Covid19Phase 1/2EpiVacCoronaNCT04527575
Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19
A Phase 1/2 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 determine the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years. The research tasks are to: evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly; evaluate the reactogenicity of the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy 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?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 27 Jul 2020to 30 Dec 2021
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Contacts with COVID-19 patients for 14 days prior to the start of the clinical trial.
- Hypersensitivity to any component of the product, allergy to the components of the vaccine.
- The history of allergic reactions to any vaccination in the past.
- Serious post-vaccination reactions/complications associated with any vaccination in the past.
- Pregnancy and breastfeeding.
- Military personnel on conscription.
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- Persons detained in pre-trial detention facilities and those serving sentences in prison.
- Children under the age of 18.
- Symptoms of any disease at the time of inclusion in the study or if it has passed less than 4 weeks since recovery.
- The history of any acute respiratory disease within less than 3 months prior to inclusion in the study.
- The history of acute infectious or non-communicable diseases, exacerbation of chronic diseases within less than 4 weeks before the start of the study.
- The history of tuberculosis (pulmonary and extrapulmonary), cancer, autoimmune diseases, skin diseases (pemphigus, psoriasis, eczema, atopic dermatitis).
- Long-term use (more than 14 days) of immunosuppressive drug, systemic glucocorticosteroids or immunomodulatory drugs within 6 months prior to the study.
- Vaccination with any vaccine within one month prior to vaccination.
- Taking immunoglobulin drugs or blood products within last 3 months prior to the study.
- The history of treatment with human immunoglobulin drugs within, less than 6 months since such treatment.
- Donation (450 ml of blood or plasma and more) within less than 2 months prior to the study.
- Acute or chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, surgery on the gastrointestinal tract (except appendectomy).
- The history of participation in other clinical trials within less than 3 months prior to the start of this study.
- Individuals with alcohol, drug dependence or drug addiction. Taking more than 10 units of alcohol per week (1 unit of alcohol is equivalent to 1/2 litre of beer, 200 ml of wine or 50 ml of alcohol) or anamnestic information about alcoholism, drug addiction, and substance misuse. Individuals with positive results of urine examination for drugs and/or with alcohol findings in the exhaled air during the visits.
- Mental illness and neurasthenia.
- Non-compliance with the inclusion criteria.
- Women in the premenopausal period (the last menstruation ≤ 1 year prior to the signing of informed consent) who are not surgically sterile and women who have reproductive potential, but do not use acceptable birth controls or do not plan to use them throughout the study and do not agree to a urine test for pregnancy during the participation in the study.
- Positive test for HIV, viral hepatitis B and C, lues venerea.
- Other comorbidities that the researcher believes may interfere with the evaluation of the study's objectives.
- And:
- The researcher's decision to exclude the volunteer for the benefit of the volunteer.
- False inclusion (violation of inclusion and non-inclusion criteria) or the appearance of non-inclusion criteria during the study.
- The decision of the researcher or the Customer 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.
- Refusal of a volunteer to continue to participate in the study or his/her indiscipline.
- 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.
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: Simple, Blind, Placebo-controlled, Randomized Study of the Safety, Reactogenicity and Immunogenicity of Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), in Volunteers Aged 18-60 Years (I-II Phase)
The aim of the clinical study is to determine the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years.
The research tasks are to:
- evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;
- evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly;
- identify the development of adverse reactions to vaccine administration;
- study the humoral and cellular immune responses following two doses of the EpiVacCorona vaccine.
Read the detailed description
The first phase of the clinical trial is an open trial. The study will enroll 14 men and women aged 18 to 30 years, inclusive, who meet the inclusion criteria and have no exclusion criteria, whose data will be used for subsequent analysis of safety and immunogenicity.
The second phase of the clinical trial is a simple, blind, placebo-controlled, randomized, parallel-group study. The study will enroll 86 men and women aged 18 to 60 years, inclusive, who meet the inclusion criteria and have no exclusion criteria whose, the data will be used for subsequent analysis of safety and immunogenicity.
If volunteers drop out of the study, they will not be replaced.
- Conditions
- Covid19
- Being tested
- EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19), Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)
- 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
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 EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations spaced 21-28 days apart.
Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)Other
The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (43 volunteers)
| Study group | Role | What they receive |
|---|---|---|
| "EpiVacCorona" (An Open Study) | Experimental | Group 1: 14 volunteers who will be vaccinated with the EpiVacCorona vaccine twice 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) |
| "EpiVacCorona" (A Simple, Blind, Randomized Study) | Experimental | Group 2: Administration of the EpiVacCorona vaccine, intramuscularly, twice, 21 days spaced apart, at a dose of 0.5 ml (43 volunteers) Receives: Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19) |
| "Placebo" (A Simple, Blind, Randomized Study) | Placebo comparator | Group 3: Тhe use of placebo (sodium chloride, solvent for the preparation of dosage forms for injection 0.9%) intramuscularly twice space 21 days apart at a dose of 0.5 ml (43 volunteers) Receives: Other: Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination
- 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; The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 9 months post vaccination versus a placebo.
Measured: throughout the study, an average of 270 days
Secondary outcomes (6)
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 geometric mean titers of specific antibodies in ELISA greater ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination compared with a placebo.
