RPCEC00000382尚未招募1 期
Phase I / II clinical trial to evaluate the safety and immunogenicity of vaccine candidates X and Y (tp) intramuscularly. Study to boost immunity in convalescent subjects of the viral disease COVID-19
Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 120 人开始时间: 2021年7月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
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: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Prevention
入排标准
- 年龄范围
- 19 years 至 80 years（—）
- 性别
- All
入选标准
- •1. Subjects aged between 19 and 80 years, both inclusive.
- •2. Subjects convalescing from COVID-19 with at least 2 months of being discharged.
- •3. Subjects who express, in writing, their consent to participate in the study.
排除标准
- •1. Subjects with a current confirmed history of COVID-19 +.
- •2. Subjects considered contacts or suspects of COVID-19 at the time of inclusion.
- •3. Subjects who report any of the following symptoms:
- •- cough or shortness of breath,
- •- loss of smell (anosmia),
- •- loss of taste (ageusia) or
- •- acute infection during the 15 days prior to inclusion
- •4. Subjects with decompensated chronic diseases at the time of inclusion.
- •5. Subjects with a finding or medical condition in the nostrils that makes it difficult to properly administer the product and follow-up (Example: chronic obstructive allergic rhinitis, obstructive nasal septum deviation, benign and malignant nasal tumors such as polyposis and squamous cell carcinoma).
- •6. Subjects with tattoos in both deltoid regions that make it difficult to see the injection site, taking into account the random nature of the treatment assignment.
- •7. Obese subjects (BMI = 35 Kg / m2) or underweight (BMI =18 Kg / m2).
- •8. Subjects who previously received treatment with a coronavirus-specific licensed or investigational vaccine.
- •9. Subjects who received treatment with any investigational product within 3 months prior to recruitment, or who anticipate their planning during the study period.
- •10. Subjects who received treatment with immunomodulators (Example: some type of Interferon, Transfer Factor, Biomodulin T, Immunoferon, Thymosin), steroids or cytostatics within the three months prior to recruitment or that may require it during the course of the study due to any condition of base.
- •11. Subjects who received treatment with blood, immunoglobulins and / or any blood product within the three months prior to enrollment.
- •12. Subjects with a history of allergy to Thiomersal or to any other component of the formulations under study.
- •13. Subjects with a history or suspicion of alcoholism or drug dependence.
- •14. Women who are pregnant, breastfeeding or willing to become pregnant during the study.
- •15. Women of childbearing potential who do not agree to use a contraceptive method during the study.
- •16. Subjects with mental and / or psychiatric disorders that prevent or limit the signing of the informed consent or the follow-up of the volunteer.
研究者
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