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| Name | Class |
|---|---|
| American Society of Hematology | OTHER |
| University of Pennsylvania | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Cohort | Previously unvaccinated persons with sickle cell disease who are scheduled to receive their initial COVID-19 vaccine series as part of standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine | Biological | Vaccination against SARS-CoV-2 administered as part of standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Post-Vaccination Side Effect or Sickle Cell Disease Related Complication |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Charles Abrams, MD | University of Pennsylvania | Principal Investigator |
| Sophie Lanzkron, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | United States | ||
| Children's National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38991137 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Cohort | Previously unvaccinated persons with sickle cell disease who are scheduled to receive their initial COVID-19 vaccine series as part of standard of care. COVID-19 Vaccine: Vaccination against SARS-CoV-2 administered as part of standard of care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
41 participants completing the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Cohort | Previously unvaccinated persons with sickle cell disease who are scheduled to receive their initial COVID-19 vaccine series as part of standard of care. COVID-19 Vaccine: Vaccination against SARS-CoV-2 administered as part of standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | units per mL | 2 months post initial vaccination |
|
|
6 months
Per protocol, in this observational study, only Grade II or higher adverse events associated with study participation (lab draws, questionnaire completion) were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Cohort | Previously unvaccinated persons with sickle cell disease who are scheduled to receive their initial COVID-19 vaccine series as part of standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Mortier | ASH Research Collaborative | 866-828-1231 | nmortier@ashrc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2022 | Oct 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Assessed by structured telephone interview conducted 2-3 days post-vaccination
| 2-3 days post vaccination |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Montefiore Hospital | The Bronx | New York | 10467 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Prisma Health - Upstate | Greenville | South Carolina | 29601 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sickle Cell Genotype | Count of Participants | Participants |
|
|
| 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 | 37 participants who provided a 6-month post vaccination sample | Posted | Median | Inter-Quartile Range | units per mL | 6 months post initial vaccination |
|
|
|
| Secondary | Post-Vaccination Side Effect or Sickle Cell Disease Related Complication | Assessed by structured telephone interview conducted 2-3 days post-vaccination | Posted | Number | participants | 2-3 days post vaccination |
|
|
|
| 1 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
ASH Research Collaborative Clinical Trial Network Participation Agreement executed between ASH Research Collaborative (Sponsor) and participating PIs & Institutions contains disclosure language.
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
| Participants reporting fever |
|
| Participants reporting headache |
|
| Participants reporting myalgia |
|
| Participants reporting Nausea |
|
| Participants reporting vaccine site redness |
|
| Participants reporting vaccine site pain |
|
| Participants reporting vaso-occlusive pain |
|