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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34307

Enrollment

Registered

2011-11-08

Start date

2011-11-08

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute worsening of symptoms exacerbation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 ( 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

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

Design outcomes

Primary

Measure	Time frame
Viral load (PCR) and TCID 50 (dilution of viral suspension that causes cytopathic effects in 50% of the cultured HELA cells). By both specific techniques as well as deep sequencing we will search for contaminating viruses and bacteria in the nasal lavages.	—

Countries

Netherlands

Outcome results