search
Back to results

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

Primary Purpose

Hookworm Infection, Allergy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Na-ASP-2 Skin Test Reagent
Sponsored by
Albert B. Sabin Vaccine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hookworm Infection focused on measuring Hookworm, Allergy, Vaccine, Skin test

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GWUMC Clinical Trials Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Na-ASP-2 Hookworm Antigen Skin Test

Arm Description

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.

Outcomes

Primary Outcome Measures

100 Mcg/ml Na-ASP-2 Prick-puncture Skin Test
Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows: 0 no discernible wheal < ½ histamine diameter ≥ ½ histamine; < histamine diameter = size of histamine control ± 1 mm > histamine diameter; < 2x diameter ≥ 2x histamine control

Secondary Outcome Measures

1000 Mcg/ml Na-ASP-2 Prick-puncture Skin Test
Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows: 0 no discernible wheal < ½ histamine diameter ≥ ½ histamine; < histamine diameter = size of histamine control ± 1 mm > histamine diameter; < 2x diameter ≥ 2x histamine control
100 Mcg/ml Na-ASP-2 Intradermal Skin Test
Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows: 0 no discernible wheal < ½ histamine diameter ≥ ½ histamine; < histamine diameter = size of histamine control ± 1 mm > histamine diameter; < 2x diameter ≥ 2x histamine control
1000 Mcg/ml Na-ASP-2 Intradermal Skin Test
Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows: 0 no discernible wheal < ½ histamine diameter ≥ ½ histamine; < histamine diameter = size of histamine control ± 1 mm > histamine diameter; < 2x diameter ≥ 2x histamine control

Full Information

First Posted
January 17, 2008
Last Updated
January 18, 2012
Sponsor
Albert B. Sabin Vaccine Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00603889
Brief Title
Development of a Skin Test for the Na-ASP-2 Hookworm Antigen
Official Title
Development of a Skin Test to Detect Immediate-type Hypersensitivity to the Experimental Na-ASP-2 Hookworm Antigen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert B. Sabin Vaccine Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: 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. Intradermal: three different concentrations of Na-ASP-2 (10, 100, and 1000 μg/mL) will be injected simultaneously, in duplicate, to the right forearm. Allergen diluent and histamine solutions will be utilized as the negative and positive controls, respectively, for both the skin prick-puncture and intradermal tests. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hookworm Infection, Allergy
Keywords
Hookworm, Allergy, Vaccine, Skin test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Na-ASP-2 Hookworm Antigen Skin Test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Na-ASP-2 Skin Test Reagent
Intervention Description
Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
Primary Outcome Measure Information:
Title
100 Mcg/ml Na-ASP-2 Prick-puncture Skin Test
Description
Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows: 0 no discernible wheal < ½ histamine diameter ≥ ½ histamine; < histamine diameter = size of histamine control ± 1 mm > histamine diameter; < 2x diameter ≥ 2x histamine control
Time Frame
15 minutes after skin test application
Secondary Outcome Measure Information:
Title
1000 Mcg/ml Na-ASP-2 Prick-puncture Skin Test
Description
Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows: 0 no discernible wheal < ½ histamine diameter ≥ ½ histamine; < histamine diameter = size of histamine control ± 1 mm > histamine diameter; < 2x diameter ≥ 2x histamine control
Time Frame
15 minutes after skin test application
Title
100 Mcg/ml Na-ASP-2 Intradermal Skin Test
Description
Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows: 0 no discernible wheal < ½ histamine diameter ≥ ½ histamine; < histamine diameter = size of histamine control ± 1 mm > histamine diameter; < 2x diameter ≥ 2x histamine control
Time Frame
15 minutes after skin test application
Title
1000 Mcg/ml Na-ASP-2 Intradermal Skin Test
Description
Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows: 0 no discernible wheal < ½ histamine diameter ≥ ½ histamine; < histamine diameter = size of histamine control ± 1 mm > histamine diameter; < 2x diameter ≥ 2x histamine control
Time Frame
15 minutes after skin test application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Parenti, MD
Organizational Affiliation
GWUMC Medical Faculty Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
GWUMC Clinical Trials Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17012856
Citation
Fujiwara RT, Bethony J, Bueno LL, Wang Y, Ahn SY, Samuel A, Bottazzi ME, Hotez P, Mendez S. Immunogenicity of the hookworm Na-ASP-2 vaccine candidate: characterization of humoral and cellular responses after vaccination in the Sprague Dawley rat. Hum Vaccin. 2005 May-Jun;1(3):123-8. doi: 10.4161/hv.1.3.1924. Epub 2005 May 20.
Results Reference
background
PubMed Identifier
16054275
Citation
Goud GN, Bottazzi ME, Zhan B, Mendez S, Deumic V, Plieskatt J, Liu S, Wang Y, Bueno L, Fujiwara R, Samuel A, Ahn SY, Solanki M, Asojo OA, Wang J, Bethony JM, Loukas A, Roy M, Hotez PJ. Expression of the Necator americanus hookworm larval antigen Na-ASP-2 in Pichia pastoris and purification of the recombinant protein for use in human clinical trials. Vaccine. 2005 Sep 15;23(39):4754-64. doi: 10.1016/j.vaccine.2005.04.040.
Results Reference
background
PubMed Identifier
18171264
Citation
Diemert DJ, Bethony JM, Hotez PJ. Hookworm vaccines. Clin Infect Dis. 2008 Jan 15;46(2):282-8. doi: 10.1086/524070.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs