NCT04780035

Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19

Multicenter Double-blind Placebo-controlled Comparative Randomized Study of the Tolerability, Safety, Immunogenicity and Prophylactic Efficacy of the EpiVacCorona Peptide Antigen-based Vaccine for the Prevention of COVID-19, With the Participation of 3000 Volunteers Aged 18 Years and Above (Phase III-IV)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,000 (actual)
• Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of the clinical study is to evaluate the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine in volunteers aged 18 and above. The study tasks are to: * evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly; * evaluate the tolerability of the EpiVacCorona vaccine when administered twice intramuscularly; * identify any adverse events to the administration of the EpiVacCorona vaccine; * investigate the humoral immune response following two doses of the EpiVacCorona vaccine; * investigate the cell-mediated immune response following two doses of the EpiVacCorona vaccine; * evaluate the prophylactic efficacy of the EpiVacCorona vaccine when administered twice intramuscularly.

Detailed description

The study will screen a maximum of 4,929 volunteers of both sexes aged 18 and above, of which 3,000 volunteers who meet the inclusion criteria and do not have the exclusion criteria will be randomized: * 2,250 volunteers who will be vaccinated with the EpiVacCorona vaccine, twice intramuscularly at a dose of 0.5 ml; * 750 volunteers who will be vaccinated with a placebo, twice intramuscularly at a dose of 0.5 ml. If volunteers drop out of the study, they will not be replaced. All volunteers will be followed up by an investigator physician for 6 months following the first vaccination in order to identify possible late adverse events. In case the volunteer has any late reactions, he/she will be invited to the clinic to correct his/her condition.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)	The EpiVacCorona vaccine is intended to prevent COVID-19. The vaccine relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide). The vaccine induces the specific immunity against the SARS-CoV-2 coronavirus following two intramuscular injections spaced 21 to 28 days apart. The EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations given 21 to 28 days apart.
OTHER	Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)	The use of placebo: intramuscularly twice, given 21 to 28 days apart at a dose of 0.5 ml

Timeline

• Start date: 2020-11-27
• Primary completion: 2021-08-31
• Completion: 2021-12-20
• First posted: 2021-03-03
• Last updated: 2022-03-16

Locations

8 sites across 1 country: Russia