Trial Outcomes & Findings for Prevalence of Hookworm Infection and Community Preparedness for Hookworm Vaccine Trials in Endemic Areas of Brazil (NCT NCT00939198)
NCT ID: NCT00939198
Last Updated: 2018-08-01
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
15 minutes after skin test application
Results posted on
2018-08-01
Participant Flow
Participant milestones
| Measure |
Na-ASP-2 Hookworm Antigen Skin Test
All participants will be skin tested with Na-ASP-2 skin test reagent (1000 mcg/ml recombinant Na-ASP-2) applied to their arms, using both the prick-puncture and intradermal techniques.
|
|---|---|
|
Overall Study
STARTED
|
87
|
|
Overall Study
COMPLETED
|
87
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevalence of Hookworm Infection and Community Preparedness for Hookworm Vaccine Trials in Endemic Areas of Brazil
Baseline characteristics by cohort
| Measure |
Na-ASP-2 Hookworm Antigen Skin Test
n=87 Participants
All participants will be skin tested with Na-ASP-2 skin test reagent (1000 mcg/ml recombinant Na-ASP-2) applied to their arms, using both the prick-puncture and intradermal techniques.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Brazil
|
87 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after skin test applicationOutcome measures
| Measure |
Na-ASP-2 Hookworm Antigen Skin Test
n=87 Participants
All participants will be skin tested with Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
Na-ASP-2 Skin Test Reagent: Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
|
|---|---|
|
Size of Wheal Diameter at Site of Skin Test Application, Measured 15 Minutes After Injection
|
3.5 cm
Interval 0.0 to 6.5
|
SECONDARY outcome
Timeframe: Upon skin testingOutcome measures
| Measure |
Na-ASP-2 Hookworm Antigen Skin Test
n=42 Participants
All participants will be skin tested with Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
Na-ASP-2 Skin Test Reagent: Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
|
|---|---|
|
Anti-Na-ASP-2 IgE Antibody Level on Day of Skin Test Reaction
|
1.89 kU/L
Interval 0.36 to 5.11
|
Adverse Events
Na-ASP-2 Hookworm Antigen Skin Test
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place