The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 4
- 主要终点
- Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
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
The objective of this study is to 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 18-29 years of age and naïve to smallpox vaccine. 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 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.
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Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults 18-29 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 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
- •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
- •military service prior to
- •history of previous smallpox vaccination.
- •children 1 year of age or younger in the household or be in close contact
- •smallpox vaccination within ten years
- •known or suspected human immunodeficiency 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
- •inoculation 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 Dose 1
Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units (PFU)/mL on Day 0.
干预措施: Vaccinia virus: ACAM2000 smallpox vaccine (Biological)
Group 2: ACAM2000 Dose 2
Participants will receive a single dose of ACAM2000 smallpox vaccine, 2.0x10-8th plaque-forming units/mL on Day 0.
干预措施: Vaccinia virus: ACAM2000 smallpox vaccine (Biological)
Group 3: ACAM2000 Dose 3
Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
干预措施: Vaccinia virus: ACAM2000 smallpox vaccine (Biological)
Group 4: ACAM2000 Dose 4
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
干预措施: Vaccinia virus: ACAM2000 smallpox vaccine (Biological)
Group 5: Dryvax® Vaccine
Participants will receive a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
干预措施: vaccinia virus (calf lymph): Dryvax (Biological)
结局指标
主要结局
Neutralizing Antibody Response 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
The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.
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
次要结局
未报告次要终点