The Effect of Dose on Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 3
- 主要终点
- The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
研究概览
简要总结
The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.
详细描述
Specifically, the objectives of this study are to:
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Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age and previously vaccinated to smallpox. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
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Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age by comparing:
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the proportion of subjects at each dose level who develop a major cutaneous reaction
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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.
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Determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age, with a history of smallpox vaccination.
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
- 28 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar.
- •females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children.
- •agree to be available for the entire study and agree to comply with all requirements.
排除标准
- •children 1 year of age or younger in the household or be in close contact
- •smallpox vaccination within ten years
- •known or suspected Human immunodeficient virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above.
- •renal disease
- •current or past history of eczema or a household member or direct contact who has eczema.
- •known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B
- •known allergy or past allergic reaction to blood products.
- •known allergy to cidofovir or sulfa-containing drugs.
- •history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome.
- •transfusion of blood or treatment with any blood product.
- •current or history of drug or alcohol abuse
- •innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
研究组 & 干预措施
Group 1: ACAM2000
Participants will receive dose 1 of the ACAM2000 smallpox vaccine
干预措施: ACAM2000 Smallpox Vaccine (Biological)
Group 2: ACAM2000
Participants will receive dose 2 of the ACAM2000 smallpox vaccine
干预措施: ACAM2000 Smallpox Vaccine (Biological)
Group 3: ACAM2000
Participants will receive dose 3 of the ACAM2000 smallpox vaccine
干预措施: ACAM2000 Smallpox Vaccine (Biological)
Group 4: ACAM2000
Participants will receive dose 4 of the ACAM2000 smallpox vaccine
干预措施: ACAM2000 Smallpox Vaccine (Biological)
Group 5: Dryvax®
Participants will receive dose 1 of Dryvax® smallpox vaccine.
干预措施: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax® (Biological)
结局指标
主要结局
The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
时间窗: Day 30 post-vaccination
The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)
Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
时间窗: Day 30 post-vaccination
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
时间窗: Days 0 to 30 post-vaccination
次要结局
未报告次要终点