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

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

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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




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 ]


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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988739


Locations
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Austria
Medical University Vienna, University Clinic for Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Pantec Biosolutions AG
Medical University of Vienna

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

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

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs