Immunoparalysis / tolerance
Conditions
Interventions
Healthy volunteers who meet all inclusion criteria and none of the exclusion
criteria that have given informed consent to participate in the study will be
randomized to become either administered wi
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >=18 and
Exclusion criteria
Exclusion criteria: -Pre-existent lung disease, including asthma -A history of allergic rhinitis -Use of any medication -Use of alcohol > 5/day or >20/wk -Use of any drugs -Current smoker or more than 5 pack-year history -Frequently have nosebleeds -Recent nasal or otologic surgery -Febrile illness or a common cold within four weeks before the LPS challenge -Currently participating in another clinical trial or donation of blood 3 months prior to the LPS challenge. -Previous spontaneous vagal collapse. -History, signs or symptoms of cardiovascular disease. -(Family) history of myocardial infarction or stroke under the age of 65 years. -Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block. -Hypertension (defined as RR systolic > 160 or RR diastolic > 90). -Hypotension (defined as RR systolic 120 µmol/l). -Liver enzyme abnormalities or positive hepatitis serology. -Positive HIV serology or medical history of any other obvious disease associated with immune deficiency. -History of allergic reaction to Fluenz®, eggs / gelatin / gentamicin -History of Guillain-Barré Syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is to investigate the local inflammatory response, measured by IP-10 in nasal wash. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include other parameters indicative of the local inflammatory response, including antibodies, immune cells, cytokines and local symptoms. Also, systemic inflammatory effects will be assessed, including circulating antibodies, immune cells and cytokines, lower respiratory tract and systemic symptoms and peak expiratory flow. Furthermore, viral load of influenza will be measured in nasal wash. Finally, changes in the mucosal microbiome will be assessed. | — |
Countries
Netherlands
Outcome results
None listed