NCT02988739

Comparison of Laser Assisted Epidermal to Intradermal Administration of Seasonal Influenza Vaccine

Safety and Immunogenicity of Laser Assisted Epidermally Administered Seasonal Influenza Vaccine in Comparison to Intradermally Administered Seasonal Influenza Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pantec Biosolutions AG · Industry
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza in Human

Interventions

Type	Name	Description
BIOLOGICAL	seasonal influenza vaccine	influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO
DEVICE	fractional Er:Yag laser	Fraction laser device to apply micorpores of defined depth and density into skin.

Timeline

• Start date: 2017-02-22
• Primary completion: 2017-07-31
• Completion: 2017-09-30
• First posted: 2016-12-09
• Last updated: 2018-03-06

Locations

1 site across 1 country: Austria