COVID-19Phase 1/2Betuvax-CoV2NCT05270954

Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine Betuvax-CoV-2

A Phase 1/2 study testing Betuvax-CoV-2 in people with COVID-19, run by Artgen Biotech at 3 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Betuvax-CoV-2
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 3 sitesRussia
Study dates: 14 Oct 2021to 24 Jul 2022
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

18 to 60 years of age.
Verified healthy condition according to the data of standard clinical, laboratory and instrumental examination methods.
For women being in an active reproductive period: Consent to adhere to appropriate methods of contraception during the entire period of the participation in the study and for 1 month after the completion of the participation in the study (appropriate methods of contraception include abstinence from sexual intercourse or any two of the following methods: an intrauterine device (intrauterine device without release and with a release of a local hormonal drug), diaphragm, spermicides, cervical caps, oral contraceptives, contraceptive sponge and/or condom); for men: Consent to adhere to appropriate dual barrier methods of contraception during the entire period of the participation in the study and 1 month after completion of the participation in the study.
Body mass index (BMI): 18.5≤ BMI≤30 kg/m2.
Negative breath alcohol test.
Negative laboratory blood tests for HIV, syphilis and hepatitis B and C.
Ability and willingness to attend all scheduled visits and undergo all procedures and examinations planned by the Protocol.
Signed and dated Informed Consent to participate in the study.

Who cannot join

Contact with COVID-19 patients during 14 days before the start of the study.
PCR SARS-CoV-2 positive test.
Titer of the total specific anti-SARS-CoV-2 antibodies (ELISA) more than 1:10.
Drug allergies, hereditary angioedema.
Hypersensitivity to any component of the vaccine or any excipients of Betuvax-CoV-2 or allergy to the components of the vaccine.
Intolerance to any of the components or any excipients of the vaccine Betuvax-CoV-2.

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Allergic reaction to previous immunizations.
Serious post-vaccination reactions/complications associated with previous immunizations.
For women of childbearing potential - lactation period, pregnancy or suspicion of it, early postpartum period.
Women in the premenopausal period (last menstrual period <1 year prior to signing informed consent) who are not surgically sterile and women who have childbearing potential but do not use or plan to use appropriate methods of contraception throughout the study and do not agree to perform a urine pregnancy test while participating in a study.
Men who serve in the military by conscription.
Individuals in custody in pre-trial detention centers and those serving sentences in places of deprivation of liberty.
Children under 18 years of age.
Chronic diseases (including oncological and autoimmune), diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as the gastrointestinal tract, liver, kidneys, blood, central nervous system; surgical interventions on the gastrointestinal tract (with the exception of appendectomy).
Active tuberculosis at the time of screening (based on history and physical examination).
Mental illness, current or in history.
Decompensated neuropsychiatric diseases, including schizophrenia, multiple sclerosis, Parkinson's disease, dementia, endogenous depression, etc., which complicate the participation of a volunteer in the study.
Acute infectious from less than 3 months before the start of the study.
Acute infectious or non-infectious diseases, exacerbation of chronic diseases from less than 4 weeks before the start of the study.
Symptoms of any diseases at the time of enrollment or if less than 4 weeks have passed since recovery.
Hepatic or renal failure, currently or in history.
Current or history of oncological diseases.
Major surgery, major trauma less than 6 months prior to study initiation.
History of splenectomy.
Other comorbidities that, in the opinion of the investigator, may interfere with the evaluation of the objectives of the study.
Blood pressure: systolic blood pressure less than 100 mmHg or above 130 mmHg and diastolic blood pressure over 90 mmHg or less than 70 mmHg.
Heart rate less than 60 beats/min or more than 90 beats/min.
Deviations from the normal values according to standard clinical, laboratory (general and biochemical blood tests, urinalysis) and instrumental methods (including ECG) examination.
Long-term use (more than 14 days) of immunosuppressants, systemic glucocorticosteroids or immunomodulatory drugs during the 6 months before the start of the study.
Any vaccination within one month prior to the start of the clinical trial.
Taking medications containing immunoglobulin or blood products during the last 3 months before the start of the study.
Donation of blood (450 ml of blood or plasma and more) less than 2 months before the start of the study.
Participation in another clinical study less than 3 months before the start of the study.
Consumption of more than 10 units of alcohol (1 unit of alcohol is equivalent to 1/2 liter of beer, 200 ml of wine or 50 ml of spirits) per week or history of alcoholism, drug addiction, drug abuse.
Smoking more than 10 cigarettes a day.
Special diet (for example, vegetarian, vegan, with limited salt intake) or a special lifestyle (work at night, extreme physical activity).
Positive urine test result for psychotropic and narcotic substances, psychoactive drugs (barbiturates, benzodiazepines, methadone, phencyclidine).
Unwillingness or inability to follow the recommendations and procedures prescribed by this protocol.

