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

Sickle Cell Disease Clinical Trial

Official title:

Investigation in Sickle Cell Disease of a New Reagent Assay Examining Natural Parvovirus B19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261480
• Other study ID #: iSCREEN
• Status: Completed
• Phase: N/A
• First received: October 6, 2014
• Last updated: September 16, 2016
• Start date: October 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria - Individuals not experiencing an acute illness (Group A):

• Males and females with a diagnosis of SCD of any genotype

• Ages > 1 year.

• Medical records available for verification of prior parvovirus B19 infection status.

Exclusion Criteria - Individuals not experiencing an acute illness (Group A):

• Patients on chronic transfusion therapy.

• Patients experiencing an acute febrile illness.

• Any medical or social reason, which in the opinion of the principal investigators (PIs) would make the participation of the subject ill-advised.

Inclusion Criteria - Individuals with confirmed (Group B) or suspected (Group C) acute parvovirus B19 infection:

• Males and females with a diagnosis of SCD of any genotype.

• Ages > 1 year.

• Symptoms of acute parvovirus infection (defined as worsened anemia with insufficient compensatory reticulocytosis in the setting of a febrile illness).

Exclusion Criteria - Individuals with confirmed (Group B) or suspected (Group C) acute parvovirus B19 infection:

• Patients on chronic transfusion therapy.

• Current epistaxis

• Any medical or social reason, which in the opinion of the principal investigators (PIs) would make the participation of the subject ill-advised.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Infection
• Sickle Cell Disease

Intervention

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

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the new VP1u ELISA and neutralizing antibodies tests in participants with documented parvovirus B19 infection		Baseline	No
Primary	Mean assay value using new VP1u ELISA and neutralization assays between Group B and Group A participants	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.	Baseline	No
Secondary	Compare the sensitivity and specificity of the VP1u ELISA with the neutralization assay	Sensitivity and specificity of VP1u ELISA will be assessed by using the neutralization assay as the gold standard.	Baseline	No
Secondary	Antibody response following acute parvovirus B19 infection	Descriptive statistics, such as mean, standard deviation, median and range, will be developed and plotted.	Baseline, and Days 7, 30 and 120	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital