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Status unknownNCT05270954Betuvax-CoV2Updated Mar 8, 2022

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

A Phase 1/2 interventional study of Betuvax-CoV-2 and Placebo in COVID-19, sponsored by Artgen Biotech. Status unknown at 3 sites in Russia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-08.

Sponsored by Artgen Biotech · Phase 1/2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2021, registered Mar 2022).
Phase
Phase 1/2
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • COVID-19

Keywords

  • SARS-CoV-2
  • coronavirus
  • recombinant vaccine
  • virus-like vaccine
  • betulin
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 116 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Artgen Biotech is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 18 to 60 years of age.
  2. Verified healthy condition according to the data of standard clinical, laboratory and instrumental examination methods.
  3. 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.
  4. Body mass index (BMI): 18.5≤ BMI≤30 kg/m2.
  5. Negative breath alcohol test.
  6. Negative laboratory blood tests for HIV, syphilis and hepatitis B and C.
  7. Ability and willingness to attend all scheduled visits and undergo all procedures and examinations planned by the Protocol.
  8. Signed and dated Informed Consent to participate in the study.

Exclusion criteria

Exclusion criteria:

  1. Contact with COVID-19 patients during 14 days before the start of the study.
  2. PCR SARS-CoV-2 positive test.
  3. Titer of the total specific anti-SARS-CoV-2 antibodies (ELISA) more than 1:10.
  4. Drug allergies, hereditary angioedema.
  5. Hypersensitivity to any component of the vaccine or any excipients of Betuvax-CoV-2 or allergy to the components of the vaccine.
  6. Intolerance to any of the components or any excipients of the vaccine Betuvax-CoV-2.
  7. Allergic reaction to previous immunizations.
  8. Serious post-vaccination reactions/complications associated with previous immunizations.
  9. For women of childbearing potential - lactation period, pregnancy or suspicion of it, early postpartum period.
  10. 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.
  11. Men who serve in the military by conscription.
  12. Individuals in custody in pre-trial detention centers and those serving sentences in places of deprivation of liberty.
  13. Children under 18 years of age.
  14. 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).
  15. Active tuberculosis at the time of screening (based on history and physical examination).
  16. Mental illness, current or in history.
  17. Decompensated neuropsychiatric diseases, including schizophrenia, multiple sclerosis, Parkinson's disease, dementia, endogenous depression, etc., which complicate the participation of a volunteer in the study.
  18. Acute infectious from less than 3 months before the start of the study.
  19. Acute infectious or non-infectious diseases, exacerbation of chronic diseases from less than 4 weeks before the start of the study.
  20. Symptoms of any diseases at the time of enrollment or if less than 4 weeks have passed since recovery.
  21. Hepatic or renal failure, currently or in history.
  22. Current or history of oncological diseases.
  23. Major surgery, major trauma less than 6 months prior to study initiation.
  24. History of splenectomy.
  25. Other comorbidities that, in the opinion of the investigator, may interfere with the evaluation of the objectives of the study.
  26. 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.
  27. Heart rate less than 60 beats/min or more than 90 beats/min.
  28. Deviations from the normal values according to standard clinical, laboratory (general and biochemical blood tests, urinalysis) and instrumental methods (including ECG) examination.
  29. Long-term use (more than 14 days) of immunosuppressants, systemic glucocorticosteroids or immunomodulatory drugs during the 6 months before the start of the study.
  30. Any vaccination within one month prior to the start of the clinical trial.
  31. Taking medications containing immunoglobulin or blood products during the last 3 months before the start of the study.
  32. Donation of blood (450 ml of blood or plasma and more) less than 2 months before the start of the study.
  33. Participation in another clinical study less than 3 months before the start of the study.
  34. 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.
  35. Smoking more than 10 cigarettes a day.
  36. Special diet (for example, vegetarian, vegan, with limited salt intake) or a special lifestyle (work at night, extreme physical activity).
  37. Positive urine test result for psychotropic and narcotic substances, psychoactive drugs (barbiturates, benzodiazepines, methadone, phencyclidine).
  38. Unwillingness or inability to follow the recommendations and procedures prescribed by this protocol.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
116 participants (actual)

Study arms

  • Active comparator
    Group 1 (Phase 1)

    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.

