Brief Summary
The purpose of this study is to assess the antibody response to COVID-19 vaccination in a cohort of patients with sickle cell disease (SCD) and to assess vaccine and SCD related complications around the time of vaccination.
Brief Title
COVID-19 Vaccine Response in Sickle Cell Disease
Detailed Description
Sickle cell disease (SCD) is a genetic disorder caused by a single base substitution of valine for a glutamine at the sixth amino acid of the gene encoding for the hemoglobin β chain. Patients with Hgb SS disease and other sickle hemoglobinopathies suffer from a variety of clinical complications related to this abnormal hemoglobin. These clinical manifestations include hemolytic anemia, painful vaso-occlusive crisis, and end organ damage. Persons with SCD generally auto-splenectomize in childhood secondary to infarctions from their hemoglobinopathy, thus increasing their risk of infection and rendering them immunosuppressed. Data suggest that general immune function in SCD patients may be impaired, and thus responses to vaccine may be suboptimal.
Patients with SCD are considered at increased risk of complications from infection from SARS-CoV-2 infection and are therefore an important group to receive vaccination against the virus. Understanding response to COVID-19 vaccination is this high-risk group of patients can provide a more targeted approach to vaccination in order to achieve adequate protection.
Patients with SCD are considered at increased risk of complications from infection from SARS-CoV-2 infection and are therefore an important group to receive vaccination against the virus. Understanding response to COVID-19 vaccination is this high-risk group of patients can provide a more targeted approach to vaccination in order to achieve adequate protection.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Sickle Cell Disease
COVID-19
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of sickle cell disease (HbSS, HbSC, HbSB0 thalassemia, HbSB+ thalassemia, HbS/Other)
2. Has not received any COVID-19 vaccination prior to enrollment
3. Scheduled for a COVID-19 vaccination (type does not matter) as part of routine clinical care
4. Willing and able to sign consent
Exclusion Criteria:
1. Unwilling to have labs drawn or complete study requirements.
2. Previous therapy curative of SCD (including bone marrow transplant and gene therapy)
3. Previous receipt of anti-COVID-19 antibody therapy
1. Diagnosis of sickle cell disease (HbSS, HbSC, HbSB0 thalassemia, HbSB+ thalassemia, HbS/Other)
2. Has not received any COVID-19 vaccination prior to enrollment
3. Scheduled for a COVID-19 vaccination (type does not matter) as part of routine clinical care
4. Willing and able to sign consent
Exclusion Criteria:
1. Unwilling to have labs drawn or complete study requirements.
2. Previous therapy curative of SCD (including bone marrow transplant and gene therapy)
3. Previous receipt of anti-COVID-19 antibody therapy
Inclusion Criteria
Inclusion Criteria:
1. Diagnosis of sickle cell disease (HbSS, HbSC, HbSB0 thalassemia, HbSB+ thalassemia, HbS/Other)
2. Has not received any COVID-19 vaccination prior to enrollment
3. Scheduled for a COVID-19 vaccination (type does not matter) as part of routine clinical care
4. Willing and able to sign consent
1. Diagnosis of sickle cell disease (HbSS, HbSC, HbSB0 thalassemia, HbSB+ thalassemia, HbS/Other)
2. Has not received any COVID-19 vaccination prior to enrollment
3. Scheduled for a COVID-19 vaccination (type does not matter) as part of routine clinical care
4. Willing and able to sign consent
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT05139992
Org Class
Other
Org Full Name
ASH Research Collaborative
Org Study Id
ASH RC CTN 2021-00001
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
COVID-19 Vaccine Response in People Living With Sickle Cell Disease
Primary Outcomes
Outcome Description
IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen
Outcome Measure
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease
Outcome Time Frame
2 months post initial vaccination
Secondary Outcomes
Outcome Description
IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen
Outcome Time Frame
6 months post initial vaccination
Outcome Measure
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease
Outcome Description
Assessed by structured telephone interview conducted 2-3 days post-vaccination
Outcome Time Frame
2-3 days post vaccination
Outcome Measure
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Up to 200 subjects with sickle cell disease will be enrolled at up to 20 sites participating in the ASH RC Sickle Cell Disease Clinical Trials Network.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Deepa Manwani
Investigator Email
dmanwani@montefiore.org
Investigator Phone
718-741-2342