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NCT02261480 · ClinicalTrials.gov registry record
A New Reagent Assay Examining Natural Parvovirus B19 Infection in Sickle Cell Disease
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 24
- Enrollment target
NCT02261480: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT02261480 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02261480 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
Study Summary
Parvovirus B19 is a small virus that is the cause of "fifth" disease, a common infection in childhood. In people with sickle cell disease (SCD), parvovirus B19 infection causes the bone marrow to stop producing red blood cells temporarily, which can be life-threatening. A novel vaccine is currently in development for children with SCD. This study is the first step within a larger parvovirus B19 multi-institutional project that will help develop this new vaccine, as it will define the value and utility of using a novel assay for measurement of parvovirus-specific antibodies. The main objective is to investigate the relationship between the newly developed VP1u ELISA assay and the gold standard neutralization assay for parvovirus B19 infection. The most accurate test, called a neutralizing antibody assay, to see if a person has had or currently has the infection is very complex and expensive and would be very difficult to use in a large research study to test the new vaccine. A new and simpler test has developed. The main goal of this study, iSCREEN, is to find out if this new test works. There will be distinct labs performing the VP1u ELISA and the neutralization assays and the respective laboratories will not have access to each other's results for individual subjects. The VP1u ELISA will be performed at St. Jude Children's Research Hospital. Neutralization assays will be conducted at the National Heart, Lung and Blood Institute.
Interventions
- OTHER Blood draw
- OTHER Nasopharyngeal wash
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-08 |
What the finished NCT02261480 record still lists
NCT02261480 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Blood draw is the first listed.
NCT02261480 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02261480 about?
NCT02261480 is a clinical study titled "A New Reagent Assay Examining Natural Parvovirus B19 Infection in Sickle Cell Disease". Parvovirus B19 is a small virus that is the cause of "fifth" disease, a common infection in childhood. In people with sickle cell disease (SCD), parvovirus B19 infection causes the bone marrow to stop producing red blood cells temporarily, which can be life-threatening. A novel vaccine is currently ...
What is the current status of trial NCT02261480?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2014-10. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02261480?
The interventions under investigation include: Blood draw (OTHER), Nasopharyngeal wash (OTHER).
Who is sponsoring clinical trial NCT02261480?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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