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

PHASE3CompletedINTERVENTIONAL
Enrollment

3,000

Participants

Timeline

Start Date

November 27, 2020

Primary Completion Date

August 31, 2021

Study Completion Date

December 20, 2021

Conditions
COVID-19
Interventions
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

Trial Locations (8)

105203

Federal State Budgetary Institution - N.I. Pirogov National Medical and Surgical Center, Ministry of Health of the Russian Federation (short name: FSBI - N.I. Pirogov NMSC, Ministry of Health of the Russian Federation), Moscow

119991

Federal State Budgetary Research Institution - Academician B.V. Petrovsky Russian Research Center for Surgery (short name: FSBRI - Academician B.V. Petrovsky RRCS), Moscow

121359

Research Center: Federal State Budgetary Institution - Central Clinical Hospital with Polyclinic, Administrative Office of the President of the Russian Federation (short name: FSBI Central Clinical Hospital with Polyclinic), Moscow

129110

State Budgetary Healthcare Institution of the Moscow region - M.F. Vladimirsky Moscow Regional Research Clinical Institute (short name: M.F. Vladimirsky SBHI MRRCI), Moscow

143408

State Budgetary Healthcare Institution of the Moscow region - Krasnogorsk City Hospital # 1 (short name: SBHI MR KCH # 1), Krasnogorsk

236016

Federal State Autonomous Educational Institution of Higher Education - Immanuel Kant Baltic University (short name: FSAEIHE- I. Kant Baltic Federal University), Kaliningrad

420103

State Autonomous Healthcare Institution - Clinical City Hospital # 7 of Kazan (short name: SAHI CCH # 7), Kazan'

625023

State Budgetary Educational Institution of Higher Professional Education - Tyumen State Medical University, Ministry of Health of the Russian Federation (short name: SBEIHPE - Tyumen State Medical University, Ministry of Health of Russian Federation), Tyumen

All Listed Sponsors
lead

"Federal Budgetary Research Institution State Research Center of Virology and Biotechnology Vector"

OTHER_GOV

NCT04780035 - Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19 | Biotech Hunter | Biotech Hunter