COVID-19 Vaccine Response in Sickle Cell Disease

NCT05139992 | Completed Results

• 1 other identifier: ASH RC CTN 2021-00001
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 8

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.

Conditions

Sickle Cell Disease; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease

  6 months post initial vaccination

• Post-Vaccination Side Effect or Sickle Cell Disease Related Complication

  2-3 days post vaccination

Study Arms (1)

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

Interventions

COVID-19 Vaccine BIOLOGICAL

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

Observational Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASH Research Collaborative: lead
• American Society of Hematology: collaborator
• University of Pennsylvania: collaborator

Study Sites (8)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Montefiore Hospital

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Prisma Health - Upstate

Greenville, South Carolina, 29601, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 38991137 RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell; COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Nicole Mortier
• Organization: ASH Research Collaborative

nmortier@ashrc.org

866-828-1231

Study Officials

• Charles Abrams, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Sophie Lanzkron, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 1, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)