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

Center of professional medicine
Perm, 614000
"Eco-Safety" R&D center
Saint Petersburg, 196143
Department of Vaccinology, Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation
Saint Petersburg, 197376

Other trials in Russia

About this study

Official title: Randomized, Double-blind, Multicenter Parallel-group Clinical Study of Safety, Tolerability and Immunogenicity of the Betuvax-CoV-2 Recombinant COVID-19 Vaccine, Suspension for Intramuscular Administration in Healthy Adult Volunteers

Randomized, double-blind, multicenter parallel-group clinical study of safety, tolerability and immunogenicity of the Betuvax-CoV-2 vaccine. The aim of this study is to investigate the safety, tolerability and immunogenicity of the Betuvax-CoV-2 Recombinant vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus, suspension for intramuscular administration, 10 μg/ml and 40 μg/ml (Ltd. Institute of New Medical Technologies, Russia) in healthy adult volunteers, aged 18 to 60 (inclusive).

Read the detailed description

Participation of the volunteers in the study includes Visit 0 (screening), Visits 1-4 and Visits 10-13 (on an inpatient basis), Visits 5-9 and Visits 14-20 (on an outpatient basis). During Visits 2 and 11, volunteers receive either a study drug (one of two dosages) or a placebo.

The study includes 116 healthy male and female volunteers aged 18 to 60 (inclusive) years who meet the inclusion criteria.

All volunteers are enrolled in two stages of the study and at each stage they are randomized into two or three groups, respectively.

Taking into account the estimated number of volunteers found by the screening results as not meeting the inclusion criteria (54 people), 170 volunteers are screened in the First and Second stage.

The vaccination course includes two intramuscular injections within a 28-day period.

The first stage of the study:

Group 1 (10 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first injection of 20 μg (0.5 ml of suspension for intramuscular administration of 40 μg/ml), the second injection of 5 μg (0.5 ml of suspension for intramuscular injection of 10 μg/ml) in 28 days.
Group 2 (10 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first and second injection of 20 μg (0.5 ml of solution for intramuscular injection of 40 μg/ml) within a 28-day period.

The second stage of the study:

Group 3 (32 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first injection of 20 μg (0.5 ml of the suspension for intramuscular administration of 40 μg/ml), the second injection of 5 μg (0.5 ml of the suspension for intramuscular injection of 10 μg/ml) in 28 days.
Group 4 (32 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first and second injection of 20 μg (0.5 ml of solution for intramuscular injection of 40 μg/ml) within a 28-day period.
Group 5 (32 people) will receive a placebo according to the following scheme: the first and second injections (0.5 ml of sodium chloride 0.9% solution, intramuscularly) within a 28-day period.

Study participants will be closely monitored for their intended outcomes. Key safety outcomes will be centrally reviewed by the Independent Data Monitoring Committee (ICMD). Investigators will be required to report anticipated safety outcomes in a timely manner (within 24 hours if possible) and to record these outcomes in the CRF in a timely manner (within 24 hours if possible).

Conditions: COVID-19
Being tested: Betuvax-CoV-2, Placebo
Keywords: SARS-CoV-2, coronavirus, recombinant vaccine, virus-like vaccine, betulin
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Betuvax-CoV-2Biological
Vaccine: Betuvax-CoV-2 intramuscular injection solution (0.5 ml)
PlaceboDrug
Also called 0.9% NaCl
Placebo: a 0.9% NaCl intramuscular injection solution (0.5 ml)

