Development of a Skin Test for the Na-ASP-2 Hookworm Antigen

Completed · Not applicable

Conditions studied: Hookworm Infection, Allergy

In brief

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.

Key facts

Study ID

NCT00603889

Run by

Albert B. Sabin Vaccine Institute

People needed

12

Starts

2008-03-01

Expected to finish

2008-05-01

Last updated by the study team

2012-02-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or females between 18 and 45 years of age, inclusive.
• Good general health as determined by means of the screening procedure.
• Willingness to participate in the study as evidenced by signing the informed consent document.

You may not qualify if…

• History of previous infection with hookworm.
• Prior extensive and continuous travel, work, or residence (> 1 month) in a hookworm-endemic region.
• Pregnancy as determined by a positive urine hCG test (if female).
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history or physical examination.
• 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 participating in the trial or would render the subject unable to comply with the protocol.
• Participation in an investigational vaccine or drug trial within 14 days of starting this study.
• Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
• History of a severe allergic reaction or anaphylaxis.
• Known immunodeficiency syndrome.
• Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
• History of a surgical splenectomy.
• 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.

Where it is running

• GWUMC Clinical Trials Unit — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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