Study of the Immune Response to and Safety Profile of COVID-19 Vaccines in Individuals With and Without Immune Deficiencies

Currently, people with immune disorders fall outside of guidance for COVID-19 vaccination, as they are typically excluded from vaccine trials. This study evaluates the immune response to COVID-19 vaccination and any vaccine-associated adverse events that may be experienced in individuals with different immune disorders. 

What does the study involve?

This study involves 6 – 10 timepoints that will be evaluated over a 24-month period; the majority take place during vaccination through one month after vaccination is completed. Participants will fill out surveys about medical history, prior COVID-19 diagnosis, and vaccine symptoms. Saliva can be submitted every other week to test for post-vaccination SARS-CoV-2 infection.

Who can participate?

We will enroll individuals 16 years of age and older. Affected study participants must have documented evidence of a primary or secondary immune disorder (excluding HIV). Healthy volunteers without evidence of an immune disorder may be eligible to participate, including unaffected relatives of participants with immune disorders.

Where Is It Taking Place? 

All samples may be collected remotely; in-person visits at the NIH are optional.

Is There a Cost? 

There is no cost to participate.

Is Compensation Provided? 

Compensation will be dependent on the sample collections and study visits that a subject participates in. 

Number of Visits

Up to 6 for remote participants, up to 10 for participants sampled at NIH Clinical Center.

Steps To Participate 

To see if you may be eligible, please email NIAIDCovidVaccineStudy@niaid.nih.gov

Visit ClinicalTrials.gov for details.

Contact Information

Email: NIAIDCovidVaccineStudy@niaid.nih.gov

Participating in Research

Watch a series of short informational videos about participating in clinical trials. These videos are intended to help potential participants understand how research works, what questions they should consider asking, and things to think about when deciding whether or not to participate in a study.

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