Study groups in NCT05270954
Study group	Role	What they receive
Group 1 (Phase 1)	Active comparator	All volunteers randomized to Group 1 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period. Receives: Biological: Betuvax-CoV-2
Group 2 (Phase 1)	Active comparator	All volunteers randomized to Group 2 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period. Receives: Biological: Betuvax-CoV-2
Group 3 (Phase 2)	Active comparator	All volunteers randomized to Group 3 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period. Receives: Biological: Betuvax-CoV-2
Group 4 (Phase 2)	Active comparator	All volunteers randomized to Group 4 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period. Receives: Biological: Betuvax-CoV-2
Group 5 (Phase 2)	Placebo comparator	Volunteers randomized to Group 5 will be administered a placebo reference drug (0.9% aqueous sodium chloride solution), twice, within a 28-day period. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Total specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Measured: 21 days after the second administration of the study drug/placebo
Total specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Measured: 90±5 days after the first administration of the study drug/placebo
Neutralizing anti-SARS-CoV-2 antibodies
The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)
Measured: 21 days after the second administration of the study drug/placebo
Neutralizing anti-SARS-CoV-2 antibodies
The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)
Measured: 90±5 days after the first administration of the study drug/placebo
Adverse events
The proportion of the volunteers with any adverse events
Measured: Within 50 days of the first dose of the study drug/placebo
Severe adverse events
The proportion of the volunteers with severe adverse events
Measured: Within 50 days of the first dose of the study drug/placebo

Secondary outcomes (50)

