Scientific Program

Day 1 :

Keynote Forum

Magdalena Tary-Lehmann

Case Western Reserve University, USA

Keynote: Title: Challenges and Successes of Measuring Antigen-Specific Immune Responses

Time : 10:00-10:45

IRDI Vaccines 2016 International Conference Keynote Speaker Magdalena Tary-Lehmann photo
Biography:

Magdalena Tary-Lehmann is an Adjunct Associate Professor of Case Western Reserve University (CASE) Department of Pathology, Co-Founding Scientist and Chief Scientific Officer for Cellular Technology Limited (CTL). She has published more than 75 papers in peer-reviewed journals. She provides guidance and oversight for technical operations in the GLP laboratory, ensuring the on-going scientific excellence of CTL. Over the past decade, she has worked with clients and regulatory agencies to develop and validate reference samples and controls for use in regulated immune monitoring assays.

Abstract:

Assessing immunogenicity is a challenge in the biopharmaceutical industry, as an increasing number of new drugs and vaccines aim to elicit a response from the cellular components of the immune system. Antigen specific responses for white blood cells such as T, B, NK and others, is of paramount importance throughout the drug/vaccine development cycle in both the preclinical and clinical phases. It is often the case that cell responses are studied based upon population levels that presume outcomes, but do not clearly enumerate the products individual cells have released. Lack of sensitivity in these assays can lead to misinterpretation of results. Therefore, it may be of key importance to employ an assay that produces high sensitivity based upon single cell responses. For this reason, assays such as ELISA and flow cytometry should be complemented with a single cell assay such as ELISPOT. Measurements of antibodies in bodily fluids (e.g., by ELISA) have provided robust and reproducible results for decades and such assays have been validated for monitoring of B cell immunity. While T cells play a critical role, reliable measurements of antigen specific T cell responses ex vivo remain seemingly problematic, as typically, T cells occur in very low frequencies in test samples, such as peripheral blood with the need to test live cells in functional assays ex vivo. Early considerations to the standardization of specimen processing, cryopreservation, sample management and assay systems are vital steps for the successful design and execution of pre-clinical and clinical trials that deliver consistent and regulatory acceptable immune monitoring data. Examples of such successful T cell monitoring in vaccine evaluations will be presented.

Keynote Forum

Fundación Salvadoreña para la Inmunoinfectologia y Medicina Tropical, USA

Fundación Salvadoreña para la Inmunoinfectologia y Medicina Tropical, USA

Keynote: Jorge Alberto Panameno Pineda

Time : 11:05-11:50

IRDI Vaccines 2016 International Conference Keynote Speaker Fundación Salvadoreña para la Inmunoinfectologia y Medicina Tropical, USA photo
Biography:

Jorge Alberto Panameno Pineda has completed his Medical Doctorate in 1990 at Universidad Evangelica of El Salvador followed by his Internal Medicine Residency at the Salvadorian Institute of Social Security and a Master of Science in Tropical Medicine and Infectious and Parasitic Diseases at the University of Brasilia, Brazil in 1996. Currenty he is the Executive Director of the Fundación Salvadoreña para la Inmunoinfectologia y Medicina Tropical, a non-profit organization dedicated to research infectious and parasitic diseases and vaccinology. He was awarded the World Health Travel Award funded by the Bill and Melinda Gates Foundation in 2012.

Abstract:

Since the late 70s, in the Caribbean, Central and South America, Dengue Fever made its appearance in the form of outbreaks, after decades of epidemiological silence. Thereafter the incidence increased, becoming an endemic disease in our days and causing a major burden on Health Systems in these regions in terms of morbidity and mortality. In December 2013, the Pan American Health Organization (PAHO) warned the regional Health Systems that the autochthonous circulation of Chikungunya virus had been detected in certain francophone Caribbean islands, by April 2014, the virus was circulating in Central America and by December it was present throughout the continent, mainly disseminated by travelers. In May 2015, again OPS issued an alert, this time about Zika virus circulation, it spread across the Pacific Ocean, landing in Brazil. The fundamental link in the chain of transmission of these three arboviruses, is the vector mosquito, its presence in the developing countries of America is directly related to the socio sanitary conditions, primarily to the lack of drinking water, which allows the mosquito to find ideal ecosystems for them to breed. Modifying these conditions may take decades, because they depend on complex social, economic and political elusive mechanisms. In this context within the options to effectively deal with these threats, vaccines present themselves as a real possibility. Although we already have the vaccine against dengue, the availability of budgets must be increased to stimulate research and development, to make available to the medical community these valuable resources that can change history.

