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

NCT02261480 | Completed

• 1 other identifier: iSCREEN
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Parvovirus B19 Infection

Outcome Measures

Primary Outcomes (2)

• 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

  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 Outcomes (2)

• Compare the sensitivity and specificity of the VP1u ELISA with the neutralization assay

  Baseline

• Antibody response following acute parvovirus B19 infection

  Baseline, and Days 7, 30 and 120

Study Arms (3)

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; 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.

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.

Other: Blood draw; Other: Nasopharyngeal wash

Interventions

Blood draw OTHER

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

Group A: Documented Prior History; Group B: No Prior History; Group C: Suspected and/or Confirmed

Nasopharyngeal wash OTHER

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 A: Documented Prior History; Group B: No Prior History; Group C: Suspected and/or Confirmed

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Anemia, Sickle Cell; Erythema Infectiosum

Interventions

Blood Specimen Collection; Nasal Lavage

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Parvoviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Erythema; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Infectious

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Therapeutic Irrigation

Study Officials

• Jane Hankins, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 10, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

US (1)