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

Completed

• Conditions: Sickle Cell Disease

• Registration Number: NCT02261480
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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.

Detailed Description

Participants with sickle cell disease (SCD) will be divided into three study groups depending on their history of parvovirus B19 infection. Each will have blood drawn and/or nasopharyngeal wash which will provide the biological material for evaluation by assay.

* Group A participants will have a documented prior history of parvovirus B19 infection (aplastic crisis).

* Group B participants will have no documented history of parvovirus B19 infection (aplastic crisis) and will serve as the negative controls for the investigation of the relationship between the VP1u ELISA and the gold standard neutralization assay for parvovirus B19 infection.

* Group C participants will have suspected and/or confirmed acute parvovirus B19 infection (febrile illness with anemia without adequate compensatory reticulocytosis).

PRIMARY OBJECTIVES

* To estimate the correlation between the VP1u enzyme-linked immunosorbent assay (ELISA) and the gold standard neutralization assay for parvovirus B19 infection in subjects with SCD who have had a documented infection from parvovirus B19 causing aplastic crisis.

* To identify a cut-off for negativity in the VP1u ELISA and in the neutralization assay in subjects with SCD.

SECONDARY OBJECTIVES

* To characterize the performance characteristics of the VP1u ELISA, including sensitivity and specificity.

* To describe the kinetics of antibody responses generated following an acute parvovirus B19 infection in the serum and in the nasal mucosa of patients with SCD.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-10
• Primary Completion: 2016-03
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between the new VP1u ELISA and neutralizing antibodies tests in participants with documented parvovirus B19 infection	Baseline
Mean assay value using new VP1u ELISA and neutralization assays between Group B and Group A participants	Baseline	To identify the cut-off for negativity for this patient population in the VP1u ELISA and in the neutralization assays, an ROC analysis will be conducted.

Secondary Outcome Measures

Name	Time	Method
Antibody response following acute parvovirus B19 infection	Baseline, and Days 7, 30 and 120	Descriptive statistics, such as mean, standard deviation, median and range, will be developed and plotted.
Compare the sensitivity and specificity of the VP1u ELISA with the neutralization assay	Baseline	Sensitivity and specificity of VP1u ELISA will be assessed by using the neutralization assay as the gold standard.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States