Covid19Phase 3NCT05021016
Study of the EpiVacCorona Vaccine With the Involvement of Volunteers Aged 60 Years and Above
A Phase 3 study testing EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) in people with Covid19, run by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" at 1 site in Russia.
Trial summary
The aim of the clinical study is to study the safety, reactogenicity and immunogenicity indicators of the EpiVacCorona vaccine, with the involvement of volunteers aged 60 years and above. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 19 Nov 2020to 30 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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) aged 60 and above with stable indicators of basic vital functions.
- Ability to attend all scheduled visits and all planned procedures and examinations.
- Postmenopausal women over 60 years old.
Who cannot join
- 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.
Show all 35Show fewer
- 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.).
- History of Guillain-Barré syndrome (acute polyradiculitis).
- Previous vaccination with rabies vaccines within less than 2 months prior to randomization, or planned vaccination with rabies vaccines within 1 month after immunization with the vaccine under study.
- Hypersensitivity to any component of the product, allergy to vaccine components.
- Persons in custody in detention facilities and those serving sentences in correctional facilities.
- Symptoms of any disease at the time of inclusion in the study or if it has passed less than 4 weeks since recovery.
- History of any acute respiratory illness less than 3 months prior to randomization.
- Acute infectious or non-infectious diseases, exacerbation of chronic diseases less than 4 weeks prior to randomization.
- History of tuberculosis (pulmonary and extrapulmonary), cancer, autoimmune diseases, skin diseases (pemphigus, psoriasis, eczema, atopic dermatitis).
- Long-term use (more than 14 days) of immunosuppressants, systemic glucocorticosteroids or immunomodulatory drugs within 6 months prior to randomization.
- Vaccination with any vaccine within one month prior to vaccination.
- Use of immunoglobulin drugs or blood products within 3 months prior to randomization.
- Acute or chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, surgery on the gastrointestinal tract (except appendectomy).
- Participation in other clinical trials less than 3 months prior to randomization.
- Persons with alcohol or drug abuse (medications or narcotics). Use of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, or 200 ml of wine or 50 ml of alcohol) or history of alcoholism, narcomania or drug (medication) abuse.
- Mental illness or neurasthenia.
- Non-compliance with the inclusion criteria.
- Positive test for HIV, viral hepatitis B and C, or syphilis.
- Serious concomitant diseases or pathological conditions not listed above, which, according to the investigator's opinion, could complicate the assessment of the study results, including any pathological deviations from the age norms and laboratory norms of blood and urine parameters, clinically significant in the investigator's opinion.
- Chronic diseases of the cardiovascular, bronchopulmonary, endocrine systems, gastrointestinal tract, liver, kidneys, blood, disease of the endocrine system in the exacerbation phase or that in the decompensation phase in the past or as detected during laboratory and imaging examination.
- And:
- The researcher's decision to exclude the volunteer for the benefit of the volunteer.
- False inclusion (violation of inclusion and nonex-inclusion criteria) or the appearance of exclusion criteria during the study.
- The decision of the researcher or the Sponsor to exclude the volunteer from the study due to a clinically significant deviation from the protocol/violation of the protocol.
- Any undesirable phenomenon requiring the appointment of drugs not authorized by the protocol of this study.
- Volunteer's refusal to continue his/her participation in the study or his/her lack of discipline.
- Volunteer's desire to complete the study early for any reason.
- Volunteer's failure to show up for a scheduled visit without the researcher's warning or loss of communication with the volunteer.
- Positive urine drug test and / or positive alcohol breath test during the visit.
Trial locations and contacts
1 site in 1 country.
Russia1 site
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 Oblast, 630559
About this study
Official title: An Open Study of the Safety, Reactogenicity and Immunogenicity of the Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), With the Involvement of Volunteers Aged 60 Years and Above (Phase III-IV)
The aim of the clinical study is to study the safety, reactogenicity and immunogenicity indicators of the EpiVacCorona vaccine, with the involvement of volunteers aged 60 years and above.
The research tasks are to:
- to evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older;
- to evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older;
- to identify any adverse effects to the administration of the vaccine;
- to study the humoral and cellular immune responses response following two doses of the EpiVacCorona vaccine, with the participation of volunteers aged 60 and older.
Read the detailed description
The study will screen a maximum of 180 volunteers, of which it is proposed to include and randomize 150 men and women aged 60 years and older who meet the inclusion criteria and who do not have the exclusion criteria whose data will be used for subsequent safety and immunogenicity analysis.
The 150 volunteers will be vaccinated with the EpiVacCorona vaccine with two doses spaced 21 days apart, intramuscularly, at a dose of 0.5 ml.
