N/A
N=87
Prevalence of Hookworm Infection and Community Preparedness for Hookworm Vaccine Trials in Endemic Areas of Brazil
Hookworm Infection
Bottom Line
View on ClinicalTrials.gov: NCT00939198 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Size of Wheal Diameter at Site of Skin Test Application, Measured 15 Minutes After Injection — 3.5 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Na-ASP-2 Skin Test Reagent (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert B. Sabin Vaccine Institute
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Size of Wheal Diameter at Site of Skin Test Application, Measured 15 Minutes After Injection |
3.5 | — |
| SECONDARY Anti-Na-ASP-2 IgE Antibody Level on Day of Skin Test Reaction |
1.89 | — |
Summary
Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life cycle. In a clinical study in previously hookworm-infected adults in Brazil, this protein induced urticarial reactions (rash) in a subset of volunteers. The clinical trial component of this study involves skin testing for immediate-type hypersensitivity to the Na-ASP-2 Antigen. Both prick-puncture and intradermal tests will be applied.
Eligibility Criteria
Inclusion Criteria
- Males and females between 6 and 45 years of age, inclusive, at the time of consenting to the parent study.
- Age greater than or equal to 18 years at the time of signing the supplemental informed consent document for the skin test procedure (parent study).
- Willingness to participate in the study as evidenced by signing the informed consent or assent document.
Exclusion Criteria
- Inability to correctly answer all questions on the informed consent comprehension questionnaire.
- Attends school or works full-time outside of the study area.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol.
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer to participate in the trial or would render the subject unable to comply with the protocol.
- Pregnancy as determined by a positive urine hCG test (if female).
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of planned skin test application.
- Extensive dermatitis precluding skin testing.
- Current use of a beta blocker (oral or topical) or anti-histamine medication. A volunteer may participate in the study if they agree to withhold use of an anti-histamine for at least 5 days prior to application of the skin test.
- Use of a tricyclic anti-depressant within the past month.
Data sourced from ClinicalTrials.gov (NCT00939198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.