ISRCTN78679862已完成1 期
Single-blind randomised controlled phase 1a trial of the safety and immunogenicity of lyophilised recombinant precipitated tropical malaria vaccine (BK-SE36) in Japan
The Research Foundation for Microbial Diseases of Osaka University (BIKEN) (Japan)0 个研究点目标入组 40 人开始时间: 2009年12月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
2010 results in https://pubmed.ncbi.nlm.nih.gov/20493274/ (added 29/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Healthy adult Japanese males aged 20 to 35 years (age on informed consent)
- •2. Those whose body mass index (BMI) is 18.5 to 25.0 kg/m^2
- •3. Those who are able to agree, comply with matters to be observed during participation in the trial, undergo consultation/examination, as described in this protocol, and report symptoms
- •4. Those who are considered to be eligible to participate in this trial based on screening:
- •4.1. Vital signs and physical examination are within baseline range
- •4.2. Haematology: within 15% deviations from the upper and lower limits of the baseline range. The differential white blood count is not questioned when the white blood cell count is within the baseline range.
- •4.3. Blood chemistry:
- •4.3.1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine within the baseline range
- •4.3.2. Total bilirubin, triglyceride (TG) within 50% deviation from the upper limit
- •4.3.3. Serum electrolytes within the baseline range
- •4.3.4. Other blood chemistry items within 15% deviation from the upper and lower limits of the baseline range
- •4.4. Urinalysis within the normal range
- •4.5. Infectious disease tests within the normal ranges
排除标准
- •1. Persons with fever (37.5°C or higher) on administration of the test vaccine
- •2. Persons with clear symptoms of serious acute disorders
- •3. Persons with a clear history of food/drug-related anaphylaxis
- •4. Persons with a clear history of malaria, or those with anti-plasmodium falciparum (SE36 antigen) antibody
- •5. Persons with a history or present illness of disorders requiring gastrointestinal surgery, serious cardiovascular/blood system/respiratory/liver/kidney/digestive tract/neuropsychiatric disorders, or developmental anomalies
- •6. Persons with a history of fever within 2 days after preventive administration with other types of vaccine, or those in whom symptoms have suggested systemic allergy
- •7. Persons with a history of convulsion
- •8. Persons under a diagnosis of immunodeficiency
- •9. Persons with a history or tentative diagnosis of drug allergy
- •10. Persons with a history of or present drug/ alcohol dependency
- •11. Persons who took any medication within 1 week before administration of this test vaccine
- •12. Persons to whom any live vaccine was administered within 4 weeks before administration of this test vaccine, or inactivated vaccine/toxoid was administered within 1 week
- •13. Persons who participated in another trial within 4 months before administration of this test vaccine
- •14. Persons in whom 200 ml of blood was collected (donation) within 1 month before administration of this test vaccine, or more than 400 ml of blood was collected within 3 months
- •15. Persons consuming excessive alcohol or cigarettes
- •16. Persons with a positive reaction on drug abuse screening
- •17. Others who are not considered to be eligible by the chief principal investigator or sub-investigator
研究者
相似试验
已完成
不适用
Is there a role for acupuncture in basal thumb arthritis? A randomised controlled trial of real versus sham acupuncture.OsteoarthritisISRCTN31227822Derby Teaching Hospitals NHS Foundation Trust70
已完成
不适用
A single-blind randomised controlled trial to determine the effectiveness of group Cognitive Behaviour Therapy (CBT) in the prevention of depression in high risk adolescentsMental and Behavioural DisordersDepressionISRCTN19083628niversity of Bath (UK)5,030
已完成
不适用
A phase 1, single-center, double-blind study of AM103 in healthy volunteersISRCTN51638237Amira Pharmaceuticals (USA)86
已完成
不适用
Comparison of 10% milk ready-to-use food to 25% milk ready-to-use food in the treatment of severely malnourished, Malawian childreChildhood severe acute malnutritionNutritional, Metabolic, EndocrineUnspecified severe protein-energy malnutritionISRCTN54186063niversity of Malawi College of Medicine (Malawi)1,874
已完成
不适用
Supervised Walking In comparison to Fitness Training for back paiChronic low back painMusculoskeletal DiseasesDorsalgiaISRCTN17592092Health Research Board (HRB) (Ireland)246