A Phase 1 interventional study of seasonal influenza vaccine and fractional Er:Yag laser in Influenza in Human, sponsored by Pantec Biosolutions AG. Completed at 1 site in Austria. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-06.
Sponsored by Pantec Biosolutions AG · Phase 1, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 20 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Pantec Biosolutions AG is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Laser pretreatment: 4 adjacent areas of 2 cm² each (14mm x 14 mm) will be pretreated with an Erbium Yttrium Aluminium Garnet laser (22,7 J/cm², 2 pulses, Density: 5%) generating micropores with a depth of approximately 91 µm. 0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be topically administered on the laser-treated area.
Biological: seasonal influenza vaccine · Device: fractional Er:Yag laser
0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area.
Biological: seasonal influenza vaccine
influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO
Also known as: INTANZA
Fraction laser device to apply micorpores of defined depth and density into skin.
Also known as: Pantec P.L.E.A.S.E.
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
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Pantec Biosolutions AG