NCT03635086已完成2 期
Observer Blinded, Randomised Study to Investigate Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination
研究概览
简要总结
The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is able to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study
- •Has a negative serum pregnancy test at screening (for female participants)
- •Has a willingness not to become pregnant or to father a child during the entire study period by practicing reliable methods of contraception
- •Has availability during the duration of the trial
排除标准
- •Has participated in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period
- •Has a history of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
- •Has a history of drug addiction including alcohol dependence within the last 2 years
- •Has an inability or unwillingness to avoid intake of more than around 20 grams alcohol per day during 48 hours after each vaccination (equals roughly 0.5 liter beer or 0.25 liter of wine)
- •Has had a vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until end of treatment period
- •Has had a prior receipt of any Chikungunya vaccine
- •Has a history of moderate or severe arthritis or arthralgia within the past 3 months prior to screening
- •Has had a recent infection within 1 week prior to screening
- •Has made blood donations including plasma donations, 90 days prior to screening visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until end of treatment period
- •Has clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study
- •Has a history of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any hematological malignancy
- •Has behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
- •Has a history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine
- •Has a history of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the participant.
- •Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants.
- •Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to the first vaccination or anticipated use before completion of the treatment period
- •Has receipt of blood products or immunoglobulins within 120 days prior to the screening visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period
- •Has pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period
- •Has unreliable contraception methods
- •Is a person in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor
结局指标
主要结局
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination
时间窗: 28 days after last vaccination (Up to Day 56)
Participant serum was collected for determination of antibody responses by 50% plaque reduction neutralization test (PRNT50). Geometric Mean Titer (GMT) of functional antibodies as measured by PRNT50 were assessed. Geometric mean titers and GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2 sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey Kramer.
次要结局
- Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells(Up to Day 56)
- Percentage of Participants With Solicited and Unsolicited Adverse Events(Up to Day 56)
- Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells(Up to Day 56)
- Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells(Up to Day 56)
- Percentage of Participants With at Least 1 Serious Adverse Event(Up to Day 56)
- Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50(Up to Day 365)
- Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells(Up to Day 56)
- Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells(Up to Day 56)
- Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells(Up to Day 56)
- Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE(Up to Day 56)
- Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells(Up to Day 56)
- Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells(Up to Day 56)
- Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA(Up to Day 56)
- Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay(Up to Day 365)
- Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE(Up to Day 56)
研究者
研究点 (2)
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