Hookworm Infection Clinical Trial
Official title:
Determination of Prevalence and Intensity of Hookworm Infection and Community Preparedness for Hookworm Vaccine Trials in Endemic Areas of Northeastern Minas Gerais, Brazil
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.
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 the prevalence and intensity of hookworm infection currently
underway in Brazil. Eligible adult participants (ages 18-45 years) in this observational
study will be invited to undergo the skin testing procedure. Skin testing will only be
performed if they agree and sign the supplemental informed consent form for this skin testing
procedure.
- Study site: Americaninhas Vaccine Center, Americaninhas, Minas Gerais, Brazil
- Number of participants to be skin tested: approximately 150 adults
- Duration of the skin testing procedures: up to 1 month; each participant will undergo
skin testing and a follow-up blood collection 21+/-7 days after skin testing.
- 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: three different concentrations of Na-ASP-2 solution (10, 100,
and 1000 μg/mL) will be applied sequentially in duplicate, to the left forearm.
2. Intradermal: one concentration of Na-ASP-2 (100 μg/mL) will be injected, 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 examined 2 and 7 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, and between 2 and 4 weeks after skin
testing, in order to measure antibodies (particularly IgG and IgE) to Na-ASP-2 using an
ELISA procedure.
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