Seasonal Human Influenza Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1 in Healthy Volunteers
The purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1
administered as single dose intranasal aerosol for vaccination against influenza A (H1N1)
virus.
This study is performed further to assess local and systemic immune response and to analyse
pharmacokinetics (shedding) of a single dose GHB01L1 aerosol administered intranasally.
GHB01L1 intends to provide a novel vaccination for influenza virus infection. Data indicate
that the GHB01L1 virus is a promising, safe and immunogenic vaccine candidate with a high
protection efficacy against the pathogenic wild-type virus challenge.
48 healthy volunteers will be included in a phase I dose escalation study investigating five
dose levels. 8 subjects per each of the five dose levels and additional 8 subjects at the
highest dose level respectively the maximum tolerated dose level will be randomized at a
ratio of 6:2 for GHB01L1 or placebo according to a fixed dose escalation plan.
After all subjects of one dose level have been treated and observed for the safety
observation period of one week, an interim safety review will be performed by an Expert
Committee. The Expert Committee will review any occurred adverse event and will decide on
dose escalation to the next dose level.
Only male healthy volunteers aged 18-50 and seronegative with respect to the applied virus
antigens (with antibody titers <1:10 detected in hemagglutination inhibition assay) will be
randomized.
GHB01L1 will be administered once on day 1. After a 3 days inpatient period follow-up visits
will be performed on day 4, 5, 8, 15 and the study will be terminated on day 29.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention