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COVID-19 Vaccine Response in Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05139992
Recruitment Status : Active, not recruiting
First Posted : December 1, 2021
Last Update Posted : March 2, 2023
Sponsor:
Collaborators:
American Society of Hematology
University of Pennsylvania
Information provided by (Responsible Party):
ASH Research Collaborative

Study Description
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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.

Condition or disease Intervention/treatment
Sickle Cell Disease COVID-19 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 Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Vaccine Response in People Living With Sickle Cell Disease
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational Cohort
Previously unvaccinated persons with sickle cell disease who are scheduled to receive their initial COVID-19 vaccine series.
 Biological: COVID-19 Vaccine
Vaccination against SARS-CoV-2


Outcome Measures
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Primary Outcome Measures :
  1. Antibody response to COVID-19 vaccine in persons with sickle cell disease [ Time Frame: 2 months post initial vaccination ]
    IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen


Secondary Outcome Measures :
  1. Antibody response to COVID-19 vaccine in persons with sickle cell disease [ Time Frame: 6 months post initial vaccination ]
    IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen

  2. Side effects of vaccination and sickle cell related complications around the time of vaccination [ Time Frame: 2-3 days post vaccination, 2 months post vaccination, 6 months post vaccination ]
    Assessed by questionnaire and medical record review

  3. Incidence of patient reported COVID-19 infections [ Time Frame: Within 6 months following vaccination ]
    Patient report


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05139992


Locations
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United States, California
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, New York
Montefiore Hospital
Bronx, New York, United States, 10467
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, South Carolina
Prisma Health - Upstate
Greenville, South Carolina, United States, 29601
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
ASH Research Collaborative
American Society of Hematology
University of Pennsylvania
Investigators
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Principal Investigator: Charles Abrams, MD University of Pennsylvania
Principal Investigator: Sophie Lanzkron, MD Johns Hopkins University
More Information
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Responsible Party: ASH Research Collaborative
ClinicalTrials.gov Identifier: NCT05139992    
Other Study ID Numbers: ASH RC CTN 2021-00001
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Anemia, Sickle Cell
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn