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Sponsored by: |
Albert B. Sabin Vaccine Institute |
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Information provided by: | Albert B. Sabin Vaccine Institute |
ClinicalTrials.gov Identifier: | NCT00603889 |
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. This study will evaluate solutions of varying concentrations of the protein in both a skin prick-puncture and intradermal test that will eventually be used to screen volunteers living in hookworm endemic areas who are being considered as potential participants in vaccine trials, to reduce the potential of inducing allergic reactions in those vaccinated with the Na-ASP-2 Hookworm Vaccine.
Condition | Intervention |
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Hookworm Infection Allergy |
Biological: Na-ASP-2 Skin Test Reagent |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment |
Official Title: | Development of a Skin Test to Detect Immediate-Type Hypersensitivity to the Experimental Na-ASP-2 Hookworm Antigen |
Estimated Enrollment: | 15 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
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Biological: Na-ASP-2 Skin Test Reagent
Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
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Each participant will have both skin prick-puncture and intradermal skin tests applied on the same study day. The prick-puncture and intradermal tests will be applied sequentially to the volar aspects of the participant's forearms:
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aimee Desrosiers | 202-741-2443 |
United States, District of Columbia | |
GWUMC Clinical Trials Unit | |
Washington, District of Columbia, United States, 20037 |
Principal Investigator: | David Parenti, MD | GWUMC Medical Faculty Associates |
Responsible Party: | Albert B. Sabin Vaccine Institute ( Ami Shah Brown, PhD/Director of Vaccine Operations ) |
Study ID Numbers: | SVI-07-02 |
Study First Received: | January 17, 2008 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00603889 |
Health Authority: | United States: Food and Drug Administration |
Hookworm Allergy Vaccine Skin test |
Hypersensitivity Hookworm Infections Parasitic Diseases |
Nematode Infections Ancylostoma duodenale Helminthiasis |
Strongylida Infections Infection Secernentea Infections |