Simple, Blind, Placebo-controlled, Randomized Study of the Safety, Reactogenicity and Immunogenicity of Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), in Volunteers Aged 18-60 Years (I-II Phase)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
The first phase of the clinical trial is an open trial. The study will enroll 14 men and women aged 18 to 30 years, inclusive, who meet the inclusion criteria and have no exclusion criteria, whose data will be used for subsequent analysis of safety and immunogenicity. The second phase of the clinical trial is a simple, blind, placebo-controlled, randomized, parallel-group study. The study will enroll 86 men and women aged 18 to 60 years, inclusive, who meet the inclusion criteria and have no exclusion criteria whose, the data will be used for subsequent analysis of safety and immunogenicity. If volunteers drop out of the study, they will not be replaced.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Contacts with COVID-19 patients for 14 days prior to the start of the clinical trial.
- •Hypersensitivity to any component of the product, allergy to the components of the vaccine.
- •The history of allergic reactions to any vaccination in the past.
- •Serious post-vaccination reactions/complications associated with any vaccination in the past.
- •Pregnancy and breastfeeding.
- •Military personnel on conscription.
- •Persons detained in pre-trial detention facilities and those serving sentences in prison.
- •Children under the age of
- •Symptoms of any disease at the time of inclusion in the study or if it has passed less than 4 weeks since recovery.
- •The history of any acute respiratory disease within less than 3 months prior to inclusion in the study.
Outcomes
Primary Outcomes
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination
Time Frame: throughout the study, an average of 270 days
• The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 9 months post vaccination versus a placebo.
Secondary Outcomes
- The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo(at days 0, 1, 14, 20, 35, 42, 90, 180, 270)
- The proportion of volunteers with an ex vivo cellular immune response following the vaccination, compared with a placebo(at days 0, 1, 14, 20, 35, 42, 90, 180, 270)
- Incidence and type of adverse events during the study(throughout the study, an average of 270 days)
- Incidence of serious adverse events during the study(throughout the study, an average of 270 days)
- The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA following the vaccination compared with a placebo.(at days 0, 1, 14, 20, 35, 42, 90, 180, 270)
- Cases of early termination of the study due to the development of adverse events / sever adverse events(throughout the study, an average of 270 days)