The Effects of Preceding LPS Administration on the Fluenz-induced Immune Response

NCT02642237 | Completed Results

• 1 other identifier: LPS-Fluenz
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the bacterial-viral interactions between LPS and Fluenz as a model for sepsis (bacterial) and Influenza (viral) infections which are common and associated with high mortality rates in the ICU. To understand these interactions is important for the development of preventive and therapeutic interventions.

Conditions

Innate Immune Response; Immune Tolerance

Keywords

Fluenz; innate immune response; endotoxin tolerance; priming

Outcome Measures

Primary Outcomes (1)

• Peak Levels of Interferon Gamma-induced Protein 10 (IP-10) in Nasal Wash Fluid

  Interferon gamma-induced protein 10 is a marker of viral-induced inflammation. Higher levels indicate a more pronounced inflammatory response upon a viral infection.

  35 days after FLuenz inoculation

Study Arms (2)

LPS-Fluenz

EXPERIMENTAL

Healthy volunteers administered intravenously with endotoxin, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin

Biological: Fluenz; Other: LPS

Placebo-Fluenz

PLACEBO COMPARATOR

Healthy volunteers administered intravenously with placebo, followed by an intranasal inoculation with Fluenz, a live-attenuated influenza vaccin

Biological: Fluenz; Other: placebo

Interventions

Fluenz BIOLOGICAL

intranasal inoculation with Fluenz

LPS-Fluenz; Placebo-Fluenz

placebo OTHER

Placebo-Fluenz

LPS OTHER

LPS-Fluenz

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy

You may not qualify if:

• Pre-existent lung disease, including asthma, severe allergic rhinitis
• Use of any medication
• Current smoker or more than 5 pack-year history
• Use of recreational drugs within 21 days prior to start of the study
• Use of caffeine or alcohol within 1 day prior to start of the study
• Surgery or trauma with significant blood loss or blood donation within 3 months prior to start of the study
• Participation in another clinical trial within 3 months prior to start of the study
• Frequent nosebleeds
• Recent nasal or otologic surgery
• (suspected) influenza infection during the last year
• Clinically significant acute (febrile) illness or a common cold within four weeks prior to start of the study
• History of frequent vaso-vagal collapse or of orthostatic hypotension History, signs or symptoms of cardiovascular disease.
• History of allergic reaction to Fluenz™, eggs / gelatin / gentamicin
• History of Guillain-Barré Syndrome
• Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Results Point of Contact

• Title: Matthijs Kox
• Organization: Radboud university medical centre

matthijs.kox@radboudumc.nl

+31243653881

Study Officials

• Peter Pickkers, Prof. Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2018
• Last Updated: May 14, 2019
• Results First Posted: April 19, 2019

Record last verified: 2019-05