View clinical trials related to Vaccinia.
Filter by:This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow.
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.
The goal of this clinical trial is to evaluate the safety, tolerance, pharmacokinetics, and biological properties of recombinant human IL-21 oncolytic vaccinia virus injection (hV01) in patients with advanced solid tumors.
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.
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.
Purpose of the study is to evaluate the safety, tolerability and pharmacokinetic parameters of the drug based on double recombinant vaccinia virus VV-GMCSF-Lact, in patients with recurrent/refractory metastatic breast cancer in successive cohorts with dose escalation with single and multiple administration. The study provides: determination of the maximum tolerated dose of the drug and the frequency, nature, intensity and duration of adverse events connected with the use of the study drug in escalating doses; detection of dose-limiting toxicity, its severity, duration and reversibility; determination of the profile of virus pharmacokinetics and antivirus antibodies; assessment of the objective response to the treatment. Stage 1,: The virus drug is administered intratumorally once according to a "3+3" design in the dosage from 1*107 PFU to 10*107 PFU. The frequency of dose-limiting toxicity (DLT) will be evaluated (non-hematological toxicity III degree and above; development of febrile neutropenia and body temperature > 38.3°C more than two days after drug administration; thrombocytopenia III degree and above and/or hemorrhagic complications; repeated increase in ALT and/or AST activity is more than 4 times higher than the normal upper limit). Escalation to the next level occurs if there is no DLT in the entire cohort under study. The study stops if the incidence of DLT in a cohort of 3 patients is 2 or 3. The maximum tolerated dose (MTD) will be considered the studied dose that is lower than the dose which DLT was determined. Stage 1 assumes randomization of no more than 36 patients. Stage 2, multiple administration: According to Stage 1 the study will move to the second stage if there will be possibility to study at least one dosage regimen based on the previously studied dose. At Stage 2 two doses in ascending order below the MTD and MTD are planned to be used. Escalation to the next level occurs if no DLT is observed during dosing of the first three patients. If DLT develops and drug administration is discontinued, the patient is not excluded from the study, her drug administration visits are skipped, and she goes through all follow-up visits. The drug will be administered intratumorally 1 time per week for 4 weeks in 3 dosages: MTD and 2 lower dosages. Each cohort will include up to 6 patients in a "3+3" design. It is expected to include up to 24 patients, taking into account the possible inclusion of patients to replace those who left.
Participants will be randomized in a 2:1 ratio to receive either two injections of CMV-MVA Triplex® or placebo administered at study Entry/Day 0 and week 4. Vaccine Group: 60 participants will receive CMV-MVA Triplex® containing 5 x 10^8 plaque-forming unit (pfu) ±0.5 x 10^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections. Placebo Group: 30 participants will receive a volume of placebo (7.5% Lactose in phosphate-buffered saline [PBS]) that matches the volume of the active vaccine injection by IM deltoid injections.
comparison of general characteristics of patients diagnosed COVID-19 positive followed In service
This is a dose-escalation, single-arm, single-center open study which aims to evaluate the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of a novel oncolytic vaccinia virus expressing bispecific antibody RGV004 in patients with relapsed/refractory B-cell lymphoma,
The study will be divided into two stages: phase Ib and phase II. The safety and phase II recommended dose (RP2D) of Pexa-Vec combined with ZKAB001 in patients with local progression of failed first-line treatment or metastatic melanoma will be evaluated in phase Ib. Objective response rate (ORR) and progression-free survival (PFS) of ZKAB001 combined with RP2D's Pexa-Vec or ZKAB001 monotherapy in patients with local progression or metastatic melanoma will be evaluated in phase II.