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

NCT04780035 | Completed Phase 3

• 1 other identifier: COV/pept-03/20
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

EpiVacCorona vaccine

Outcome Measures

Primary Outcomes (2)

• The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, within 6 months post vaccination versus a placebo

  The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 6 months post vaccination versus a placebo

  within 6 months after the first vaccination

• The prophylactic efficacy of the vaccine

  The prophylactic efficacy of the vaccine under study is ≥50% compared to a placebo, with the lower limit of the confidence interval of the point estimate for the primary efficacy variable \> 30%

  9 months after the first vaccination

Secondary Outcomes (5)

• The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies

  21-28 days after the second vaccination

• The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers

  21-28 days after the second vaccination

• The frequency of severe cases of COVID-19 following a single / double vaccination

  through the whole study, an average of 9 months

• Duration of disease

  through the whole study, an average of 9 months

• The incidence of asymptomatic COVID-19 following a single / double vaccination

  through the whole study, an average of 9 months

Study Arms (2)

Group "Vaccine"

EXPERIMENTAL

2,250 volunteers who will be vaccinated with the EpiVacCorona vaccine, twice intramuscularly at a dose of 0.5 ml.

Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)

"Control Group"

PLACEBO COMPARATOR

750 volunteers who will be vaccinated with a placebo, twice intramuscularly at a dose of 0.5 ml.

Other: Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)

Interventions

EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) BIOLOGICAL

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.

Group "Vaccine"

Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) OTHER

The use of placebo: intramuscularly twice, given 21 to 28 days apart at a dose of 0.5 ml

"Control Group"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability of a signed and dated informed consent of the volunteer to participate in a clinical trial, prior to any of the study procedures.
• Volunteers (men and women) above the age of 18 years with stable indicators of basic vital functions.
• Ability to attend all scheduled visits and all planned procedures and examinations.
• Consent of volunteers to use effective contraceptive methods throughout the study, including the observation period for possible post-vaccination reactions.

You may not qualify if:

• History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or another coronavirus infection (HCoV-229E, HCOV-OC43, HCoV-NL63, HCoV-HKU1).
• History of exposure to confirmed or suspected cases of SARS-CoV-2 infection within 1 month prior to randomization.
• Positive for IgM or IgG to SARS-CoV-2 as detected during screening.
• Positive PCR test for SARS-CoV-2 as detected during screening.
• Clinically and laboratory (according to PCR data) confirmed disease caused by SARS-CoV-2 coronavirus, at the moment or in the past.
• Serious post-vaccination reaction (body temperature above 40 °C , hyperemia or edema greater than 8 cm in diameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination; convulsions, with or without of a febrile state) to a previous vaccination in the past.
• Aggravated allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, history of serum disease, history of hypersensitivity or allergic reactions to the administration of any vaccines, any known allergic reactions to vaccine components, etc.).
• Hypersensitivity to any component of the product, allergy to vaccine components.
• History of vaccination with any vaccine within one month prior to randomization.
• Previous vaccination with rabies vaccines less than 2 months prior to randomization, or planned vaccination with rabies vaccines within 1 month after immunization with the vaccine under study.
• Pregnancy or breastfeeding.
• The military.
• Persons in custody in detention facilities and those serving sentences in correctional facilities.
• Children under the age of 18.
• History of any acute respiratory illness less than 3 months prior to randomization.

Sponsors & Collaborators

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

Study Sites (8)

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

Krasnogorsk, Moscow Oblast, 143408, Russia

Location

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

Kaliningrad, 236016, Russia

Location

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

Kazan', 420103, Russia

Location

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, 105203, Russia

Location

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

Moscow, 119991, Russia

Location

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, 121359, Russia

Location

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

Moscow, 129110, Russia

Location

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, 625023, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

EpiVacCorona vaccine; Sodium Chloride; Solutions; Injections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• 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

  STUDY DIRECTOR

• Nikita V. Lomakin

  Federal State Budgetary Institution - Central Clinical Hospital with Polyclinic, Administrative Office of the President of the Russian Federation

  PRINCIPAL INVESTIGATOR

• Vitaly G. Gusarov

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

  PRINCIPAL INVESTIGATOR

• Maria A. Chukina

  Federal State Budgetary Research Institution - Academician B.V. Petrovsky Russian Research Center for Surgery

  PRINCIPAL INVESTIGATOR

• Stanislav A. Terpigorev

  State Budgetary Healthcare Institution of the Moscow region - M.F. Vladimirsky Moscow Regional Research Clinical Institute

  PRINCIPAL INVESTIGATOR

• Svetlana B. Erofeeva

  State Budgetary Healthcare Institution of the Moscow region - Krasnogorsk City Hospital # 1

  PRINCIPAL INVESTIGATOR

• Olga A. Rychkova

  State Budgetary Educational Institution of Higher Professional Education - Tyumen State Medical University, Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

• Viktoria Y. Delyan, Associate Professor

  State Autonomous Healthcare Institution - Clinical City Hospital # 7 of Kazan

  PRINCIPAL INVESTIGATOR

• Vladimir V. Rafalsky

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 3, 2021
• Study Start: November 27, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 20, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (8)