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

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.

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

Sponsors & Collaborators

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

  lead OTHER_GOV

Principal Investigators

• Rinat A. Maksyutov, PhD · Federal Budgetary Research Institution - State Research Center of Virology and Biotechnology "Vector", Federal Service for Surveillance on Consumer Rights Protection and Human Well-being

• Nikita V. Lomakin · Federal State Budgetary Institution - Central Clinical Hospital with Polyclinic, Administrative Office of the President of the Russian Federation

• Vitaly G. Gusarov · Federal State Budgetary Institution - N.I. Pirogov National Medical and Surgical Center, Ministry of Health of the Russian Federation

• Maria A. Chukina · Federal State Budgetary Research Institution - Academician B.V. Petrovsky Russian Research Center for Surgery

• Stanislav A. Terpigorev · State Budgetary Healthcare Institution of the Moscow region - M.F. Vladimirsky Moscow Regional Research Clinical Institute

• Svetlana B. Erofeeva · State Budgetary Healthcare Institution of the Moscow region - Krasnogorsk City Hospital # 1

• Olga A. Rychkova · State Budgetary Educational Institution of Higher Professional Education - Tyumen State Medical University, Ministry of Health of the Russian Federation

• Viktoria Y. Delyan, Associate Professor · State Autonomous Healthcare Institution - Clinical City Hospital # 7 of Kazan

• Vladimir V. Rafalsky · Federal State Autonomous Educational Institution of Higher Education - Immanuel Kant Baltic University (short name: FSAEIHE- I. Kant Baltic Federal University)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-27

Primary Completion

2021-08-31

Completion

2021-12-20

Countries

• Russia

Study Locations