Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease

NCT06605378 — Recruiting, 60 participants, Ensoma

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

RegistryNCT06605378
StatusRecruiting
Study typeObservational
Enrollment60 (Estimated)
SponsorEnsoma (Industry)
ConditionsChronic Granulomatous Disease (CGD)
Datesstart 2024-11-18, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-09-20, last updated 2026-08-17
Locations52 sites in United States, United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Granulomatous Disease (CGD)

-Summary

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

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+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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Circulating inflammatory cytokine levels [1 Day]: Level of inflammatory cytokines in blood

+Eligibility

Sex: All

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.

+Locations (52)

FacilityCityCountryStatus
Home-based telemedicineMontgomery, AlabamaUnited StatesRecruiting
Home-based telemedicinePhoenix, ArizonaUnited StatesRecruiting
Home-based telemedicineLittle Rock, ArkansasUnited StatesRecruiting
Home-based telemedicineSacramento, CaliforniaUnited StatesRecruiting
University of California, San FranciscoSan Francisco, CaliforniaUnited StatesRecruiting
Home-based telemedicineDenver, ColoradoUnited StatesRecruiting
Home-based telemedicineHartford, ConnecticutUnited StatesRecruiting
Home-based telemedicineDover, DelawareUnited StatesRecruiting
Home-based telemedicineWashington D.C., District of ColumbiaUnited StatesRecruiting
Home-based telemedicineTallahassee, FloridaUnited StatesRecruiting
Home-based telemedicineAtlanta, GeorgiaUnited StatesRecruiting
Home-based telemedicineBoise, IdahoUnited StatesRecruiting
Home-based telemedicineSpringfield, IllinoisUnited StatesRecruiting
Home-based telemedicineIndianapolis, IndianaUnited StatesRecruiting
Home-based telemedicineDes Moines, IowaUnited StatesRecruiting
Home-based telemedicineTopeka, KansasUnited StatesRecruiting
Home-based telemedicineFrankfort, KentuckyUnited StatesRecruiting
Home-based telemedicineBaton Rouge, LouisianaUnited StatesRecruiting
Home-based telemedicineAugusta, MaineUnited StatesRecruiting
Home-based telemedicineAnnapolis, MarylandUnited StatesRecruiting
Home-based telemedicineBoston, MassachusettsUnited StatesRecruiting
Home-based telemedicineLansing, MichiganUnited StatesRecruiting
Home-based telemedicineSaint Paul, MinnesotaUnited StatesRecruiting
Home-based telemedicineJackson, MississippiUnited StatesRecruiting
Home-based telemedicineJefferson City, MissouriUnited StatesRecruiting
Home-based telemedicineHelena, MontanaUnited StatesRecruiting
Home-based telemedicineLincoln, NebraskaUnited StatesRecruiting
Home-based telemedicineCarson City, NevadaUnited StatesRecruiting
Home-based telemedicineConcord, New HampshireUnited StatesRecruiting
Home-based telemedicineTrenton, New JerseyUnited StatesRecruiting
Home-based telemedicineSanta Fe, New MexicoUnited StatesRecruiting
Home-based telemedicineAlbany, New YorkUnited StatesRecruiting
Science 37, IncMorrisville, North CarolinaUnited StatesRecruiting
Home-based telemedicineBismarck, North DakotaUnited StatesRecruiting
Home-based telemedicineColumbus, OhioUnited StatesRecruiting
Home-based telemedicineOklahoma City, OklahomaUnited StatesRecruiting
Home-based telemedicineSalem, OregonUnited StatesRecruiting
Home-based telemedicineHarrisburg, PennsylvaniaUnited StatesRecruiting
Home-based telemedicineProvidence, Rhode IslandUnited StatesRecruiting
Home-based telemedicineColumbia, South CarolinaUnited StatesRecruiting
Home-based telemedicinePierre, South DakotaUnited StatesRecruiting
Home-based telemedicineNashville, TennesseeUnited StatesRecruiting
Home-based telemedicineAustin, TexasUnited StatesRecruiting
Home-based telemedicineSalt Lake City, UtahUnited StatesRecruiting
Home-based telemedicineMontpelier, VermontUnited StatesRecruiting
Home-based telemedicineRichmond, VirginiaUnited StatesRecruiting
Home-based telemedicineOlympia, WashingtonUnited StatesRecruiting
Home-based telemedicineCharleston, West VirginiaUnited StatesRecruiting
Home-based telemedicineMadison, WisconsinUnited StatesRecruiting
Home-based telemedicineCheyenne, WyomingUnited StatesRecruiting
Great Ormond Street Hospital for ChildrenLondonUnited KingdomCompleted
Royal Free London NHS Foundation TrustLondonUnited KingdomCompleted

+Publications

  • Results publication: 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
  • Results publication: 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