NCT01477580已完成1 期
A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine (V180) in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 98
- 主要终点
- Seroconversion rate for each serotype
研究概览
简要总结
This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health
- •Voluntarily agrees to participate by giving written informed consent
- •Able to read, understand, and complete study questionnaires
- •Able to complete all scheduled visits and comply with study procedures
- •Access to a telephone
- •Agrees to avoid unusual, vigorous exercise from 72 hours before any dose of study vaccine/placebo through 15 days after that dose
- •Weighs ≥110 pounds (50 kg) and has a body mass index (BMI) of 19 to 32 kg/m^2
- •No fever (temperature ≥100.4°F/38.0°C) for 72 hours prior to vaccination
- •Females of reproductive potential agree to remain abstinent or to use 2 acceptable methods of birth control from enrollment through 6 weeks after the last dose of study vaccine/placebo
排除标准
- •History of receiving any flavivirus vaccine (e.g. Japanese encephalitis, tick-borne encephalitis, or yellow fever) or planned receipt of any such vaccine during the study period
- •History of any flavivirus infection or serologic evidence of any flavivirus infection, including West Nile, dengue, yellow fever, Saint Louis encephalitis (if available), Kunjin, Murray Valley encephalitis, and Japanese encephalitis
- •History of residence for a cumulative period of >1 year in a country where dengue, Japanese encephalitis virus, or yellow fever virus is common
- •Planned travel to an area where dengue is common through 28 days after receiving the last dose of study vaccine/placebo
- •Known hypersensitivity to any component of the dengue vaccine
- •Abuse of drugs or alcohol within 12 months prior to screening
- •Pregnant or breastfeeding, or expecting to conceive in the time from enrollment through 6 weeks after the last dose of study vaccine/placebo
- •Positive serum test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and/or hepatitis C antibody
- •Known, suspected, or a history of immunocompromise
- •History of malignancy within 5 years prior to enrollment
- •Poorly controlled diabetes mellitus
- •Use of any immunosuppressive therapy (except topical and inhaled/nebulized steroids)
- •Receipt of any licensed non-live vaccine within 14 days prior to the first dose of study vaccine/placebo or plans to receive a licensed non-live vaccine during the time between receiving the first dose and 28 days after receiving the last dose of study vaccine/placebo
- •Receipt of any licensed live vaccine within 30 days prior to the first dose of study vaccine/placebo or plans to receive a licensed live vaccine during the time between receiving the first dose and 28 after receiving the last dose of study vaccine/placebo
- •Received investigational drugs or vaccines within 2 months prior to the first dose of study vaccine/placebo
- •History of receiving 1 or more doses of an investigational dengue vaccine
- •Participation in another clinical study within 42 days prior to enrollment, or plans to participate in another clinical study from enrollment through 1 year after the last dose of study vaccine/placebo
- •Planned donation of eggs or sperm from the time of enrollment through 28 days after the last dose of study vaccine/placebo
- •Prior receipt of a blood transfusion or blood products within 6 months prior to the first dose of study vaccine/placebo
- •Hospitalization for acute illness within 3 months prior to the first dose of vaccine/placebo
研究组 & 干预措施
Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Experimental
干预措施: Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant (Biological)
Medium-Dose V180 with Alhydrogel™ adjuvant
Experimental
干预措施: Medium-dose V180 with Alhydrogel™ adjuvant (Biological)
High-dose Non-adjuvanted V180
Experimental
干预措施: High-dose V180 (non-adjuvanted) (Biological)
High-dose V180 with low-dose ISCOMATRIX™ adjuvant
Experimental
干预措施: High-dose V180 with low-dose ISCOMATRIX™ adjuvant (Biological)
High-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Experimental
干预措施: High-dose V180 with medium-dose ISCOMATRIX™ adjuvant (Biological)
Low-dose V180 with high-dose ISCOMATRIX™ adjuvant
Experimental
干预措施: Low-dose V180 with high-dose ISCOMATRIX™ adjuvant (Biological)
Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant
Experimental
干预措施: Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant (Biological)
High-dose V180 with high-dose ISCOMATRIX™ adjuvant
Experimental
干预措施: High-dose V180 with high-dose ISCOMATRIX™ adjuvant (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
Low-dose V180 with low-dose ISCOMATRIX™ adjuvant
Experimental
干预措施: Low-dose V180 with low-dose ISCOMATRIX™ adjuvant (Biological)
Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant
Experimental
干预措施: Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant (Biological)
Medium-dose Non-adjuvanted V180
Experimental
干预措施: Medium-dose V180 (non-adjuvanted) (Biological)
Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant
Experimental
干预措施: Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant (Biological)
结局指标
主要结局
Seroconversion rate for each serotype
时间窗: 28 days postdose 3 (Day 84)
Geometric mean titer (GMT) of virus neutralizing antibodies for each serotype
时间窗: 28 days postdose 3 (Day 84)
次要结局
未报告次要终点
研究者
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