Safety and immunogenicity evaluation of recombinant E.coli BK-SE36 malaria vaccine candidate with aluminium hydroxide gel as adjuvant administered either subcutaneously or intramuscularly in healthy malaria exposed African children living in Burkina Faso: A double blinded, randomized, controlled, age de-escalating, phase Ib clinical trial followed by an extended single blind follow up phase.

obelpharma Co., Ltd0 个研究点目标入组 108 人开始时间: 2014年11月8日最近更新: 2023年5月29日

适应症

试验速览

阶段: 1 期
状态: Other
发起方
入组人数: 108

研究概览入排标准研究者记录与标识符相似试验

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: 12 Month(s) 至 60 Month(s)（—）
性别: All

入选标准

•Specific inclusion criteria for cohort 1 (25-60 months): Female or male subject aged 25-60 months inclusive at the time of the first vaccination
•Specific inclusion criteria for cohort 1 (25-60 months): Female or male subject aged 25-60 months inclusive at the time of the first vaccination
•Residing within the Banfora health district and planning to stay for the study duration
•Appear to be in generally good health based on malnutrition index and clinical and laboratory investigation
•Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by an impartial witness.
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study. The trial period for each subject is ca 18 months.

排除标准

•Previous participation in any malaria vaccine trial
•History of blood transfusion within the last 3 months
•Symptoms, physical signs or 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 trial results or compromise the health of the volunteers
•Any clinically significant laboratory abnormalities on screened blood samples outside the normal range, as defined at the clinical trial site.
•Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior to recruitment. (For corticosteroids, this will mean prednisone, or equivalent, ¿ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination (No testing will be done for HIV)
•A family history of congenital or hereditary immunodeficiency
•Major congenital defects
•Subjects with splenectomy
•History of anaphylaxis or known severe hypersensitivity to any of the vaccine components (adjuvant or antigen or excipient)
•Administration of gamma globulin: 4 weeks prior and after each vaccination if administration is necessary during the study period, the volunteer will be withdrawn from the study
•Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s)
•Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
•Weight-for-age Z score of less than ¿3 or other clinical signs of malnutrition
•Current participation in another clinical trial, or within 12 weeks of this study

研究者

发起方

obelpharma Co., Ltd

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