Ebola hemorrhagic fever, also known as Ebola virus disease or EVD, is one of the most dangerous viral diseases in humans and animals. In this open-label, dose-escalation clinical trial, we assessed the safety, side effects, and immunogenicity of a novel, heterologous prime-boost vaccine against Ebola, which was administered in 2 doses to 84 healthy adults of both sexes between 18 and 55 years. The vaccine consists of live-attenuated recombinant vesicular stomatitis virus (VSV) and adenovirus serotype-5 (Ad5) expressing Ebola envelope glycoprotein. The most common adverse event was pain at the injection site, although no serious adverse events were reported. The vaccine did not significantly impact blood, urine, and immune indices. Seroconversion rate was 100 %. Antigen-specific IgG geometric mean titer at day 42 was 3,277 (95 % confidence interval 2,401–4,473) in volunteers immunized at full dose. Neutralizing antibodies were detected in 93.1 % of volunteers immunized at full dose, with geometric mean titer 20. Antigen-specific response in peripheral blood mononuclear cells was also detected in 100 % of participants, as well as in CD4+ and CD8+ T cells in 82.8 % and 58.6 % of participants vaccinated at full dose, respectively. The data indicate that the vaccine is safe and induces strong humoral and cellular immune response in up to 100 % of healthy adult volunteers, and provide a rationale for testing efficacy in Phase III trials. Indeed, the strong immune response to the vaccine may elicit long-term protection. This trial was registered with grls.rosminzdrav.ru (No. 495*), and with zakupki.gov.ru (No. 0373100043215000055).

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The choice of non-drug methods for the treatment of systemic scleroderma is currently very limited. Several studies show that extracorporeal photochemotherapy can improve kidney and lung function and reduce skin fibrosis in patients with systemic scleroderma. We studied the dynamics of clinical and laboratory parameters in patients with systemic scleroderma with an assessment before and after 12 months against the background of complex treatment, which included programmed extracorporeal photochemotherapy. Indications for inclusion in the study was the ineffectiveness of standard therapy with glucocorticoids and cytostatics or the impossibility of their use, as well as signs of an unfavorable prognosis of the disease: diffuse form, high skin count (14), rapid progression with a significant initial decrease in the glomerular filtration rate, forced vital capacity, high immunological activity (high titer of antinuclear factor and positivity for antibodies to Scl-70). When evaluating the results of complex treatment, a good clinical effect was observed in all patients: the induration of the skin decreased, the functionality of the lungs and kidneys increased. A significant decrease in the disease activity index was noted. These positive changes were the basis for a decrease in the daily dose of glucocorticoids. Significantly significant changes were observed in a decrease in the immunological activity of the disease: levels of C-reactive protein, erythrocyte sedimentation rate and immunoglobulin G, antinuclear factor titer and all types of circulating immune complexes. The results of our study confirm the data of other studies that demonstrated the positive effect of extracorporeal photochemotherapy as a component of the complex treatment of systemic scleroderma.