Safety and Immunogenicity of Laser Assisted Epidermally Administered Seasonal Influenza Vaccine in Comparison to Intradermally Administered Seasonal Influenza Vaccine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Frequency of vaccine specific T-cell responders
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: fractional Er:Yag laser (Device)
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.
干预措施: seasonal influenza vaccine (Biological)
Intradermal application
0,1 ml of Intanza (15 µg, seasonal trivalent influenza vaccine) will be intradermally injected in the deltoid area.
干预措施: seasonal influenza vaccine (Biological)
结局指标
主要结局
Frequency of vaccine specific T-cell responders
时间窗: day 1, day 15 and day 29
Number of subjects achieving a T-cell stimulation index of \>3
Haemagglutination inhibition (HAI)
时间窗: day 1 and day 29
HAI against each vaccine virus strain
次要结局
- Seroconversion rate(day 1 and day 29)
- Seroprotection rate(day 1 and day 29)
- Frequency and severity of local and systemic adverse events following vaccination(day 1 to day 29)
- Geometric Mean fold rise (GMFR) of antibody titers(day 1 and day 29)
- Magnitude of T-cell response(day 1 , day 15 and day 29)