COVID-19 Vaccine Response in Sickle Cell Disease

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of sickle cell disease (HbSS, HbSC, HbSB0 thalassemia, HbSB+ thalassemia, HbS/Other)
Has not received any COVID-19 vaccination prior to enrollment
Scheduled for a COVID-19 vaccination (type does not matter) as part of routine clinical care
Willing and able to sign consent

Exclusion Criteria

Unwilling to have labs drawn or complete study requirements.
Previous therapy curative of SCD (including bone marrow transplant and gene therapy)
Previous receipt of anti-COVID-19 antibody therapy

Arm && Interventions

Group	Intervention	Description
Observational Cohort	COVID-19 Vaccine	Previously unvaccinated persons with sickle cell disease who are scheduled to receive their initial COVID-19 vaccine series as part of standard of care.
Observational Cohort	COVID-19 Vaccine	Previously unvaccinated persons with sickle cell disease who are scheduled to receive their initial COVID-19 vaccine series.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (8): Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Prisma Health - Upstate
🇺🇸
Greenville, South Carolina, United States
Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
UCSF Benioff Children's Hospital Oakland
🇺🇸
Oakland, California, United States
Children's National Medical Center
🇺🇸
Washington, District of Columbia, United States
Montefiore Hospital
🇺🇸
Bronx, New York, United States