Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06605378

Enrollment

Registered

2024-09-20

Start date

2024-11-18

Completion date

2026-12-01

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Granulomatous Disease (CGD)

Keywords

CGD, X-CGD, Chronic Granulomatous Disease, Granulomatous Disease, Chronic, Autosomal Recessive Chronic Granulomatous Disease

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Circulating inflammatory cytokine levels	1 Day	Level of inflammatory cytokines in blood

Countries

United Kingdom, United States

Contacts

CONTACTAndrew Dietz, MD, MSCR

ddietz@ensoma.com617-766-3917

Outcome results