Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

August 13, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ensoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Morna Dorsey, Claire Booth, Jonathan Cotliar, Esther Shamir, Mansi Purwar, Patrick Au, Chris Plescia, Andrew Dietz, Siobhan Burns; Cytokine Profile in Patients with Chronic Granulomatous Disease (CGD). J Hum Immun 1 May 2026; 2 (CIS2026): eCIS2026abstract.45. doi: https://doi.org/10.70962/CIS2026abstract.45
  • Claire Booth, Morna Dorsey, Jonathan Cotliar, Esther Shamir, Patrick Au, Chris Plescia, Siobhan Burns, Andrew Dietz; Preexisting Antibodies to Virus-Like Particles (VLP) Derived from Helper-Dependent Adenovirus (HDAd) in Patients with Chronic Granulomatous Disease (CGD). J Hum Immun 1 May 2026; 2 (CIS2026): eCIS2026abstract.88. doi: https://doi.org/10.70962/CIS2026abstract.88

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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