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NCT00603889 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Albert B. Sabin Vaccine Institute.

Completed
Registry status
NA
Development phase
12
Enrollment target

NCT00603889: Completed NA study, sponsored by Albert B. Sabin Vaccine Institute.

NCT00603889 is a NA study that has completed, run by Albert B. Sabin Vaccine Institute. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00603889, a NA study, has completed, sponsored by Albert B. Sabin Vaccine Institute.

COMPLETED
Registry status
NA
Development phase
12 participants
Enrollment target

Study 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.

Primary Outcome

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 1. \< ½ histamine diameter 2. ≥ ½ histamine; \< histamine diameter 3. = size of histamine c

Interventions

  • BIOLOGICAL Na-ASP-2 Skin Test Reagent

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2008-03
Est. Completion 2008-05
Phase NA

What the finished NCT00603889 record still lists

NCT00603889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Na-ASP-2 Skin Test Reagent is the first listed.

NCT00603889 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00603889 about?

NCT00603889 is a clinical study titled "Development of a Skin Test for the Na-ASP-2 Hookworm Antigen". 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 concentrat...

What is the current status of trial NCT00603889?

This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2008-03. Estimated completion is 2008-05.

What interventions are being tested in trial NCT00603889?

The interventions under investigation include: Na-ASP-2 Skin Test Reagent (BIOLOGICAL).

Who is sponsoring clinical trial NCT00603889?

This trial is sponsored by Albert B. Sabin Vaccine Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00603889's enrollment target sits among peer trials

12 1913th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00603889, the US trial registry maintained by the National Library of Medicine. NCT00603889 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.