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临床试验/NCT04034290
NCT04034290已完成2 期

A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product With a Period of Open Safety Assessment in Two Modes of Administration, in Healthy Volunteers

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation2 个研究点 分布在 2 个国家目标入组 224 人开始时间: 2019年10月18日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
224
试验地点
2
主要终点
Number of Participants With Adverse Events

研究概览

简要总结

The aim of the present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination

详细描述

In the first stage estimate of safety of vaccine after its single administration to the nasal cavity by the drip method or by spray - dispenser during the period of observation in 30 days with the participation of 24 volunteers, divided into 2 groups of 12 people for each method of administration

After interim analysis of safety data is subject to the consent of the local ethics Committee of the Research Centre about the possibility of further studies of the drug - will be started the second phase of the study, which, along with continued security research, provides the definition of the parameters of immunogenicity of the study drug. The second phase of the study will included 200 participants, including 100 people will receive the study drug and 100 will be a control group of observation - that is, will get a placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

This clinical trial on the second stage is designed as a double blind randomized placebo-controlled study

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With Adverse Events

时间窗: through the whole study, an average of 180 days

Determination of Number of Participants With Adverse Events

Antibody levels a measured by an enzyme-linked immunosorbent assay (ELISA)

时间窗: through the whole study, an average of 90 days

Determination of antibody levels measured by an ELISA vs. baseline values and vs placebo

次要结局

  • Assessment of antigen-specific cell-mediated immune response(at days 0 and 7)

研究者

研究点 (2)

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