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About
The primary objective is to determine the dose level of live, wild-type A/California/ H1N1 2009 virus that has an appropriate safety and illness/infectivity profile to be used as an influenza virus, challenge strain in future intervention studies.
Illness parameters were collected by subject symptom scores as well as by physical examination. Virus parameters were measured by PCR and cell culture assay (performed by VisMederi srl).
Enrollment
Sex
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Volunteers
Inclusion criteria
Male or female aged 18-45 years inclusive.
Able to give written informed consent to participate.
Healthy, as determined by medical history, physical examination, vital signs, 12 lead ECG, and clinical safety laboratory examinations at baseline, as determined by the Investigator.
Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by an HAI titre of ≤ 10 prior to challenge.
Non-habitual smoker (habitual smokers are persons who smoke more than 4 cigarettes or other tobacco products on a weekly basis) and agree to not use tobacco products during participation in the study.
Females should fulfil one of the following criteria:
Comprehension of the study requirements, expressed availability for the required study period, and ability to be quarantined for up to 10 days and to attend the scheduled follow-up visit.
Negative alcohol and urine drug screening tests prior to entering quarantine.
Being willing to adhere to the prohibitions and restrictions specified in this protocol
Exclusion criteria
29 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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