CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 308 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04852276
NCT04852276N/ACompleted

Analysis of the Immune Response to COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations

National Institute of Allergy and Infectious Diseases (NIAID)·observational·Posted Apr 21, 2021·Updated Oct 1, 2024

In Brief

An observational study for Immunodeficiencies and Immune Dysregulations. Completed, enrolled 308 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 21, 2021
Enrollment StartApr 20, 2021
Primary CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.2 years ago