COVID-19 Vaccine Response in Sickle Cell Disease

NCT ID: NCT05139992

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-12-31

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.

Conditions

Sickle Cell Disease; COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: BIOLOGICAL

Vaccination against SARS-CoV-2 administered as part of standard of care

Interventions

COVID-19 Vaccine

Vaccination against SARS-CoV-2 administered as part of standard of care

Intervention Type: BIOLOGICAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Hematology

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

ASH Research Collaborative

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Sophie Lanzkron, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Montefiore Hospital

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Prisma Health - Upstate

Greenville, South Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Anderson AR, Strouse JJ, Manwani D, Brandow AM, Vichinsky E, Campbell A, Leavey PJ, Nero A, Ibrahim IF, Field JJ, Baer A, Soto-Calderon H, Vincent L, Zhao Y, Santos JJS, Hensley SE, Mortier N, Lanzkron S, Neuberg D, Abrams CS. COVID-19 mRNA vaccination responses in individuals with sickle cell disease: an ASH RC Sickle Cell Research Network Study. Blood Adv. 2024 Sep 10;8(17):4549-4553. doi: 10.1182/bloodadvances.2024013878.

Reference Type: RESULT

PMID: 38991137 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ASH RC CTN 2021-00001

Identifier Type: -

Identifier Source: org_study_id