A Phase 2/3 interventional study of VAC∆6 vaccine (10⁷ PFU) and VAC∆6 vaccine (10⁶ PFU) in Smallpox, Monkeypox and Cowpox, sponsored by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector". Completed at 2 sites in Russian Federation. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" · Phase 2/3, Interventional, and Prevention
The Aim:
Study immunogenicity, confirm the safety and tolerability of different schedules of vaccination with "live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus" using a complex of clinical and laboratory-instrumental techniques.
The research tasks are to:
This is a Double-blind, Comparative, Randomized, Placebo-controlled Study on Immunogenicity, Reactogenicity and Safety of Live Cell-Based Vaccine Against Smallpox and Other Orthopoxvirus Infections (VAC∆6 Vaccine) Based on Vaccinia Virus in 18-60-year-old Volunteers.
The study included 334 healthy volunteers of both sexes aged 18-60 years who met the inclusion criteria and had no exclusion criteria.
The study was carried out in two stages:
The first stage is an open comparative study of the safety, reactogenicity, immunological activity and protective efficacy of VAC∆6 vaccine in parallel groups of 30 volunteers aged 18 to 60 who met the inclusion criteria. Volunteers were divided into two groups:
The second stage is a Double-blind, Comparative, Randomized, Placebo-controlled study on Immunogenicity, Reactogenicity, and Safety of the VAC∆6 Vaccine in Parallel Groups. Randomization was carried out using the envelope method. The sealed opaque envelopes included in the Investigator's File were distributed to the clinical sites in the required quantity prior to the start of the study.
Substances were submitted for testing in encrypted form. The encryption technique was chosen and implemented by the sponsor - FBRI SRC VB "Vector", Rospotrebnadzor. Decryption was carried out after study report submission to the Federal Budgetary Research Institution, State Research Center of Virology and Biotechnology "Vector", Rospotrebnadzor.
A total of 304 volunteers aged 18-60 took part in the second stage of the clinical study, of which 158 were men and 146 were women, who met the inclusion criteria and had no exclusion criteria. The volunteers were assigned to study sites as follows:
FGBUZ MSCH-163, FMBA Russia - 272 volunteers randomized into four groups:
State Budgetary Health Institution of the Novosibirsk Region "Municipal Infectious Disease Clinical Hospital No. 1" - 32 volunteers randomized into two groups:
Group 8: 16 volunteers who received a single intradermal placebo dose of 0.2 ml.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 334 is above 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.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
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.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
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.
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.
15 volunteers aged 18 to 60 who met the inclusion criteria and who received a single intradermal VAC∆6 dose of 1x10⁷ PFU/0.2ml. Live smallpox vaccine was administered by scarification 2 months after the vaccination. (The first stage is an open comparative study of the safety, reactogenicity, immunological activity and protective efficacy of VAC∆6 vaccine in two parallel groups).
Biological: VAC∆6 vaccine (10⁷ PFU) · Biological: Live Smallpox Vaccine
15 volunteers aged 18 to 60 who met the inclusion criteria and who received two intradermal VAC∆6 doses of 10⁶ PFU/0.2ml (given 28 days apart). Live smallpox vaccine was administered by scarification one month after the full vaccination series. (The first stage is an open comparative study of the safety, reactogenicity, immunological activity and protective efficacy of VAC∆6 vaccine in two parallel groups).
Biological: VAC∆6 vaccine (10⁶ PFU) · Biological: Live Smallpox Vaccine
76 volunteers aged 18 to 60 who met the inclusion criteria and who received two intradermal VAC∆6 doses of 10⁶ PFU/0.2 ml (given 28 days apart). (The second stage is a Double-blind, Comparative, Randomized, Placebo-controlled study on Immunogenicity, Reactogenicity, and Safety of the VAC∆6 Vaccine in Parallel Groups).
Biological: VAC∆6 vaccine (10⁶ PFU)
76 volunteers aged 18 to 60 who met the inclusion criteria and who received two intradermal placebo doses of 0.2 ml (given 28 days apart). (The second stage is a Double-blind, Comparative, Randomized, Placebo-controlled study on Immunogenicity, Reactogenicity, and Safety of the VAC∆6 Vaccine in Parallel Groups).
Other: Placebo (Sodium chloride bufus, 0.9%)
60 volunteers aged 18 to 60 who met the inclusion criteria and who received a single intradermal VAC∆6 dose of 10⁷ PFU/0.2 ml. (The second stage is a Double-blind, Comparative, Randomized, Placebo-controlled study on Immunogenicity, Reactogenicity, and Safety of the VAC∆6 Vaccine in Parallel Groups).
