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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02261480
Recruitment Status : Completed
First Posted : October 10, 2014
Last Update Posted : September 19, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date October 6, 2014
First Posted Date October 10, 2014
Last Update Posted Date September 19, 2016
Study Start Date October 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2014)
  • Correlation between the new VP1u ELISA and neutralizing antibodies tests in participants with documented parvovirus B19 infection [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 28, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: October 6, 2014)
  • Compare the sensitivity and specificity of the VP1u ELISA with VP1u ELISA [ Time Frame: Baseline ]
    Sensitivity and specificity of VP1u ELISA will be assessed by using the neutralization assay as the gold standard.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A New Reagent Assay Examining Natural Parvovirus B19 Infection in Sickle Cell Disease
Official Title Investigation in Sickle Cell Disease of a New Reagent Assay Examining Natural Parvovirus B19 Infection
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood and/or nasopharyngeal wash samples will be taken and retained. If participants agree, leftover samples will be saved for potential health research in the future.
Sampling Method Non-Probability Sample
Study Population Sickle cell disease patients being seen at St. Jude Children's Research Hospital.
Condition 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.
  • 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.
Study Groups/Cohorts
  • 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.

    Interventions:
    • Other: Blood draw
    • Other: Nasopharyngeal wash
  • 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.

    Interventions:
    • Other: Blood draw
    • Other: Nasopharyngeal wash
  • 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.

    Interventions:
    • Other: Blood draw
    • Other: Nasopharyngeal wash
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 28, 2016)		 24
Original Estimated Enrollment
 (submitted: October 6, 2014)		 89
Actual Study Completion Date August 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02261480
Other Study ID Numbers iSCREEN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party St. Jude Children's Research Hospital
Original Responsible Party Same as current
Current Study Sponsor St. Jude Children's Research Hospital
Original Study Sponsor Same as current
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jane Hankins, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date September 2016