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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 |
- 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
- 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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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
- 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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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
- 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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