COVID-19, Sickle Cell Disease
Conditions
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.
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.
Interventions
BIOLOGICALCOVID-19 Vaccine
Vaccination against SARS-CoV-2 administered as part of standard of care
Sponsors
American Society of Hematology
University of Pennsylvania
ASH Research Collaborative
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease | 2 months post initial vaccination | IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease | 6 months post initial vaccination | IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen |
| Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | 2-3 days post vaccination | Assessed by structured telephone interview conducted 2-3 days post-vaccination |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observational Cohort Previously unvaccinated persons with sickle cell disease who are scheduled to receive their initial COVID-19 vaccine series as part of standard of care.
COVID-19 Vaccine: Vaccination against SARS-CoV-2 administered as part of standard of care | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | Observational Cohort |
|---|---|
| Age, Categorical <=18 years | 24 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 24 Participants |
| Sickle Cell Genotype HbS/Beta plus thalassemia | 1 Participants |
| Sickle Cell Genotype HbS/Beta zero thalassemia | 1 Participants |
| Sickle Cell Genotype HbSC | 9 Participants |
| Sickle Cell Genotype HbSS | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 59 |
| other Total, other adverse events | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 |
Outcome results
Primary
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease
IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen
Time frame: 2 months post initial vaccination
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Observational Cohort | Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease | 32.155 units per mL |
Secondary
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease
IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen
Time frame: 6 months post initial vaccination
Population: 37 participants who provided a 6-month post vaccination sample
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Observational Cohort | Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease | 21.43 units per mL |
Secondary
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication
Assessed by structured telephone interview conducted 2-3 days post-vaccination
Time frame: 2-3 days post vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting at least one side effect | 20 participants |
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting arthralgia | 4 participants |
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting chills | 3 participants |
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting fever | 3 participants |
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting headache | 5 participants |
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting myalgia | 12 participants |
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting Nausea | 1 participants |
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting vaccine site redness | 3 participants |
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting vaccine site pain | 14 participants |
| Observational Cohort | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Participants reporting vaso-occlusive pain | 5 participants |