Trial Outcomes & Findings for Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen (NCT NCT00633009)
NCT ID: NCT00633009
Last Updated: 2013-11-20
Results Overview
Skin test response of subjects in the trial were evaluated 48 hours post injection after each of three skin test given at 30 day intervals in naive individuals (no exposure to the Leishmania organism). (Actual times 0, 30 and 60 days).The outcome measure was designated as number of participants who became sensitized to the Leishmania antigen. This is defined as those participants that had a negative skin test result, followed by a positive response in a subsequent skin test without having been exposed to the Leishmania organism.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
62 days
Results posted on
2013-11-20
Participant Flow
Participant milestones
| Measure |
15 ug Study Group
Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. All participants received a placebo skin test concurrently with active drug.
|
30 ug Study Group
Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
|
50 ug Study Group
Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
27
|
11
|
|
Overall Study
COMPLETED
|
8
|
23
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
Baseline characteristics by cohort
| Measure |
15 ug Study Group
n=12 Participants
Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
|
30 ug Study Group
n=27 Participants
Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
|
50 ug Study Group
n=11 Participants
Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
34 years
STANDARD_DEVIATION 11 • n=5 Participants
|
28 years
STANDARD_DEVIATION 12 • n=7 Participants
|
35 years
STANDARD_DEVIATION 13 • n=5 Participants
|
31 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
27 participants
n=7 Participants
|
11 participants
n=5 Participants
|
50 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 62 daysPopulation: Number of participants completed.
Skin test response of subjects in the trial were evaluated 48 hours post injection after each of three skin test given at 30 day intervals in naive individuals (no exposure to the Leishmania organism). (Actual times 0, 30 and 60 days).The outcome measure was designated as number of participants who became sensitized to the Leishmania antigen. This is defined as those participants that had a negative skin test result, followed by a positive response in a subsequent skin test without having been exposed to the Leishmania organism.
Outcome measures
| Measure |
15 ug Study Group
n=8 Participants
|
30 ug Study Group
n=23 Participants
|
50 ug Study Group
n=10 Participants
|
|---|---|---|---|
|
Sensitizing Effects of LtSTA in Leishmania Naive Adults
|
8 participants
|
22 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 74 daysLocal and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.
Outcome measures
| Measure |
15 ug Study Group
n=12 Participants
|
30 ug Study Group
n=27 Participants
|
50 ug Study Group
n=11 Participants
|
|---|---|---|---|
|
The Safety of 15, 30 and 50µg/0.1mL Doses of LtSTA in Healthy Adult Volunteers Who Have Had no Known Previous Exposure to Leishmania Parasites
|
3 No. of participants with reactions
|
6 No. of participants with reactions
|
2 No. of participants with reactions
|
Adverse Events
15 ug Study Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
30 ug Study Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50 ug Study Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
15 ug Study Group
n=12 participants at risk
|
30 ug Study Group
n=27 participants at risk
|
50 ug Study Group
n=11 participants at risk
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching
|
25.0%
3/12 • Number of events 3 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
18.5%
5/27 • Number of events 5 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
18.2%
2/11 • Number of events 2 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
|
Skin and subcutaneous tissue disorders
Burning
|
8.3%
1/12 • Number of events 1 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
11.1%
3/27 • Number of events 3 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
9.1%
1/11 • Number of events 1 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
|
Skin and subcutaneous tissue disorders
Pain
|
8.3%
1/12 • Number of events 1 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
3.7%
1/27 • Number of events 1 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
0.00%
0/11 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
|
General disorders
Body Aches
|
8.3%
1/12 • Number of events 1 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
0.00%
0/27 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
9.1%
1/11 • Number of events 1 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
|
General disorders
Weakness
|
8.3%
1/12 • Number of events 1 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
0.00%
0/27 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
0.00%
0/11 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
|
General disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
0.00%
0/27 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
0.00%
0/11 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
|
General disorders
Nausea
|
16.7%
2/12 • Number of events 2 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
0.00%
0/27 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
0.00%
0/11 • 106 Days
Injections of LtSTA were given 3 times over a 90 day period at 30 days +/- 7 days. Final skin test readings were taken at 48 hours after the third injection. Adverse event data were collected for an additional 14 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place