Phase I Clinical Study of the Subunit Betulin-Adjuvanted Tetravalent Candidate Influenza Vaccine TetraFluBet.

Objectives: This study aimed to determine the safety, tolerability and immunogenicity of TetraFluBet, an inactivated subunit influenza vaccine that contains a corpuscular immuno-adjuvant derived from natural betulin.

Methods: We conducted a prospective, randomized, open-labeled, single-center, phase I trial. The study was conducted in two stages: 5 volunteers in stage I and 25 volunteers in stage II.

Safety and Immunogenicity of Betuvax-CoV-2, an RBD-Fc-Based SARS-CoV-2 Recombinant Vaccine: Preliminary Results of the First-in-Human, Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Trial.

Unlabelled: COVID-19, being a life-threatening infection that evolves rapidly, remains a major public health concern calling for the development of vaccines with broad protection against different pathogenic strains and high immunogenicity. Aside from this, other concerns in mass immunization settings are also the scalability of production and relative affordability of the technology. In that regard, adjuvanted protein vaccines with particles mimicking the virus stand out among known vaccine technologies.

An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine "Sputnik Light" for prevention of coronavirus infection in healthy adults.

Background: While the world is experiencing another wave of COVID-19 pandemic, global vaccination program is hampered by an evident shortage in the supply of licensed vaccines. In an effort to satisfy vaccine demands we developed a new single-dose vaccine based on recombinant adenovirus type 26 (rAd26) vector carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) glycoprotein - "Sputnik Light".

Methods: We conducted an open label, prospective, non-randomised phase 1/2 trial aimed to assess safety, tolerability, and immunogenicity of "Sputnik Light" vaccine in a single center in Russia.

[Efficacy and safety of treatment with ampasse: the results of a randomized, double-blind, placebo-controlled trial in patients with chronic cerebrovascular disorders].

Objective: To assess the efficacy and safety of the drug ampasse in the treatment of patients with chronic cerebrovascular disorders (CCVD).

Materials And Methods: A multicenter, randomized, double-blind, placebo-controlled, confirmatory study of the efficacy and safety of ampasse (phase III) was conducted in 124 patients aged 50 to 75 years. The main group (MG) - 62 patients, received the test drug ampasse, solution for intravenous administration, 5 mg/ml, at a dose of 5 ml (25 mg), intravenously bolus slowly, the duration of treatment was 15 days.

[The practice of using a domestic antiviral drug in the etiotropic therapy of acute respiratory viral infection].

Aim: Evaluation of efficacy, safety, tolerability, and determination of the optimal dose of riamilovir in patients diagnosed with acute respiratory viral infection (ARVI).

Materials And Methods: The study included 270 patients with uncomplicated ARVI of mild and moderate severity (with a laboratory-confirmed PCR method for the presence of ARVI antigens, absence of influenza virus antigens). Patients were included in the study after signing an informed consent.