An observational study in Sickle Cell Disease, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2016-09-19.
Sponsored by St. Jude Children's Research Hospital · Observational
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.
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.
PRIMARY OBJECTIVES
SECONDARY OBJECTIVES
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 24 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
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Sickle cell disease patients being seen at St. Jude Children's Research Hospital.
Inclusion Criteria - Individuals not experiencing an acute illness (Group A):
Exclusion Criteria - Individuals not experiencing an acute illness (Group A):
Inclusion Criteria - Individuals with confirmed (Group B) or suspected (Group C) acute parvovirus B19 infection:
Exclusion Criteria - Individuals with confirmed (Group B) or suspected (Group C) acute parvovirus B19 infection:
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
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
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
When possible, blood will be drawn as an extra aliquot utilizing the same needle stick procedure performed for standard of care.
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.
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
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.
Time frame: Baseline
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.
Time frame: Baseline
Antibody response following acute parvovirus B19 infection
Descriptive statistics, such as mean, standard deviation, median and range, will be developed and plotted.
Time frame: Baseline, and Days 7, 30 and 120
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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St. Jude Children's Research Hospital