2 Academy Pavlov Street

Saint Petersburg, Russia

2 Academy Pavlov Street

Saint Petersburg, Russia
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PubMed | Changchun BCHT Biotechnology Co., Jilin University, 2 Academy Pavlov Street and Colorado State University
Type: Journal Article | Journal: Vaccine | Year: 2016

We evaluated the safety and efficacy of a live attenuated influenza vaccine (LAIV) product in ferrets. The BCHT LAIV product was significantly less virulent than wild-type H1N1 virus, when evaluated by comparing virus shedding and histopathologic lesions. The data indicated strong evidence for an attenuated phenotype of LAIV. Furthermore, the vaccine induced robust humoral immune responses in seronegative ferrets, and protected ferrets against development of fever, weight loss and turbinate inflammatory lesions after challenging with H3N2 wide-type influenza virus. Thus, the BCHT LAIV product was safe in healthy seronegative ferrets and protected ferrets against infection of H3N2 influenza virus.


Stittelaar K.J.,Viroclinics Biosciences | Veldhuis Kroeze E.J.B.,Viroclinics Biosciences | Veldhuis Kroeze E.J.B.,Erasmus Medical Center | Rudenko L.,2 Academy Pavlov Street | And 5 more authors.
Vaccine | Year: 2011

The advent of the H1N1 influenza pandemic (pH1N1) in 2009 triggered the rapid production of pandemic influenza vaccines, since seasonal influenza vaccines were expected and demonstrated not to provide significant cross-protection against the newly emerged pandemic virus. To increase vaccine production capacity and further evaluate the effectiveness of different candidate pandemic influenza vaccines, the World Health Organization stimulated the evaluation of different vaccination concepts including the use of live attenuated influenza vaccines (LAIVs). Therefore, we have immunized ferrets intranasally with a single dose of pH1N1-LAIV from different manufacturers. They all induced adequate serum HI antibody titers in the ferrets and protected them against intratracheal wild-type pH1N1 virus challenge: pH1N1 virus replication in the upper respiratory tract and lungs was reduced and no disease signs or severe broncho-interstitial pneumonia were observed in any of the vaccinated ferrets. These data together with the relatively efficient production process emphasize the potential of the LAIV concept for pandemic preparedness. © 2011 Elsevier Ltd.


Stepanov I.I.,2 Academy Pavlov Street | Abramson C.I.,Oklahoma State University | Warschausky S.,University of Michigan
Child Neuropsychology | Year: 2011

A mathematical model is proposed to measure the learning curve in the California Verbal Learning Test-Children's Version. The model is based on the first-order system transfer function in the form Y = B3*exp[-B2*(X- 1)]+B4*{1-exp[-B2*(X-1)]}, where X is the trial number, Y is the number of recalled correct words, B2 is the learning rate, B3 is interpreted as readiness to learn and B4 as the ability to learn. Children's readiness to learn and ability to learn were lower than adults. Modeling revealed that girls had greater readiness to learn and ability to learn than boys. © 2011 Psychology Press, an imprint of the Taylor & Francis Group, an Informa business.


Stepanov I.I.,2 Academy Pavlov Street | Abramson C.I.,Oklahoma State University | Wolf O.T.,Ruhr University Bochum | Convit A.,New York University | Convit A.,Nathan Kline Institute for Psychiatric Research
Journal of the International Neuropsychological Society | Year: 2010

Very few attempts have been made to apply a mathematical model to the learning curve in the California Verbal Learning Test list A immediate recall. Our rationale was to find out whether modeling of the learning curve can add additional information to the standard CVLT-II measures. We applied a standard transfer function in the form Y = B3*exp(-B2*(X-1))+B4*(1- exp(-B2*(X-1))), where X is the trial number; Y is the number of recalled correct words, B2 is the learning rate, B3 is readiness to learn and B4 is ability to learn. The coefficients of the model were found to be independent measures not duplicating standard CVLT-II measures. Regression analysis revealed that readiness to learn (B3) and ability to learn (B4) were significantly (p <.05) higher in a group of healthy participants than in a group of participants with type 2 diabetes mellitus (T2DM), but the learning rate (B2) did not differ (p >.2). The proposed model is appropriate for clinical application and as a guide for research and may be used as a good supplemental tool for the CVLT-II and similar memory tests. Copyright © The International Neuropsychological Society 2010.


Abramson C.I.,Oklahoma State University | Stepanov I.I.,2 Academy Pavlov Street
Bulletin of Environmental Contamination and Toxicology | Year: 2012

No attempts have been made to apply a mathematical model to the learning curve in honey bees exposed to pesticides. We applied a standard transfer function in the form Y = B3*exp(-B2 *(X -1)) B4 *(1 -exp(-B2 *(X -1))), where X is the trial number; Y is proportion of correct responses, B2 is the learning rate, B3 is readiness to learn and B4 is ability to learn. Reanalyzing previously published data on the effect of insect growth regulators tebufenozide and diflubenzuron on the classical conditioning of proboscis extension, the model revealed additional effects not detected with standard statistical tests of significance. © Springer Science+Business Media, LLC 2012.


