Trial Outcomes & Findings for Immunobiology of Diabetes and Tuberculosis (NCT NCT00568854)
NCT ID: NCT00568854
Last Updated: 2016-08-16
Results Overview
Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
5 months
Results posted on
2016-08-16
Participant Flow
Participant milestones
| Measure |
Participants With Diabetes
Persons with diagnosis of diabetes. Received biological intervention: BCG
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
|
Participants Without Diabetes
Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunobiology of Diabetes and Tuberculosis
Baseline characteristics by cohort
| Measure |
Participants With Diabetes
n=6 Participants
Persons with diagnosis of diabetes. Received biological intervention: BCG
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
|
Participants Without Diabetes
n=4 Participants
Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
41.5 years
n=7 Participants
|
54.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Hemoglobin A1C
|
6.65 %
n=5 Participants
|
5.65 %
n=7 Participants
|
6.1 %
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsParticipants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.
Outcome measures
| Measure |
Participants With Diabetes
n=6 Participants
Persons with diagnosis of diabetes. Received biological intervention: BCG
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
|
Participants Without Diabetes
n=4 Participants
Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
|
|---|---|---|
|
Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test
|
0 mm
Interval 0.0 to 10.0
|
3 mm
Interval 0.0 to 6.0
|
PRIMARY outcome
Timeframe: 5 monthsBlood was sampled at times 0, 2, 4, 6, 8, 12, 16, and 20 weeks post BCG vaccination and Interferon gamma production was measured as change from pre-vaccination baseline. Timeline of peak IFn-g response was measured for both study groups.
Outcome measures
| Measure |
Participants With Diabetes
n=6 Participants
Persons with diagnosis of diabetes. Received biological intervention: BCG
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
|
Participants Without Diabetes
n=4 Participants
Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.
BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication.
|
|---|---|---|
|
Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination
|
8 weeks when peak response was observed
Standard Deviation 1
|
8 weeks when peak response was observed
Standard Deviation 1
|
Adverse Events
Participants With Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Without Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alicia Chang
Los Angeles County Department of Public Health
Phone: 213-745-0846
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place