ACTRN12622001097730招募中1 期
A pilot volunteer infection study to determine the utility of the Plasmodium falciparum 3D7-MBE008 master cell bank in assessing malaria transmission blocking interventions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Male or female (non-pregnant, non-lactating) aged 18 to 55 years inclusive who will be contactable and available for the duration of the trial and up to two weeks following the End of Study visit.
- •2. Total body weight greater than or equal to 50 kg, and a body mass index within the range of 18 to 32 kg/m2 (inclusive).
- •3. Certified as healthy by a comprehensive clinical assessment (detailed medical history and full physical examination).
- •4. At least normal G6PD enzyme activity levels as defined by the parameters of the specific quantitative G6PD test employed.
- •5. Fully vaccinated (meaning first, second and booster dose) against COVID-19 at least 7 days prior to inoculation with the malaria challenge agent.
- •6. Vital signs at screening and pre-inoculation (measured after 5 min in the supine position):
- •Systolic blood pressure (SBP) - 90–140 mmHg,
- •Diastolic blood pressure (DBP) - 40–90 mmHg,
- •Heart rate (HR) 40–100 bpm.
排除标准
- •1. Any history of malaria or participation in a previous malaria challenge study or malaria vaccine study.
- •2. Must not have travelled to or lived (greater than 2 weeks) in a malaria-endemic region during the past 12 months or planned travel to a malaria-endemic region during the course of the study. Must not have lived for greater than 1 year in a malaria-endemic region in the past 10 years. Must not have ever lived in a malaria-endemic region for more than 10 years inclusive.
- •3. Has evidence of increased cardiovascular disease risk.
- •4. Known hypersensitivity to artesunate or any of its excipients, artemether or other artemisinin derivatives, proguanil/atovaquone, primaquine, or 4-aminoquinolines.
- •5. Haematology, clinical chemistry or urinalysis results at screening or at the eligibility visit that are outside of Sponsor-approved clinically acceptable laboratory ranges and are considered clinically significant by the Investigator.
- •6. Participation in any investigational product trial within the 12 weeks preceding inoculation.
- •7. Symptomatic postural hypotension at screening (confirmed on two consecutive readings).
- •8. History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergies (including but not limited to allergy to any of the antimalarial rescue medications), or any history of anaphylaxis or other severe allergic reactions including face, mouth, or throat swelling or any difficulty breathing.
- •9. History of convulsion (including drug or vaccine-induced episodes).
- •10. Presence of current or suspected serious chronic diseases.
- •11. Individuals with history of schizophrenia bi-polar disease, psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis.
- •12. Presence of clinically significant infectious disease or fever (e.g., sublingual temperature greater than or equal to 38.5 Degrees Celsius) within the five days prior to inoculation.
- •13. Blood product donation to any blood bank during the 12 weeks (whole blood) or 4 weeks (plasma and platelets) prior to malaria challenge agent administration.
- •14. Cardiac/QT risk.
研究者
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