The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection. It is also performed to assess immunogenicity and pharmacokinetics (shedding).
GHB16L2 intends to provide a novel vaccination for influenza virus infection. 80 healthy volunteers will be included at a ratio of 1:1 for GHB16L2 or placebo. GHB16L2 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
80
Medical University Vienna, Department of Clinical Pharmacology
Vienna, Austria
Number of participants with Adverse Events
Time frame: From baseline to 30 days after end of study
Seroconversion rates at day 29
Seroconversion rates for HAI, MNA, IgA and IgG
Time frame: At day 29 (end of study)
Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding)
Time frame: 1 week post immunisation
Immune response factor at day 29
Immune response factors for HAI, MNA, IgA and IgG
Time frame: At day 29 (end of study)
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