Clinical trial NCT05139992: COVID-19 Vaccine Response in Sickle Cell Disease
Official title: COVID-19 Vaccine Response in People Living With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
COVID-19
Lead sponsor: ASH Research Collaborative
Sponsor class: OTHER
Collaborators: name: American Society of Hematology
name: University of Pennsylvania
First posted: 2021-12-01
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease
timeFrame: 2 months post initial vaccination
Secondary outcomes:
measure: Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease
timeFrame: 6 months post initial vaccination
measure: Post-Vaccination Side Effect or Sickle Cell Disease Related Complication
timeFrame: 2-3 days post vaccination
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Bronx
country: United States
facility: Montefiore Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Pennsylvania
name: Charles Abrams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Sophie Lanzkron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.