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NCT04780035
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Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19 |
Completed |
Phase 3 |
Nov/27/2020 |
Dec/20/2021 |
- Alternative id -
COV/pept-03/20
- Interventions -
Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19), Other: Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)
- Study type - Interventional
- Study results -
No Results Available
- Study locations -
State Budgetary Healthcare Institution of the Moscow region - Krasnogorsk City Hospital # 1 (short name: SBHI MR KCH # 1), Krasnogorsk, Moscow Region, Russian Federation; Federal State Autonomous Educational Institution of Higher Education - Immanuel Kant Baltic University (short name: FSAEIHE- I. Kant Baltic Federal University), Kaliningrad, Russian Federation; State Autonomous Healthcare Institution - Clinical City Hospital # 7 of Kazan (short name: SAHI CCH # 7), Kazan, Russian Federation; 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, Russian Federation; Federal State Budgetary Research Institution - Academician B.V. Petrovsky Russian Research Center for Surgery (short name: FSBRI - Academician B.V. Petrovsky RRCS), Moscow, Russian Federation; 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, Russian Federation; State Budgetary Healthcare Institution of the Moscow region - M.F. Vladimirsky Moscow Regional Research Clinical Institute (short name: M.F. Vladimirsky SBHI MRRCI), Moscow, Russian Federation; 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, Russian Federation
- Study designs -
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention
- Enrollment -
3000
- Age -
18 Years and older (Adult, Older Adult)
- Outcome measures -
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, within 6 months post vaccination versus a placebo, The prophylactic efficacy of the vaccine, The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies, The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers, The frequency of severe cases of COVID-19 following a single / double vaccination, Duration of disease, The incidence of asymptomatic COVID-19 following a single / double vaccination
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NCT05021016
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Study of the EpiVacCorona Vaccine With the Involvement of Volunteers Aged 60 Years and Above |
Completed |
Phase 3 |
Nov/19/2020 |
Jan/30/2021 |
- Alternative id -
COV/pept-02/20
- Interventions -
Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)
- Study type - Interventional
- Study results -
No Results Available
- Study locations -
Federal State Budgetary Institution of Healthcare "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency" (FGBUZ MSCH-163, FMBA of Russia), Kol'tsovo, Novosibirsk Region, Russian Federation
- Study designs -
Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention
- Enrollment -
150
- Age -
60 Years and older (Adult, Older Adult)
- Outcome measures -
Geometric mean titer (GMT) of antibodies in virus neutralization reaction, Geometric mean titer (GMT) of specific antibodies in ELISA, Specific neutralizing antibody titers in ELISA, The proportion of vaccinated volunteers with laboratory-confirmed SARS-CoV-2 symptoms in combination with one or more of the selected symptomsoV-2 symptoms in combination with one or more of the following symptoms, The proportion of volunteers with a T-cell response, Geometric mean titers (GMT) of antibodies in the volunteers following vaccination and those in the convalescent volunteers vaccinated with the vaccine that recovered from COVID-19
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NCT04527575
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Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19 |
Completed |
Phase 1|Phase 2 |
Jul/27/2020 |
Dec/30/2021 |
- Acronym - EpiVacCorona
- Alternative id -
COV/pept-01/20
- Interventions -
Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19), Other: Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)
- Study type - Interventional
- Study results -
No Results Available
- Study locations -
Federal State Budgetary Institution of Healthcare "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency" (FGBUZ MSCH-163, FMBA of Russia), Koltsovo, Novosibirsk Region, Russian Federation
- Study designs -
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention
- Enrollment -
100
- Age -
18 Years to 60 Years (Adult)
- Outcome measures -
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination, 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., 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, The proportion of volunteers with an ex vivo cellular immune response following the vaccination, compared with a placebo, Incidence and type of adverse events during the study, Incidence of serious adverse events during the study, Cases of early termination of the study due to the development of adverse events / sever adverse events
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