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

NCT00939198 | Completed Results

• 1 other identifier: SVI-06-01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Hookworm Infection

Keywords

Hookworm; Allergy; Vaccine; Skin Test; Immediate-type hypersensitivity to Na-ASP-2 hookworm antigen

Outcome Measures

Primary Outcomes (1)

• Size of Wheal Diameter at Site of Skin Test Application, Measured 15 Minutes After Injection

  15 minutes after skin test application

Secondary Outcomes (1)

• Anti-Na-ASP-2 IgE Antibody Level on Day of Skin Test Reaction

  Upon skin testing

Study Arms (1)

Na-ASP-2 Hookworm Antigen Skin Test

EXPERIMENTAL

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.

Biological: Na-ASP-2 Skin Test Reagent

Interventions

Na-ASP-2 Skin Test Reagent BIOLOGICAL

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

Na-ASP-2 Hookworm Antigen Skin Test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert B. Sabin Vaccine Institute: lead

Study Sites (1)

Centro de Pesquisas Rene Rachou

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (3)

• 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.

  PMID: 17012856 BACKGROUND

• 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.

  PMID: 16054275 BACKGROUND

• Diemert DJ, Bethony JM, Hotez PJ. Hookworm vaccines. Clin Infect Dis. 2008 Jan 15;46(2):282-8. doi: 10.1086/524070.

  PMID: 18171264 BACKGROUND

MeSH Terms

Conditions

Hookworm Infections; Ancylostomiasis; Hypersensitivity

Condition Hierarchy (Ancestors)

Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Immune System Diseases

Results Point of Contact

• Title: Dr. David Diemert
• Organization: George Washington University

ddiemert@gwu.edu

2029942909

Study Officials

• Jeffrey Bethony, PhD

  Albert B. Sabin Vaccine Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 1, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-07

Locations

BR (1)