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A new study conducted at the NIH Clinical Center will examine the immune response of people with immune deficiencies or dysregulations to the COVID-19 vaccines.
A new study conducted at the NIH Clinical Center will examine the immune response of people with immune deficiencies or dysregulations to the COVID-19 vaccines.
What you need to know
Millions of people in the United States live with conditions that weaken or disrupt their immune systems. Some conditions, such as combined immunodeficiency, are genetic and have been in a person’s body since birth. Others, such as HIV/AIDS and diabetes, may be acquired later in life. These conditions can affect many aspects of health, putting people who have them at higher risk for infection from contagious diseases such as the flu. These conditions can also affect how the body responds to vaccines. Researchers know very little about how COVID-19 — and the vaccines to prevent it — affect people with immune conditions. A new study at the NIH Clinical Center hopes to change that.
What is this research?
Researchers are recruiting 500 people to participate in this study: 400 people with immune conditions and 100 healthy people. Research teams will identify participants by reviewing their medical and research records or through referral from a community practitioner.
Each participant will give a blood sample within a month of getting their final dose of the vaccine. They will answer questions about whether they’ve had COVID-19 before and what their symptoms were. If they choose, they can also give blood samples again 6, 12, and 24 months later.
The research team will study the blood samples to learn how the participants’ immune systems interact with the vaccine over time and whether this response varies between healthy people and people with immune conditions. They will also analyze the questionnaire results to see whether COVID-19 affects people with immune conditions differently.
The study is supported by the National Institute of Allergy and Infectious Diseases.
Why is this research important?
The first COVID-19 vaccines were tested and approved for emergency use in late 2020. Clinical trials to test the safety and efficacy of the vaccines were rigorous, but they focused on people with healthy immune systems. This means that we don’t have much information on how well the vaccines can protect people with chronic immune conditions or on how or whether COVID-19 affects people with these conditions differently.
Learning more about these questions can help researchers and health care providers ensure that people with immune conditions get the safest and most effective care to protect them from COVID-19.
Where can I go to learn more?
Information about the design of this trial and how you or someone you know may be able to participate.
Primary Immune Deficiency Diseases (PIDDs)
Information about primary immune deficiencies, including types of PIDDs, ongoing clinical trials, and how to talk to your doctor about PIDDs.
Frequently asked questions about vaccine research and more information about the COVID-19 vaccines.
Sources
National Institutes of Health. (2020). COVID-19 vaccine responses to be studied in people with immune deficits. Retrieved May 17, 2021, from https://www.nih.gov/news-events/news-releases/covid-19-vaccine-responses-be-studied-people-immune-deficits.
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