Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

February 28, 2026 updated by: Ensoma

A Cross-Sectional, Observational Study of the Prevalence of Adenoviral-Specific Antibodies and Inflammatory Cytokines in Participants With Chronic Granulomatous Disease

This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.

Study Overview

Status

Recruiting

Conditions

Detailed Description

In this observational study, blood samples will be collected from adult and pediatric patients with CGD. The level of circulating adenovirus antibodies and inflammatory cytokines will be measured to characterize the prevalence of these markers in this population.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Completed
        • Great Ormond Street Hospital for Children
      • London, United Kingdom
        • Completed
        • Royal Free London NHS Foundation Trust
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36104
    • Arizona
      • Phoenix, Arizona, United States, 85001
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
    • California
      • Sacramento, California, United States, 95814
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California, San Francisco
        • Principal Investigator:
          • Morna Dorsey, MD
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80202
    • Connecticut
      • Hartford, Connecticut, United States, 06103
    • Delaware
      • Dover, Delaware, United States, 19901
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20001
    • Florida
      • Tallahassee, Florida, United States, 32301
    • Georgia
      • Atlanta, Georgia, United States, 30303
    • Idaho
      • Boise, Idaho, United States, 83702
    • Illinois
      • Springfield, Illinois, United States, 62701
    • Indiana
      • Indianapolis, Indiana, United States, 46225
    • Iowa
      • Des Moines, Iowa, United States, 50309
    • Kansas
      • Topeka, Kansas, United States, 66603
    • Kentucky
      • Frankfort, Kentucky, United States, 40601
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70802
    • Maine
      • Augusta, Maine, United States, 04330
    • Maryland
      • Annapolis, Maryland, United States, 21401
    • Massachusetts
      • Boston, Massachusetts, United States, 02210
    • Michigan
      • Lansing, Michigan, United States, 48933
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
    • Mississippi
      • Jackson, Mississippi, United States, 39205
    • Missouri
      • Jefferson City, Missouri, United States, 65101
    • Montana
      • Helena, Montana, United States, 59623
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
    • Nevada
      • Carson City, Nevada, United States, 89701
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
    • New Jersey
      • Trenton, New Jersey, United States, 08608
    • New Mexico
      • Santa Fe, New Mexico, United States, 87501
    • New York
      • Albany, New York, United States, 12207
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
    • Ohio
      • Columbus, Ohio, United States, 43215
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
    • Oregon
      • Salem, Oregon, United States, 97301
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
    • South Carolina
      • Columbia, South Carolina, United States, 29217
    • South Dakota
      • Pierre, South Dakota, United States, 57501
    • Tennessee
      • Nashville, Tennessee, United States, 37219
    • Texas
      • Austin, Texas, United States, 78701
    • Utah
      • Salt Lake City, Utah, United States, 84111
    • Vermont
      • Montpelier, Vermont, United States, 05602
    • Virginia
      • Richmond, Virginia, United States, 23219
    • Washington
      • Olympia, Washington, United States, 98507
    • West Virginia
      • Charleston, West Virginia, United States, 25301
    • Wisconsin
      • Madison, Wisconsin, United States, 53703
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with CGD

Description

Inclusion Criteria:

  • The participant must have been diagnosed with CGD based on the referring physician's confirmation that NADPH oxidase activity is ≤5% (i.e., the percentage of dihydrorhodamine-positive [DHR+] cells is ≤5% by flow cytometry) OR based on confirmed pathogenic mutation in a CGD associated gene (CYBB, CYBA, NCF1, NCF2, NCF4, or CYBC1).
  • The participant or the participant's legally authorized guardian or representative (if applicable) must be capable of giving signed informed consent.
  • The participant (with assistance from the participant's legally authorized guardian/representative or primary caregiver, if applicable) must be capable of complying with the requirements and restrictions listed in the protocol and informed consent form (ICF).

Exclusion Criteria:

  • The participant has undergone an allogeneic bone marrow transplant or investigational gene therapy.
  • The participant is unable to comply with the sample collection procedure based on investigator judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total adenoviral-specific antibody (TAb) titer
Time Frame: 1 Day
Level of total adenoviral-specific antibody in blood
1 Day
Adenoviral-specific neutralizing antibody (NAb) titer
Time Frame: 1 Day
Level of adenoviral-specific neutralizing antibodies in blood
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating inflammatory cytokine levels
Time Frame: 1 Day
Level of inflammatory cytokines in blood
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ensoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN-374-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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