Comparison of Laser Assisted Epidermal to Intradermal Administration of Seasonal Influenza Vaccine
Primary Purpose
Influenza in Human
Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
seasonal influenza vaccine
fractional Er:Yag laser
Sponsored by
About this trial
This is an interventional prevention trial for Influenza in Human
Eligibility 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)
Sites / Locations
- Medical University Vienna, University Clinic for Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser assisted epidermal application
Intradermal application
Arm Description
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.
0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area.
Outcomes
Primary Outcome Measures
Haemagglutination inhibition (HAI)
HAI against each vaccine virus strain
Frequency of vaccine specific T-cell responders
Number of subjects achieving a T-cell stimulation index of >3
Secondary Outcome Measures
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
Seroprotection rate
Proportion of subjects achieving a HAI titer of > 1:40 against each vaccine virus strain at 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.
Magnitude of T-cell response
Magnitude of T-cell response (SI values) against influenza vaccine on day 1, day 15 and day 29.
Frequency and severity of local and systemic adverse events following vaccination
Full Information
NCT ID
NCT02988739
First Posted
December 6, 2016
Last Updated
March 5, 2018
Sponsor
Pantec Biosolutions AG
Collaborators
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02988739
Brief Title
Comparison of Laser Assisted Epidermal to Intradermal Administration of Seasonal Influenza Vaccine
Official Title
Safety and Immunogenicity of Laser Assisted Epidermally Administered Seasonal Influenza Vaccine in Comparison to Intradermally Administered Seasonal Influenza Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pantec Biosolutions AG
Collaborators
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza in Human
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser assisted epidermal application
Arm Type
Experimental
Arm Description
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.
Arm Title
Intradermal application
Arm Type
Active Comparator
Arm Description
0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area.
Intervention Type
Biological
Intervention Name(s)
seasonal influenza vaccine
Other Intervention Name(s)
INTANZA
Intervention Description
influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO
Intervention Type
Device
Intervention Name(s)
fractional Er:Yag laser
Other Intervention Name(s)
Pantec P.L.E.A.S.E.
Intervention Description
Fraction laser device to apply micorpores of defined depth and density into skin.
Primary Outcome Measure Information:
Title
Haemagglutination inhibition (HAI)
Description
HAI against each vaccine virus strain
Time Frame
day 1 and day 29
Title
Frequency of vaccine specific T-cell responders
Description
Number of subjects achieving a T-cell stimulation index of >3
Time Frame
day 1, day 15 and day 29
Secondary Outcome Measure Information:
Title
Seroconversion rate
Description
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
Title
Seroprotection rate
Description
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
Title
Geometric Mean fold rise (GMFR) of antibody titers
Description
GMFR of antibody titers against each vaccine virus strain from day 1 to day 29.
Time Frame
day 1 and day 29
Title
Magnitude of T-cell response
Description
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
Title
Frequency and severity of local and systemic adverse events following vaccination
Time Frame
day 1 to day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Medical University Vienna, University Clinic for Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
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Comparison of Laser Assisted Epidermal to Intradermal Administration of Seasonal Influenza Vaccine
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