An interventional study of Na-ASP-2 Skin Test Reagent in Hookworm Infection, sponsored by Albert B. Sabin Vaccine Institute. Completed at 1 site in Brazil. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-01.
Sponsored by Albert B. Sabin Vaccine Institute · Not applicable, Interventional, and Diagnostic
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.
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:
39 studies on the registry are indexed under Hookworm Infections; 5 are open to participants now.
This study's enrollment of 87 is below the median of 182 across 36 interventional studies indexed under Hookworm Infections.
Browse Hookworm Infections studies →Albert B. Sabin Vaccine Institute is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
Size of Wheal Diameter at Site of Skin Test Application, Measured 15 Minutes After Injection
Time frame: 15 minutes after skin test application
Anti-Na-ASP-2 IgE Antibody Level on Day of Skin Test Reaction
Time frame: Upon skin testing
| Milestone | Na-ASP-2 Hookworm Antigen Skin Test |
|---|---|
| Started | 87 |
| Completed | 87 |
| Not completed | 0 |
| cm | Na-ASP-2 Hookworm Antigen Skin Test |
|---|---|
| Size of Wheal Diameter at Site of Skin Test Application, Measured 15 Minutes After Injection | 3.5 (0 to 6.5) |
| kU/L | Na-ASP-2 Hookworm Antigen Skin Test |
|---|---|
| Anti-Na-ASP-2 IgE Antibody Level on Day of Skin Test Reaction | 1.89 (0.36 to 5.11) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Na-ASP-2 Hookworm Antigen Skin Test | — | 0/87 (0%) | 0/87 (0%) |
| Age, Categorical(Participants) | Na-ASP-2 Hookworm Antigen Skin Test |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 87 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Na-ASP-2 Hookworm Antigen Skin Test |
|---|---|
| Female | 48 |
| Male | 39 |
| Race (NIH/OMB)(Participants) | Na-ASP-2 Hookworm Antigen Skin Test |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 87 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Na-ASP-2 Hookworm Antigen Skin Test |
|---|---|
| Brazil | 87 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Albert B. Sabin Vaccine Institute