    Biological: Betuvax-CoV-2

  • Active comparator
    Group 2 (Phase 1)

    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.

    Biological: Betuvax-CoV-2

  • Active comparator
    Group 3 (Phase 2)

    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.

    Biological: Betuvax-CoV-2

  • Active comparator
    Group 4 (Phase 2)

    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.

    Biological: Betuvax-CoV-2

  • Placebo comparator
    Group 5 (Phase 2)

    Volunteers randomized to Group 5 will be administered a placebo reference drug (0.9% aqueous sodium chloride solution), twice, within a 28-day period.

    Drug: Placebo

Interventions

  • BiologicalBetuvax-CoV-2

    Vaccine: Betuvax-CoV-2 intramuscular injection solution (0.5 ml)

  • DrugPlacebo

    Placebo: a 0.9% NaCl intramuscular injection solution (0.5 ml)

    Also known as: 0.9% NaCl

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 21 days after the second administration of the study drug/placebo

  2. 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)

    Time frame: 90±5 days after the first administration of the study drug/placebo

  3. 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)

    Time frame: 21 days after the second administration of the study drug/placebo

  4. 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)

    Time frame: 90±5 days after the first administration of the study drug/placebo

  5. Adverse events

    The proportion of the volunteers with any adverse events

    Time frame: Within 50 days of the first dose of the study drug/placebo

  6. Severe adverse events

    The proportion of the volunteers with severe adverse events

    Time frame: Within 50 days of the first dose of the study drug/placebo

Secondary outcomes

  1. 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)

    Time frame: 180±5 days after the first administration of the study drug/placebo

  2. 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)

    Time frame: 21 days after the second administration of the study drug/placebo

  3. 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)

    Time frame: 90±5 days after the first dose of the study drug/placebo

  4. 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)

    Time frame: 180±5 days after the first dose of the study drug/placebo

  5. 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)

    Time frame: 21 days after the second administration of the study drug/placebo

  6. 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)

    Time frame: 90±5 days after the first dose of the study drug/placebo

  7. 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)

    Time frame: 180±5 days after the first dose of the study drug/placebo

  8. 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)

    Time frame: 180±5 days after the first administration of the study drug/placebo

  9. 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)

    Time frame: 21 days after the second administration of the study drug/placebo

  10. 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)

    Time frame: 90±5 days after the first administration of the study drug/placebo

  11. 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)

    Time frame: 180±5 days after the first administration of the study drug/placebo

  12. 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)

    Time frame: 21 days after the second administration of the study drug/placebo

  13. 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)

    Time frame: 90±5 days after the first administration of the study drug/placebo

  14. 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)

    Time frame: 180±5 days after the first administration of the study drug/placebo

  15. 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)

    Time frame: 21 days after the second administration of the study drug/placebo

  16. 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)

    Time frame: 90±5 days after the first administration of the study drug/placebo

  17. 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)

    Time frame: 180±5 days after the first administration of the study drug/placebo

  18. 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)

    Time frame: 21 days after the second dose of the study drug (only in Phase 1)

  19. 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)

    Time frame: 90±5 days after the first dose of the study drug (only in Phase 1)

  20. Specific anti-SARS-CoV-2 cellular immune response

    The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT)

    Time frame: 21 days after the second dose of the study drug/placebo

  21. Specific anti-SARS-CoV-2 cellular immune response

    The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT)

    Time frame: 90±5 days after the first dose of the study drug/placebo

  22. Specific anti-SARS-CoV-2 cellular immune response

    The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT)

    Time frame: 180±5 days after the first dose of the study drug/placebo

  23. 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

    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

  24. 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

    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

  25. 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

    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

  26. 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

    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

  27. 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

    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

  28. 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

    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

  29. Lethal outcome

    The proportion of the volunteers with lethal outcome, and a PCR-confirmed SARS-CoV-2 infection

