COVID-19 Vaccine Response in Sickle Cell Disease

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Sickle Cell Disease
• Intervention / Treatment: Biological: COVID-19 Vaccine

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.

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • UCSF Benioff Children's Hospital Oakland
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Prisma Health - Upstate
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: COVID-19 Vaccine; Vaccination against SARS-CoV-2 administered as part of standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease	IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen	2 months post initial vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease	IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen	6 months post initial vaccination
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication	Assessed by structured telephone interview conducted 2-3 days post-vaccination	2-3 days post vaccination

Collaborators and Investigators

• Sponsor: ASH Research Collaborative
• Collaborators: University of Pennsylvania; American Society of Hematology
• Investigators: Principal Investigator: Charles Abrams, MD, University of Pennsylvania; Principal Investigator: Sophie Lanzkron, MD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Hematologic Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; COVID-19; Anemia, Sickle Cell
• Other Study ID Numbers: ASH RC CTN 2021-00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No