NCT05085470已完成不适用
Safety and Protective Efficacy of Repeated Controlled Human Schistosoma Mansoni Infection
Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年10月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Protective efficacy
研究概览
简要总结
A group of 24 healthy volunteers are challenged one or three times with 20 male Schistosoma mansoni cercariae to investigate whether this leads to protection and to identify potential correlates of protection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is aged ≥ 18 and ≤ 45 years and in good health.
- •Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- •Subject is able to communicate well with the investigator, is available to attend all study visits.
- •Subject will remain within Europe (excluding Corsica) during the study period.
- •Subject agrees to refrain from blood and plasma donation to Sanquin or for other purposes throughout the study period.
- •For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
- •Subject has signed informed consent.
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, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immune-deficient, (severe) psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following:
- •body weight <50 kg or Body Mass Index (BMI) <18.0 or >35.0 kg/m2 at screening;
- •positive HIV, hepatitis B virus or hepatitis C virus screening tests;
- •the use of immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period;
- •history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years;
- •any history of treatment for severe psychiatric disease by a psychiatrist in the past year;
- •history of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset.
- •The chronic use of any drug known to interact with praziquantel, artesunate or lumefantrine metabolism (e.g. phenytoin, carbamazepine, phenobarbital, primidone, dexamethasone, rifampicin, cimetidine, flecainide, metoprolol, imipramine, amitriptyline, clomipramine, class IA and III anti-arrythmics, antipsychotics, antidepressants, macrolides, fluoroquinolones, imidazole- and triazole antimycotics, antihistamines). Because lumefantrine may cause extension of QT-time, chronic use of drugs with effect on QT interval will result in exclusion from study participation.
- •For female subjects: positive urine pregnancy test at screening.
- •Any history of schistosomiasis or treatment for schistosomiasis.
- •Positive serology for schistosomiasis or elevated serum CAA at screening.
- •Known hypersensitivity to or contra-indications (including co-medication) for use of praziquantel, artesunate or lumefantrine.
- •Being an employee or student of the department of Parasitology or Infectious diseases of the LUMC.
结局指标
主要结局
Protective efficacy
时间窗: From week 18 until week 30
The protective efficacy of repeated exposure to male Sm cercariae measured by the difference in frequency of serum circulating aniodic antigen (CAA) positivity (≥1.0 pg/mL) between the reinfection group and the infection control group at any timepoint after the final infection at week 18 and before week 30
Safety of (repeated) exposure to male Sm cercariae based on self-reported adverse events
时间窗: 38 weeks
Frequency and severity of adverse events after (repeated) human Sm infection with male cercariae
次要结局
- Time to CAA positivity(From week 18 until week 30)
- Peak serum CAA levels(From week 18 until week 30)
- Eosinophils(From week 18 until week 30)
- Antibody responses(From week 18 until week 30)
- Cellular responses(From week 18 until week 30)
- Attack rate(26 weeks)
研究者
Meta Roestenberg
Prof
Leiden University Medical Center
研究点 (2)
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