CTRI/2010/091/000301已完成1 期
A Phase I, Randomised, Controlled, Dose-Escalating, Single-Blind Clinical Trial to Evaluate the Safety and Immunogenicity of JAIVAC-1 Vaccine (PfMSP-119 and PfF2) formulated with Montanide ISA 720 in Healthy Indian Male Subjects between 18 to 45 Years of Age
International Center for Genetic Engineering and Biotechnology MVDP0 个研究点目标入组 45 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
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
入选标准
- •1. Male subject aged 18 to 45 years (both inclusive)
- •2. Subject with general good health based on the medical history
- •and clinical examination
- •3. Subject must be willing to sign the Informed Consent Form
- •4. Subject must be reachable by phone during the entire study
- •period (12 months)
- •5. Subject must be capable and willing to complete and return
- •diary cards and to attend all follow-up visits
- •6. Male subject must agree to use one of the following medicallyacceptable
- •birth control measures throughout the duration of
- •the study (birth control counselling and measures will be
- •provided by sites as required)
- •? Double barrier method (e.g. condom with spermicidal
- •jelly) used for the entire study period
- •? Should be Surgically sterile (vasectomy)
排除标准
- •1. Subject with evidence of IgG antibodies against PfMSP-119 and
- •PfF2 as measured by ELISA
- •2. Subject with prior history of immunisation with Hepatitis B vaccine
- •3. Subject with known history of malaria
- •4. Subject with history of allergic reactions, hypersensitivity or
- •anaphylaxis to any of the components of the study vaccines
- •(JAIVAC-1 ? Montanide ISA 720 malaria vaccine or Hepatitis B
- •vaccine) (including adjuvant or peptide) or with history of serious
- •allergic reactions to any substance, requiring hospitalisation or
- •emergency medical care
- •5. Subject with previous vaccination with any other malaria candidate
- •6. Subject with use of an investigational or non-registered drug or
- •vaccine other than the study vaccines within three (3) months
- •preceding the first study vaccination, or planned use during the
- •entire clinical trial period
- •7. Subject, who receives any vaccination or gamma globulin during
- •the three-month period prior to the first vaccination
- •8. Subject with chronic administration (defined as more than 14 days)
- •of immuno-suppressants or other immune-modifying drugs within
- •six months prior to the first vaccination. This includes any dose
- •level of oral steroids or inhaled steroids, but not topical steroids
- •9. Subjects will be excluded if AST 40 IU/L, ALT 41 IU/L, γ
- •GT 71 IU/L, Total Bilirubin 1.2 mg/ dL, Indirect Bilirubin
- •1.2 mg/ dL, Direct Bilirubin 0.4 mg/dL, Serum Creatinine 1.2
- •mg/ dL(Appendix B and B-1).
- •10. Subjects will be excluded in case of out of range values for the
- •following parameters: Hemoglobin 13 to 18 g/ dL, RBC count 4.0
- •to 7.0 Ã? 10E6/µL TLC 4.0 to 11.0 Ã? 10E3/µL, platelet count 150
- •to 500 Ã? 10E3/µL, Neutrophils 40 to 75 % or Eosinophils 10
- •%, Sodium 136 to 145 mEq/L, Potassium 3.5 to 5.1 mEq/L,
- •Random Blood Glucose 45 to 130 mg/dl and Alkaline Phosphatase
- •40 to 129 U/L (Appendix B and B-1)
- •11. Subjects with other clinically significant abnormal laboratory values
- •based on the normal reference range (Refer Appendix B and B1)
- •apart from the laboratory parameters listed above.
研究者
相似试验
Unknown
1 期
Malaria vaccine study in healthy Indian adult males.CTRI/2020/03/023739ICGEB
已完成
1 期
Phase 1 Clinical study to test the safety of Plasmodium Vivax (Malaria) Vaccine in Healthy Volunteers.CTRI/2016/09/007289International Centre for Genetic Engineering and Biotechnology36
进行中（未招募）
不适用
A phase 1 dose-escalating study for CT-P27 on its own and in combination with TamifluDiseases of th respiratory systemKCT0001617Celltrion36
进行中（未招募）
1 期
A Pneumococcal Vaccine Study A Phase 1, Randomized, Single Dose, Blinded, Dose-Escalation Study to Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active ComparatorHealthy volunteers (toddlers), Assess Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active ComparatorMedDRA version: 20.0Level: LLTClassification code 10078416Term: Invasive bacterial infectionSystem Organ Class: 100000004862EUCTR2019-004503-12-Outside-EU/EEAAstellas Pharma Global Development Inc.
已完成
1 期
A First in Human study in ascending doses of FDY-5301.acute myocardial infarctionACTRN12616001165471Clinical Network Services Pty Ltd40