Influenza in HumanPhase 1NCT02988739
Comparison of Laser Assisted Epidermal to Intradermal Administration of Seasonal Influenza Vaccine
A Phase 1 study testing seasonal influenza vaccine and fractional Er:Yag laser in people with Influenza in Human, run by Pantec Biosolutions AG at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza in Human
- What is being tested?
- seasonal influenza vaccine and fractional Er:Yag laser
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 22 Feb 2017to 30 Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna, University Clinic for Clinical Pharmacology
Vienna, 1090
About this study
Official title: Safety and Immunogenicity of Laser Assisted Epidermally Administered Seasonal Influenza Vaccine in Comparison to Intradermally Administered Seasonal Influenza Vaccine
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.
Read the 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
- Being tested
- seasonal influenza vaccine, fractional Er:Yag laser
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seasonal influenza vaccineBiological
Also called INTANZA
influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO
fractional Er:Yag laserDevice
Also called Pantec P.L.E.A.S.E.
Fraction laser device to apply micorpores of defined depth and density into skin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: seasonal influenza vaccine; Device: fractional Er:Yag laser |
| Intradermal application | Active comparator | 0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area. Receives: Biological: seasonal influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemagglutination inhibition (HAI)
HAI against each vaccine virus strain
Measured: day 1 and day 29
Frequency of vaccine specific T-cell responders
Number of subjects achieving a T-cell stimulation index of >3
Measured: day 1, day 15 and day 29
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: day 1 , day 15 and day 29
Frequency and severity of local and systemic adverse events following vaccination
Measured: day 1 to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start22 Feb 2017
- Primary completion31 Jul 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza in HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pantec Biosolutions AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988739
- Sponsor's protocol ID
- PCT-007
- Status last verified
- Mar 2018
- First submitted
- 6 Dec 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Laser Assisted Epidermally Administered Seasonal Influenza Vaccine in Comparison to Intradermally Administered Seasonal Influenza Vaccine
- ClinicalTrials.gov ID
- NCT02988739
- Acronym / sponsor ID
- PCT-007
- Conditions
- Influenza in Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pantec Biosolutions AGIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser assisted epidermal application | Experimental | Biological: seasonal influenza vaccine, Device: fractional Er:Yag laserLaser 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 | Biological: seasonal influenza vaccine0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| seasonal influenza vaccineAlso: INTANZAinfluenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO | Biological | Intradermal application, Laser assisted epidermal application |
| fractional Er:Yag laserAlso: Pantec P.L.E.A.S.E.Fraction laser device to apply micorpores of defined depth and density into skin. | Device | Laser assisted epidermal application |
Primary outcome
Haemagglutination inhibition (HAI)
Time frame: day 1 and day 29
HAI against each vaccine virus strain
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
5 secondary outcomes
Seroconversion rate
Time frame: day 1 and day 29
Seroprotection rate
Time frame: day 1 and day 29
Geometric Mean fold rise (GMFR) of antibody titers
Time frame: day 1 and day 29
Magnitude of T-cell response
Time frame: day 1 , day 15 and day 29
Frequency and severity of local and systemic adverse events following vaccination
Time frame: day 1 to day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing seasonal influenza vaccine and fractional Er:Yag laser in people with Influenza in Human, run by Pantec Biosolutions AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemagglutination inhibition (HAI) (time frame: day 1 and day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.