Prevalence of Hookworm Infection and Community Preparedness for Hookworm Vaccine Trials in Endemic Areas of Brazil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Albert B. Sabin Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00939198
First received: July 13, 2009
Last updated: January 6, 2014
Last verified: January 2014

July 13, 2009
January 6, 2014
August 2009
January 2012   (final data collection date for primary outcome measure)
Size of wheal diameter at site of skin test application, measured 15 minutes after injection [ Time Frame: 15 minutes after skin test application ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00939198 on ClinicalTrials.gov Archive Site
Anti-Na-ASP-2 IgE antibody level on day of skin test reaction [ Time Frame: Upon skin testing ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevalence of Hookworm Infection and Community Preparedness for Hookworm Vaccine Trials in Endemic Areas of Brazil
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Hookworm Infection
Biological: Na-ASP-2 Skin Test Reagent
Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
Experimental: Na-ASP-2 Hookworm Antigen Skin Test
All participants will be skin tested with Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
Intervention: Biological: Na-ASP-2 Skin Test Reagent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
December 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females between 6 and 45 years of age, inclusive, at the time of consenting to the parent study.
  • Age greater than or equal to 18 years at the time of signing the supplemental informed consent document for the skin test procedure (parent study).
  • Willingness to participate in the study as evidenced by signing the informed consent or assent document.

Exclusion Criteria:

  • Inability to correctly answer all questions on the informed consent comprehension questionnaire.
  • Attends school or works full-time outside of the study area.
  • 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 to participate in the trial or would render the subject unable to comply with the protocol.
  • Pregnancy as determined by a positive urine hCG test (if female).
  • Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of planned skin test application.
  • 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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00939198
SVI-06-01
No
Albert B. Sabin Vaccine Institute
Albert B. Sabin Vaccine Institute
Not Provided
Principal Investigator: Jeffrey Bethony, PhD Albert B. Sabin Vaccine Institute
Albert B. Sabin Vaccine Institute
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP