EUCTR2018-000211-25-GB进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent obtained before any trial-related activities
- •2. Healthy men or women aged 18 to 55 years on the day of consenting
- •3. Ability 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
- •4. All female subjects must have a negative serum pregnancy test at screening
- •5. Willingness not to become pregnant or to father a child during the entire study period by
- •practicing reliable methods of contraception as specified in protocol section 8.11.4
- •6. Availability during the duration of the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participation in another clinical study (including exposure to an investigational medicinal
- •product ore device) within one month before the screening visit or planned concurrent
- •participation in another clinical study before completion of the treatment period (day 56)
- •2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection or
- •current hepatitis B/C infection
- •3. History of drug addiction including alcohol dependence within the last 2 years
- •4. Inability or unwillingness to avoid intake of more than around 20g alcohol per day during
- •48 hours after each vaccination (equals roughly 0.5 L beer or 0.25 L of wine)
- •5. Vaccination within 4 weeks prior to first vaccination or planning to receive any non-study
- •vaccine until end of treatment period (day 56)
- •6. Prior receipt of any Chikungunya vaccine
- •7. History of moderate or severe arthritis or arthralgia within the past 3 months prior to
- •Screening Visit
- •8. Recent infection within 1 week prior to Screening Visit (possibility of deferral)
- •9. 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 (day 56)
- •10. Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory,
- •skin, haematological, 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
- •11. History of neoplastic disease (excluding non-melanoma skin cancer that was
- •successfully treated) within the past 5 years or a history of any haematological
- •12. Behavioural, 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
- •13. 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
- •14. History of anaphylaxis to drugs or other allergic reactions, which the investigator
- •considers compromising the safety of the volunteer
- •15. 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 subjects. (Prior to taking any
- •medication within 72 h before study vaccination, the subject should consult the
- •investigator)
- •16. 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 (day 56)
- •17. 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 (day 56)
- •18. Pregnancy (positive pregnancy test at screening or during the treatment period) or
- •lactation at screening, or planning to become pregnant during the treatment period
- •19. Unreliable contraception methods (for details please refer to protocol section 8.11.4)
- •20. Persons in a direct relationship with the sponsor, an investigator or other study team
- •members. Direct dependent relationships include close relati
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