NL-OMON35056已完成不适用
Experimental human malaria infection by intradermal injection of Plasmodium falciparum sporozoites (PfSPZ Challenge) - TIP2
Sanaria Inc., Stephen L. Hoffman, M.D.0 个研究点目标入组 18 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
- 18
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. Good health based on history and clinical examination
- •3. Negative pregnancy test
- •4. Use of adequate contraception for females
- •5. All volunteers must sign the informed consent form demonstrating their understanding of the meaning and procedures of the study
- •6. Volunteer agrees to inform the general practitioner and agrees to sign a request to release medical information concerning contra-indications for participation in the study
- •7. Willingness to undergo a Pf sporozoite challenge
- •8. For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 till 3 days after treatment)
- •9. Reachable (24/7) by mobile phone during the whole study period
- •10. Living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 till 3 days after treatment)
- •11. Available to attend all study visits
- •12. Agreement to refrain from blood donation to Sanquin or for other purposes, during the study period until day 140.
- •13. Willingness to undergo HIV, hepatitis B and hepatitis C tests
- •14. Negative urine toxicology screening test at screening visit and day before challenge
- •15. Willingness to take a curative regimen of Malarone®
排除标准
- •1. History of malaria
- •2. Plans to travel to malaria endemic areas during the 140 day study period
- •3. Plans to travel outside of the Netherlands during day 0-28 of the study
- •4. Previous participation in any malaria vaccine study and/or positive serology for Pf
- •5. Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
- •6. History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
- •7. History of arrhythmias or prolonged QT-interval
- •8. Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old
- •9. An estimated, ten year risk of fatal cardiovascular disease of >=5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
- •10. Clinically significant abnormalities in electrocardiogram (ECG) at screening
- •11. Body Mass Index (BMI) below 18 or above 30 kg/m2
- •12. Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis
- •13. Positive HIV, HBV or HCV tests
- •14. Participation in any other clinical study within 30 days prior to the onset of the study
- •15. Enrollment in any other clinical study during the study period
- •16. Pregnant or lactating women
- •17. Volunteers unable to give written informed consent
- •18. Volunteers unable to be closely followed for social, geographic or psychological reasons
- •19. Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
- •20. A history of psychiatric disease
- •21. Known hypersensitivity to anti-malaria drugs
- •22. 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
- •23. Contra-indications to Malarone® including treatment taken by the volunteer that interferes with Malarone®
- •24. Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
- •25. Co-workers of the departments of Medical Microbiology or Internal Medicine of the Radboud University Nijmegen Medical Centre or Sanaria Inc.
- •26. A history of sickle cell anemia, sickle cell trait, thallasemia, thallasemia trait or G6PD deficiency
研究者
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