Trial Outcomes & Findings for Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines (NCT NCT05592223)
NCT ID: NCT05592223
Last Updated: 2025-12-16
Results Overview
Through microbial culture, quantify in colony forming units (CFU) BCG bacterial burden in skin biopsies from challenge sites. Outcome measure if the mean cfu from day 15 biopsy specimens.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
15 days after BCG dosing
Results posted on
2025-12-16
Participant Flow
Cohort A recruitment period 01 NOV 2022-01 DEC 2022 Cohort B recruitment period 01 JUL 2023-01 AUG 2023
Participant milestones
| Measure |
BCG Challenged-Isoniazid Treated
Received INH at a dose of 300 mg for three days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Isoniazid: INH in the dose of 300 mg for three days post BCG injection.
|
BCG Challenged-Isoniazid Untreated
Did not receive any INH dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
BCG Challenged-RIF Treated
Did receive RIF in the dose of 600 mg for seven days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Rifampin: RIF in the dose of 600 mg for seven days post BCG injection.
|
BCG Challenged-Rifampin Untreated
Did not receive any Rif dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
Baseline characteristics by cohort
| Measure |
BCG Challenged-Isoniazid Treated
n=5 Participants
Received INH at a dose of 300 mg for three days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Isoniazid: INH in the dose of 300 mg for three days post BCG injection.
|
BCG Challenged-Isoniazid Untreated
n=5 Participants
Did not receive any INH dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
BCG Challenged-RIF Treated
n=5 Participants
Did receive RIF in the dose of 600 mg for seven days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Rifampin: RIF in the dose of 600 mg for seven days post BCG injection.
|
BCG Challenged-Rifampin Untreated
n=5 Participants
Did not receive any Rif dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Median Age (Range)
|
28 years
n=6 Participants
|
40 years
n=5 Participants
|
31 years
n=5 Participants
|
36 years
n=387 Participants
|
35 years
n=18 Participants
|
|
Sex/Gender, Customized
Male
|
3 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=387 Participants
|
11 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=387 Participants
|
8 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Intersex
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=387 Participants
|
1 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=387 Participants
|
4 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=387 Participants
|
16 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=387 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=387 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=387 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=387 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=387 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=387 Participants
|
12 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=387 Participants
|
3 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=387 Participants
|
3 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 15 days after BCG dosingThrough microbial culture, quantify in colony forming units (CFU) BCG bacterial burden in skin biopsies from challenge sites. Outcome measure if the mean cfu from day 15 biopsy specimens.
Outcome measures
| Measure |
BCG Challenged-Isoniazid Treated
n=5 Participants
Received INH at a dose of 300 mg for three days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Isoniazid: INH in the dose of 300 mg for three days post BCG injection.
|
BCG Challenged-Isoniazid Untreated
n=5 Participants
Did not receive any INH dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
BCG Challenged-RIF Treated
n=5 Participants
Did receive RIF in the dose of 600 mg for seven days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Rifampin: RIF in the dose of 600 mg for seven days post BCG injection.
|
BCG Challenged-Rifampin Untreated
n=5 Participants
Did not receive any Rif dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
|---|---|---|---|---|
|
Assess Viable BCG Bacteria From Intradermal Challenge Site From Culture.
|
20,440 CFU
Standard Deviation 40,516
|
80 CFU
Standard Deviation 92
|
5 CFU
Standard Deviation 12
|
10,673 CFU
Standard Deviation 12,646
|
SECONDARY outcome
Timeframe: Through study completion, an average of 16 weeks.Mild (grade 1): events do not require treatment and do not interfere with the patient's daily activities Moderate (grade 2): events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning and daily activities Severe (grade 3): events interrupt a patient's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating.
Outcome measures
| Measure |
BCG Challenged-Isoniazid Treated
n=5 Participants
Received INH at a dose of 300 mg for three days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Isoniazid: INH in the dose of 300 mg for three days post BCG injection.
|
BCG Challenged-Isoniazid Untreated
n=5 Participants
Did not receive any INH dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
BCG Challenged-RIF Treated
n=5 Participants
Did receive RIF in the dose of 600 mg for seven days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Rifampin: RIF in the dose of 600 mg for seven days post BCG injection.
|
BCG Challenged-Rifampin Untreated
n=5 Participants
Did not receive any Rif dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
|---|---|---|---|---|
|
The Rate of AE's/SAE's
All AEs · Number experiencing no Adverse Events
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
The Rate of AE's/SAE's
Grade 3 AEs · Number experiencing any Adverse Event
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
The Rate of AE's/SAE's
Grade 3 AEs · Number experiencing no Adverse Events
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
The Rate of AE's/SAE's
All AEs · Number experiencing any Adverse Event
|
5 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 15 post BCG dosingPopulation: One participant declined day 15 biopsy
Assessing the number of real time BCG genomes present in skin biopsies from challenge sites.
