Trial Outcomes & Findings for COVID-19 Vaccine Response in Sickle Cell Disease (NCT NCT05139992)

NCT ID: NCT05139992

Last Updated: 2025-02-14

Results Overview

IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen

• Recruitment status: COMPLETED
• Target enrollment: 59 participants
• Primary outcome timeframe: 2 months post initial vaccination
• Results posted on: 2025-02-14

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	59
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	12
Overall Study Lost to Follow-up	6

Baseline Characteristics

COVID-19 Vaccine Response in Sickle Cell Disease

Baseline characteristics by cohort

Measure	Observational Cohort n=41 Participants 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
Age, Categorical <=18 years	24 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Sickle Cell Genotype HbSS	30 Participants n=5 Participants
Sickle Cell Genotype HbS/Beta zero thalassemia	1 Participants n=5 Participants
Sickle Cell Genotype HbSC	9 Participants n=5 Participants
Sickle Cell Genotype HbS/Beta plus thalassemia	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months post initial vaccination

IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen

Outcome measures

Measure	Observational Cohort n=41 Participants Previously unvaccinated persons with sickle cell disease who scheduled to receive their initial COVID-19 vaccine series as part of standard of care.
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease	32.155 units per mL Interval 16.9 to 65.0

SECONDARY outcome

Timeframe: 6 months post initial vaccination

Population: 37 participants who provided a 6-month post vaccination sample

IgG ELISA based antibody titer to SARS-CoV-2 spike RBD antigen

Outcome measures

Measure	Observational Cohort n=37 Participants Previously unvaccinated persons with sickle cell disease who scheduled to receive their initial COVID-19 vaccine series as part of standard of care.
Antibody Response to COVID-19 Vaccine in Persons With Sickle Cell Disease	21.43 units per mL Interval 10.32 to 57.48

SECONDARY outcome

Timeframe: 2-3 days post vaccination

Assessed by structured telephone interview conducted 2-3 days post-vaccination

Outcome measures

Measure	Observational Cohort n=41 Participants Previously unvaccinated persons with sickle cell disease who scheduled to receive their initial COVID-19 vaccine series as part of standard of care.
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting myalgia	12 participants
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting arthralgia	4 participants
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting chills	3 participants
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting fever	3 participants
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting at least one side effect	20 participants
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting headache	5 participants
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting Nausea	1 participants
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting vaccine site redness	3 participants
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting vaccine site pain	14 participants
Post-Vaccination Side Effect or Sickle Cell Disease Related Complication Participants reporting vaso-occlusive pain	5 participants

Adverse Events

Observational Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicole Mortier

ASH Research Collaborative

Phone: 866-828-1231

Email: nmortier@ashrc.org

Results disclosure agreements

• Principal investigator is a sponsor employee ASH Research Collaborative Clinical Trial Network Participation Agreement executed between ASH Research Collaborative (Sponsor) and participating PIs \& Institutions contains disclosure language.
• Publication restrictions are in place

Restriction type: OTHER