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A New Reagent Assay Examining Natural Parvovirus B19 Infection in Sickle Cell Disease

NCT02261480 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2016-09-19

No results posted yet for this 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.

Conditions

Interventions

OTHER

Blood draw

When possible, blood will be drawn as an extra aliquot utilizing the same needle stick procedure performed for standard of care.

OTHER

Nasopharyngeal wash

Nasopharyngeal washes are optional for Group A and Group B participants. Nasopharyngeal washes will be performed on all subjects in Group C. The technique used will be the same as used for regular standard of care per St. Jude guidelines.

Sponsors & Collaborators

Principal Investigators

  • Jane Hankins, MD · St. Jude Children's Research Hospital

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-03-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261480 on ClinicalTrials.gov