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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 7: 16 volunteers who received a single intradermal VAC∆6 dose of 10⁷ PFU/0.2 ml;
Group 8: 16 volunteers who received a single intradermal placebo dose of 0.2 ml.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (The first stage): VAC∆6 (10⁷ PFU), Live Smallpox Vaccine (2 months after the vaccination) | Experimental | 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). |
|
| Group 2 (The first stage): VAC∆6 (10⁶ PFU), Live Smallpox Vaccine (1 month after the vaccination) | Experimental | 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). |
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| Group 3 (The second stage): two intradermal VAC∆6 (10⁶ PFU/0.2 ml) given 28 days apart. | Experimental | 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). |
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| Group 4 (The second stage): two intradermal placebo doses of 0.2 ml (given 28 days apart). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAC∆6 vaccine (10⁷ PFU) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in antibody titers. | Determination of antibody titers to poxviruses using ELISA. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir I. Kuzubov, PhD | Medical and Sanitary Unit No. 163 (FGBUZ MSCH-163, FMBA Russia) (Novosibirsk) | Principal Investigator |
| Irina V Krasil'nikova, PhD | Municipal Infectious Disease Clinical Hospital No. 1 (Novosibirsk) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Institution of Healthcare "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency" (FGBUZ MSCH-163, FMBA of Russia) | Kol'tsovo | Novosibirsk Oblast | 630559 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26798498 | Background | Yakubitskiy SN, Kolosova IV, Maksyutov RA, Shchelkunov SN. Attenuation of Vaccinia Virus. Acta Naturae. 2015 Oct-Dec;7(4):113-21. | |
| 28740731 | Background | Maksyutov RA, Yakubitskyi SN, Kolosova IV, Shchelkunov SN. Comparing New-Generation Candidate Vaccines against Human Orthopoxvirus Infections. Acta Naturae. 2017 Apr-Jun;9(2):88-93. |
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This was a clinical study of VAC∆6 vaccine designed to induce specific immunity to human-pathogenic orthopoxviruses (VARV, MPXV, CPXV, VACV)
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Double-blind Study
| Placebo Comparator |
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). |
|
| Group 5 (The second stage) in the FGBUZ MSCH-163: a single intradermal VAC∆6 (10⁷ PFU/0.2 ml). | Experimental | 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). |
|
| Group 6 (The second stage) in the FGBUZ MSCH-163: a single intradermal placebo dose of 0.2 ml. | Placebo Comparator | 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). |
|
| Group 7 (The second stage) in the Hospital No. 1: a single intradermal VAC∆6 (10⁷ PFU/0.2 ml). | Experimental | 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). |
|
| Group 8 (The second stage): in the Hospital No. 1: a single intradermal placebo dose of 0.2 ml. | Placebo Comparator | 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). |
|
|
| VAC∆6 vaccine (10⁶ PFU) | Biological | 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 | Biological | 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. |
|
| Placebo (Sodium chloride bufus, 0.9%) | Other | 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). |
|
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%. |
| 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%. | 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%. | 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:
| 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:
| 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. | 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Groups 3, 4: at days 14, 41. Groups 5 - 8: at day 14. |
| State Budgetary Health Institution of the Novosibirsk Region "Municipal Infectious Disease Clinical Hospital No. 1" | Novosibirsk | 630099 | Russia |
| 32962316 | Background | Olson VA, Shchelkunov SN. Are We Prepared in Case of a Possible Smallpox-Like Disease Emergence? Viruses. 2017 Aug 27;9(9):242. doi: 10.3390/v9090242. |
| 36680142 | Background | Shchelkunova GA, Shchelkunov SN. Smallpox, Monkeypox and Other Human Orthopoxvirus Infections. Viruses. 2022 Dec 29;15(1):103. doi: 10.3390/v15010103. |
| 29340212 | Background | Shchelkunova GA, Shchelkunov SN. 40 Years without Smallpox. Acta Naturae. 2017 Oct-Dec;9(4):4-12. |
| 32477596 | Background | Shchelkunov SN, Shchelkunova GA. Genes that Control Vaccinia Virus Immunogenicity. Acta Naturae. 2020 Jan-Mar;12(1):33-41. doi: 10.32607/actanaturae.10935. |
| 32167685 | Background | Shchelkunov SN, Shchelkunova GA. [We should be prepared to smallpox re-emergence.]. Vopr Virusol. 2019;64(5):206-214. doi: 10.36233/0507-4088-2019-64-5-206-214. Russian. |
| 35903306 | Background | Maksyutov RA, Yakubitskiy SN, Kolosova IV, Tregubchak TV, Shvalov AN, Gavrilova EV, Shchelkunov SN. Genome stability of the vaccine strain VACDelta6. Vavilovskii Zhurnal Genet Selektsii. 2022 Jul;26(4):394-401. doi: 10.18699/VJGB-22-48. |
| Background | Marennikova S.S., Shchelkunov S.N. Orthopoxviruses pathogenic for humans (monograph) // KMK Scientific Press Ltd., M. - 1998, - 386 p (in Russian). |
| Background | Kolosova I.V., Babkina I.N., Yakubitsky S.N., Maksyutov R.A., Safronov P.F., Shchelkunov S.N. Recombinant strain L-IVP 1421ABJCN of vaccinia virus with deleted virulence genes A56R, B8R, J2R, C3L, N1L to obtain a live cell-based attenuated vaccine against smallpox and other orthopoxviruses pathogenic to humans // RF Patent No. 2588388, priority 20.04.2015 (in Russian). |
| Background | Yakubitsky S.N., Kolosova I.V., Maksyutov R.A., Shchelkunov S.N. Recombinant strain VACΔ6 of vaccinia virus with deleted virulence genes C3L, N1L, J2R, A35R, A56R, B8R for obtaining a live cell-based attenuated vaccine against smallpox and other human orthopoxvirus infections // RF Patent No. 2621868, priority 24.06.2016 (in Russian). |
| ID | Term |
|---|---|
| D012899 | Smallpox |
| D045908 | Mpox, Monkeypox |
| D015605 | Cowpox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018419 | Primate Diseases |
| D000820 | Animal Diseases |
| D012376 | Rodent Diseases |
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