RPCEC00000345尚未招募1 期
Adaptive phase I / II clinical trial, randomized, of parallel groups, to evaluate the safety and immunogenicity in adults of two vaccine candidates, based on recombinant RBD subunits for the prevention of COVID-19 in regimens that use the nasal route of administration. (COVID-19)
Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 88 人开始时间: 2020年11月26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
- 88
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 54 years（—）
- 性别
- All
入选标准
- •1) Women and men, 19 to 54 years of age (Phase I) and 19 to 80 years of age (Phase II).
- •2) Physical examination without clinically significant alterations.
- •3) Laboratory tests within or outside the reference range, but not clinically significant.
- •4) Willingness of the subject to participate expressed through the delivery of signed informed consent.
排除标准
- •1) History of COVID-19 or current condition of COVID-19 +, confirmed by laboratory PCR and / or rapid test).
- •2) Contact or suspect of COVID-19 at the time of inclusion.
- •3) Presence of fever or cough or shortness of breath or anosmia / ageusia, or acute infection during the 15 days prior to the administration of the vaccine candidate or at the time of its application.
- •4) Decompensated chronic diseases.
- •5) Those who have been at high risk of exposure: close contacts of confirmed cases of SARS-CoV-2 infection, front-line healthcare professionals for COVID-19 patients working in the ER, ICU and other areas higher risk.
- •6) Any finding or medical condition in the nostrils that makes it difficult to properly administer the product and follow-up (eg, chronic obstructive allergic rhinitis, obstructive nasal septum deviation, benign and malignant nostril tumors such as polyposis and squamous cell carcinoma).
- •7) Tattoos in both deltoid regions that make it difficult to observe the injection site, taking into account the random nature of the allocation of treatment.
- •8) Findings in laboratory tests outside the reference values ??and that are clinically significant.
- •9) Obesity (BMI = 35 Kg / m2) or underweight (BMI =18 Kg / m2)
- •10) Have previously received a licensed or investigational vaccine, specific for coronavirus.
- •11) Use of any investigational product (drug or vaccine) within 3 months prior to recruitment, or planned for during the study period.
- •12) Having been treated within the previous three months or the possibility of requiring treatment during the trial for any underlying condition with: immunomodulators (eg some type of Interferon, Transfer Factor, Biomodulin T, Immunoferon, Thymosin), or with steroids by any route of administration, or with cytostatics.
- •13) Have received blood, immunoglobulins and / or any blood product within the three months prior to inclusion.
- •14) Allergy to Thimerosal or any other component of the formulations under study (Allergy to Thimerosal in Phase II is not relevant if the group with CIGB 66 is not selected).
- •15) History or suspicion of alcoholism or drug dependence.
- •16) Pregnancy, breastfeeding or willingness to get pregnant during the study. Women of childbearing potential who do not agree to use effective contraception within 3 months after completing the third study dose.
- •17) Presence of mental and / or psychiatric disorders that make it impossible to sign the informed consent or follow-up of the volunteer.
研究者
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