RPCEC00000397已完成未知
Exploratory study of the SOBERANA Plus ST vaccine, to evaluate its reactogenicity and immunogenicity in adults from Italy: COVID-19 convalescents; and subjects without a history of this disease and previously immunized against SARS-CoV-2. (COVID-19) - SOBERANA PLUS TURI
Finlay Vaccine Institute (IFV)0 个研究点开始时间: 2021年11月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- Non-randomized controlled trial. Masking: Open. 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. The participant understands and agrees to comply with the study procedures and provides written informed consent.
- •2. Adults, 19 to 59 years of age, at time of consent.
- •3. Subjects with BMI of 18.5 to 34.9 kg/m2.
排除标准
- •1. A) COVID-19 convalescent group: a) A history of SARS-CoV-2 infection at time of recruitment or medical discharge for COVID-19 during the two months before recruitment; b) History of severe or asymptomatic COVID-19. B) Group of healthy individuals immunized with another vaccine: History of COVID-19.
- •2. Acute illness, febrile, 7 days prior to administration of investigational product or at screening.
- •3. Current use of any prescription of non-steroidal anti-inflammatory drugs (NSAIDs) or antimicrobial medications within 7 days prior to vaccination.
- •4. Any chronic medical disease or condition that, in the opinion of the clinical investigator, precludes study participation (e.g., subjects with respiratory disease (e.g., chronic obstructive pulmonary disease, asthma), diabetes mellitus, thyroid disease, cardiovascular disease (e.g., congestive heart failure, hypertension, and ischemic heart disease), liver and kidney chronic diseases, neurological conditions or bleeding disorder, psychiatric condition, etc.).
- •5. Any primary or secondary immunodeficiency.
- •6. Ongoing malignancy or recent diagnosis of malignancy.
- •7. A history of alcohol abuse or other recreational drug use within 30 days before the first vaccine administration, except smoking.
- •8. Demonstrated inability to comply with the study procedures (Mental problems or disorders).
- •9. A history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticarial, angioedema,).
- •10. A history of hypersensitivity to some vaccine component.
- •11. Participated in another investigational study involving any investigational product within 3 month prior to the day of enrollment.
- •12. A) COVID-19 convalescent group: a) Subjects vaccinated with any vaccine against SARS-CoV-2. B) Group of healthy individuals previously immunized with another vaccine: Subjects are excluded if they were not vaccinated between 3 and 12 months before recruitment.
- •13. Received any vaccine within 30 days prior to the day of enrollment.
- •14. Received systemic immunosuppressant or immune-modifying drugs, including cytostatic drugs and steroids.
- •15. History of transfusion of blood or blood products in the last 3 months.
- •16. Difficulties to comply with the schedule of clinical visit or to continue follow up clinical visits.
- •17. Splenectomy or splenic dysfunction.
- •18. Women of childbearing potential not using safe contraceptive methods during the study
- •19. Pregnancy, puerperium, or breastfeeding.
- •20. Any abnormality or permanent body art (e.g., tattoo) that would interfere with the observation of local reactions at the injection site (both deltoid region).
研究者
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