NL-OMON44351已完成不适用
Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy volunteers in the Netherlands - CPS135
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
研究概览
简要总结
Trial ended prematurely
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. Subject is aged >= 18 and <= 35 years and in good health.
- •2. Subject has adequate understanding of the procedures of the study and agrees
- •to abide strictly thereby.
- •3. Subject is able to communicate well with the investigator and is available
- •to attend all study visits.
- •4. The subject will remain within the Netherlands during the challenge period,
- •not travel to a malaria-endemic area during the study period, and is reachable
- •(24/7) by mobile telephone throughout the entire study period.
- •5. Subject agrees to inform his/her general practitioner about participation in
- •the study and to sign a request to release by the General Practitioner (GP),
- •and medical specialist when necessary, any relevant medical information
- •concerning possible contra-indications for participation in the study.
- •6. The subject agrees to refrain from blood donation to Sanquin or for other
- •purposes throughout the study period and for a defined period thereafter
- •according to current Sanquin guidelines.
- •7. For female subjects: subject agrees to use adequate contraception and not to
- •breastfeed for the duration of study. Acceptable forms of contraception
- •include: established use of oral, injected or implanted hormonal
- •contraceptives; intrauterine device or intrauterine system; barrier methods
- •(condoms or diaphragm with additional spermicide); male partner*s sterilisation
- •(with appropriate post-vasectomy documentation of absence of sperm in the
- •ejaculate); true abstinence when this is in line with the preferred and usual
- •lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation,
- •symptothermal, post-ovulation methods) and withdrawal are not acceptable
- •methods of contraception.
- •8. Subject agrees to refrain from intensive physical exercise (disproportionate
- •to the subjects usual daily activity or exercise routine) during the malaria
- •challenge period.
- •9. Subject agrees to avoid additional triggers that may cause elevations in
- •liver enzymes including alcohol from baseline up to 1 week post treatment.
- •10. Subject has signed informed consent.
排除标准
- •1. 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,
- •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. These include, but are not limited to, any of the
- •1.1 Body weight <50 kg or Body Mass Index (BMI) <18 or >30 kg/m2 at screening.
- •1.2 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*s, 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.
- •1.3 A medical history of functional asplenia, sickle cell trait/disease,
- •thalassaemia trait/disease or G6PD deficiency.
- •1.4 History of epilepsy in the period of five years prior to study onset, even
- •if no longer on medication.
- •1.5 Screening tests positive for Human Immunodeficiency Virus (HIV), or active
- •Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
- •1.6 Chronic use of i) immunosuppressive drugs, ii) antibiotics or
- •antimalarials, iii) or other 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.
- •1.7 History of malignancy of any organ system (other than localized basal cell
- •carcinoma of the skin), treated or untreated, within the past 5 years.
- •1.8 Any history of treatment for severe psychiatric disease by a psychiatrist
- •in the past year.
- •1.9 History of drug or alcohol abuse interfering with normal social function in
- •the period of one year prior to study onset, positive urine toxicology test for
- •cocaine or amphetamines at screening or inclusion, or positive urine toxicology
- •test for cannabis at inclusion.
- •2. For female subjects: positive urine pregnancy test at screening or at
- •3. Any history of malaria, positive serology for P. falciparum, or previous
- •participation in any malaria (vaccine) study.
- •4. Known hypersensitivity to or contra-indications (including co-medication)
- •for use of Mefloquine, Malarone or artemether-lumefantrine, or history of
- •severe (allergic) reactions to mosquito bites.
- •5. Receipt of any vaccinations in the 3 months prior to the start of the study
- •or plans to receive any other vaccinations during the study period or up to 90
- •days thereafter.
- •6. Participation in any other clinical study in the 30 days prior to the start
- •of the study or during the study period.
- •7. Being an employee or student of the department of Medical Microbiology of
- •the Radboudumc or the department of Internal Medicine.
- •8. Any other condition or situation that would, in the opinion of the
- •investigator, place the subject at an unacceptable risk of injury or render the
- •subject unable to meet the requirements of the protocol.
研究者
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