Russian Federal Biomedical Agency
Russian Federal Biomedical Agency
Ilyina N.,Russian Federal Biomedical Agency |
Kharit S.,Federal State Budget Institute Science Res Institute Of Childrens Infections Of The Russ Federal Biomedical Agency |
Namazova-Baranova L.,Russian Academy of Sciences |
Asatryan A.,Federal Budgetary Institute Of Science St Petersburg Science Res Institute Of Epidemiology And Microbiol Named After Pasteur |
And 4 more authors.
Human Vaccines and Immunotherapeutics | Year: 2014
Neisseria meningitidis is the leading cause of bacterial invasive infections in people aged <15 years in the Russian Federation. The aim of this phase III, multicenter, open-label study was to assess the immunogenicity and safety of the quadrivalent meningococcal CRM197-conjugate vaccine MenAC WY when administered to healthy Russian subjects aged 2 years and above. A total of 197 subjects were immunized with a single dose of the vaccine, and serogroup-specific serum bactericidal activity was measured pre and 1-month post-vaccination with human complement (hSBA) serum titers. Regardless of baseline serostatus, 1 month after a single dose of MenAC WY-CRM197 85% (95%CI, 79-90%) of subjects showed serologic response against serogroup A, 74% (67-80%) against serogroup C, 60% (53-67%) against serogroup W, and 83% (77-88%) against serogroup Y. The percentage of subjects with hSBA titers ≥ 1:8 1 month after vaccination was 89% (83-93%) against serogroup A, 84% (78-89%) against serogroup C, 97% (93-99%) against serogroup W, and 88% (82-92%) against serogroup Y. Comparable results were obtained across all subjects: children (2 to 10 years), adolescents (11 to 17 years), and adults (≥18 years). The MenAC WY-CRM197 vaccine showed an acceptable safety profile and was well tolerated across all age groups, with no serious adverse events or deaths reported during the study. In conclusion, a single dose of meningococcal MenAC WY-CRM197 vaccine is immunogenic and has an acceptable safety profile, provides a broad protection against the most frequent epidemic serogroups, and is a suitable alternative to currently available unconjugated monovalent or bivalent polysaccharide vaccines in Russia. © 2014 Landes Bioscience.
Piruzian L.A.,RAS Semenov Institute of Chemical Physics |
Protasova O.V.,RAS Semenov Institute of Chemical Physics |
Maksimova I.A.,Russian Academy of Sciences |
Morukov B.V.,Russian Academy of Sciences |
And 2 more authors.
Human Physiology | Year: 2014
Total and ultrafiltered calcium, total and inorganic phosphorus in blood serum, and diurnal secretion of calcium and phosphorus in urine were determined in humans before (baseline data) and on days 30, 60, and 105 of isolation. Calcium and phosphorus contents in hair were determined before isolation and on day 105 of the experiment. The measurements were performed by means of inductively coupled plasma atomic emission spectrometry. Levels of total and ultrafiltered calcium, total and inorganic phosphorus, as well as urine calcium and phosphorus in daily urine and hair varied within admissible physiological ranges at all stages of investigation. Shifts in the serum calcium and phosphorus balance, accounted for by their physiologically active forms, is an immediate reaction to the experimental conditions. Calcium and phosphorus levels deviated from the baseline values after 30 days of isolation and then remained stable util day 105. © 2014, Pleiades Publishing, Inc.