NL-OMON51178已完成不适用
Safety, Tolerability and Plasmodium falciparum transmission-reducing activity of R0.6C vaccine adjuvanted with Alhydrogel alone or combined with Matrix-M in healthy malaria-naïve adults in the Netherlands - STOP-TRANS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
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 64（—）
入选标准
- •1. Subject must sign written informed consent to participate in the trial.
- •2. Subject is a male or non-pregnant and non-lactating female age >= 18 and <= 55
- •years and in good health.
- •3. Subject is able to understand planned study procedures and demonstrate
- •comprehension of the protocol procedures and knowledge of study by passing a
- •quiz (assessment of understanding).
- •4. In the opinion of the investigator, the subject can and will comply with the
- •requirements of the protocol.
- •5. Subjects are available to attend all study visits and are reachable by phone
- •throughout the entire study period from day -1 until day 224 (end of study).
- •6. The subject will remain within reasonable travelling distance from the study
- •center from day -1 until day 7 after each R0.6C administration and agrees not
- •to travel to a malaria-endemic area during the study period
- •7. Subject agrees to their general practitioner (GP) being informed about
- •participation in the study and agrees to sign a form to request the release by
- •their GP, and medical specialist when necessary, of any relevant medical
- •information concerning possible contra-indications for participation in the
- •study to the investigator(s).
- •8. The subject agrees to refrain from blood donation to Sanquin or for other
- •purposes throughout the study period according to current Sanquin guidelines.
- •9. Female subjects of non-childbearing potential may be enrolled in the study.
- •All subjects of childbearing potential must agree to use continuous adequate
- •contraception until 2 months after completion of the study. Female subjects
- •must agree not to breastfeed from 30 days prior to R0.6C administration until 2
- •months after completion of the study. Female subjects must have a negative
- •pregnancy test at the inclusion visit.
排除标准
- •1. Acute or chronic disease at time of R0.6C administration, clinically
- •significant pulmonary, cardiovascular, hepatic, renal, neurological or
- •immunological functional abnormality, as determined by medical history,
- •physical examination or laboratory screening tests:
- •a. Acute disease is defined as the presence of a moderate or severe illness
- •with or without fever. For subjects with an illness on the day of R0.6C
- •administration, the vaccination may be postponed up to 7 days.
- •b. Fever is defined as an oral, axillary or tympanic temperature >= 38.0°C.
- •c. Any abnormal and clinically significant baseline laboratory screening tests
- •of ALT, AST, creatinine, hemoglobin, platelet count or total white blood cell
- •count, as defined in the protocol according to the FDA Toxicity Grading Scale
- •for Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine
- •Clinical Trials (appendix 1).
- •2. History of malignancy of any organ system (other than localized basal cell
- •carcinoma of the skin), treated or untreated, within the past 5 years.
- •3. Chronic use of i) immunosuppressive drugs, 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.
- •4. 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 at inclusion.
- •5. Screening tests positive for Human Immunodeficiency Virus (HIV), active
- •Hepatitis B Virus (HBV), Hepatitis C Virus (HCV).
- •6. Use of any other investigational or non-registered product (drug or vaccine)
- •during the study period.
- •7. Known hypersensitivity to macrolides.
- •8. Participation in any other clinical study involving an investigational
- •product in the 30 days prior to the start of the study or during the study
- •9. Receipt of any other vaccination within 30 days prior to or up to 14 days
- •after any R0.6C vaccination. Exceptions are made for vaccination against
- •influenza and the novel coronavirus SARS-CoV2.
- •10. Any history of malaria, positive serology for P. falciparum, or previous
- •participation in any malaria (vaccine) study or CHMI.
- •11. Body weight > 115 kg
- •12. Being an employee or student of the department of Medical Microbiology of
- •the Radboudumc at the time of screening, or a person otherwise related to the
- •investigator.
- •13. 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, or affects the
- •interpretability of the trial results.
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