Total specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Measured: 180±5 days after the first administration of the study drug/placebo
IgG-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with an increased level of the IgG-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Measured: 21 days after the second administration of the study drug/placebo
IgG-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with an increased level of the IgG-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Measured: 90±5 days after the first dose of the study drug/placebo
IgG-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with an increased level of the IgG-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Measured: 180±5 days after the first dose of the study drug/placebo
IgM-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with an increased level of the IgM-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Measured: 21 days after the second administration of the study drug/placebo
IgM-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with an increased level of the IgM-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Measured: 90±5 days after the first dose of the study drug/placebo
IgM-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with an increased level of the IgM-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Measured: 180±5 days after the first dose of the study drug/placebo
Neutralizing anti-SARS-CoV-2 antibodies
The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)
Measured: 180±5 days after the first administration of the study drug/placebo
Geometric mean titers of the total anti-SARS-CoV-2 antibodies
The proportion of the volunteers with geometric mean titers of the total anti-SARS-CoV-2 antibodies (ELISA test)
Measured: 21 days after the second administration of the study drug/placebo
Geometric mean titers of the total anti-SARS-CoV-2 antibodies
The proportion of the volunteers with geometric mean titers of the total anti-SARS-CoV-2 antibodies (ELISA test)
Measured: 90±5 days after the first administration of the study drug/placebo
Geometric mean titers of the total anti-SARS-CoV-2 antibodies
The proportion of the volunteers with geometric mean titers of the total anti-SARS-CoV-2 antibodies (ELISA test)
Measured: 180±5 days after the first administration of the study drug/placebo
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies (ELISA test)
Measured: 21 days after the second administration of the study drug/placebo
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies (ELISA test)
Measured: 90±5 days after the first administration of the study drug/placebo
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies (ELISA test)
Measured: 180±5 days after the first administration of the study drug/placebo
Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies (ELISA test)
Measured: 21 days after the second administration of the study drug/placebo
Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies (ELISA test)
Measured: 90±5 days after the first administration of the study drug/placebo
Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies
The proportion of the volunteers with geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies (ELISA test)
Measured: 180±5 days after the first administration of the study drug/placebo
Specific anti-SARS-CoV-2 cellular immune response (Phase 1)
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (flow cytometry)
Measured: 21 days after the second dose of the study drug (only in Phase 1)
Specific anti-SARS-CoV-2 cellular immune response (Phase 1)
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (flow cytometry)
Measured: 90±5 days after the first dose of the study drug (only in Phase 1)
Specific anti-SARS-CoV-2 cellular immune response
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT)
Measured: 21 days after the second dose of the study drug/placebo
Specific anti-SARS-CoV-2 cellular immune response
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT)
Measured: 90±5 days after the first dose of the study drug/placebo
Specific anti-SARS-CoV-2 cellular immune response
The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT)
Measured: 180±5 days after the first dose of the study drug/placebo
COVID-19 symptoms
The proportion of the volunteers with at least one COVID-19 symptom (fever, chills, dyspnoea, difficulty breathing, cough, sore throat, fatigue, muscle pain, loss or decrease in taste and/or odor, nasal congestion, runny nose, headache, nausea, vomiting, diarrhea) and a PCR-confirmed SARS-CoV-2 infection
Measured: From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of study drug/placebo
COVID-19 symptoms
The proportion of the volunteers with at least one COVID-19 symptom (fever, chills, dyspnoea, difficulty breathing, cough, sore throat, fatigue, muscle pain, loss or decrease in taste and/or odor, nasal congestion, runny nose, headache, nausea, vomiting, diarrhea) and a PCR-confirmed SARS-CoV-2 infection
Measured: From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of study drug/placebo
Moderate, severe or extremely severe course of COVID-19, or lethal outcome
The proportion of the volunteers with COVID-19 of moderate, severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection
Measured: From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of the study drug/placebo
Moderate, severe or extremely severe course of COVID-19, or lethal outcome
The proportion of the volunteers with COVID-19 of moderate, severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection
Measured: From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo
Severe or extremely severe course of COVID-19, or lethal outcome
The proportion of the volunteers with COVID-19 of severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection
Measured: From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of the study drug/placebo
Severe or extremely severe course of COVID-19, or lethal outcome
The proportion of the volunteers with COVID-19 of severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection
Measured: From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo
Lethal outcome
The proportion of the volunteers with lethal outcome, and a PCR-confirmed SARS-CoV-2 infection
Measured: From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of the study drug/placebo
Lethal outcome
The proportion of the volunteers with lethal outcome, and a PCR-confirmed SARS-CoV-2 infection
Measured: From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo
Allergic reactions
The proportion of the volunteers with immediate side effects (allergic reactions)
Measured: Within 2 hours of the first study drug/placebo administration
Allergic reactions
The proportion of the volunteers with immediate side effects (allergic reactions)
Measured: Within 2 hours of the second study drug/placebo administration
Local post-vaccination reactions
The proportion of the volunteers with local post-vaccination reactions
Measured: Within 7 days after the first administration of the study drug/placebo
Local post-vaccination reactions
The proportion of the volunteers with local post-vaccination reactions
Measured: Within 7 days after the second administration of the study drug/placebo
Severe local post-vaccination reactions
The proportion of the volunteers with >grade 3 of local post-vaccination reactions
Measured: Within 7 days of the first study drug/placebo administration
Severe local post-vaccination reactions
The proportion of the volunteers with >grade 3 of local post-vaccination reactions
Measured: Within 7 days of the second study drug/placebo administration
Systemic post-vaccination reactions
The proportion of the volunteers with systemic post-vaccination reactions
Measured: Within 7 days after the first administration of the study drug/placebo
Systemic post-vaccination reactions
The proportion of the volunteers with systemic post-vaccination reactions
Measured: Within 7 days after the second administration of the study drug/placebo
Severe systemic post-vaccination reactions
The proportion of the volunteers with >grade 3 of severe systemic post-vaccination reactions
Measured: Within 7 days after the first administration of the study drug/placebo
Severe systemic post-vaccination reactions
The proportion of the volunteers with >grade 3 of severe systemic post-vaccination reactions
Measured: Within 7 days after the second administration of the study drug/placebo
Any adverse events
The proportion of the volunteers with any adverse events
Measured: Within 90±5 days after the first dose of the study drug/placebo
Any adverse events
The proportion of the volunteers with any adverse events
Measured: Within 180±5 days after the first dose of the study drug/placebo
Adverse events of special interest
The proportion of the volunteers with adverse events of special interest, adverse reactions that require medical attention, with newly developed chronic diseases
Measured: Within 50 days after the first dose of the study drug/placebo
Adverse events of special interest
The proportion of the volunteers with adverse events of special interest, adverse reactions that require medical attention, with newly developed chronic diseases
Measured: Within 90±5 days after the first dose of the study drug/placebo
Adverse events of special interest
The proportion of the volunteers with adverse events of special interest, adverse reactions that require medical attention, with newly developed chronic diseases
Measured: Within 180±5 days after the first dose of the study drug/placebo
Severe adverse events
The proportion of the volunteers with severe adverse events
Measured: Within 90±5 days after the first dose of the study drug/placebo
Severe adverse events
The proportion of the volunteers with severe adverse events
Measured: Within 180±5 days after the first dose of the study drug/placebo
Prematurely terminated participation
The proportion of the volunteers who prematurely terminated their participation in the study due to the development of adverse events or severe adverse events associated with the use of the study drug
Measured: Within 50 days after the administration of the first dose of the study drug/placebo
Prematurely terminated participation
The proportion of the volunteers who prematurely terminated their participation in the study due to the development of adverse events or severe adverse events associated with the use of the study drug
Measured: Within 90±5 days after the administration of the first dose of the study drug/placebo
Prematurely terminated participation
The proportion of the volunteers who prematurely terminated their participation in the study due to the development of adverse events or severe adverse events associated with the use of the study drug
Measured: Within 180±5 days after the administration of the first dose of the study drug/placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 202124 Jul 2022

First posted8 Mar 2022
Study start14 Oct 2021
Primary completion25 Apr 2022 (estimated)
Study completion24 Jul 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05270954
Sponsor's protocol ID: Betuvax-CoV-2.2021.CT1-2.RUS
Acronym: Betuvax-CoV2
Status last verified: Mar 2022
First submitted: 2 Mar 2022
Last updated: 8 Mar 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Kudriavtsev AV, Vakhrusheva AV, Kryuchkov NA, Frolova ME, Blagodatskikh KA, Ivanishin TV, Djonovic M, Romanovskaya-Romanko EA, Kovalenko AN, Lioznov DA, Zubkova TG, Teplykh SV, Oseshnyuk RA, Stukova MA, Isaev AA, Krasilnikov IV. Safety and Immunogenicity of Betuvax-CoV-2, an RBD-Fc-Based SARS-CoV-2 Recombinant Vaccine: Preliminary Results of the First-in-Human, Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Trial. Vaccines (Basel). 2023 Feb 1;11(2):326. doi: 10.3390/vaccines11020326.
PubMed 36851204

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-blind, Multicenter Parallel-group Clinical Study of Safety, Tolerability and Immunogenicity of the Betuvax-CoV-2 Recombinant COVID-19 Vaccine, Suspension for Intramuscular Administration in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT05270954
Acronym / sponsor ID: Betuvax-CoV2 / Betuvax-CoV-2.2021.CT1-2.RUS
Conditions: COVID-19
Keywords: SARS-CoV-2, coronavirus, recombinant vaccine, virus-like vaccine, betulin
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 116 participants (actual)
Lead sponsor: Artgen BiotechUniversity, hospital or other
Collaborators: Betuvax LLC, CEG BIO LLC
Study start: 14 Oct 2021 (actual)
Primary completion: 25 Apr 2022 (estimated)
Study completion: 24 Jul 2022 (estimated)
First posted: 8 Mar 2022 (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.

Detailed description

The study includes 116 healthy male and female volunteers aged 18 to 60 (inclusive) years who meet the inclusion criteria.

All volunteers are enrolled in two stages of the study and at each stage they are randomized into two or three groups, respectively.

Taking into account the estimated number of volunteers found by the screening results as not meeting the inclusion criteria (54 people), 170 volunteers are screened in the First and Second stage.

The vaccination course includes two intramuscular injections within a 28-day period.

The first stage of the study:

Group 1 (10 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first injection of 20 μg (0.5 ml of suspension for intramuscular administration of 40 μg/ml), the second injection of 5 μg (0.5 ml of suspension for intramuscular injection of 10 μg/ml) in 28 days.
Group 2 (10 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first and second injection of 20 μg (0.5 ml of solution for intramuscular injection of 40 μg/ml) within a 28-day period.

