Status:
COMPLETED
COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Immunodeficiencies
Immune Dysregulations
Eligibility:
All Genders
3+ years
Brief Summary
Background: The immune system defends the body against disease and infection. Immune deficiencies are health conditions that decrease the strength of this response. Vaccines stimulate the immune syst...
Detailed Description
Study Description: This prospective cohort study will assess the pre- and post-vaccination immune responses in individuals with select immunodeficiencies and immune dysregulations compared to healthy...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet the following criteria:
- Aged 3 years and older.
- Must be eligible to receive (based on official FDA authorization or approval) and scheduled to receive or have already received a COVID-19 vaccine outside of this facility.
- Must meet the definition of affected participant or control participant:
- Affected participants must have evidence of a primary or secondary immune deficiency or dysregulation under another NIAID protocol or as documented by an outside physician.
- Control participants are healthy volunteers that do not have evidence of a primary or secondary immune deficiency or dysregulation and may include unaffected relatives of affected participants.
- Ability to provide informed consent.
- Willing to have blood samples stored for future research.
- Able to proficiently speak, read, and write English.
- EXCLUSION CRITERIA:
- Individuals meeting any of the following criteria will be excluded from study participation:
- Receipt of any other vaccine within 14 days prior to screening.
- Planned non-COVID-19 vaccination within 28 days after COVID-19 vaccination(s).
- Any condition that, in the opinion of the investigator, contraindicates participation in this study (e.g. specific autoinflammatory diseases, interferonopathies).
- Self-reported history of HIV.
Exclusion
Key Trial Info
Start Date :
April 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT04852276
Start Date
April 20 2021
End Date
August 31 2023
Last Update
October 1 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892