A New Reagent Assay Examining Natural Parvovirus B19 Infection in Sickle Cell Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Anemia |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 1 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | May 2017 |
| Contact: | Jane Hankins, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
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.
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.
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.
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.
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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Jane Hankins, MD
Phone: 866-278-5833
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