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NCT04852276 · ClinicalTrials.gov registry record
COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations
A clinical trial of Immunodeficiencies and Immune Dysregulations, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 308
- Enrollment target
- 1
- Study location
NCT04852276 is a study of Immunodeficiencies and Immune Dysregulations that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 308 participants, below the 344-participant average among 8 other Immunodeficiencies trials with a reported enrollment target (10% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04852276, a study of Immunodeficiencies and Immune Dysregulations, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 308 participants
- Enrollment target
- 1
- Study location
Study 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 system to create a defense against a specific type of germ. Researchers want to compare immune system responses to COVID-19 vaccines in people with and without immune deficiencies. Objective: To learn about how people with immune deficiencies respond to COVID-19 vaccines. Eligibility: People age 3 and older with an immune deficiency who plan to get a COVID-19 vaccine. Healthy volunteers are also needed. Design: Participants will be pre-screened for eligibility, including COVID-19 vaccination history and immune status. Participants will give a blood sample before they get their first COVID-19 vaccine. Blood will be drawn from an arm vein using a needle. Blood can be drawn at the NIH, at a local doctor's office, or at a laboratory. It may also be drawn through a fingerstick at home. Participants will also complete 2 online surveys about their health and COVID-19 history. Additional surveys are optional. Participants will give a second blood sample 2 to 4 weeks after they get the vaccine. They will complete 2 surveys about changes in their health and side effects from the vaccine. If participants get another COVID-19 vaccine dose, they will repeat the blood draw and surveys 3 to 4 weeks later. Participants may give 3 optional blood samples in the 24 months after their last vaccine. They may also give saliva samples every 2 weeks while they are in the study for 6 months following their last vaccine. Participation will last from 1 month to 2 years after the participant's last vaccine.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2021-04-20 |
| Est. Completion | 2023-08-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04852276
The ClinicalTrials.gov registry entry for NCT04852276 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 344-participant average among 8 other Immunodeficiencies trials with a reported enrollment target (10% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Immunodeficiencies appearing as the primary indexed condition, and to 0 interventions.
NCT04852276 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04852276 about?
NCT04852276 is a clinical study titled "COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations". 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 system to create a defense against a specific type of germ. Researchers want to compare immune system re...
What is the current status of trial NCT04852276?
This trial is currently completed. The enrollment target is 308 participants. The study started on 2021-04-20. Estimated completion is 2023-08-31.
What conditions does trial NCT04852276 study?
This clinical trial studies the following conditions: Immunodeficiencies, Immune Dysregulations.
Who is sponsoring clinical trial NCT04852276?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04852276 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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