N/A
N=59
COVID-19 Vaccine Response in Sickle Cell Disease
Sickle Cell Disease · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05139992 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease — 32.155 units per mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- COVID-19 Vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- ASH Research Collaborative
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease |
21.43 | — |
| SECONDARY Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease |
21.43 | — |
| SECONDARY Post-Vaccination Side Effect or Sickle Cell Disease Related Complication |
20; 4; 3; 3; 5; 12 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05139992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.