Viral infections in general, and the "common cold" induced by HRV-16 in particular. MedDRA version: 14.1 Level: PT Classification code 10061494 Term: Rhinovirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Human Rhinovirus Type 16
Product Code: HRV-16
Pharmaceutical Form: Nasal drops, solution
INN or Proposed INN: human rhinovirus 16
Current Sponsor code: HRV-16
Other descriptive name: hum
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =18 and =35 - Healthy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy or lactating - Pre-existent lung disease, including asthma - A history of allergic rhinitis with positive allergen skin tests - Use of any medication - Use of nutritional supplements / probiotics - Use of alcohol > 5 units/day or >20 units/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 HRV challenge - Currently participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To determine: 1. The viral load of HRV-16 infection in nasal washes 2. The incubation period of HRV-16 infection. 3. The effects of HRV-16 infection on cold symptoms, temperature, and spirometry. 4. Suitable inflammatory parameters (and their kinetics) that play a role in the HRV-16-induced local inflammatory response 5. Whether HRV-16 infection can induce a systemic immune response and its kinetics 6. The effect of HRV-16 seropositivity on the clinical and immunological response to re-infection with HRV-16. 7. If a subject is protected against re-infection with HRV-16 within one week (tolerance formation to HRV), and if so which mechanisms play a role (local and systemic) 8. Whether HRV-16 infection modulates the immune response of circulating leukocytes by measuring the cytokine response, of leukocytes ex vivo stimulated with different inflammatory stimuli. 9. The relationship of the nasal and gut microbiota on HRV-16 (re-)infection and vice-versa. ;Primary end point(s): The primary outcome measure is the infection rate (defined by a positive viral culture, qPCR and/or a four-fold rise in antibody titre) of healthy volunteers inoculated with a standardized dose of HRV-16. ;Timepoint(s) of evaluation of this end point: Days 0, days 2, and days 28;Main Objective: To set up the Human Rhinovirus (HRV)-model in our centre, using HRV serotype 16 (HRV-16). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incubation period of HRV-16 infection. - Symptom scores measured by diary cards (WURSS 21 scoring method) - Temperature - Forced expiratory volume at a timed interval of 1 second (FEV1), and forced expiratory flow 25-75% (FEF 25-75%). - Leukocyte counts and differentiation (NK-cells, CD4 / CD8, neutrophils), and cytokine levels in nasal washes (including but not limited to IL-8, IL-1ß, CCL5) - Leukocyte counts and circulating plasma cytokines (including but not limited to TNF-a, IL-6, IL-10, IFN-?, IL-8, CCL5) - The cytokine response (including but not limited to TNF-a, IL-6, IL-10, IFN-?), of leukocytes ex vivo stimulated with different stimuli (including but not limited to LPS, HRV, Staphylococcus aureus). - Composition of the nasal and gut microbiota ;Timepoint(s) of evaluation of this end point: days 0, 1, 2, 3, 4, 7, 8, 9, 10, 11, 14, 28 | — |
Countries
Netherlands
Contacts
Public ContactR. Koch
Radboud University Nijmegen Medical Centre
Outcome results
None listed