Viewing Study NCT02609932



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Study NCT ID: NCT02609932
Status: COMPLETED
Last Update Posted: 2019-02-15
First Post: 2015-11-11

Brief Title: Effect of IFN-γ on Innate Immune Cells
Sponsor: University of Colorado Denver
Organization: University of Colorado Denver

Study Overview

Official Title: Effect of Interferon-gamma 1-b on Innate Immune Cells
Status: COMPLETED
Status Verified Date: 2019-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The investigators hypothesize that neutrophils and monocytes developed under the influence of Interferon- gamma-1b IFN-γ-1b Actimmune in vivo will display enhanced function across a broad range of activities related in large part to the transcriptional activation effects of this cytokine The investigators will evaluate the effects of IFN-γ in healthy human subjects in vivo on gene expression biologic activity markers and functional activity of myeloid cells in single dose studies and in steady state studies
Detailed Description: Named for their potent ability to interfere and protect against viral infections interferons IFNs have many regulatory effects on the immune system1 Of the members of the two classes of these compounds IFN-γ has the most diverse and powerful immune effects Studies have mostly evaluated IFN-γ interactions with cells of adaptive immunity including macrophages and lymphocytes Effects on innate immunity particularly polymorphonuclear leukocytes or neutrophils and monocytes are less well studied However investigations have suggested that IFN-γ may be involved in signal transduction gene expression the respiratory burst and neutrophil NADPH oxidase Nox2 activity phagocytosis motility microbicidal activity and apoptosis Not all of these functions are enhanced by IFN-γ but the clinical use of this cytokine has been driven in part by these results For example the primary motivation for initiating investigation of its beneficial clinical effects in Chronic Granulomatous Disease CGD was its effects on Nox2 activity2 Most data in this area was based on studies using differentiated neutrophils from peripheral blood1 However the phenotype of neutrophils developed under the influence of this cytokine not just changes expressed by exposure of differentiated cells to IFN-γ is critical to understanding the physiologic effects of IFN-γ and the broad applications for its use in treatment of a range of human diseases To expand their understanding of the role of IFN-γ in the development and functional integrity of the neutrophil the investigators have completed a series of studies with PLB-985 cells in an in vitro culture system of myeloid cells In this proposal the investigators will evaluate innate immune activation and phagocyte function in healthy adult volunteers who are receiving IFN-γ

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
UL1TR001082 NIH None httpsreporternihgovquickSearchUL1TR001082