A Phase 1 interventional study of VAC∆6 vaccine - оnce at a dose of 10⁶ PFU and VAC∆6 vaccine - once at a dose of 10⁷ PFU in Smallpox, Monkeypox and Cowpox, sponsored by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector". Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-09.
Sponsored by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" · Phase 1, Interventional, and Prevention
The aim of the clinical study is to study the safety and tolerability of the live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus, in intracutaneous administration.
The research tasks are to:
This study is an open-label, controlled, parallel-group clinical trial. The study included 60 healthy volunteers of both sexes aged 18-40 years who had not been vaccinated against smallpox, had no vaccine marks and anti-smallpox virus neutralizing antibodies in their sera as well as those who met the inclusion criteria and did not have any exclusion criteria.
Distribution of volunteers by groups:
Group 1: 15 volunteers vaccinated once intradermally at a dose of 10⁶ plaque-forming units (PFU) (0.2 ml) of the VAC∆6 vaccine in the outer surface of the shoulder 8-10 cm below the shoulder joint; Group 2: 15 volunteers vaccinated once intradermally at a dose of 10⁷ PFU (0.2 ml) of the VAC∆6 vaccine in the outer surface of the shoulder 8-10 cm below the shoulder joint; Group 3: 15 volunteers vaccinated twice spaced 28 days apart, intradermally at a dose of 10⁶ PFU (0.2 ml) of the VAC∆6 vaccine in the outer surface of the shoulder 8-10 cm below the shoulder joint; Group 4: 15 volunteers vaccinated by the two-step vaccination method: Step 1 - the first vaccination once subcutaneously with 1 dose (0.5 ml) of the inactivated smallpox vaccine OspaVir® in the area of the left shoulder 8-10 cm below the shoulder joint; Step 2 - the second vaccination once by the method of multiple puncture into the outer surface of the shoulder 8-10 cm below the shoulder joint with a live smallpox vaccine at a dose of 1x 10⁶ PFU 7 days following the first vaccination with OspaVir®.
Since the product "Live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus" was used for the first time for human vaccination, the vaccination of volunteers was started at a low dose, i.e. 1x10⁶ PFU.
The first five volunteers included in Group 1 were vaccinated intradermally at a dose of 1x10⁶ PFU. The volunteers were monitored daily; 14 days after vaccination, in the absence of side effects and after the results were agreed upon, vaccination was performed for the remaining 10 Group 1 volunteers and the first 5 volunteers of Group 2 who were vaccinated at a dose of 1x10⁷ PFU. After 14 days, in the absence of adverse effects (AEs) or serious adverse effects (SAEs), the rest of the volunteers included in Group 2 were vaccinated.
After receiving the results indicating the absence of AEs or SAEs in the volunteers vaccinated once with the VAC∆6 vaccine at a dose of 1x10⁶ PFU, the first vaccination of Group 3 volunteers was performed, the dose of the vaccine was 1x10⁶ PFU, and after 28 days - the second vaccination was performed.
Group 4 was vaccinated with reference products: live smallpox vaccine (smallpox vaccine) and the OspaVir® vaccine, an inactivated smallpox vaccine.
Vaccination was performed in two steps:
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 60 is below the median of 150 across 61 interventional studies indexed under Smallpox.
Browse Smallpox studies →Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Healthy volunteers (men and women) aged 18 to 40:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15 healthy volunteers of both sexes aged 18-40 years who had not been vaccinated against smallpox, had no vaccine marks and anti-smallpox virus neutralizing antibodies in their sera as well as those who met the inclusion criteria and did not have any exclusion criteria
Biological: VAC∆6 vaccine - оnce at a dose of 10⁶ PFU
15 healthy volunteers of both sexes aged 18-40 years who had not been vaccinated against smallpox, had no vaccine marks and anti-smallpox virus neutralizing antibodies in their sera as well as those who met the inclusion criteria and did not have any exclusion criteria
Biological: VAC∆6 vaccine - once at a dose of 10⁷ PFU
15 healthy volunteers of both sexes aged 18-40 years who had not been vaccinated against smallpox, had no vaccine marks and anti-smallpox virus neutralizing antibodies in their sera as well as those who met the inclusion criteria and did not have any exclusion criteria
Biological: VAC∆6 vaccine - twice at a dose of 10⁶ PFU
15 healthy volunteers of both sexes aged 18-40 years who had not been vaccinated against smallpox, had no vaccine marks and anti-smallpox virus neutralizing antibodies in their sera as well as those who met the inclusion criteria and did not have any exclusion criteria
Biological: Live smallpox vaccine (Smallpox vaccine) + The OspaVir® inactivated smallpox vaccine
15 volunteers vaccinated once intradermally at a dose of 10⁶ PFU (0.2 ml) of the VAC∆6 vaccine in the outer surface of the shoulder 8-10 cm below the shoulder joint
15 volunteers vaccinated once intradermally at a dose of 10⁷ PFU (0.2 ml) of the VAC∆6 vaccine in the outer surface of the shoulder 8-10 cm below the shoulder joint
15 volunteers vaccinated twice spaced 28 days apart, intradermally at a dose of 10⁶ PFU (0.2 ml) of the VAC∆6 vaccine in the outer surface of the shoulder 8-10 cm below the shoulder joint
15 volunteers vaccinated by the two-step vaccination method: Step 1 - the first vaccination once subcutaneously with 1 dose (0.5 ml) of the inactivated smallpox vaccine OspaVir® in the area of the left shoulder 8-10 cm below the shoulder joint; Step 2 - the second vaccination once by the method of multiple puncture into the outer surface of the shoulder 8-10 cm below the shoulder joint with a live smallpox vaccine at a dose of 1x 106 PFU 7 days following the first vaccination with OspaVir®.
