Status:
COMPLETED
Prevalence of Hookworm Infection and Community Preparedness for Hookworm Vaccine Trials in Endemic Areas of Brazil
Lead Sponsor:
Albert B. Sabin Vaccine Institute
Conditions:
Hookworm Infection
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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 ...
Detailed Description
The clinical testing of the Na-ASP-2 Skin Test Reagent to detect Immediate-type hypersensitivity to the Na-ASP-2 hookworm antigen will be conducted as part of a larger, on-going observational study of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00939198
Start Date
August 1 2009
End Date
December 1 2012
Last Update
August 1 2018
Active Locations (1)
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1
Centro de Pesquisas Rene Rachou
Belo Horizonte, Minas Gerais, Brazil