Biological: VAC∆6 vaccine (10⁷ PFU)
60 volunteers aged 18 to 60 who met the inclusion criteria and who received a single intradermal placebo dose of 0.2 ml. (The second stage is a Double-blind, Comparative, Randomized, Placebo-controlled study on Immunogenicity, Reactogenicity, and Safety of the VAC∆6 Vaccine in Parallel Groups).
Other: Placebo (Sodium chloride bufus, 0.9%)
16 volunteers aged 18 to 60 who met the inclusion criteria and who received a single intradermal VAC∆6 dose of 10⁷ PFU/0.2 ml. (The second stage is a Double-blind, Comparative, Randomized, Placebo-controlled study on Immunogenicity, Reactogenicity, and Safety of the VAC∆6 Vaccine in Parallel Groups).
Biological: VAC∆6 vaccine (10⁷ PFU)
16 volunteers aged 18 to 60 who met the inclusion criteria and who received a single intradermal placebo dose of 0.2 ml. (The second stage is a Double-blind, Comparative, Randomized, Placebo-controlled study on Immunogenicity, Reactogenicity, and Safety of the VAC∆6 Vaccine in Parallel Groups).
Other: Placebo (Sodium chloride bufus, 0.9%)
Live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus (manufactured by FBRI SRC VB "Vector", Rospotrebnadzor). Batch: 08-10.19 (expiry date: 13.10.2021). Dosage: single intradermal dose of 10⁷ PFU/0.2 ml of vaccinia virus.
Live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus (manufactured by FBRI SRC VB "Vector", Rospotrebnadzor). Batch: 08-10.19 (expiry date: 13.10.2021). Dosage: two intradermal doses of 10⁶ PFU/0.2 ml of vaccinia virus (given 28 days apart).
Live smallpox vaccine (Smallpox vaccine) (manufactured by the Federal State Unitary Enterprise NPO Microgen of the Ministry of Health of Russia). Batch No. Т30 (expiry date: March, 2021). Dosage: Single 1x10⁶ PFU dose administered by multiple-pricking technique on the 30th/60th day after full series of vaccination with VAC∆6.
Sodium chloride bufus, a 0.9% solvent for the preparation of a dosage form for injections (manufactured by JSC Pharmaceutical manufacturing company "Obnovlenie", Russia). Batch: 391219 (expiry date: January, 2025).
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: Group 1: at days 1, 30, 60, 89. Groups 2, 3, 4: at days 1, 28, 57, 87, 117. Groups 5, 6, 7, 8: at days 1, 30, 60, 90.
Change in antibody titers.
Determination of antibody titers to poxviruses using ELISA.
Time frame: Group 1: at days 0, 1, 30, 60, 89. Groups 2, 3, 4: at days 0, 1, 28, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 30, 60, 90.
Determination of the lymphocyte migration index (MI)
Determination of the lymphocyte migration index (MI) is carried out in order to conduct a subsequent assessment of the activity of specific DTH effectors in vitro. The MI is calculated by the formula: MI=A/B, where A is the number of cells in the control wells, B is the number of cells in the experimental wells with an inhibitory dose. On control days, the changes in the activity of DTH effectors in vitro is assessed. The assessment of the activity of specific DTH effectors in vitro is carried out according to the MI, which characterizes the migration activity of leukocytes; according to the index of inhibition of migration (MII), which characterizes the intensity of production of lymphokines, and according to the integral indicator of the effector functions (IEF). These MI, MII and IEF for each vaccinated person are compared with the corresponding normal parameters. The reaction is considered positive if the difference between the experimental and control values exceeds 20%.
Time frame: Group 1: at days 30, 89. Groups 2, 3, 4: at days 1, 28, 57, 117. Groups 5, 6, 7, 8: at days 1, 30, 90.
Determination of the lymphocyte migration inhibition index (MII)
Determination of the lymphocyte migration inhibition index (MII) is carried out in order to conduct a subsequent assessment of the activity of specific DTH effectors in vitro. The MII is calculated by the formula: MII=B/А, where A is the number of cells in the control wells, B is the number of cells in the experimental wells with an inhibitory dose. On control days, the changes in the activity of DTH effectors in vitro is assessed. The assessment of the activity of specific DTH effectors in vitro is carried out according to the migration index (MI), which characterizes the migration activity of leukocytes; according to the MII, which characterizes the intensity of production of lymphokines, and according to the integral indicator of the effector functions (IEF). These MI, MII and IEF for each vaccinated person are compared with the corresponding normal parameters. The reaction is considered positive if the difference between the experimental and control values exceeds 20%.
Time frame: Group 1: at days 30, 89. Groups 2, 3, 4: at days 1, 28, 57, 117. Groups 5, 6, 7, 8: at days 1, 30, 90.
