NL-OMON36588已完成不适用
Immunization with different numbers of Plasmodium falciparum infected mosquito-bites under chloroquine prophylaxis - ZonMw1
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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 至 99（—）
入选标准
- •1. Age > 18 and < 35 years healthy volunteers (males or females)
- •2. General good health based on history and clinical examination
- •3. Negative pregnancy test
- •4. Use of adequate contraception for females
- •5. All volunteers have to sign the informed consent form following proper understanding of the meaning and procedures of the study
- •6. Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the study
- •7. Willingness to undergo a P. falciparum sporozoite challenge
- •8. For volunteers not living in Leiden: agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 after challenge till 3 days after treatment)
- •9. Reachable by mobile phone during the whole study period
- •10. Availability to attend all study visits
- •11. Agreement to refrain from blood donation to Sanquin or for other purposes, during the course of the study
- •12. Willingness to undergo an HIV, hepatitis B and C test
- •13. Negative urine toxicology screening test at screening visit and day before challenge
- •14. Willingness to take a prophylactic regime of chloroquine and curative regimen of Malarone
排除标准
- •1. History of malaria
- •2. Plans to travel to malaria endemic areas during the study period
- •3. Previous participation in any malaria vaccine study and/or positive serology for Pf
- •4. Symptoms, physical signs and laboratory values suggestive of systemic disorders which could interfere with the interpretation of the study results or compromise the health of the volunteers
- •5. History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
- •6. History of arrhythmias or prolonged QT-interval
- •7. Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old
- •8. An estimated, ten year risk of fatal cardiovascular disease of >=5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
- •9. Clinically significant abnormalities in electrocardiogram (ECG) at screening
- •10. Body Mass Index (BMI) below 18 or above 30 kg/m2
- •11. Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis
- •12. Positive HIV, HBV or HCV tests
- •13. Participation in any other clinical study within 30 days prior to the onset of the study
- •14. Enrollment in any other clinical study during the study period
- •15. Pregnant or lactating women
- •16. Volunteers unable to give written informed consent
- •17. Volunteers unable to be closely followed for social, geographic or psychological reasons
- •18. Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
- •19. A history of psychiatric disease
- •20. Known hypersensitivity to Malarone® or chloroquine
- •21. The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period
- •22. Contra-indications to Malarone® or chloroquine including treatment taken by the volunteer that interferes with Malarone® or chloroquine
- •23. Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
- •24. Co-workers of the departments of Medical Microbiology, Parasitology, or Internal Medicine of the Leiden University medical Centre
- •25. A history of sickle cell anemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency
研究者
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