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

• ClinicalTrials.gov Identifier: NCT02988739
• Recruitment Status: Completed
• First Posted: December 9, 2016
• Last Update Posted: March 6, 2018
• Sponsor: Pantec Biosolutions AG
• Collaborator: Medical University of Vienna
• Information provided by (Responsible Party): Pantec Biosolutions AG

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Influenza in Human	Biological: seasonal influenza vaccine; Device: fractional Er:Yag laser	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Safety and Immunogenicity of Laser Assisted Epidermally Administered Seasonal Influenza Vaccine in Comparison to Intradermally Administered Seasonal Influenza Vaccine
• Actual Study Start Date: February 22, 2017
• Actual Primary Completion Date: July 31, 2017
• Actual Study Completion Date: September 30, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Laser assisted epidermal application; 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; influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO; Other Name: INTANZA; Device: fractional Er:Yag laser; Fraction laser device to apply micorpores of defined depth and density into skin.; Other Name: Pantec P.L.E.A.S.E.
Active Comparator: Intradermal application; 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; Other Name: INTANZA

Outcome Measures

Primary Outcome Measures :

1. Haemagglutination inhibition (HAI) [ Time Frame: day 1 and day 29 ]
   HAI against each vaccine virus strain
2. Frequency of vaccine specific T-cell responders [ Time Frame: day 1, day 15 and day 29 ]
   Number of subjects achieving a T-cell stimulation index of >3

Secondary Outcome Measures :

1. Seroconversion rate [ Time Frame: day 1 and day 29 ]
   Proportion of subjects achieving at least a four fold HAI titer increase against each vaccine virus strain from day 1 to day 29
2. Seroprotection rate [ Time Frame: day 1 and day 29 ]
   Proportion of subjects achieving a HAI titer of > 1:40 against each vaccine virus strain at day 29
3. Geometric Mean fold rise (GMFR) of antibody titers [ Time Frame: day 1 and day 29 ]
   GMFR of antibody titers against each vaccine virus strain from day 1 to day 29.
4. Magnitude of T-cell response [ Time Frame: day 1 , day 15 and day 29 ]
   Magnitude of T-cell response (SI values) against influenza vaccine on day 1, day 15 and day 29.
5. Frequency and severity of local and systemic adverse events following vaccination [ Time Frame: day 1 to day 29 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Written informed consent
• 18-30 years old (male or female),
• Photo type I to IV (according to Fitzpatrick scale),
• Subject must be willing and able to comply with study protocol for the duration of the study,
• Females of childbearing potential (FCB) must maintain reliable contraception throughout the study.

Exclusion Criteria:

• Known pregnancy or positive pregnancy test for women of child bearing potential,
• Positive screening assessment for human immunodeficiency virus or viral hepatitis (Hepatitis B or Hepatitis C)
• Known or suspected immune dysfunction that is caused by a medical condition, or any other cause and that would interfere with the conduct of the study,
• Use, within the past 3 months, of any topical or systemic treatment that would interfere with assessment and/or investigational treatment (anti-inflammatory drugs, immune suppressors or any immune modulator agent),
• Use of any topical treatment on the injection site within the last four weeks,
• Photo type V and VI (according to Fitzpatrick scale),
• Skin lesions or excessive hair growth at treatment site,
• Any history of seasonal influenza in the past 6 months,
• Any seasonal influenza vaccine in the past,
• Preexisting HAI antibody titers of >40 against more than one influenza strain included in the vaccine,
• Acute illness or febrile illness (over 37,5°C) within one week prior to enrollment,
• Hypersensitivity to elements of the influenza vaccine (e.g. egg),
• Administration of any live vaccine (< 28 days) or inactivated/toxoid vaccine (< 14 days) or planned vaccination within 3 months after inclusion,
• Medical history of skin cancer,
• History of Guillain Barre syndrome or brachial neuritis following previous vaccination,
• Any history of having blood transfusions or administration with gamma globulin in the past 3 months
• Women of childbearing potential not actively practicing birth control or using medically accepted device or therapy,
• Subject being judged as inadequate for following the procedures of the trial by investigator,
• Participation in another clinical trial (including follow up phase of a previous clinical trial)

Contacts and Locations

Locations

Austria

Medical University Vienna, University Clinic for Clinical Pharmacology

Vienna, Austria, 1090

Sponsors and Collaborators

Pantec Biosolutions AG

Medical University of Vienna

More Information

• Responsible Party: Pantec Biosolutions AG
• ClinicalTrials.gov Identifier: NCT02988739
• Other Study ID Numbers: PCT-007
• First Posted: December 9, 2016
• Last Update Posted: March 6, 2018
• Last Verified: March 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases