COVID-19 Vaccine Response in Sickle Cell Disease

Sponsor

ASH Research Collaborative (Other)

Overall Status

Recruiting

CT.gov ID

NCT05139992

Collaborator

American Society of Hematology (Other), University of Pennsylvania (Other)

200

Enrollment

Locations

Anticipated Duration (Months)

33.3

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Antibody response to COVID-19 vaccine in persons with sickle cell disease [2 months post initial vaccination]
IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen

Secondary Outcome Measures

Antibody response to COVID-19 vaccine in persons with sickle cell disease [6 months post initial vaccination]
IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen
Side effects of vaccination and sickle cell related complications around the time of vaccination [2-3 days post vaccination, 2 months post vaccination, 6 months post vaccination]
Assessed by questionnaire and medical record review
Incidence of patient reported COVID-19 infections [Within 6 months following vaccination]
Patient report

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's National Medical Center	Washington	District of Columbia	United States	20010
2	Johns Hopkins University	Baltimore	Maryland	United States	21205
3	Montefiore Hospital	Bronx	New York	United States	10467
4	Duke University Medical Center	Durham	North Carolina	United States	27710
5	Prisma Health - Upstate	Greenville	South Carolina	United States	29601
6	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

ASH Research Collaborative
American Society of Hematology
University of Pennsylvania

Investigators

Principal Investigator: Charles Abrams, MD, University of Pennsylvania
Principal Investigator: Sophie Lanzkron, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ASH Research Collaborative

ClinicalTrials.gov Identifier:

NCT05139992

Other Study ID Numbers:

ASH RC CTN 2021-00001

First Posted:

Dec 1, 2021

Last Update Posted:

Dec 17, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Anemia, Sickle Cell

Study Results

No Results Posted as of Dec 17, 2021