Sickle Cell DiseaseNCT05139992
COVID-19 Vaccine Response in Sickle Cell Disease
An observational study of Sickle Cell Disease and COVID-19, run by ASH Research Collaborative at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Disease, COVID-19
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 59 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Dec 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Prisma Health - Upstate
Greenville, South Carolina, 29601
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Montefiore Hospital
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: COVID-19 Vaccine Response in People Living With Sickle Cell Disease
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.
Read the 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.
- Conditions
- Sickle Cell Disease, COVID-19
- Being tested
- COVID-19 Vaccine
- Medical subject headings
- Anemia, Sickle Cell, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
Vaccination against SARS-CoV-2 administered as part of standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease
IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen
Measured: 2 months post initial vaccination
Secondary outcomes (2)
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease
IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen
Measured: 6 months post initial vaccination
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication
Assessed by structured telephone interview conducted 2-3 days post-vaccination
Measured: 2-3 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASH Research Collaborative
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Hematology, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Charles Abrams, MD, Principal investigator, University of PennsylvaniaSophie Lanzkron, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139992
- Sponsor's protocol ID
- ASH RC CTN 2021-00001
- Status last verified
- Jan 2025
- First submitted
- 29 Nov 2021
- Last updated
- 14 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38991137
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccine Response in People Living With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05139992
- Acronym / sponsor ID
- ASH RC CTN 2021-00001
- Conditions
- Sickle Cell Disease, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- ASH Research CollaborativeUniversity, hospital or other
- Collaborators
- American Society of Hematology, University of Pennsylvania
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 14 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Biological: COVID-19 VaccinePreviously unvaccinated persons with sickle cell disease who are scheduled to receive their initial COVID-19 vaccine series as part of standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccineVaccination against SARS-CoV-2 administered as part of standard of care | Biological | Observational Cohort |
Primary outcome
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
2 secondary outcomes
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease
Time frame: 6 months post initial vaccination
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication
Time frame: 2-3 days post vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38991137Anderson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Abrams, MD principal investigator
University of Pennsylvania
Sophie Lanzkron, MD principal investigator
Johns Hopkins University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and COVID-19, run by ASH Research Collaborative at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease (time frame: 2 months post initial vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05139992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.