PACTR202312585218142尚未招募1 期
Adaptation of blood-stage Controlled Human Malaria Infection for evaluation of transmission-blocking malaria interventions in malaria-endemic countries
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- Male
入选标准
- •Male volunteers aged 18-45 years and in good health.
- •Volunteer has adequate understanding of the procedures of the study and is able and willing (in the investigator's opinion) to comply with all study requirements.
- •Participant is willing and able to give informed consent for participation in the trial.
- •Participant with low malaria exposure as determined by anti-schizont ELISA
- •Literacy in Kiswahili.
- •Anti-schizont antibody levels below 50th centile of the most recently available population anti-schizont in Bagamoyo district
排除标准
- •Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, gastrointestinal, renal, hepatic, neurological, dermatological (e.g. psoriasis, contact dermatitis etc.), allergy, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results.
- •A heightened risk of cardiovascular disease, as determined by: an estimated ten-year risk of fatal cardiovascular disease of =5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old.
- •Body mass index (BMI) of <18 or >30 Kg/m2
- •A medical history of functional asplenia
- •Female volunteers
- •Confirmed parasite positive by PCR a day before challenge i.e., at C-1.
- •Screening tests positive for Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
- •Chronic use (>30 days) of i) immunosuppressive drugs, ii) antibiotics, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral antihistamines exempted) or expected use of such during the study period.
- •Any recent (within 30 days) or current systemic therapy with an antibiotic or drug with potential antimalarial activity (chloroquine, doxycycline, tetracycline, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, erythromycin, hydroxychloroquine, etc.) (Allowable time frame for use at the Investigator'sdiscretion).
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the
研究者
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