Rudenko L.,2 Academy Pavlov Street | Yeolekar L.,Serum Institute of India | Kiseleva I.,2 Academy Pavlov Street | Isakova-Sivak I.,2 Academy Pavlov Street
Vaccine | Year: 2016

Influenza is a viral infection that affects much of the global population each year. Vaccination remains the most effective tool for preventing the disease. Live attenuated influenza vaccine (LAIV) has been used since the 1950s to protect humans against seasonal influenza. LAIVs developed by the Institute of Experimental Medicine (IEM), Saint Petersburg, Russia, have been successfully used in Russia since 1987. In 2006, the World Health Organization (WHO) announced a Global action plan for influenza vaccines (GAP). WHO, recognizing potential advantages of LAIV over the inactivated influenza vaccine in a pandemic situation, included LAIV in the GAP. BioDiem Ltd., a vaccine development company based in Melbourne, Australia which held the rights for the Russian LAIV, licensed this technology to WHO in 2009. WHO was permitted to grant sub-licenses to vaccine manufacturers in newly industrialized and developing countries to use the Russian LAIV for the development, manufacture, use and sale of pandemic and seasonal LAIVs. To date, WHO has granted sub-licenses to vaccine manufacturers in China (Changchun BCHT Biotechnology Co., Ltd.), India (Serum Institute of India Pvt. Ltd.) and Thailand (Government Pharmaceutical Organization). In parallel, in 2009, IEM signed an agreement with WHO, under which IEM committed to supply pandemic and seasonal candidate vaccine viruses to the sub-licensees. This paper describes the progress made by collaborators from China, India, Russia and Thailand in developing preventive measures, including LAIV against pandemic influenza. © 2016 Elsevier Ltd


Rudenko L.,2 Academy Pavlov Street | Isakova-Sivak I.,2 Academy Pavlov Street | Donina S.,2 Academy Pavlov Street
Vaccine | Year: 2013

After recent emergence of new avian influenza A(H7N9) viruses in humans many people and Governments are asking about H7 influenza vaccine which could provide cross-protection against new viruses, until H7N9 vaccine is prepared from a relevant strain. Here we scientifically justify that available H7N3 live attenuated influenza vaccine (LAIV) can be protective against H7N9 viruses due to the presence of conserved immune epitopes in its hemagglutinin. We used Immune Epitope Database analysis resource to predict B-cell and CTL epitopes distributed across H7N3 HA molecule and assessed their identity with new H7N9 viruses at near 70% and 60% of the epitopes, respectively. In addition, we tested serum samples of volunteers participated in phase I clinical trial of H7N3 LAIV for the presence of anti-H7N9 hemagglutination-inhibition and neutralizing antibodies and found seroconversions in 44.8% of vaccinated persons, which suggests the potential of H7N3 LAIV to protect against new H7N9 avian influenza viruses. © 2013 Elsevier Ltd.


Isakova-Sivak I.,2 Academy Pavlov Street | Rudenko L.,2 Academy Pavlov Street
Expert Review of Vaccines | Year: 2015

Live attenuated influenza vaccines (LAIVs) are believed to be immunologically superior to inactivated influenza vaccines, because they can induce a variety of adaptive immune responses, including serum antibodies, mucosal and cell-mediated immunity. In addition to the licensed cold-adapted LAIV backbones, a number of alternative LAIV approaches are currently being developed and evaluated in preclinical and clinical studies. This review summarizes recent progress in the development and evaluation of LAIVs, with special attention to their safety, immunogenicity and infectivity for humans, and discusses their perspectives for the future. © 2015 Informa UK, Ltd.


Rudenko L.,2 Academy Pavlov Street | Isakova-Sivak I.,2 Academy Pavlov Street
Expert Review of Vaccines | Year: 2015

Continuously evolving avian influenza viruses pose a constant threat to the human public health. In response to this threat, a number of pandemic vaccine candidates have been prepared and evaluated in animal models and clinical trials. This review summarizes the data from the development and preclinical and clinical evaluation of pandemic live attenuated influenza vaccines (LAIV) based on Russian master donor virus A/Leningrad/134/17/57. LAIV candidates of H5N1, H5N2, H7N3, H1N1 and H2N2 subtypes were safe, immunogenic and protected animals from challenge with homologous and heterologous viruses. Clinical trials of the pandemic LAIVs demonstrated their safety and immunogenicity for healthy adult volunteers. The vaccine viruses were infectious, genetically stable and did not transmit to unvaccinated contacts. In addition, here we discuss criteria for the assessment of pandemic LAIV immunogenicity and efficacy necessary for their licensure. © 2015 Informa UK, Ltd.


Rudenko L.,2 Academy Pavlov Street | Isakova-Sivak I.,2 Academy Pavlov Street | Rekstin A.,2 Academy Pavlov Street
Expert Review of Vaccines | Year: 2014

As of October 2013, H7N9 avian influenza viruses caused 137 human cases with 45 fatalities. Recent studies revealed that only minor adaptive changes are required for H7N9 viruses to become pandemic. Vaccination is a primary measure to protect population from severe disease and reduce the impact of epidemics and pandemics on public health. Several H7N9 candidate vaccine viruses have been generated and are now undergoing preclinical and clinical testings, which will take several months. Meanwhile, there are several vaccine candidates with H7 hemagglutinin, which can be used to prime the immune system for a robust immune response to booster vaccination with H7N9 vaccine, with perspectives of a substantial dose sparing. H7N3 live-attenuated influenza vaccine besides being attractive priming vaccine in prime-boost strategies, has a potential to protect against H7N9 virus, as was demonstrated by immune epitope analysis and by the detection of cross-reactive antibodies in serum samples of volunteers. © Informa UK, Ltd.

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