PACTR202205899641128招募中2 期
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in an Age De-Escalation, Dose-Escalation Trial and a Randomized, Placebo-Controlled, Double-Blind Trial of Children in Western Kenya
ational Institutes of Health0 个研究点目标入组 396 人开始时间: 2022年5月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 396
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
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1. Healthy children aged 5 months to 10 years (Part 1) or 5-59 months (Part 2).
- •2. Weight =5 kg and weight =30 kg (Part 1) or weight =5 kg and =22.5 kg (Part 2).
- •3. Hemoglobin level =8 g/dL.
- •4. Height and weight Z-scores >-2.
- •5. Living within Alego-Usonga sub-county.
- •6. Able to participate for the duration of the trial.
- •7. Parent and/or guardian of participant able to provide informed consent.
排除标准
- •1. Taking long-term cotrimoxazole.
- •2. Participation or planned participation in an interventional trial with an investigational product until the last required protocol visit or receipt of
- •an investigational product within the past 30 days.
- •4. Participation in part 1 of this study (for individuals being screened for enrollment into part 2)
- •5. Age < 12 months at the time the RTS,S/AS01 vaccine is anticipated to become available in the whole of Siaya County
- •6. Current significant medical condition (neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, authoimmune, renal, oncologic, or hematological) or evidence of any other serious underlying medical condition identified by medical history, physical examination, or laboratory examination.
- •7. Any history of menses.
- •8. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol.
- •9. Parental/guardian study comprehension examination score of <80% correct or per investigator discretion.
- •10. Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks prior to study agent administration.
- •11. Known allergies or contraindication to dihydroartemisinin-piperaquine.
- •12. Use or known need at the time of enrolment (DP administration) for concomitant prohibited medication.
- •13. Increased risk of salivary gland hypofunction (dryness of the mouth, swelling under the tongue and/or below the ear, halitosis)
- •14. History of any other illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the subject’s participation in the protocol or compromise the scientific objectives, or other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or render the subject unable to comply with the protocol.
研究者
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