Allergy Clinical Trial
Official title:
Development of a Skin Test to Detect Immediate-type Hypersensitivity to the Experimental Na-ASP-2 Hookworm Antigen
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.
- Study site: George Washington University Medical Center
- Number of participants: up to 15
- Study duration: up to 3 months; each participant will undergo a minimum of one
screening visit and one study visit.
- 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:
1. Skin prick-puncture: four different concentrations of Na-ASP-2 solution (1, 10,
100, and 1000 μg/mL) will be applied simultaneously in duplicate, to the left
forearm.
2. Intradermal: three different concentrations of Na-ASP-2 (10, 100, and 1000 μg/mL)
will be injected simultaneously, in duplicate, to the right forearm.
3. Allergen diluent and histamine solutions will be utilized as the negative and
positive controls, respectively, for both the skin prick-puncture and intradermal
tests.
4. Participants will be observed in the study clinic for at least 30 minutes
following application of the skin tests, and will be contacted via telephone 2
days following skin testing.
5. Sizes of the wheal and erythema reactions for each application will be recorded
and graded in comparison to the histamine positive control reaction.
- Each participant will have blood collected via venipuncture (a maximum of 25 mL)
immediately prior to application of the skin tests, in order to measure antibodies
(particularly IgG and IgE) to Na-ASP-2 using an ELISA procedure.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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