N/A
N=30
The Effects of Preceding LPS Administration on the Fluenz-induced Immune Response
Innate Immune Response · Immune Tolerance
Bottom Line
View on ClinicalTrials.gov: NCT02642237 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Peak Levels of Interferon Gamma-induced Protein 10 (IP-10) in Nasal Wash Fluid — 2000; 1900 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fluenz (Biological); placebo (Other); LPS (Other)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Radboud University Medical Center
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Levels of Interferon Gamma-induced Protein 10 (IP-10) in Nasal Wash Fluid |
2000; 1900 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy
Exclusion Criteria
- 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.
- Hypertension (defined as Blood pressure (RR) systolic > 160 or RR diastolic > 90).
- Hypotension (defined as RR systolic 120 μmol/l).
- Liver function abnormality: alkaline phosphatase>230 U/L and/or Alanine-aminotransferase (ALT)>90 units per Liter (U/L)
- C-reactive protein (CRP) > 20 mg/L, white blood cell count (WBC) > 12x109/L
- Vaccination with influenza this season
- Recent vaccination
Data sourced from ClinicalTrials.gov (NCT02642237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.