an interventional prevention trial for Alzheimer Disease, Late Onset focused on measuring Alzheimer's disease, biomarker, BCG, plasma amyloid, peptides 42/40, heterologous effect, immune risk profile, CMV, HHV5, immunosenescence
Eligibility Criteria
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.
Sites / Locations
- Mindful Diagnostics and Therapeutics
Arms of the Study
Arm 1
Experimental
BCG Vaccinated
Experimental: BCG Group FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing ~1x10^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (~2x10^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area. A follow up "booster" dose will be given one month after the initial dose.