NCT00316602已完成2 期
A Multicenter, Open-label, Controlled Phase II Study to Evaluate Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-40 Year Old Subjects With Diagnosed Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 632
- 试验地点
- 41
- 主要终点
- Percentage of Participants With Seroconversion by ELISA
研究概览
简要总结
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1 (Healthy Participants):
- •Subjects without present or history of any kind of atopy.
- •Group 2 (Atopic Dermatitis Participants):
- •Subjects with diagnosed atopic dermatitis.
- •All study subjects:
- •Male and female subjects between 18 and 40 years of age without history of smallpox vaccination.
- •Women must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
- •Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the last vaccination.
- •Lab values without clinically significant findings.
- •Electrocardiogram (ECG) without clinically significant findings.
排除标准
- •Pregnant or breast-feeding women.
- •Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- •History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- •Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
- •History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.
- •History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
- •History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years.
- •Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool: (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older.
- •History of anaphylaxis or severe allergic reaction.
- •Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
- •Administration of immunomodulatory substances.
研究组 & 干预措施
Healthy Participants
Experimental
Healthy, vaccinia naive subjects without Atopic Dermatitis, receiving two doses of MVA-BN (IMVAMUNE)
干预措施: IMVAMUNE (Biological)
Atopic Dermatitis Participants
Experimental
Vaccinia naive subjects with diagnosed Atopic Dermatitis. "Diagnosed" AD included subjects with either history of or subjects with currently active AD (defined as scoring AD [SCORAD] <= 30), receiving two doses of MVA-BN (IMVAMUNE)
干预措施: IMVAMUNE (Biological)
结局指标
主要结局
Percentage of Participants With Seroconversion by ELISA
时间窗: week 6
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
次要结局
- Percentage of Participants With Seroconversion by ELISA(within 32 weeks)
- ELISA GMT(within 32 weeks)
- PRNT GMT(within 32 weeks)
- Number of Participants With Related Grade >=3 Adverse Events(within 29 days after vaccination)
- Number of Participants With Solicited Local Adverse Events(within 8 days after any vaccination)
- Number of Unsolicited Non-serious Adverse Events: Intensity(within 29 days after any vaccination)
- Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination(within 29 days after any vaccination)
- Percentage of Participants With Seroconversion by PRNT(within 32 weeks)
- ELISPOT IFN-γ Values(within 6 weeks)
- Number of Participants With Solicited General AEs(within 8 days after any vaccination)
- Number of Participants With SAEs(within 32 weeks)
研究者
研究点 (41)
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