EUCTR2012-000322-21-NL进行中（未招募）1 期
Controlled human malaria infection after immunization with cryopreserved Plasmodium falciparum sporozoites under chloroquine prophylaxis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Sanaria Inc.
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Healthy volunteers (males or females) of = 18 and = 35 years of age
- •2.Good health based on history and clinical examination (physical examination and laboratory screening)
- •3.Negative pregnancy test
- •4.Use of adequate contraception for females
- •5.Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study
- •6.Agreement to inform the general practitioner and to sign a request to release medical information concerning contraindications for participation in the study
- •7.Willingness to undergo administration of PfSPZ Challenge by needle and syringe and willingness to undergo challenge by mosquito bites
- •8.For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial centre or living in Nijmegen with a third party that could contact the clinicians in case of alteration of consciousness during a part of the study (day 5 after challenge until treatment is finished)
- •9.Reachable (24/7) by mobile phone during the whole study period
- •10.For volunteers living in Nijmegen: 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 centre during a part of the study (day 5 after challenge until treatment is finished)
- •11.Available to attend all study visits
- •12.Agreement to refrain from blood donation to Sanquin or for other purposes, during the whole study period
- •13.Willingness to undergo HIV, hepatitis B and hepatitis C tests
- •14.Negative urine toxicology screening test at screening visit and the day before challenge
- •15.Willingness to take a prophylactic regime of chloroquine and a curative regimen of Malarone®
- •16.Willingness to undergo ophthalmologic examination after passing all other inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of malaria
- •2.Plans to travel to malaria endemic areas during the study period
- •3.Plans to travel outside of the Netherlands during the challenge period
- •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 of 1st and/or 2nd degree relatives who experienced cardiac events when < 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 haematology blood tests
- •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.Enrolment in any other clinical study during the study period
- •16.For women: pregnancy or lactation
- •17.Volunteers unable to give written informed consent
- •18.Volunteers unable to be closely followed for social, geographic or psychological reasons
- •19.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.A history of convulsions
- •22.Known hypersensitivity to Malarone® or chloroquine
- •23.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
- •24.Contraindications to Malarone® or chloroquine including treatment taken by the volunteer that interferes with Malarone® or chloroquine
- •25.Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
- •26.Co-workers or trainees of the departments of Medical Microbiology or Internal Medicine of the RUNMC
- •27.Known history of sickle cell anaemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency. If there is any suspicion of G6PD deficiency (based on medical history during screening or ethnic background (Mediterranean, African, or Asian), we will assess G6PD status of that particular subject before inclusion.
- •28.Abnormalities during ophthalmologic examination
研究者
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