A Pilot Study of the Effects of BCG Immunization on CSF and Blood-based Biomarkers in Older Adults.

Completed · Phase 2

Conditions studied: Healthy

In brief

A pilot study of the effects of Bacillus Calmette-Guérin (BCG) immunization on cerebrospinal fluid and blood-based biomarkers in older adults.

Key facts

Study ID

NCT04507126

Run by

Massachusetts General Hospital

People needed

20

Starts

2021-03-01

Expected to finish

2022-12-09

Last updated by the study team

2025-12-12

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Study subjects meeting all the following criteria will be allowed to enroll in the study:
• Age 55-80 inclusive;
• Montreal Cognitive Assessment (MoCA ) ≥18;
• Normal cognition as defined by Montreal Cognitive Assessment (MoCA) ≥ 26 or Mild Cognitive Impairment (MCI) as defined by the National Institute of Health Alzheimer's Association (NIA-AA) Workgroup (2011) and MoCA score between 18 and 25 (inclusive);
• Education level, English language skills, and literacy indicates subject will be able to complete all assessments;
• Ability to provide informed consent;
• Willing and able to complete all assessment and study procedures, including blood draws, lumbar punctures, and clinical assessments;
• If on cholinesterase inhibitor and/or memantine, doses are stable for 3 months prior to baseline;
• Negative test results for Human Immunodeficiency Virus (HIV) antibody and Tuberculosis (TB) (QuantiFERON) at screening;
• No prior Bacillus Calmette-Guérin (BCG) exposure either through birth vaccinations (born in North American) or BCG bladder cancer treatment.
• Documentation of current flu season vaccination dated at least 60 days prior to baseline visit.

You may not qualify if…

• Study subjects meeting any of the following criteria will not be allowed to enroll in the study:
• History of chronic infectious disease, such as HIV or untreated or active hepatitis;
• History of tuberculosis, positive interferon-gamma release assay (IGRA, also known as the QuantiFERON-TB test), including a test with a high reactivity to mycobacteria of non-tuberculosis variety;
• Prior BCG vaccination, positive T-spot tuberculosis test or a T-spot test showing significant Mycobacteria exposure;
• A positive Severe acute respiratory syndrome coronavirus, Polymerase Chain Reaction (PCR) result within 3 months of screening, or known close contact with a confirmed Coronavirus 19 (COVID-19) positive person or symptoms highly suspicious for COVID-19 (per Center for Disease Control (CDC) guidelines) within 1 month of screening, including fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea, and/or sore throat, based on clinician's judgment;
• History of treatment with metformin within the past one year;
• Previous participation (ever) in active immunization research for Alzheimer's Disease (AD) or passive immunotherapy or other disease-modifying treatments for AD within the past three months;
• Current treatment with immunosuppressants (calcineurin inhibitors, corticosteroids, or biological or cytotoxic immunosuppressants, or disease or condition likely to require high dose steroid or immunosuppressive therapy);
• Other conditions or treatments associated with increased risk of infections or treatment with immunosuppressive medications for any reason;
• Current treatment with aspirin > 160 mg/day or chronic, daily nonsteroidal anti-inflammatory drugs (NSAIDs);
• Chronic use of antibiotics;
• History of keloid formation;
• Living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example, HIV+ or taking immunosuppressive medications for any reason), or in a job (e.g. healthcare) in which the subject works with immunosuppressed populations;
• Other/confounding neurological or psychiatric condition, unstable medical or psychiatric conditions, contraindications to BCG use and lab abnormalities or concurrent medication use posing risk for BCG or study procedures;
• Laboratory abnormalities in B12, Folate, thyroid stimulating hormone (TSH), or other common laboratory parameters that may contribute to cognitive dysfunction;
• Laboratory abnormalities in Complete Blood Count (CBC), electrolytes, Liver Function Tests (LFTs), Blood Urea Nitrogen (BUN), Creatinine (Cr), total serum immunoglobulins, erythrocyte sedimentation rate (ESR), C reactive protein (CRP), or urinalysis posing risk to treatment with BCG per clinician judgment;
• Laboratory abnormalities in prothrombin time /international normalized ratio (PT-INR), which would pose a risk to performing the lumbar puncture procedure;
• Discontinuation of cholinesterase inhibitor or memantine within one month (28 days) prior to baseline visit;
• Females who are pregnant, lactating or of child-bearing potential;
• If male with female partner(s) of childbearing potential, unwilling or unable to adhere to contraception requirements specified in the protocol.
• Administration of live vaccine <60 days prior to Baseline.
• Increased intracranial pressure as determined on a fundoscopy/neurological examination performed within 30 days of Lumbar Puncture (LP);
• COVID-19 vaccination < 60 days prior to baseline or within 14 days of BCG immunizations.

Where it is running

• Clinical Translational Research Unit — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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