NCT05139992

COVID-19 Vaccine Response in Sickle Cell Disease

COVID-19 Vaccine Response in People Living With Sickle Cell Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: ASH Research Collaborative · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine	Vaccination against SARS-CoV-2 administered as part of standard of care

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-12-01
• Last updated: 2025-02-14
• Results posted: 2025-02-14

Locations

8 sites across 1 country: United States