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In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II (VECTORII)

Primary Purpose

Innate Immune Response, Endotoxemia, Inflammation

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

C1-esterase inhibitor

Endotoxin

About this trial

This is an interventional basic science trial for Innate Immune Response

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male volunteers (18-35 years old)

Exclusion Criteria:

Relevant medical history
Drug-, nicotine-abuses
Tendency towards fainting
Hyper- or hypotension
Use of any medication

Sites / Locations

Radboud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

C1-esterase inhibitor

Placebo

Arm Description

C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg

Placebo (saline 0.9%) infusion followed by administration of Endotoxin 2ng/kg

Outcomes

Primary Outcome Measures

Neutrophil phenotype and redistribution

Secondary Outcome Measures

Cytokines and other markers of inflammation

C1-inhibitor and complement concentration and activity

Full Information

NCT ID

NCT01766414

First Posted

January 4, 2013

Last Updated

November 27, 2014

Sponsor

Radboud University Medical Center

Collaborators

UMC Utrecht, Prothya Biosolutions

1. Study Identification

Unique Protocol Identification Number

NCT01766414

Brief Title

In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II

Acronym

VECTORII

Official Title

In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - A Randomized Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

Collaborators

UMC Utrecht, Prothya Biosolutions

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. This can range from mild disease to extreme conditions, such as multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked contrast to adaptive immunity which is very sensitive to immune modulators such as steroids, the innate immune system cannot be sufficiently targeted by currently available anti-inflammatory drugs. The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human endotoxemia model can modulate the innate immune response. In this study, human endotoxemia will be used as a model for inflammation. Subjects will, prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be sampled to determine the levels of markers of the innate immune response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Innate Immune Response, Endotoxemia, Inflammation, Sepsis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

C1-esterase inhibitor

Arm Type

Active Comparator

Arm Description

C1-esterase inhibitor 100 U/kg infusion followed by administration of Endotoxin 2ng/kg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (saline 0.9%) infusion followed by administration of Endotoxin 2ng/kg

Intervention Type

Drug

Intervention Name(s)

C1-esterase inhibitor

Other Intervention Name(s)

Cetor

Intervention Description

intravenously

Intervention Type

Drug

Intervention Name(s)

Endotoxin

Other Intervention Name(s)

2 ng/kg E. coli reference endotoxin 11:H 10:K negative

Intervention Description

intravenously

Primary Outcome Measure Information:

Title

Neutrophil phenotype and redistribution

Time Frame

8 hrs after LPS administration

Secondary Outcome Measure Information:

Title

Cytokines and other markers of inflammation

Time Frame

8 hrs after LPS administration

Title

C1-inhibitor and complement concentration and activity

Time Frame

8 hrs after LPS administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male volunteers (18-35 years old) Exclusion Criteria: Relevant medical history Drug-, nicotine-abuses Tendency towards fainting Hyper- or hypotension Use of any medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans Hoeven, Prof

Organizational Affiliation

UMC Nijmegen

Official's Role

Study Director

Facility Information:

Facility Name

Radboud University

City

Nijmegen

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

28515092

Citation

Tak T, Wijten P, Heeres M, Pickkers P, Scholten A, Heck AJR, Vrisekoop N, Leenen LP, Borghans JAM, Tesselaar K, Koenderman L. Human CD62Ldim neutrophils identified as a separate subset by proteome profiling and in vivo pulse-chase labeling. Blood. 2017 Jun 29;129(26):3476-3485. doi: 10.1182/blood-2016-07-727669. Epub 2017 May 17.

Results Reference

derived

Learn more about this trial

In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II

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