Sickle Cell DiseaseNCT02261480
A New Reagent Assay Examining Natural Parvovirus B19 Infection in Sickle Cell Disease
An observational study of Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Blood draw and Nasopharyngeal wash
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sickle cell disease patients being seen at St. Jude Children's Research Hospital.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: 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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Blood draw, Nasopharyngeal wash
- Keywords
- Parvovirus B19 Infection
- Medical subject headings
- Anemia, Sickle Cell, Erythema Infectiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
When possible, blood will be drawn as an extra aliquot utilizing the same needle stick procedure performed for standard of care.
Nasopharyngeal washOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Blood draw; Other: Nasopharyngeal wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the new VP1u ELISA and neutralizing antibodies tests in participants with documented parvovirus B19 infection
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
Antibody response following acute parvovirus B19 infection
Descriptive statistics, such as mean, standard deviation, median and range, will be developed and plotted.
Measured: Baseline, and Days 7, 30 and 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jane Hankins, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261480
- Sponsor's protocol ID
- iSCREEN
- Status last verified
- Sep 2016
- First submitted
- 6 Oct 2014
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation in Sickle Cell Disease of a New Reagent Assay Examining Natural Parvovirus B19 Infection
- ClinicalTrials.gov ID
- NCT02261480
- Acronym / sponsor ID
- iSCREEN
- Conditions
- Sickle Cell Disease
- Keywords
- Parvovirus B19 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Documented Prior History | – | Other: Blood draw, Other: Nasopharyngeal washPediatric 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. |
| Group B: No Prior History | – | Other: Blood draw, Other: Nasopharyngeal washPediatric 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. |
| Group C: Suspected and/or Confirmed | – | Other: Blood draw, Other: Nasopharyngeal washSickle 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sickle cell disease patients being seen at St. Jude Children's Research Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawWhen possible, blood will be drawn as an extra aliquot utilizing the same needle stick procedure performed for standard of care. | Other | Group A: Documented Prior History, Group B: No Prior History, Group C: Suspected and/or Confirmed |
| Nasopharyngeal washNasopharyngeal 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. | Other | Group A: Documented Prior History, Group B: No Prior History, Group C: Suspected and/or Confirmed |
Primary outcome
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.
2 secondary outcomes
Compare the sensitivity and specificity of the VP1u ELISA with the neutralization assay
Time frame: Baseline
Antibody response following acute parvovirus B19 infection
Time frame: Baseline, and Days 7, 30 and 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Hankins, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the new VP1u ELISA and neutralizing antibodies tests in participants with documented parvovirus B19 infection (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.