Collection of nasal lavage fluid from experimentally infected healthy human volunteers for the generation of a GMP batch of HRV16

Completed

Conditions: acute worsening of symptoms
exacerbation
10024970

Registration Number: NL-OMON34307

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

* Age between 18 * 60 years
* No cold for at least 6 weeks prior to the study. A cold is present if 2 of the following 3 criteria are present:
1. a cumulative symptom score of least 14 over a 6-day period.
2. the subjective impression of a cold.
3. rhinorrhoea (<=nasal drainage/runny nose) on at least 3 days.
* No BCG vaccination
* Normal chest X-ray
* No history of lung disease; Forced Expiratory Volume (FEV)1 > 80% predicted
* No history of seasonal or perennial rhinitis or sinusitis
* Non-smoking or stopped smoking more than 12 months ago and * 5 pack years (PY)
* No other clinically significant abnormality on medical history and clinical examination
* No participation in any clinical investigational drug treatment protocol within the preceding 30 days
* Being available 9 to 12 months post infection for safety measurements
* Having a GP

Exclusion Criteria

* A titer of > 4 in serum for antibodies directed against HRV16
* Participants who share the same house(hold)
* Pregnant or intending to become pregnant during the study period (till visit 9) and lactating women
* Any of the following infectious micro-organisms, diseases:
- Antibodies and PCR (on plasma) for Human T-lymphotropic virus Type I (HTLV-1) and type II (HTLV-2)
- Antibodies and PCR (on plasma) for Human Immunodeficiency Virus (HIV)
- Antibodies and PCR (on plasma) for Hepatitis A, B and C virus (HAV, HBV, HCV)
- tuberculosis (tuberculin test)
* The presence of any of the following respiratory viruses and bacteria in nasal lavage and/or throat swabs, by PCR:
- influenza A&B, Enterovirus sp., Adenovirus sp., Rhinovirus sp., human metapneumovirus, RSV, parainfluenza 1-4, human parechovirus, Bocavirus, Coronavirus sp.
- Chlamydia pneumoniae, Mycoplasma pneumonia and Legionella sp.
* Seasonal allergies at the time of the study
* Any maintenance drug usage
* Any NSAID usage 2 weeks prior to up till 7 days after inoculation
* Any other medical condition at the discretion of the study physician