Outcome measures
| Measure |
BCG Challenged-Isoniazid Treated
n=5 Participants
Received INH at a dose of 300 mg for three days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Isoniazid: INH in the dose of 300 mg for three days post BCG injection.
|
BCG Challenged-Isoniazid Untreated
n=4 Participants
Did not receive any INH dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
BCG Challenged-RIF Treated
n=5 Participants
Did receive RIF in the dose of 600 mg for seven days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Rifampin: RIF in the dose of 600 mg for seven days post BCG injection.
|
BCG Challenged-Rifampin Untreated
n=5 Participants
Did not receive any Rif dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
|---|---|---|---|---|
|
Assess Quantitative Bacterial 16S Ribosomal DNA PCR
|
8239.4 copies
Standard Deviation 15243.9
|
97.7 copies
Standard Deviation 115.9
|
5.34 copies
Standard Deviation 11.9
|
10,673.4 copies
Standard Deviation 12645.7
|
SECONDARY outcome
Timeframe: Day 144To assess the IgG immune response after INH or RIF dosing. The AUC we report is not a integration of concentration over time. Instead, AUC reported here quantifies the overall antibody binding signal across a titration series from a single time point (Day 144). In this assay, each sample from a single visit is measured at multiple dilutions, and the signal is expressed AUC in unit MFI × log₁₀(dilution). Plotting MFI as a function of dilution generates a curve that reflects how strongly and consistently the antibodies bind over the dilution range. The AUC therefore summarizes the entire binding titration curve - capturing both signal intensity and how long the signal is maintained across dilutions.
Outcome measures
| Measure |
BCG Challenged-Isoniazid Treated
n=5 Participants
Received INH at a dose of 300 mg for three days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Isoniazid: INH in the dose of 300 mg for three days post BCG injection.
|
BCG Challenged-Isoniazid Untreated
n=5 Participants
Did not receive any INH dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
BCG Challenged-RIF Treated
n=5 Participants
Did receive RIF in the dose of 600 mg for seven days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Rifampin: RIF in the dose of 600 mg for seven days post BCG injection.
|
BCG Challenged-Rifampin Untreated
n=5 Participants
Did not receive any Rif dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
|---|---|---|---|---|
|
Quantification by AUC of IgG in the Blood After BCG Immunization and INH or RIF Dosing.
|
319.4 MFI × log₁₀ dilution
Interval 276.3 to 469.1
|
822.5 MFI × log₁₀ dilution
Interval 192.0 to 946.3
|
2888.8 MFI × log₁₀ dilution
Interval 1941.878 to 4600.566
|
1951.5 MFI × log₁₀ dilution
Interval 888.232 to 3436.136
|
Adverse Events
BCG Challenged-Isoniazid Treated
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BCG Challenged-Isoniazid Untreated
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
BCG Challenged-RIF Treated
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BCG Challenged-Rifampin Untreated
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BCG Challenged-Isoniazid Treated
n=5 participants at risk
Received INH at a dose of 300 mg for three days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Isoniazid: INH in the dose of 300 mg for three days post BCG injection.
|
BCG Challenged-Isoniazid Untreated
n=5 participants at risk
Did not receive any INH dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
BCG Challenged-RIF Treated
n=5 participants at risk
Did receive RIF in the dose of 600 mg for seven days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Rifampin: RIF in the dose of 600 mg for seven days post BCG injection.
|
BCG Challenged-Rifampin Untreated
n=5 participants at risk
Did not receive any Rif dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Severe Back Pain
|
0.00%
0/5 • Adverse Events were collected through day 114 after vaccination
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected through day 114 after vaccination
|
0.00%
0/5 • Adverse Events were collected through day 114 after vaccination
|
0.00%
0/5 • Adverse Events were collected through day 114 after vaccination
|
Other adverse events
| Measure |
BCG Challenged-Isoniazid Treated
n=5 participants at risk
Received INH at a dose of 300 mg for three days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Isoniazid: INH in the dose of 300 mg for three days post BCG injection.
|
BCG Challenged-Isoniazid Untreated
n=5 participants at risk
Did not receive any INH dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
BCG Challenged-RIF Treated
n=5 participants at risk
Did receive RIF in the dose of 600 mg for seven days post BCG injection.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
Rifampin: RIF in the dose of 600 mg for seven days post BCG injection.
|
BCG Challenged-Rifampin Untreated
n=5 participants at risk
Did not receive any Rif dose.
BCG Vaccine USP: 2x10\^6 cfu Tice® BCG (ID)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
BCG Site Abscess
|
0.00%
0/5 • Adverse Events were collected through day 114 after vaccination
|
0.00%
0/5 • Adverse Events were collected through day 114 after vaccination
|
0.00%
0/5 • Adverse Events were collected through day 114 after vaccination
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected through day 114 after vaccination
|
|
Skin and subcutaneous tissue disorders
Injection site erythema
|
100.0%
5/5 • Number of events 5 • Adverse Events were collected through day 114 after vaccination
|
100.0%
5/5 • Number of events 5 • Adverse Events were collected through day 114 after vaccination
|
100.0%
5/5 • Number of events 5 • Adverse Events were collected through day 114 after vaccination
|
100.0%
5/5 • Number of events 5 • Adverse Events were collected through day 114 after vaccination
|
|
Skin and subcutaneous tissue disorders
Injection Site induration
|
100.0%
5/5 • Number of events 5 • Adverse Events were collected through day 114 after vaccination
|
100.0%
5/5 • Number of events 5 • Adverse Events were collected through day 114 after vaccination
|
100.0%
5/5 • Number of events 5 • Adverse Events were collected through day 114 after vaccination
|
100.0%
5/5 • Number of events 5 • Adverse Events were collected through day 114 after vaccination
|
Additional Information
Dr. Elizabeth Chandler Church
Fred Hutchinson Cancer Center
Phone: 2066676982
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place