The second stage of the study:

Group 3 (32 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first injection of 20 μg (0.5 ml of the suspension for intramuscular administration of 40 μg/ml), the second injection of 5 μg (0.5 ml of the suspension for intramuscular injection of 10 μg/ml) in 28 days.
Group 4 (32 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first and second injection of 20 μg (0.5 ml of solution for intramuscular injection of 40 μg/ml) within a 28-day period.
Group 5 (32 people) will receive a placebo according to the following scheme: the first and second injections (0.5 ml of sodium chloride 0.9% solution, intramuscularly) within a 28-day period.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Group 1 (Phase 1)	Active comparator	Biological: Betuvax-CoV-2All volunteers randomized to Group 1 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period.
Group 2 (Phase 1)	Active comparator	Biological: Betuvax-CoV-2All volunteers randomized to Group 2 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period.
Group 3 (Phase 2)	Active comparator	Biological: Betuvax-CoV-2All volunteers randomized to Group 3 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period.
Group 4 (Phase 2)	Active comparator	Biological: Betuvax-CoV-2All volunteers randomized to Group 4 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period.
Group 5 (Phase 2)	Placebo comparator	Drug: PlaceboVolunteers randomized to Group 5 will be administered a placebo reference drug (0.9% aqueous sodium chloride solution), twice, within a 28-day period.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

18 to 60 years of age.
Verified healthy condition according to the data of standard clinical, laboratory and instrumental examination methods.
For women being in an active reproductive period: Consent to adhere to appropriate methods of contraception during the entire period of the participation in the study and for 1 month after the completion of the participation in the study (appropriate methods of contraception include abstinence from sexual intercourse or any two of the following methods: an intrauterine device (intrauterine device without release and with a release of a local hormonal drug), diaphragm, spermicides, cervical caps, oral contraceptives, contraceptive sponge and/or condom); for men: Consent to adhere to appropriate dual barrier methods of contraception during the entire period of the participation in the study and 1 month after completion of the participation in the study.
Body mass index (BMI): 18.5≤ BMI≤30 kg/m2.
Negative breath alcohol test.

Key exclusion criteria (38 listed)

Contact with COVID-19 patients during 14 days before the start of the study.
PCR SARS-CoV-2 positive test.
Titer of the total specific anti-SARS-CoV-2 antibodies (ELISA) more than 1:10.
Drug allergies, hereditary angioedema.
Hypersensitivity to any component of the vaccine or any excipients of Betuvax-CoV-2 or allergy to the components of the vaccine.

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
Betuvax-CoV-2Vaccine: Betuvax-CoV-2 intramuscular injection solution (0.5 ml)	Biological	Group 1 (Phase 1), Group 2 (Phase 1), Group 3 (Phase 2), Group 4 (Phase 2)
PlaceboAlso: 0.9% NaClPlacebo: a 0.9% NaCl intramuscular injection solution (0.5 ml)	Drug	Group 5 (Phase 2)

Primary outcome

Total specific anti-SARS-CoV-2 antibodies
Time frame: 21 days after the second administration of the study drug/placebo
The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Total specific anti-SARS-CoV-2 antibodies
Time frame: 90±5 days after the first administration of the study drug/placebo
The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Neutralizing anti-SARS-CoV-2 antibodies
Time frame: 21 days after the second administration of the study drug/placebo
The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)
Neutralizing anti-SARS-CoV-2 antibodies
Time frame: 90±5 days after the first administration of the study drug/placebo
The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)
Adverse events
Time frame: Within 50 days of the first dose of the study drug/placebo
The proportion of the volunteers with any adverse events
Severe adverse events
Time frame: Within 50 days of the first dose of the study drug/placebo
The proportion of the volunteers with severe adverse events

