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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 224
- Locations
- 2
- Primary Endpoint
- Number of Participants With Adverse Events
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
This clinical trial on the second stage is designed as a double blind randomized placebo-controlled study
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: 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)
Time Frame: through the whole study, an average of 90 days
Determination of antibody levels measured by an ELISA vs. baseline values and vs placebo
Secondary Outcomes
- Assessment of antigen-specific cell-mediated immune response(at days 0 and 7)