PACTR201610001813366Other未知
A Phase Ib Randomised, Controlled, Single-blind Study to Assess the Safety, Immunogenicity of the Malaria Vaccine Candidate R21 With Matrix-M1 Adjuvant in West African Adult Volunteers
Oxford University0 个研究点目标入组 24 人开始时间: 2016年10月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
- 入组人数
- 24
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
- 年龄范围
- 18 Year(s) 至 45 Year(s)（—）
- 性别
- All
入选标准
- •The volunteer must satisfy all the following criteria to be eligible for the study:
- •Healthy adults ages 18 to 45 years.
- •Willingness to remain in study area for the period of the study.
- •Able and willing (in the Investigator's opinion) to comply with all study requirements.
- •Women only: Must practice and show documented evidence of continuous effective contraception (e.g. depo-progesterone) or must be willing to take contraceptive measures not to become pregnant for the duration of the study. Willing to have pregnancy tests at screening and vaccination time points.
- •Agreement to refrain from blood donation during the course of the study.
- •Written informed consent to participate in the trial.
排除标准
- •Hb less than 10.0g/dl
- •Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
- •Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
- •Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic (more than 14 days) immunosuppressant or other immune-modifying drugs medication (for corticosteroids, this will mean prednisolone, or equivalent, ¿ 0.5mg/kg/day) within the past 6 months (inhaled and topical steroids are allowed).
- •Use of immunoglobulins or blood products within 3 months prior to enrolment.
- •History of allergic disease or hypersensitivity reactions likely to be exacerbated by any component of the study vaccines.
- •Any history of anaphylaxis post-vaccination.
- •History of clinically significant contact dermititis.
- •Pregnancy, lactation or intention to become pregnant during the study.
- •Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- •History of serious psychiatric condition that may affect participation in the study.
- •History of splenectomy.
- •Any other serious chronic illness requiring hospitalsupervision.
- •HIV or Hepatitis B surface antigen seropositivity.
- •Volunteers unable to be closely followed for social, geographic or psychological reasons.
- •Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat test will be requested.
- •Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
研究者
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