Trial Outcomes & Findings for A Pilot Study of the Effects of BCG Immunization on CSF and Blood-based Biomarkers in Older Adults. (NCT NCT04507126)
NCT ID: NCT04507126
Last Updated: 2025-12-12
Results Overview
Heat-killed BCG or Lipopolysaccharide (LPS) applied to peripheral blood mononuclear cells (PBMCs) from subjects at 0 and 90d after study start. Calculated as median fold change of cytokine levels in media at day 90 (pg/mL) compared to day 0 (pg/mL)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Day 90 compared to Day 0
Results posted on
2025-12-12
Participant Flow
Participant milestones
| Measure |
BCG Immunization
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
Enrolled
|
20
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
BCG Immunization
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Protocol Violation
|
4
|
Baseline Characteristics
A Pilot Study of the Effects of BCG Immunization on CSF and Blood-based Biomarkers in Older Adults.
Baseline characteristics by cohort
| Measure |
BCG Immunization
n=16 Participants
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Age, Customized
55-80 Years Old
|
16 Participants
n=26 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
White - caucasian/european heritage
|
16 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic
|
16 Participants
n=26 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=26 Participants
|
|
Cerebrospinal Fluid (CSF) collection
|
16 Participants
n=26 Participants
|
|
Blood collection
|
16 Participants
n=26 Participants
|
|
Number of participants that participated in cognitive testing
|
16 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Day 90 compared to Day 0Heat-killed BCG or Lipopolysaccharide (LPS) applied to peripheral blood mononuclear cells (PBMCs) from subjects at 0 and 90d after study start. Calculated as median fold change of cytokine levels in media at day 90 (pg/mL) compared to day 0 (pg/mL)
Outcome measures
| Measure |
BCG Immunization
n=10 Participants
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Median Fold Change of Cytokine Levels From Day 0 to Day 90
Interferon-gamma cytokine
|
3254 pg/mL
Interval 281.1 to 7169.0
|
|
Median Fold Change of Cytokine Levels From Day 0 to Day 90
Interleukin-1 beta cytokine
|
1.997 pg/mL
Interval -5.641 to 15.08
|
|
Median Fold Change of Cytokine Levels From Day 0 to Day 90
Interleukin 6 cytokine
|
16.83 pg/mL
Interval -319.8 to 717.5
|
|
Median Fold Change of Cytokine Levels From Day 0 to Day 90
Tumor necrosis factor alpha cytokine
|
-33.89 pg/mL
Interval -529.3 to 1746.0
|
PRIMARY outcome
Timeframe: AEs were collected from baseline through study completion, an average of 390 daysNumber of Participants With Treatment-Related Adverse Events to determine safety of BCG
Outcome measures
| Measure |
BCG Immunization
n=16 Participants
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 90 compared to Day 0Median difference of biomarkers measured in pg/mL (Amyloid-β42/40, phospho-tau (p181 tau), glial fibrillary astrocytic protein (GFAP) and neurofilament light protein (NFL) biomarkers) in CSF from baseline to 90 days.
Outcome measures
| Measure |
BCG Immunization
n=15 Participants
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Median Difference in CSF Biomarkers of Alzheimer's Disease (AD) Pathology From Day 0 to Day 90
AB42/40
|
-0.0005220 pg/mL
Interval -0.002264 to 0.002382
|
|
Median Difference in CSF Biomarkers of Alzheimer's Disease (AD) Pathology From Day 0 to Day 90
NFL
|
-47.17 pg/mL
Interval -361.6 to 125.7
|
|
Median Difference in CSF Biomarkers of Alzheimer's Disease (AD) Pathology From Day 0 to Day 90
GFAP
|
789.7 pg/mL
Interval -693.0 to 3842.0
|
|
Median Difference in CSF Biomarkers of Alzheimer's Disease (AD) Pathology From Day 0 to Day 90
p181- Tau
|
1.058 pg/mL
Interval -0.9333 to 4.767
|
SECONDARY outcome
Timeframe: Day 90 compared to Day 0Median Fold change in CSF biomarkers from baseline measured in pg/mL (Interleukin 6 (IL6), Tumor Necrosis Factor alpha (TNFa), interleukin 1 beta (IL1beta), Interferon gamma (IFNg))
Outcome measures
| Measure |
BCG Immunization
n=16 Participants
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Median Fold Change in CSF Biomarkers of Pharmacodynamic Response From Day 0 to Day 90
Interferon gamma (IFNg)
|
-.01 pg/mL
Interval -3.015 to 4.5
|
|
Median Fold Change in CSF Biomarkers of Pharmacodynamic Response From Day 0 to Day 90
Interleukin 6 (IL6)
|
7.332 pg/mL
Interval -783.0 to 548.2
|
|
Median Fold Change in CSF Biomarkers of Pharmacodynamic Response From Day 0 to Day 90
Tumor Necrosis Factor alpha (TNFa)
|
-.8676 pg/mL
Interval -14.66 to 6.242
|
|
Median Fold Change in CSF Biomarkers of Pharmacodynamic Response From Day 0 to Day 90
Interleukin 1 beta (IL1B)
|
23.74 pg/mL
Interval -7.202 to 72.03
|
SECONDARY outcome
Timeframe: Day 90 compared to Day 0Mean change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) from baseline to 3 months after BCG injection. Total Scaled Index (TSI) . Higher scores mean better performance on the RBANS Total Scaled Index. TSI Minimum 40, TSI Maximum 160.
