Publications by authors named "O A Perminova"

18 Publications

Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study.

Epidemiol Infect 2021 04 5;149:e90. Epub 2021 Apr 5.

Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA, USA.

Invasive meningococcal disease has high morbidity and mortality, with infants and young children among those at greatest risk. This phase III, open-label, randomised study in toddlers aged 12-23 months evaluated the immunogenicity and safety of meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT), a tetanus toxoid conjugated vaccine against meningococcal serogroups A, C, W and Y, when coadministered with paediatric vaccines (measles, mumps and rubella [MMR]; varicella [V]; 6-in-1 combination vaccine against diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b [DTaP-IPV-HepB-Hib] and pneumococcal conjugate vaccine [PCV13])(NCT03205371). Immunogenicity to each meningococcal serogroup was assessed by serum bactericidal antibody assay using human complement (hSBA). Vaccine safety profiles were described up to 30 days post-vaccination. A total of 1183 participants were enrolled. The proportion with seroprotection (hSBA ≥1:8) to each meningococcal serogroup at Day 30 was comparable between the MenACYW-TT and MenACYW-TT + MMR + V groups (≥92 and ≥96%, respectively), between the MenACYW-TT and MenACYW-TT + DTaP-IPV-HepB-Hib groups (≥90% for both) and between the MenACYW-TT and MenACYW-TT + PCV13 groups (≥91 and ≥84%, respectively). The safety profiles of MenACYW-TT, and MMR + V, DTaP-IPV-HepB-Hib, and PCV13, with or without MenACYW-TT, were generally comparable. Coadministration of MenACYW-TT with paediatric vaccines in toddlers had no clinically relevant effect on the immunogenicity and safety of any of the vaccines.
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April 2021

[Therapy of perinatal brain injury outcomes: results of a multicenter double-blind placebo-controlled randomized study of tenoten for children (liquid dosage form)].

Zh Nevrol Psikhiatr Im S S Korsakova 2019 ;119(7. Vyp. 2):33-39

Kazan State Medical University, Kazan, Russia.

Objective: To evaluate the efficacy and safety of tenoten for children (a novel liquid pediatric formulation) in the treatment of perinatal brain injury (PBI) outcomes.

Material And Methods: The multicenter double-blind placebo-controlled randomized trial enrolled 184 children (aged 29 days-9 months) with the total score 12-27 according to Djurba-Mastukova scale and the level of physical development 25-75 centiles. Patients were randomized into tenoten (10 drops per day) and placebo groups. Treatment period was 12 weeks ± 5 days. Percentage of patients with ≥4 points improvement according to Djurba-Mastukova scale (responder rate) was used as a primary efficacy endpoint.

Results And Conclusion: Patients in the tenoten group had a significant result on primary efficacy endpoint: 77.5% of participants responded to therapy (p=0.02 vs. placebo). In addition, the safety of tenoten for children in the treatment of PBI outcomes is shown. Tenoten for children (a novel liquid pediatric formulation) has been shown to be an effective medication in treatment of PBI outcomes that helps to achieve therapeutic results with minimal side-effects, good tolerability and the high level of adherence to therapy.
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November 2019

Assessment of pesticides in soil from obsolete pesticides stores: a Caribbean case study.

Environ Monit Assess 2019 Jul 17;191(8):498. Epub 2019 Jul 17.

Plant Production and Protection Division (AGPMC), FAO HQ, Rome, Italy.

The fate of highly hazardous or persistent pesticides in soils and their potential for environmental and health risks depends on the physical and chemical properties of the pesticide, soil properties including biological health and climatic conditions. Assessing the fate and impact of pesticides in soil is complicated in the Caribbean due to the high diversity of soils and duality of climate. The FAO supported national competent authorities from 11 countries in the Caribbean in the assessment of obsolete stocks and potentially contaminated soil. The Environmental Management Tool Kit (EMKT) prioritised Fond Cole and Camden Base as the only critical sites. Preliminary site investigations that utilised the rapid environmental assessment (REA) methodology identified that contamination was restricted to an impervious layer at the Camden site. Pesticide properties varied across groups, with the organochlorides exhibiting greater sorptive capacity and lower leaching potential relative to the organophosphates. All tested soils were non-saline with alkaline pH and notably sandy in texture with low adsorptive capacity. Analysis of pesticide levels revealed low to undetected quantities across contaminated sites. Traces of Endrin and Dieldrin were found in Marienburg, Suriname. Overall, assessment of soil contamination from stored obsolete pesticides revealed minimal contamination, however, detailed assessment considering contamination gradients should be performed where pesticides were identified.
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July 2019

Safety and Immunogenicity of Two Doses of a Quadrivalent Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Indian and Russian Children Aged 9 to 17 Months.

