| Статус: | Completed |
| Фаза: | Phase 2/Phase 3 |
| Начало: | 1 октября 2021 г. |
| Окончание: | 1 апреля 2022 г. |
| Описание: | 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: 1. To study the immunological activity of a single VAC∆6 vaccine dose of 1x10⁷ plaque-forming units (PFU). 2. To study the immunological activity of two VAC∆6 vaccine doses (given 28 days apart) of 1x10⁶ PFU. 3. Assess the safety of different VAC∆6 vaccination schedules using a set of clinical and laboratory-instrumental techniques (thermometry, measurement of blood pressure, heart and lung auscultation, ECG, common blood and urine tests, biochemical, immunological and virological studies). 4. Assess the reactogenicity of different VAC∆6 vaccination schedules (number of local and systemic reactions, the percentage of those vaccinated with systemic and local reactions of various severity degrees). 5. To identify VAC∆6 vaccine-associated adverse events. 6. Study cell-mediated immunity induced by different VAC∆6 vaccination schedules. 7. Determine the presence of the virus in specific skin formations (crusts, pustules), saliva, blood and urine. 8. Evaluate the protective efficacy of one and two doses of the studied VAC∆6 vaccine. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 3 |
| Начало: | 19 ноября 2020 г. |
| Окончание: | 30 января 2021 г. |
| Описание: | The aim of the clinical study is to study the safety, reactogenicity and immunogenicity indicators of the EpiVacCorona vaccine, with the involvement of volunteers aged 60 years and above. The research tasks are to: - to evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older; - to evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older; - to identify any adverse effects to the administration of the vaccine; - to study the humoral and cellular immune responses response following two doses of the EpiVacCorona vaccine, with the participation of volunteers aged 60 and older. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 1 |
| Начало: | 4 сентября 2020 г. |
| Окончание: | 9 марта 2022 г. |
| Описание: | The Aim: To study safety, tolerability and pharmacokinetics of NIOCH-14 when administered orally using a set of clinical and laboratory-instrumental methods. The research tasks are to: - to assess the safety and tolerability of different single doses of the drug; - to assess the safety and tolerability of different repeated doses of the drug; - to study pharmacokinetics of single and repeated administration of the drug; - to assess the data on safety and tolerability to select the optimal drug dosing schedule to resolve the issue of conducting phase II clinical trial in an expanded cohort of volunteers. |
| смотреть на ClinicalTrials.gov |
| Статус: | Completed |
| Фаза: | Phase 1 |
| Начало: | 18 мая 2019 г. |
| Окончание: | 27 января 2020 г. |
| Описание: | 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: - evaluate the safety of various schemes for the use of the VAC∆6 vaccine using a set of clinical and laboratory-instrumental methods (thermometry, blood pressure registration, auscultation of the heart and lungs, electrocardiography (ECG), complete blood count and common urine test, biochemical, immunological, and virological studies); - evaluate the reactogenicity of various schemes for the use of the VAC∆6 vaccine (taking into account the number of local and systemic reactions, the percentage of those vaccinated with various degrees of manifestation of systemic and local reactions); - evaluate the possibility of virus shedding into the environment by volunteers; - evaluate the immunological efficacy of various vaccine administration schemes; - identify the development of undesirable reactions to the administration of the vaccine; - evaluate the cellular immune response to the introduction of various schemes for the use of the vaccine; - evaluate preliminary efficacy data in order to select an optimal scheme for the administration of the vaccine to make a decision on conducting Phase II clinical trials in an extended group of volunteers. |
| смотреть на ClinicalTrials.gov |