drugset / Trial / NCT04527575
Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19
Phase 1/2
Completed
100 enrolled
Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
RandomizedParallel-groupDouble-blindPrevention
Summary
The aim of the clinical study is to determine the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years. The research tasks are to: * evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly; * evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly; * identify the development of adverse reactions to vaccine administration; * study the humoral and cellular immune responses following two doses of the EpiVacCorona vaccine.
Timeline
- Start
- 2020-07-27
- Primary completion
- 2021-12-30
- Completion
- 2021-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EpiVacCorona | Vaccine | 0.5 ml | Intramuscular |