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The Mechanistic Biology of Primary Immunodeficiency Disorders

NCT03394053 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2026-04-29

No results posted yet for this study

Summary

Background:

Primary immunodeficiency disorders, or PIDs, are diseases that weaken the immune system. This makes it easier for a person to get sick. Some PIDs are mild and may not be diagnosed until later in life. Other kinds are severe and can be identified shortly after birth. Researchers want to learn more about PIDs by comparing data from relatives and healthy volunteers to people with a PID.

Objective:

To learn more about PIDs, including their genetic causes.

Eligibility:

People ages 0-90 with a PID or their healthy biological relatives the same ages

Healthy volunteers ages 18-75

Design:

Participants will be screened with a medical history, physical exam, and HIV blood test. They may have a pregnancy test.

Participants may repeat the screening tests.

Blood taken at screening will be used for genetic tests and research tests. Participants will be told test results that affect their health. Some blood will be stored for future research.

Adult participants with a PID may have a small piece of skin removed. The area will be numbed. A small tool will take a piece of skin about the size of a pencil eraser.

Researchers may collect fluid or tissue samples from PID participants regular medical care. They will use them for research tests.

Participants with a PID will have 3 follow-up visits over 10 years (for infants, 2 years). Visits will include a physical exam, medical history, and blood draw.

Participants with a PID and their relatives will be called once a year for 10 years. They will talk about how they are feeling and if they have developed any new symptoms or illnesses.

...

Conditions

  • Primary Immunodeficiency Disorders

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Luigi D Notarangelo, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
1 Day
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2029-12-31
Completion
2040-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03394053 on ClinicalTrials.gov