50 secondary outcomes

Total specific anti-SARS-CoV-2 antibodies
Time frame: 180±5 days after the first administration of the study drug/placebo
IgG-specific anti-SARS-CoV-2 antibodies
Time frame: 21 days after the second administration of the study drug/placebo
IgG-specific anti-SARS-CoV-2 antibodies
Time frame: 90±5 days after the first dose of the study drug/placebo
IgG-specific anti-SARS-CoV-2 antibodies
Time frame: 180±5 days after the first dose of the study drug/placebo
IgM-specific anti-SARS-CoV-2 antibodies
Time frame: 21 days after the second administration of the study drug/placebo
IgM-specific anti-SARS-CoV-2 antibodies
Time frame: 90±5 days after the first dose of the study drug/placebo
IgM-specific anti-SARS-CoV-2 antibodies
Time frame: 180±5 days after the first dose of the study drug/placebo
Neutralizing anti-SARS-CoV-2 antibodies
Time frame: 180±5 days after the first administration of the study drug/placebo
Geometric mean titers of the total anti-SARS-CoV-2 antibodies
Time frame: 21 days after the second administration of the study drug/placebo
Geometric mean titers of the total anti-SARS-CoV-2 antibodies
Time frame: 90±5 days after the first administration of the study drug/placebo
Geometric mean titers of the total anti-SARS-CoV-2 antibodies
Time frame: 180±5 days after the first administration of the study drug/placebo
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies
Time frame: 21 days after the second administration of the study drug/placebo
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies
Time frame: 90±5 days after the first administration of the study drug/placebo
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies
Time frame: 180±5 days after the first administration of the study drug/placebo
Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies
Time frame: 21 days after the second administration of the study drug/placebo
Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies
Time frame: 90±5 days after the first administration of the study drug/placebo
Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies
Time frame: 180±5 days after the first administration of the study drug/placebo
Specific anti-SARS-CoV-2 cellular immune response (Phase 1)
Time frame: 21 days after the second dose of the study drug (only in Phase 1)
Specific anti-SARS-CoV-2 cellular immune response (Phase 1)
Time frame: 90±5 days after the first dose of the study drug (only in Phase 1)
Specific anti-SARS-CoV-2 cellular immune response
Time frame: 21 days after the second dose of the study drug/placebo
Specific anti-SARS-CoV-2 cellular immune response
Time frame: 90±5 days after the first dose of the study drug/placebo
Specific anti-SARS-CoV-2 cellular immune response
Time frame: 180±5 days after the first dose of the study drug/placebo
COVID-19 symptoms
Time frame: From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of study drug/placebo
COVID-19 symptoms
Time frame: From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of study drug/placebo
Moderate, severe or extremely severe course of COVID-19, or lethal outcome
Time frame: From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of the study drug/placebo
Moderate, severe or extremely severe course of COVID-19, or lethal outcome
Time frame: From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo
Severe or extremely severe course of COVID-19, or lethal outcome
Time frame: From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of the study drug/placebo
Severe or extremely severe course of COVID-19, or lethal outcome
Time frame: From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo
Lethal outcome
Time frame: From the 7th day after the second administration of the study drug/placebo till the 90±5 day after the first dose of the study drug/placebo
Lethal outcome
Time frame: From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo
Allergic reactions
Time frame: Within 2 hours of the first study drug/placebo administration
Allergic reactions
Time frame: Within 2 hours of the second study drug/placebo administration
Local post-vaccination reactions
Time frame: Within 7 days after the first administration of the study drug/placebo
Local post-vaccination reactions
Time frame: Within 7 days after the second administration of the study drug/placebo
Severe local post-vaccination reactions
Time frame: Within 7 days of the first study drug/placebo administration
Severe local post-vaccination reactions
Time frame: Within 7 days of the second study drug/placebo administration
Systemic post-vaccination reactions
Time frame: Within 7 days after the first administration of the study drug/placebo
Systemic post-vaccination reactions
Time frame: Within 7 days after the second administration of the study drug/placebo
Severe systemic post-vaccination reactions
Time frame: Within 7 days after the first administration of the study drug/placebo
Severe systemic post-vaccination reactions
Time frame: Within 7 days after the second administration of the study drug/placebo

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
Derived from this study: PubMed 36851204Kudriavtsev AV, Vakhrusheva AV, Kryuchkov NA, Frolova ME, Blagodatskikh KA, Ivanishin TV, Djonovic M, Romanovskaya-Romanko EA, Kovalenko AN, Lioznov DA, Zubkova TG, Teplykh SV, Oseshnyuk RA, Stukova MA, Isaev AA, Krasilnikov IV. Safety and Immunogenicity of Betuvax-CoV-2, an RBD-Fc-Based SARS-CoV-2 Recombinant Vaccine: Preliminary Results of the First-in-Human, Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Trial. Vaccines (Basel). 2023 Feb 1;11(2):326. doi: 10.3390/vaccines11020326.
Individual participant dataSharing planned: Yes

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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites 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 Betuvax-CoV-2 in people with COVID-19, run by Artgen Biotech at 3 sites 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 8 inclusion and 38 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: status not confirmed, as of the sponsor's last update on 8 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 3 sites 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?

Results are not available in the source record.

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?

Total specific anti-SARS-CoV-2 antibodies (time frame: 21 days after the second administration of the study drug/placebo). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05270954, which also lists 1 linked publication.

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 8 Mar 2022.