CTRI/2020/04/024533已完成1 期
Phase I open label, clinical trial to evaluate the safety, tolerability and immunogenicity ofChikungunya vaccine in healthy adults of 18 to 50 years age - CHIKV40ug
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.>=18 and <=50 yrs inclusive on the day of screening
- •2.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study
- •3.Medical history and physical examination without clinically significant findings at the time of screening.
- •4.Hematological and biochemical values either within institutional normal range and accompanied by physician approval.
- •5.Agree to keep a daily record of symptoms for the duration of the study
- •6.Available for clinical followâ??up throughout the study period via telephone contact as well as clinic visits
- •7.Female specific criteria:
- •a.If female of child bearing potential â?? have a negative urine pregnancy test result within 24 hrs of the scheduled first vaccination; (a woman who has not undergone permanent sterilization procedure, and has had 4 menstrual periods in last 12 months is considered as â??female of child bearing potential).
排除标准
- •Female specific criteria:
- •Woman who is breast feeding or planning to become pregnant during the
- •study period.
- •General Criteria:
- •1.History of suspected or confirmed Chikungunya fever.
- •(Case definition for Suspected Chikungunya:
- •A subject meeting both the clinical and epidemiological criteria.
- •2.Clinical criteria: acute onset of fever >38.5°C and severe
- •arthralgia/arthritis not explained by other medical conditions.
- •3.Epidemiological criteria: residing or having visited epidemic areas,
- •having reported transmission within 15 days prior to the onset of
- •Case definition for Confirmed Chikungunya:
- •4.A subject meeting the laboratory criteria of positive ELISA test for
- •CHIKV IgG.)
- •5.Clinically significant abnormal clinical laboratory values including
- •blood pressure(>=140 mmHg systolic and >=90 mmHg diastolic) when 3
- •measurements are taken 30 min apart, in sitting position and atrest
- •6.Body mass index (BMI) >= 25 [BMI will be calculated as weight in
- •Kilograms/(height in metres)2]
- •7.Test positive for HIV or Hepatitis B inf8.ection
- •History of cardiovascular disease
- •8.History of immune deficiency or autoimmune disease
- •9.Have active or history of arthritis (joint swelling, pain, tenderness,
- •warmth or erythema) within the last 6 months from date ofscreening
- •10.Have an active or history of malignant conditions including
- •haematological malignancy.
- •11.Have a history of degenerative neurological disease (e.g.
- •GuillainBarre Syndrome, multiple sclerosis)
- •12.Have received any vaccination within 4 weeks prior to the vaccination
- •in this study
- •13.Have received blood transfusion or immunoglobulin within 30 days
- •prior to vaccination in this study
- •14. Have a history of serious reactions to any vaccines that preclude
- •receipt of study vaccinations as determined by the investigator
- •15.Have asthma that is unstable or required emergent care, urgent care,
- •hospitalization or intubation during the past two years or that is expected
- •to require the use of oral or intravenous corticosteroids
- •16.Have diabetes mellitus (type I or II), with the exception of history of
- •gestational diabetes
- •17.Have received any investigational drug in 6 weeks prior to screening
- •18.Is currently participating in any form of clinical trial that involves
- •intervention.
- •19.Is likely to participate in any other clinical trial during the study
研究者
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