Changes in the percentage of vaccinees with a titer of virus-neutralizing antibodies to vaccinia virus ≥1:40, at specified time intervals.
On control days, the percentage of the vaccinees with a titer of virus-neutralizing antibodies to vaccinia virus ≥1:40 is recorded in the neutralization test in embryonated chicken eggs. Value changes of this indicator between time points are assessed.
Time frame: Groups 1, 2, 3: at days 0, 21, 30, 60, 90, 180. Group 4: at days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Recording the number of local reactions.
On control days, the sum of local reactions is recorded: formation of inoculation elements (redness, swelling and papulo-nodules, pustules, vesicles, erythema, induration). Value changes of this indicator between time points are assessed. Evaluation criteria for local reactions: 1. The intensity or severity of adverse reactions should be assessed on a 4-point scale: 0 - none (no symptoms); 1 - mild (presence of mild symptoms); 2 - medium (symptoms that noticeably impair normal daily activities); 3 - severe (symptoms that interfere with normal daily activities). 2. The severity of local reactions was assessed according to the following criteria: * Hyperemia \< 50.0 mm (⌀) or an infiltrate \< 25.0 mm (⌀) - weak; * Hyperemia ≤ 50.0 mm (⌀) or an infiltrate 26.0-50.0 mm (⌀) - medium; * Infiltrate \> 50.0 mm (⌀) - strong.
Time frame: Groups 1, 2: at days 0 - 14, 21. Group 3: at days 0 - 14, 21, 28 - 42, 49. Group 4: at days 0 - 22, 29.
Changes in the activity of delayed-type hypersensitivity (DTH) effectors to vaccinia virus at specified time intervals.
On control days, the changes in the activity of DTH effectors to vaccinia virus are assessed. The assessment of the activity of specific DTH effectors in vitro should be carried out according to the migration index (MI), which characterizes the migration activity of leukocytes; according to the migration inhibition index (MII), which characterizes the intensity of lymphokine production, and according to the integral indicator of the effector functions (IEF). The reaction is considered positive if the difference between the experimental and control values is greater than 20%.
Time frame: Groups 1, 2: at days 1, 30, 90. Groups 3, 4: at days 1, 30, 60, 90.
Changes in the content of Class A, M, G, and E immunoglobulins.
On control days, the changes in the content of Class A (in mg/ml), M (in mg/ml), G (in mg/ml), and E (in IU/ml) immunoglobulins is assessed.
Time frame: Groups 1, 2, 3: at days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: at days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Changes in the content of T cells and their subpopulations: cluster of differentiation 3 (CD3+), cluster of differentiation 4 (CD4+), cluster of differentiation 8 (CD8+), CD4+/CD8+.
On control days, the changes in the content of T cells and their subpopulations is assessed: CD3+ (in % in relation to the total number of lymphocytes), CD4+ (in % in relation to CD3+), CD8+ (in % in relation to CD3+), CD4+/CD8+.
Time frame: Groups 1, 2, 3: at days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: at days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Recording the number of systemic reactions.
Recording the number of systemic reactions (malaise, headache, rise in body temperature, weakness, sweating, sleep and appetite disorders, nausea, vomiting, abdominal pain, etc.). Evaluating criteria for systemic reactions: 1. The intensity or severity of adverse reactions should be assessed on a 4-point scale: 0 - none (no symptoms); 1 - mild (presence of mild symptoms); 2 - medium (symptoms that noticeably impair normal daily activities); 3 - severe (symptoms that interfere with normal daily activities). 2. The temperature response should be evaluated according to the following categories in °С: 0 (none) ≤ 37 °C; 1 (weak) \> 37 °С - ≤ 37.5 °С; 2 (medium) \> 37.5 °С - ≤ 38.5 °С; 3 (strong) \> 38.5°C.
