PACTR201503001038304Other1 期
A randomized, controlled, double-blind, single-center phase 1 clinical trial to evaluate safety, tolerability, immunogenicity and efficacy of CAF01 and aluminum hydroxide as adjuvants for the malaria vaccine candidate GMZ2 in health adult African volunteer
Centre de Recherches Medicales Lambarene0 个研究点目标入组 50 人开始时间: 2015年2月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- Other
- 发起方
- 入组人数
- 50
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 40 Year(s)（—）
- 性别
- All
入选标准
- •¿ Healthy adults aged 18 to 40 years.
- •¿ Able and willing (in the Investigator¿s opinion) to comply with all study requirements.
- •¿ Agreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local blood banking eligibility criteria
- •¿ Residence in Lambaréné or surroundings for the period of the trial.
- •¿ History of long term residence (>10 years) in area known to have significant transmission of P. falciparum
- •¿ Written informed consent to receive GMZ2 for immunization and PfSPZ Challenge for CHMI.
- •¿ Answer all questions on the informed consent quiz correctly.
- •¿ Willingness to take two curative anti-malarial regimens.
- •¿ Reachable (24/7) by mobile phone during the immunization, CHMI and follow-up.
- •¿ A body mass index <35.
排除标准
- •¿ Receipt of an investigational product in the 30 days preceding enrollment, or planned receipt during the study period.
- •¿ Prior receipt of an investigational malaria vaccine.
- •¿ Immunization with more than 3 other vaccines within the past month.
- •¿ Positive HIV test.
- •¿ Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe and chronic (more than 14 days) infections, immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).
- •¿ Use of immunoglobulins or blood products within 3 months prior to enrolment.
- •¿ Sickle cell disease or any clinically relevant blood disorder.
- •¿ A history of allergic disease or reactions likely to be exacerbated by vaccine administration.
- •¿ 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.
- •¿ Any other serious chronic illness requiring hospital specialist supervision.
- •¿ Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 60 g per day.
- •¿ Suspected or known injecting drug abuse in the 5 years preceding enrollment.
- •¿ Contraindications to the use of the first-line anti-malarial medications: artemether/lumefantrine or atovaquone/proguanil.
- •¿ Positive for hepatitis B surface antigen (HBs-antigen).
- •¿ Seropositive for hepatitis C virus (antibodies to HCV).
- •¿ Subjects unable to be closely followed for social, geographic or psychological reasons.
- •¿ Any clinically significant abnormal finding on biochemistry or hematology blood tests, urine analysis or clinical examination.
- •¿ History of seizure.
- •¿ Subjects unable to be closely followed for social, geographic or psychological reasons.
- •¿ Abnormal electrocardiogram on screening: pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, non-sinus rhythm except isolated premature atrial contractions, right of left bundle branch block, advanced A-V heart block (secondary or tertiary).
- •¿ A QT/QTc interval > 450 ms.
- •¿ Any other significant disease, disorder or finding which, in the opinion of the Investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability
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