NCT00053508终止2 期
The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM1000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination A Phase 2, Randomized, Double-Blind, Dose-Response Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 274
- 试验地点
- 3
- 主要终点
- The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15.
研究概览
简要总结
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
详细描述
In addition to assessment of safety parameters, the objective of this study is to determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. Specifically, the objectives of this study are to:
- Compare the safety and tolerability of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
- Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age by comparing: (a)the proportion of subjects at each dose level who develop a major cutaneous reaction; (b)the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30.
- Determine the minimum dose of ACAM1000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in good general health.
- •not pregnant and using effective birth control
- •agreed to participate in entire study and comply with protocol requirements.
排除标准
- •military service prior to
- •no previous smallpox vaccination.
- •no contact with with children 1 year of age or younger
- •immunodeficiency individuals or close contacts who are immunodeficient
- •past history or current renal disease
- •diagnosis or past history of eczema
- •known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B).
- •known allergy or past allergic to blood products.
- •known allergy or past allergic reaction to cidofovir or sulfa-containing drugs.
- •transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit.
- •serology positive for HIV, hepatitis B or hepatitis C.
- •current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness.
- •inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0.
研究组 & 干预措施
Group 4
Active Comparator
Dryvax
干预措施: vaccinia virus (calf lymph) smallpox vaccine: Dryvax (Biological)
Group 3
Experimental
ACAM1000
干预措施: ACAM1000 (Biological)
Group 2
Experimental
ACAM1000
干预措施: ACAM1000 (Biological)
Group 1
Experimental
ACAM1000
干预措施: ACAM1000 (Biological)
结局指标
主要结局
The proportion of subjects in each treatment group who develop a major cutaneous reaction on Day 7, Day 10, and/or Day 15.
时间窗: Day 7, Day 10, and/or Day 15
次要结局
- 1.The comparison of treatment groups for the proportion of subjects developing a >fourfold rise in neutralizing antibodies. 2. neutralizing antibody response. 3. geometric mean neutralizing titer on day 31 will be compared between treatment groups.(days 0 and 30, day 31)
研究者
研究点 (3)
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