COVID-19 Vaccine Response in Sickle Cell Disease

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05139992
• Other study ID #: ASH RC CTN 2021-00001
• Status: Active, not recruiting
• Start date: December 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: ASH Research Collaborative
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• COVID-19
• Sickle Cell Disease

Intervention

Biological:
• COVID-19 Vaccine
Vaccination against SARS-CoV-2

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Montefiore Hospital	Bronx	New York
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Prisma Health - Upstate	Greenville	South Carolina
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

Sponsors (3)

Lead Sponsor	Collaborator
ASH Research Collaborative	American Society of Hematology, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Side effects of vaccination and sickle cell related complications around the time of vaccination	Assessed by questionnaire and medical record review	2-3 days post vaccination, 2 months post vaccination, 6 months post vaccination
Secondary	Incidence of patient reported COVID-19 infections	Patient report	Within 6 months following vaccination