PACTR201901672024347已完成未知
Repeat direct venous inoculation of Plasmodium falciparum sporozoites, strain NF54 and clone 7G8, in healthy adult volunteers naturally exposed to malaria in Gabon: a randomized open-label study
Centre de Recherches Medicale de Lambarene0 个研究点目标入组 56 人开始时间: 2019年1月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 56
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adults aged 18 to 45 years
- •Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •Women only: Must agree to practice continuous effective contraception for the duration of the study (a method which results in a failure rate less than 1% per year)
- •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
- •Written informed consent to receive PfSPZ products:
- •oPfSPZ Challenge (NF54)
- •oPfSPZ Challenge (7G8)
- •Reachable (24/7) by mobile phone from the time of each PfSPZ Challenge inoculation until treatment is successfully completed
- •Willingness to take antimalarial medication
- •Agreement to stay overnight for observation at any time during follow-up post-challenge if judged clinically necessary
- •Answer all questions on the informed consent quiz correctly
排除标准
- •Use of antimalarials within past 30 days
- •Recent use of systemic antibiotics with known antimalarial activity
- •Receipt of an investigational product within past 30 days, or during the study
- •Immunization with >3 vaccines within past 4 weeks
- •HIV infection
- •Hb <10 g/dL (F) or <12 g/dL (M)
- •Sickle cell anaemia (e.g. HbSS, HbSC)
- •Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe infections or chronic (>14 days) immunosuppressant med. within the past 6 months (except inhaled/ topical steroids)
- •Use of immunoglobulins or blood products within past 3 months
- •Pregnancy, lactation or intention to become pregnant during the study
- •Contraindications to artemether-lumefantrine or low-dose primaquine
- •History of cancer (except basal cell ca. and cervical ca. in situ)
- •History of serious psychiatric condition
- •Any other serious chronic illness requiring hospital specialist supervision
- •Suspected or known current alcohol abuse (>60g (M) or >40g (F) per day)
- •Suspected or known injecting drug abuse in past 5 years
- •HBsAg-positivity
- •Anti-HCV positivity
- •Moderate or higher (>10%) risk of fatal or non-fatal cardiovascular event within 5 years determined by non-invasive criteria
- •BMI >35 kg/m2
- •Abnormal ECG on screening: pathologic Q wave, significant ST-T wave changes, LVH, clinically significant arrhythmias, LBBB, secondary or tertiary A-V heart block or a QT/QTcB interval >450 ms
- •Volunteers unable to be closely followed for social, geographic or psychological reasons
- •Any clinically significant abnormal finding on biochemistry, hematology, urine analysis or clinical examination
- •History of seizure (except uncomplicated febrile convulsion in childhood)
- •Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the volunteer’s risk of participation, or ability to participate, in the study or impair interpretation of the study data
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