Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical University of Vienna | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser assisted epidermal application | Experimental | 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. |
|
| Intradermal application | Active Comparator | 0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| seasonal influenza vaccine | Biological | influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemagglutination inhibition (HAI) | HAI against each vaccine virus strain | day 1 and day 29 |
| Frequency of vaccine specific T-cell responders | Number of subjects achieving a T-cell stimulation index of >3 | day 1, day 15 and day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna, University Clinic for Clinical Pharmacology | Vienna | 1090 | Austria |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| fractional Er:Yag laser | Device | Fraction laser device to apply micorpores of defined depth and density into skin. |
|
|
| 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. | 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. | day 1 , day 15 and day 29 |
| Frequency and severity of local and systemic adverse events following vaccination | day 1 to day 29 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |