The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus. This study is also performed to assess safety, tolerability and pharmacokinetics (shedding) of a single dose of GHB11L1 administered by liquid nasal spray.
GHB11L1 intends to provide a novel vaccination for influenza virus infection. 48 healthy volunteers will be included in this phase IIa study investigating three dose levels. 16 subjects will be randomised at a ratio of 3:1 for GHB11L1 or placebo. Healthy male volunteers, 18-50 years of age and seronegative with respect to the applied virus antigens (antibody titers \<1:10 detected) will be randomised. GHB11L1 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
49
Medical University Vienna, Department of Clinical Pharmacology
Vienna, Austria
Local and systemic immune response
Time frame: From baseline to day 29 (end of study)
Clinical signs and symptoms, laboratory tests Pharmacokinetics: qualitative assessment of viral recovery (shedding) in nasal mucosal samples.
Time frame: From written informed consent to 30 days after end of study
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