Outcome measures
| Measure |
BCG Immunization
n=16 Participants
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Cognitive Measures (RBANS) Total Scored Index, 3 Months After BCG Injection
Day 0
|
98.1 units on TSI scale
Interval 88.57 to 107.7
|
|
Cognitive Measures (RBANS) Total Scored Index, 3 Months After BCG Injection
Day 90
|
104.1 units on TSI scale
Interval 93.32 to 114.8
|
SECONDARY outcome
Timeframe: Time Frame: Day 90 compared to Day 0Median Fold change in circulating cytokines in plasma from baseline measured in pg/mL (IL6, TNFa, IL1beta, IFNg)
Outcome measures
| Measure |
BCG Immunization
n=16 Participants
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Median Fold Change in Circulating Cytokines From Day 0 to Day 90
IL1beta
|
33.47 pg/mL
Interval -20.48 to 109.1
|
|
Median Fold Change in Circulating Cytokines From Day 0 to Day 90
IL6
|
332.9 pg/mL
Interval -769.4 to 1020.0
|
|
Median Fold Change in Circulating Cytokines From Day 0 to Day 90
TNFa
|
24.80 pg/mL
Interval -22.71 to 145.8
|
|
Median Fold Change in Circulating Cytokines From Day 0 to Day 90
IFNg
|
259.8 pg/mL
Interval 27.32 to 789.4
|
Adverse Events
BCG Immunization
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BCG Immunization
n=16 participants at risk
All participants will receive two Bacillus Calmette-Guérin (Japan BCG) vaccine injections spaced four week apart. Each injection will have 1.8-3.9 x 10\^6 colony forming units (CFU) reconstituted in 0.1 mL saline.
Bacillus Calmette-Guerin (BCG): Vaccine
|
|---|---|
|
Nervous system disorders
Post Lumbar Puncture Headache
|
25.0%
4/16 • Number of events 4 • Adverse event data was collected from baseline to end of study, up to 396 days.
Adverse events were systematically collected at each study visit and reviewed by the study PI regularly.
|
|
Nervous system disorders
Intermittent headache
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected from baseline to end of study, up to 396 days.
Adverse events were systematically collected at each study visit and reviewed by the study PI regularly.
|
|
Nervous system disorders
Back pain
|
18.8%
3/16 • Number of events 3 • Adverse event data was collected from baseline to end of study, up to 396 days.
Adverse events were systematically collected at each study visit and reviewed by the study PI regularly.
|
|
Nervous system disorders
Fatigue
|
12.5%
2/16 • Number of events 2 • Adverse event data was collected from baseline to end of study, up to 396 days.
Adverse events were systematically collected at each study visit and reviewed by the study PI regularly.
|
|
Skin and subcutaneous tissue disorders
Hematoma at blood draw site
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected from baseline to end of study, up to 396 days.
Adverse events were systematically collected at each study visit and reviewed by the study PI regularly.
|
|
Skin and subcutaneous tissue disorders
Removal of squamous cell carcinoma
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected from baseline to end of study, up to 396 days.
Adverse events were systematically collected at each study visit and reviewed by the study PI regularly.
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected from baseline to end of study, up to 396 days.
Adverse events were systematically collected at each study visit and reviewed by the study PI regularly.
|
|
Psychiatric disorders
Increased stress
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected from baseline to end of study, up to 396 days.
Adverse events were systematically collected at each study visit and reviewed by the study PI regularly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place