RPCEC00000338已完成1 期
Phase I, randomized, double-blind and adaptive study to evaluate the safety, reactogenicity and explore the immunogenicity of different formulations of the Prophylactic Vaccine Candidates against SARS - CoV - 2, FINLAY- FR-1 and FINLAY- FR-1A (COVID-19). - SOBERANA 01A
Finlay Vaccine Institute (IFV)0 个研究点目标入组 60 人开始时间: 2020年10月17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
- 60
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
- Randomized trial. Masking: Double Blind. Control group: Uncontrolled. Assignment: Parallel. Purpose: Prevention
入排标准
- 年龄范围
- 19 years 至 59 years（—）
- 性别
- All
入选标准
- •1. Subjects who give their informed consent to participate in the study by writing.
- •2. Subjects aged between 19 and 59 years.
- •3. Body mass index between 18.5 and 29.9 kg / m2.
- •4. Women of childbearing potential use safe contraceptive methods during the study.
- •5. General, regional and apparatus physical examination: normal or without clinically significant alterations.
- •6. Laboratory results within or outside the range of reference values ??but not clinically significant
排除标准
- •1. Subjects with acute febrile or infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application.
- •2. Subjects with antimicrobial treatment in the 7 days prior to the administration of the vaccine.
- •3. Subjects with chronic non-communicable diseases not controlled according to clinical or laboratory criteria (bronchial asthma, chronic obstructive pulmonary disease, ischemic heart disease, arterial hypertension, diabetes mellitus, thyroid, neurological, hemolymphopoietic system diseases, psychiatric disease at a psychotic level) .
- •4. Subjects with congenital or acquired immune system disease.
- •5. Subjects with a history of unresolved neoplastic disease.
- •6. Subjects with a personal history of liver or kidney failure.
- •7. Subjects with a history of abuse of toxic substances during the last 30 days or addictive illness to toxic substances, except if the subject is in abstinence, in the case of alcoholics and smoking.
- •8. Subjects with diminished mental faculties.
- •9. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria).
- •10. Subjects with a history of hypersensitivity to thiomersal or to some of the components of the formulation.
- •11. Subjects with a history of SARS-CoV 2 and COVID-19 who meet any of the following criteria:
- •a) Previous or current history of SARS-CoV 2 infection.
- •b) Be declared in the category of contact or suspect at the time of inclusion.
- •c) Subject with specific antibodies to SARS-CoV 2.
- •d) Patient with PCR positive for SARS-CoV 2.
- •12. Participation in another clinical trial in the last 3 months.
- •13. Application of another vaccine in the last 30 days.
- •14. Application of the VA-MENGOC-BC vaccine in the last 3 months.
- •15. Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Levamisole, Heberferon, Thymosin) or predictably those people that due to their underlying disease require immunomodulatory treatment, which may coincide during the development of the study.
- •16. Transfusion of blood or blood products in the last 3 months.
- •17. Subjects with difficulties in attending the planned follow-up consultations.
- •18. Splenectomy or splenic dysfunction.
- •19. Pregnancy, puerperium or lactation.
- •20. Subjects with tattoos in the deltoid region on both arms.
- •21. Subjects positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or syphilis specific antibody.
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