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Development of a Skin Test for the Na-ASP-2 Hookworm Antigen
This study is not yet open for participant recruitment.
Verified by Albert B. Sabin Vaccine Institute, January 2008
Sponsored by: Albert B. Sabin Vaccine Institute
Information provided by: Albert B. Sabin Vaccine Institute
ClinicalTrials.gov Identifier: NCT00603889
  Purpose

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
Hookworm Infection
Allergy
Biological: Na-ASP-2 Skin Test Reagent

MedlinePlus related topics: Allergy
U.S. FDA Resources
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

Further study details as provided by Albert B. Sabin Vaccine Institute:

Primary Outcome Measures:
  • Size of skin test reactions to application of prick-puncture and intradermal injections of test antigen solutions and positive and negative controls [ Time Frame: 15 minutes after skin test application ] [ Designated as safety issue: Yes ]

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
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.
Biological: Na-ASP-2 Skin Test Reagent
Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603889

Contacts
Contact: Aimee Desrosiers 202-741-2443

Locations
United States, District of Columbia
GWUMC Clinical Trials Unit
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
Albert B. Sabin Vaccine Institute
Investigators
Principal Investigator: David Parenti, MD GWUMC Medical Faculty Associates
  More Information

Publications:
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

Keywords provided by Albert B. Sabin Vaccine Institute:
Hookworm
Allergy
Vaccine
Skin test

Study placed in the following topic categories:
Hypersensitivity
Hookworm Infections
Parasitic Diseases
Nematode Infections
Ancylostoma duodenale
Helminthiasis

Additional relevant MeSH terms:
Strongylida Infections
Infection
Secernentea Infections

ClinicalTrials.gov processed this record on February 06, 2009