Measured: at days 0, 1, 14, 20, 35, 42, 90, 180, 270
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 increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.
Measured: at days 0, 1, 14, 20, 35, 42, 90, 180, 270
The proportion of volunteers with an ex vivo cellular immune response following the vaccination, compared with a placebo
- The proportion of volunteers with an ex vivo cellular immune response 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.
Measured: at days 0, 1, 14, 20, 35, 42, 90, 180, 270
Incidence and type of adverse events during the study
- Immediate adverse events (allergic reactions) that occur within 2 hours after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer;
- adverse events (local and systemic reactions) that occur within 7 days after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer;
- other adverse events that occur 7 days after each vaccination (from 8 to 42 days after the first vaccination, excluding the allowable interval of visits) and noted by the volunteer in the Self-observation Diary.
Measured: throughout the study, an average of 270 days
Incidence of serious adverse events during the study
- Incidence of serious adverse events during the study.
Measured: throughout the study, an average of 270 days
Cases of early termination of the study due to the development of adverse events / sever adverse events
- Cases of early termination of participation of volunteers in the study due to the development of adverse events / sever adverse events associated with the use of products under study.
Measured: throughout the study, an average of 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start27 Jul 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple, blind, placebo-controlled, randomized study involving healthy volunteers
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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, Principal investigator, FGBUZ MSCH-163, FMBA of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527575
- Sponsor's protocol ID
- COV/pept-01/20
- Acronym
- EpiVacCorona
- Status last verified
- Mar 2022
- First submitted
- 11 Aug 2020
- Last updated
- 16 Mar 2022
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple, Blind, Placebo-controlled, Randomized Study of the Safety, Reactogenicity and Immunogenicity of Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), in Volunteers Aged 18-60 Years (I-II Phase)
- ClinicalTrials.gov ID
- NCT04527575
- Acronym / sponsor ID
- EpiVacCorona / COV/pept-01/20
- Conditions
- Covid19
- Keywords
- Covid19, SARS-CoV-2, EpiVacCorona, vaccination
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"Other government
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 26 Aug 2020 (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 determine the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years.
The research tasks are to:
- evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;
- evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly;
- identify the development of adverse reactions to vaccine administration;
- study the humoral and cellular immune responses following two doses of the EpiVacCorona vaccine.
Detailed description
The first phase of the clinical trial is an open trial. The study will enroll 14 men and women aged 18 to 30 years, inclusive, who meet the inclusion criteria and have no exclusion criteria, whose data will be used for subsequent analysis of safety and immunogenicity.
The second phase of the clinical trial is a simple, blind, placebo-controlled, randomized, parallel-group study. The study will enroll 86 men and women aged 18 to 60 years, inclusive, who meet the inclusion criteria and have no exclusion criteria whose, the data will be used for subsequent analysis of safety and immunogenicity.
If volunteers drop out of the study, they will not be replaced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Simple, blind, placebo-controlled, randomized study involving healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| "EpiVacCorona" (An Open Study) | Experimental | Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)Group 1: 14 volunteers who will be vaccinated with the EpiVacCorona vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml |
| "EpiVacCorona" (A Simple, Blind, Randomized Study) | Experimental | Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)Group 2: Administration of the EpiVacCorona vaccine, intramuscularly, twice, 21 days spaced apart, at a dose of 0.5 ml (43 volunteers) |
| "Placebo" (A Simple, Blind, Randomized Study) | Placebo comparator | Other: Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)Group 3: Тhe use of placebo (sodium chloride, solvent for the preparation of dosage forms for injection 0.9%) intramuscularly twice space 21 days apart at a dose of 0.5 ml (43 volunteers) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (33 listed)
- Contacts with COVID-19 patients for 14 days prior to the start of the clinical trial.
- Hypersensitivity to any component of the product, allergy to the components of the vaccine.
- The history of allergic reactions to any vaccination in the past.
- Serious post-vaccination reactions/complications associated with any vaccination in the past.
- Pregnancy and breastfeeding.
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)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 EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations spaced 21-28 days apart. | Biological | "EpiVacCorona" (A Simple, Blind, Randomized Study), "EpiVacCorona" (An Open Study) |
| Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (43 volunteers) | Other | "Placebo" (A Simple, Blind, Randomized Study) |
Primary outcome
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination
Time frame: throughout the study, an average of 270 days
• 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; The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 9 months post vaccination versus a placebo.
6 secondary outcomes
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.
Time frame: at days 0, 1, 14, 20, 35, 42, 90, 180, 270
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
Time frame: at days 0, 1, 14, 20, 35, 42, 90, 180, 270
The proportion of volunteers with an ex vivo cellular immune response following the vaccination, compared with a placebo
Time frame: at days 0, 1, 14, 20, 35, 42, 90, 180, 270
Incidence and type of adverse events during the study
Time frame: throughout the study, an average of 270 days
Incidence of serious adverse events during the study
Time frame: throughout the study, an average of 270 days
Cases of early termination of the study due to the development of adverse events / sever adverse events
Time frame: throughout the study, an average of 270 days
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 16 Mar 2022.
- Individual participant dataSharing planned: No
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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 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 1/2 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 0 inclusion and 33 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 16 Mar 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination (time frame: throughout the study, an average of 270 days). 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 16 Mar 2022.