Trial Outcomes & Findings for Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections (NCT NCT04884308)
NCT ID: NCT04884308
Last Updated: 2025-02-10
Results Overview
Change in concentration of interferon (IFN) gamma levels in blood after Bacille Calmette-Guérin (BCG) incubation relative to baseline as measured by SFUs. Spot forming units (SFU) is a measure of immune response of mononuclear cells in response to M. avium lysate. Higher values indicate a stronger immune response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
3 months
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
Cystic Fibrosis
Participants with Cystic Fibrosis.
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
Non Cystic Fibrosis Bronchiectasis
Participants with Non Cystic Fibrosis Bronchiectasis.
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
Healthy Volunteer
Participants with no condition (healthy volunteers).
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
2
|
14
|
|
Overall Study
COMPLETED
|
14
|
2
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
Baseline characteristics by cohort
| Measure |
Cystic Fibrosis
n=14 Participants
Participants with Cystic Fibrosis.
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
Non Cystic Fibrosis Bronchiectasis
n=2 Participants
Participants with Non Cystic Fibrosis Bronchiectasis.
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
Healthy Volunteer
n=14 Participants
Participants with no condition (healthy volunteers).
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 22.3 • n=7 Participants
|
35.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
SFU count
|
35.22 Spot forming units (SFU)
STANDARD_DEVIATION 35.18 • n=5 Participants
|
32.5 Spot forming units (SFU)
STANDARD_DEVIATION 17.68 • n=7 Participants
|
38.75 Spot forming units (SFU)
STANDARD_DEVIATION 48.14 • n=5 Participants
|
35.49 Spot forming units (SFU)
STANDARD_DEVIATION 33.67 • n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Analyzed all participants enrolled
Change in concentration of interferon (IFN) gamma levels in blood after Bacille Calmette-Guérin (BCG) incubation relative to baseline as measured by SFUs. Spot forming units (SFU) is a measure of immune response of mononuclear cells in response to M. avium lysate. Higher values indicate a stronger immune response.
Outcome measures
| Measure |
Cystic Fibrosis
n=14 Participants
Participants with Cystic Fibrosis.
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
Non Cystic Fibrosis Bronchiectasis
n=2 Participants
Participants with Non Cystic Fibrosis Bronchiectasis.
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
Healthy Volunteer
n=14 Participants
Participants with no condition (healthy volunteers).
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
|---|---|---|---|
|
BCG Uptake
|
48.06 spot forming units
Standard Error 23.52
|
0.84 spot forming units
Standard Error 16.92
|
35.97 spot forming units
Standard Error 23.64
|
Adverse Events
Cystic Fibrosis
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Non Cystic Fibrosis Bronchiectasis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy Volunteer
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cystic Fibrosis
n=14 participants at risk
Participants with Cystic Fibrosis.
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
Non Cystic Fibrosis Bronchiectasis
n=2 participants at risk
Participants with Non Cystic Fibrosis Bronchiectasis.
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
Healthy Volunteer
n=14 participants at risk
Participants with no condition (healthy volunteers).
BCG TICE Vaccine: Intradermal vaccination with BCG TICE
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site pain
|
42.9%
6/14 • Number of events 6 • 6 months
|
0.00%
0/2 • 6 months
|
71.4%
10/14 • Number of events 10 • 6 months
|
|
Skin and subcutaneous tissue disorders
Swelling
|
35.7%
5/14 • Number of events 5 • 6 months
|
0.00%
0/2 • 6 months
|
14.3%
2/14 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
pustule
|
7.1%
1/14 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/14 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place