The vaccine will be administered in procedure room settings only by a highly qualified specialist (vaccinator).
- Conditions
- Covid19
- Being tested
- EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)
- Keywords
- Covid19, SARS-CoV-2, EpiVacCorona, vaccination
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: "Vaccine" | Experimental | 150 volunteers who will be vaccinated with the EpiVacCorona vaccine with two doses spaced 21 days apart, intramuscularly, at a dose of 0.5 ml Receives: Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) of antibodies in virus neutralization reaction
Geometric mean titer (GMT) of antibodies on day 21 following the second vaccination dose (Visit 17) in virus neutralization reaction
Measured: 21 days after the second vaccination dose
Secondary outcomes (5)
Geometric mean titer (GMT) of specific antibodies in ELISA
The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA is more than 4 times greater 21 days following the second vaccination dose
Measured: 21 days after the second vaccination dose
Specific neutralizing antibody titers in ELISA
The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA is more than 4 times greater 21 days following the second vaccination
Measured: 21 days after the second vaccination dose
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 vaccinated volunteers with laboratory-confirmed SARS-CoV-2 symptoms in combination with one or more of the following symptoms: fever or chills; cough; labored breathing or shortness of breath; fatigue; muscle pain; headache; loss of taste or smell; sore throat; nasal congestion or runny nose; nausea or vomiting; diarrhea within 6 months following vaccination
Measured: within 6 months following the first vaccination
The proportion of volunteers with a T-cell response
The proportion of volunteers with a T-cell response (CD4 +, CD8 +, CD4 + / CD8 +, concentration of interferon gamma, IL-2, IL-4) 21 days following the second vaccination dose
Measured: 21 days after the second vaccination dose
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
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 of varying severity
Measured: within 6 months following the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start19 Nov 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vladimir I. Kuzubov, PhD, Principal investigator, FGBUZ MSCH-163, FMBA of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021016
- Sponsor's protocol ID
- COV/pept-02/20
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study of the Safety, Reactogenicity and Immunogenicity of the Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), With the Involvement of Volunteers Aged 60 Years and Above (Phase III-IV)
- ClinicalTrials.gov ID
- NCT05021016
- Acronym / sponsor ID
- COV/pept-02/20
- Conditions
- Covid19
- Keywords
- Covid19, SARS-CoV-2, EpiVacCorona, vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"Other government
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the clinical study is to study the safety, reactogenicity and immunogenicity indicators of the EpiVacCorona vaccine, with the involvement of volunteers aged 60 years and above.
The research tasks are to:
- to evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older;
- to evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older;
- to identify any adverse effects to the administration of the vaccine;
- to study the humoral and cellular immune responses response following two doses of the EpiVacCorona vaccine, with the participation of volunteers aged 60 and older.
Detailed description
The study will screen a maximum of 180 volunteers, of which it is proposed to include and randomize 150 men and women aged 60 years and older who meet the inclusion criteria and who do not have the exclusion criteria whose data will be used for subsequent safety and immunogenicity analysis.
The 150 volunteers will be vaccinated with the EpiVacCorona vaccine with two doses spaced 21 days apart, intramuscularly, at a dose of 0.5 ml.
The vaccine will be administered in procedure room settings only by a highly qualified specialist (vaccinator).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: "Vaccine" | Experimental | Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)150 volunteers who will be vaccinated with the EpiVacCorona vaccine with two doses spaced 21 days apart, intramuscularly, at a dose of 0.5 ml |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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) aged 60 and above with stable indicators of basic vital functions.
- Ability to attend all scheduled visits and all planned procedures and examinations.
- Postmenopausal women over 60 years old.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Group 1: "Vaccine" |
Primary outcome
Geometric mean titer (GMT) of antibodies in virus neutralization reaction
Time frame: 21 days after the second vaccination dose
Geometric mean titer (GMT) of antibodies on day 21 following the second vaccination dose (Visit 17) in virus neutralization reaction
5 secondary outcomes
Geometric mean titer (GMT) of specific antibodies in ELISA
Time frame: 21 days after the second vaccination dose
Specific neutralizing antibody titers in ELISA
Time frame: 21 days after the second vaccination dose
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
Time frame: within 6 months following the first vaccination
The proportion of volunteers with a T-cell response
Time frame: 21 days after the second vaccination dose
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
Time frame: within 6 months following the first vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir I. Kuzubov, PhD principal investigator
FGBUZ MSCH-163, FMBA of Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) in people with Covid19, run by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer (GMT) of antibodies in virus neutralization reaction (time frame: 21 days after the second vaccination dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.