It is the aim of the present study to compare the immunogenicity induced by a laser-assisted epidermally administered seasonal influenza vaccine to an intradermally administered seasonal influenza vaccine.
The skin is an attractive tissue for vaccination due to the impact of the cutaneous micro-environment on the adaptive and non-adaptive immune responses. Conventionally many vaccines are administered subcutaneously. Immune-competent cells however are not resident in the subcutaneous fat tissue, but instead are located in the epidermis and the dermis of the skin. Depending on the targeted skin layer and administration method, different immunological outcomes are thus anticipated following vaccination. In the present study, the immunogenicity (in terms of activation of B-cell mediated and T-cell mediated immune responses) of laser-assisted epidermally administered seasonal influenza vaccine will be compared to needle-based intradermal administration of the same seasonal influenza vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO
Fraction laser device to apply micorpores of defined depth and density into skin.
Medical University Vienna, University Clinic for Clinical Pharmacology
Vienna, Austria
Haemagglutination inhibition (HAI)
HAI against each vaccine virus strain
Time frame: day 1 and day 29
Frequency of vaccine specific T-cell responders
Number of subjects achieving a T-cell stimulation index of \>3
Time frame: day 1, day 15 and day 29
Seroconversion rate
Proportion of subjects achieving at least a four fold HAI titer increase against each vaccine virus strain from day 1 to day 29
Time frame: day 1 and day 29
Seroprotection rate
Proportion of subjects achieving a HAI titer of \> 1:40 against each vaccine virus strain at day 29
Time frame: day 1 and day 29
Geometric Mean fold rise (GMFR) of antibody titers
GMFR of antibody titers against each vaccine virus strain from day 1 to day 29.
Time frame: day 1 and day 29
Magnitude of T-cell response
Magnitude of T-cell response (SI values) against influenza vaccine on day 1, day 15 and day 29.
Time frame: day 1 , day 15 and day 29
Frequency and severity of local and systemic adverse events following vaccination
Time frame: day 1 to day 29
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