    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

  30. Lethal outcome

    The proportion of the volunteers with lethal outcome, and a PCR-confirmed SARS-CoV-2 infection

    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

  31. Allergic reactions

    The proportion of the volunteers with immediate side effects (allergic reactions)

    Time frame: Within 2 hours of the first study drug/placebo administration

  32. Allergic reactions

    The proportion of the volunteers with immediate side effects (allergic reactions)

    Time frame: Within 2 hours of the second study drug/placebo administration

  33. Local post-vaccination reactions

    The proportion of the volunteers with local post-vaccination reactions

    Time frame: Within 7 days after the first administration of the study drug/placebo

  34. Local post-vaccination reactions

    The proportion of the volunteers with local post-vaccination reactions

    Time frame: Within 7 days after the second administration of the study drug/placebo

  35. Severe local post-vaccination reactions

    The proportion of the volunteers with \>grade 3 of local post-vaccination reactions

    Time frame: Within 7 days of the first study drug/placebo administration

  36. Severe local post-vaccination reactions

    The proportion of the volunteers with \>grade 3 of local post-vaccination reactions

    Time frame: Within 7 days of the second study drug/placebo administration

  37. Systemic post-vaccination reactions

    The proportion of the volunteers with systemic post-vaccination reactions

    Time frame: Within 7 days after the first administration of the study drug/placebo

  38. Systemic post-vaccination reactions

    The proportion of the volunteers with systemic post-vaccination reactions

    Time frame: Within 7 days after the second administration of the study drug/placebo

  39. Severe systemic post-vaccination reactions

    The proportion of the volunteers with \>grade 3 of severe systemic post-vaccination reactions

    Time frame: Within 7 days after the first administration of the study drug/placebo

  40. Severe systemic post-vaccination reactions

    The proportion of the volunteers with \>grade 3 of severe systemic post-vaccination reactions

    Time frame: Within 7 days after the second administration of the study drug/placebo

  41. Any adverse events

    The proportion of the volunteers with any adverse events

    Time frame: Within 90±5 days after the first dose of the study drug/placebo

  42. Any adverse events

    The proportion of the volunteers with any adverse events

    Time frame: Within 180±5 days after the first dose of the study drug/placebo

  43. 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

    Time frame: Within 50 days after the first dose of the study drug/placebo

  44. 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

    Time frame: Within 90±5 days after the first dose of the study drug/placebo

  45. 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

    Time frame: Within 180±5 days after the first dose of the study drug/placebo

  46. Severe adverse events

    The proportion of the volunteers with severe adverse events

    Time frame: Within 90±5 days after the first dose of the study drug/placebo

  47. Severe adverse events

    The proportion of the volunteers with severe adverse events

    Time frame: Within 180±5 days after the first dose of the study drug/placebo

  48. 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

    Time frame: Within 50 days after the administration of the first dose of the study drug/placebo

  49. 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

    Time frame: Within 90±5 days after the administration of the first dose of the study drug/placebo

  50. 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

    Time frame: Within 180±5 days after the administration of the first dose of the study drug/placebo

07

Study locations

3 sites
  • Center of professional medicine
    Perm, 614000, Russia
  • "Eco-Safety" R&D center
    Saint Petersburg, 196143, Russia
  • Department of Vaccinology, Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation
    Saint Petersburg, 197376, Russia
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for Apr 2022, 6 months after the start.

Of 99 non-industry phase 1/2 interventional studies under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 6 months is below that.

Counting every sponsor, half of 171 studies reached it within 9 months; a quarter within 3 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2022
First posted
Mar 8, 2022
StartActual
Oct 14, 2021
Primary completionEst.
Apr 25, 2022
CompletionEst.
Jul 24, 2022
Last update
Mar 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05270954
Lead sponsor
Artgen Biotech
Collaborators
Betuvax LLC, CEG BIO LLC
Responsible party
Sponsor
First posted
Mar 8, 2022
Start date
Oct 14, 2021
Primary completion
Apr 25, 2022 (estimated)
Completion
Jul 24, 2022 (estimated)
Last update
Mar 8, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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