Indian Pediatr 2018 Dec;55(12):1050-1055

Medical Affairs, Sanofi Pasteur, Mumbai, India. Correspondence to: Dr Himanshu Dubey, Sanofi House, CTS No. 117-B, L and T Business Park, Saki Vihar Road, Powai, Mumbai 400 072, India.

Objective: Evaluation of tolerability, safety and immunogenicity of a two-dose series of a quadrivalent meningococcal polysaccharide diptheria toxoid conjugate (ACYW-D) vaccine in Indian and Russian infants/toddlers.

Design: Open-label, single-arm, phase III multi-national trial.

Study Participants: 300 children aged 9-17 months, previously unvaccinated against meningococcal disease from four sites each in India (n=200) and the Russian Federation (n=100).

Intervention: Two 0.5 mL doses of ACYW-D by intramuscular injection, 3-6 months apart.

Main Outcome Measures: Meningococcal antibody titers to serogroups A, C, W-135 and Y, determined using a serum bactericidal assay in the presence of human complement before vaccination and 28 days after the second vaccination. Titers ≥1:8 against either/all of the A, C, W-135 or Y were considered sero-protective.

Results: After dose 2, 95.7-99.5% and 92.9-99.0% of infants/toddlers achieved seroprotection across the four serogroups in India and the Russian Federation, respectively. No immediate adverse events were reported after any dose of ACYW-D. Solicited reactions were reported in 49.2% of participants, and were mainly of Grade 1 severity, and resolved within three days. Unsolicited adverse events were reported in 19.1% of infants: one event (Grade 3 diarrhea, resolving within one day) was considered related to study vaccine. No non-serious adverse events led to premature withdrawal from the study. Four serious adverse events were reported; none were considered related to study vaccine. No deaths occurred during the study.

Conclusions: A two-dose series of ACYW-D vaccine in Indian and Russian children (9-17 month) was well-tolerated with no safety concerns, and induced robust bactericidal antibody responses against the meningococcal serogroups contained in the vaccine.
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December 2018

[The Experimental Model of Autoimmune Process: the Role of Epigenetic Variation in the Population of Mice Hybrids].

Vestn Ross Akad Med Nauk 2015 (2):152-8

Background: At the development of graft versus host disease in genetically homogeneous population of (C57BI/6 x DBA/2) Fl mice two clinical phenotypes of SLE-like disease were revealed: lupus+ (immune complex glomerulonephritis and hemnolytic anemia) and lupus - (hemolytic anemia). The GvHD phenotypic heterogeneity is determined by the Th2-polarization: Th2 lymphocyte predominant activity, leads to the lupus+development, or prevalence activity of Th1 cells, leads to the lupus- development.

Objective: Our aim was to evaluate the possibility of using an experimental model of autoimmnune disease for studying and testing of epigenetic modifications, shifting Th1/Th2 balance in vivo.

Methods: Chronic GVHD was induced in B6D2F1 mice by the transplantation of 130x10(6) parental DBA/2 splenocytes. Anti-ds-DNA, total IgG and IgGI, IgG2a Abs were measured by ELISA.

Results: Six- to 8-week-old female DBA/2 and B6D2F1 mice were obtained from Biological Research Laboratory (Novosibirsk). It was established that regular moderate physical activity (unladed swimming) shifted Th1/Th2 balance towards Th1. This leads to a decrease in a population of recipients the lupus+ mice from 57 to 26% (p <0,001) with significantly reduced hypergammaglobulinemia (IgG from 2,8 to 2,0 mg/ml; p <0,047) and DNA antibodies titer from 0,18 to 0,12 OD (p =0,05). Administration of epigenetic modificator bisphenol A at low doses, which mimicking estrogen effects, enhances the proportion of lupus+ mice in experimental groups from 33 to 64% (p <0,001) and impairs their clinical status by the increasing the urine protein level from 2.8 to 4,2 mg/ml (p <0,001) in animals.

Conclusion: Th1/Th2 - balance presumably is determined by the immune system epigenetic modification in experimental mice, formed on the previous stages of ontogeny and defines the direction of immune processes development in individual animal.
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September 2015