COVID-19 Vaccine Response in Sickle Cell Disease

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    200
  • sponsor
    ASH Research Collaborative
Updated on 26 January 2022
thalassemia
sickle hemoglobin

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.

Details
Condition Sickle Cell Disease, COVID-19
Treatment covid-19 vaccine
Clinical Study IdentifierNCT05139992
SponsorASH Research Collaborative
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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