Determination of the integral indicator of the effector functions (IEF)
Determination of the integral indicator of the effector functions (IEF) is carried out in order to conduct a subsequent assessment of the activity of specific DTH effectors in vitro. The IEF is calculated by the formula: IEF=С/B, where C is the number of lymphocytes in the test wells with the stimulation dose and B is the number of lymphocytes in the test wells with the inhibitory dose. On control days, the changes in the activity of DTH effectors in vitro in each vaccinated person is assessed. The assessment of the activity of specific DTH effectors is carried out according to the migration index (MI), which characterizes the migration activity of leukocytes; according to the index of inhibition of migration (MII), and according to the IEF. These MI, MII and IEF for each vaccinated person are compared with the corresponding normal parameters. The reaction is considered positive if the difference between the experimental and control values exceeds 20%.
Time frame: Group 1: at days 30, 89. Groups 2, 3, 4: at days 1, 28, 57, 117. Groups 5, 6, 7, 8: at days 1, 30, 90.
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: Group 1: at days 1-14, 21, 30, 60-74, 80, 89. Group 2: at days 1-14, 21, 28-41, 48, 57, 87-100, 107, 116. Groups 3, 4: at days 1-14, 21, 28-41, 48, 57, 87, 117. Groups 5, 6, 7, 8: at days 1-14, 21, 30.
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: Group 1: at days 1-14, 21, 30, 60-74, 80, 89. Group 2: at days 1-14, 21, 28-41, 48, 57, 87-100, 107, 116. Groups 3, 4: at days 1-14, 21, 28-41, 48, 57, 87, 117. Groups 5, 6, 7, 8: at days 1-14, 21, 30.
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: Group 1: at days 1-14, 21, 30, 60-74, 80, 89. Group 2: at days 1-14, 21, 28-41, 48, 57, 87-100, 107, 116. Groups 3, 4: at days 1-14, 21, 28-41, 48, 57, 87, 117. Groups 5, 6, 7, 8: at days 1-14, 21, 30.
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: Group 1: at days 0-14, 21, 30, 60-74, 80, 89. Group 2: at days 0-14, 21, 28-41, 48, 57, 87-100, 107, 116. Groups 3, 4: at days 0-14, 21, 28-41, 48, 57, 87, 117. Groups 5, 6, 7, 8: at days 1-14, 21, 30.
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: Group 1: at days 0-14, 21, 30, 60-74, 80, 89. Group 2: at days 0-14, 21, 28-41, 48, 57, 87-100, 107, 116. Groups 3, 4: at days 0-14, 21, 28-41, 48, 57, 87, 117. Groups 5, 6, 7, 8: at days 1-14, 21, 30.
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: Group 1: at days 0-14, 21, 30, 60-74, 80, 89. Group 2: at days 0-14, 21, 28-41, 48, 57, 87-100, 107, 116. Groups 3, 4: at days 0-14, 21, 28-41, 48, 57, 87, 117. Groups 5, 6, 7, 8: at days 1-14, 21, 30.
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: Group 1: at days 0-14, 21, 30, 60-74, 80, 89. Group 2: at days 0-14, 21, 28-41, 48, 57, 87-100, 107, 116. Groups 3, 4: at days 0-14, 21, 28-41, 48, 57, 87, 117. Groups 5, 6, 7, 8: at days 1-14, 21, 30.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
Monitoring of the IgE level (as part of a biochemical blood test).
On control days, a biochemical blood test is performed: the changes in the content of Class E (in IU/ml) immunoglobulins is assessed.
Time frame: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
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: Group 1: at days 0, 1, 5, 14, 30, 60, 66, 73, 89. Group 2: at days 0, 1, 5, 14, 28, 32, 41, 57, 87, 93, 100, 116. Groups 3, 4: at days 0, 1, 5, 14, 28, 31, 41, 57, 87, 117. Groups 5, 6, 7, 8: at days 0, 1, 5, 14, 30, 60, 90.
Number of participants with vaccinia virus in blood, urine and saliva.
Оn control days, the determination of the vaccinia virus in blood, urine, and is carried out.
Time frame: Groups 3, 4: at days 2-14, 29-41. Groups 5, 6, 7, 8: at days 2-14.
Number of participants with vaccinia virus in specific skin formations (crusts, pustules).
Оn control days, the determination of the vaccinia virus in specific skin formations (crusts, pustules) is carried out.
Time frame: Groups 3, 4: at days 14, 41. Groups 5 - 8: at day 14.
Plan to share: No
Ran from Oct 2021 to primary completion in Dec 2021, 2 months.
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Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"