Time frame: Groups 1, 2: at days 0 - 14, 21. Group 3: at days 0 - 14, 21, 28 - 42, 49. Group 4: at days 0 - 22, 29.
Recording of the percentage of the vaccinated with various degrees of manifestation of systemic and local reactions.
Recording of the percentage of the vaccinated with various degrees of manifestation of systemic and local reactions.
Time frame: Groups 1, 2: at days 0 - 14, 21. Group 3: at days 0 - 14, 21, 28 - 42, 49. Group 4: at days 0 - 22, 29.
Body temperature monitoring at specified time intervals.
Body temperature is recorded (in degrees Celsius, °C) on control days. The changes in the values of this indicator between time points are assessed.
Time frame: Groups 1, 2, 3: at days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: at days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Arterial blood pressure monitoring at specified time intervals.
Systolic and diastolic blood pressure is recorded (in mmHg). The changes in the values of this indicator between time points are assessed.
Time frame: roups 1, 2, 3: at days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: at days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Heart rate monitoring at specified time intervals.
The heart rate is recorded (in beats per minute) on control days. The changes in the values of this indicator between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the frequency of respiratory movements at specified time intervals.
The frequency of respiratory movements (per minute) is recorded on control days. The changes in the values of this indicator between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.]
Monitoring of the content of erythrocytes (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of erythrocytes (10\^12 pcs/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of leukocytes (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of leukocytes (10⁹ pcs/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of hemoglobin (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of hemoglobin (g/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of platelets (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of platelets (10⁹ pcs/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of stab neutrophils (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of stab neutrophils (in %) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of segmented neutrophils (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of segmented neutrophils (in %) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of eosinophils (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of eosinophils (in %) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of basophils (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of basophils (in %) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of monocytes (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of monocytes (in %) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of lymphocytes (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: the content of lymphocytes (in %) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Erythrocyte sedimentation rate (ESR) monitoring (as part of a clinical (general) blood test).
On control days, a clinical (general) blood test is performed: ESR (in mm/h) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the enzyme activity of alanine transaminase (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the enzyme activity of alanine transaminase (in U/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the enzyme activity of aspartate aminotransferase (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the enzyme activity of aspartate aminotransferase (in U/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the enzyme activity of lactate dehydrogenase (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the enzyme activity of lactate dehydrogenase (in U/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the enzyme activity of alkaline phosphatase (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the enzyme activity of alkaline phosphatase (in U/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of B-lipoproteins (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the content of B-lipoproteins (in mmol/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of cholesterol (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the content of cholesterol (in mmol/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of total protein (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the content of total protein (in g/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of total bilirubin (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the content of total bilirubin (in µmol/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of glucose (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the content of glucose (in mmol/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of creatinine (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the content of creatinine (in µmol/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of urea (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the content of urea (in mmol/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of thymol test (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the thymol test (in S-H units) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of C reactive protein (CRP) (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the content of CRP (in mg/ml) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the prothrombin index (PTI) (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the prothrombin index (in %) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of urine transparency (as part of a common urine test).
On control days, a common urine test is performed: urine transparency is assessed. The changes in urine transparency between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the specific gravity of urine (as part of a common urine test).
On control days, a common urine test is performed: the specific gravity of urine is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of protein (as part of a common urine test).
On control days, a common urine test is performed: the content of protein (in g/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of glucose (as part of a common urine test).
On control days, a common urine test is performed: the content of glucose (in mmol / l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of leukocytes (as part of a common urine test).
On control days, a common urine test is performed: the content of leukocytes (10⁹/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the content of erythrocytes (as part of a common urine test).
On control days, a common urine test is performed: the content of erythrocytes (10\^12/l) is measured. The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the casts in urine (as part of a common urine test).
On control days, a common urine test is performed: the number of casts in the urine is counted (units in the field of view). The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of the salts in urine (as part of a common urine test).
On control days, a common urine test is performed: the number of salt crystals in the urine is counted (crystals per field of view). The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Monitoring of bacteria in urine (as part of a common urine test).
On control days, a common urine test is performed: the number of bacteria in the urine is counted (units in the field of view). The changes in values between time points are assessed.
Time frame: Groups 1, 2, 3: days 0, 5, 14, 21, 30, 60, 90, 180. Group 4: days 0, 5, 12, 21, 28, 37, 67, 97, 187.
Plan to share: No
Ran from May 2019 to primary completion in Jul 2019, 2 months.
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Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"