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

September 16, 2016 updated by: St. Jude Children's Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sickle cell disease patients being seen at St. Jude Children's Research Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A: Documented Prior History

Pediatric and adult participants with sickle cell disease (SCD) with a documented prior history of parvovirus B19 infection (aplastic crisis).

Group A participants will have blood draw and nasopharyngeal wash on day 1 only. Nasopharyngeal wash will be optional for Group A.
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.
Group B: No Prior History

Pediatric and adult participants with SCD who have never had a documented parvovirus B19 infection (aplastic crisis).

Group B participants will have blood draw and nasopharyngeal wash on day 1 only. Nasopharyngeal wash will be optional for Group B.
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.
Group C: Suspected and/or Confirmed

Sickle cell disease patients with suspected and/or confirmed acute parvovirus B19 infection, the latter defined as febrile illness with anemia without adequate compensatory reticulocytosis.

Group C participants will have blood draw and nasopharyngeal wash on day 1, day 7±4 days, day 30±7 days, and day 120±14 days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the new VP1u ELISA and neutralizing antibodies tests in participants with documented parvovirus B19 infection
Time Frame: Baseline
Baseline
Mean assay value using new VP1u ELISA and neutralization assays between Group B and Group A participants
Time Frame: 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.
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 16, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISCREEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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