Keynote Forum

Giulio Filippo Tarro

Foundation de Beaumont Bonelli for Cancer Research, Italy

Keynote: Emerging H1N1 Influenza A virus and its specific prevention

Time : 11:50-12:35

IRDI Vaccines 2016 International Conference Keynote Speaker Giulio Filippo Tarro photo
Biography:

Giulio Filippo Tarro was graduated from Medicine School, Naples University in 1962. He was the Research Associate at the Division of Virology and Cancer Research, Children’s Hospital from 1965-1968, Assistant Professor of Research Pediatrics, College Medicine (1968-1969), Cincinnati University, Oncological Virology Professor, Naples University (1972-1985), Chief of Division of Virology (1973-2003), Head of Department Diagnostic Laboratories, (2003-2006), D. Cotugno Hospital for Infectious Diseases. Since 2007, he was the Chairman of Committee of Biotechnologies and VirusSphere, World Academy Biomedical Technologies, UNESCO, Adjunct Professor at Department of Biology, Temple University, College of Science and Technology and he has received the Sbarro Health Research Organization Lifetime Achievement Award in 2010. He is also the President of Foundation de Beaumont Bonelli for Cancer Research.

Abstract:

Giulio Filippo Tarro was graduated from Medicine School, Naples University in 1962. He was the Research Associate at the Division of Virology and Cancer Research, Children’s Hospital from 1965-1968, Assistant Professor of Research Pediatrics, College Medicine (1968-1969), Cincinnati University, Oncological Virology Professor, Naples University (1972-1985), Chief of Division of Virology (1973-2003), Head of Department Diagnostic Laboratories, (2003-2006), D. Cotugno Hospital for Infectious Diseases. Since 2007, he was the Chairman of Committee of Biotechnologies and VirusSphere, World Academy Biomedical Technologies, UNESCO, Adjunct Professor at Department of Biology, Temple University, College of Science and Technology and he has received the Sbarro Health Research Organization Lifetime Achievement Award in 2010. He is also the President of Foundation de Beaumont Bonelli for Cancer Research.

  • Status of vaccines research and methodology | Influenza Epidemiology and Diseases Management | Influenza Treatment & Therapies | Ethical Issues in Pandemic Influenza Virus | Recent Advancement in Influenza Vaccine
Speaker

Chair

Ahdi Amer

Wayne State University School of Medicine, USA

Speaker
Biography:

Steven Pincus obtained his Ph.D.in Biochemistry from the State University of NY at Buffalo.  He obtained  post-doctoral training in the microbiology department at the State University of NY at Stony Brook.  Over his career he has held multiple positions at Virogenetics, Elusys Therapeutics and Novavax where he has developed  vaccines and monoclonal antibody therapeutics against viral and  microbial targets and supporting these projects with the development of appropriate analytical methods.  At Fujifilm Diosynth Biotechnologies Texas ( a CDMO) he is AVP Virology and Analytical Development.  He leads teams working with tissue culture, virus propagation and methods transfer/development for multiple clients.  

Abstract:

Multiple virus vectors are being developed as vaccines, therapeutic deliverly systems and as oncolytic treatments for cancers.  Classical approaches to produce viruses have  included a limited number of cell lines (CEF, Vero) grown in roller bottles or in suspension attached to microcarriers.  To produce high dose bulk drug substance for the newer vectors alternative cell lines (duck cells, retina cells, kidney cells) are being developed that can be grown in suspension culture.  Since many cell lines are difficult to adopt to suspension culture alternative ways of growing large numbers of adherent  cells are being developed which allow cultivation of large numbers of cells in a reduced footprint compared to that required with tissue culture flasks or roller bottles.  Fujifilm Diosynth Biotechnologies Texas  is a contract development and manufacturing  organization  speciallizing in production of viral therapeutics and vaccines.  To meet the needs of clients we are evaluating several adherent cell production  technologies for their ability to support the growth of cell lines and  production of virus.   We are evaluating suspension cell lines from alternative sources for their growth and ability to produce virus and to examine whether the use of alternative media can improve the productivity of a less favorable suspension cell line. Virus infectious titer is determined by TCID50, plaque assay, immuno staining and FACS titration.Total virus particles can be determined by HPLC methods  FACS and immunostain can evaluate the titer based on expression of an inserted gene to maintain a potent virus population.

Speaker
Biography:

Doa’a Ahmed Saleh is a Professor of Public Health, Preventive and Social Medicine at the Faculty of Medicine, Cairo University, Egypt. She teaches epidemiology and public health and leads research in communicable and non-communicable diseases and health system research.

Abstract:

Egypt was affected by the influenza A (H1N1) 2009 pandemic, which was the last influenza pandemic in the 20th century. It is not possible to predict neither the timing nor the impact of future influenza pandemics. Thus, it is recommended that influenza pandemic plans be prepared and updated regularly. Plans should consider the health care workers’ preparedness to face such infectious pandemics. The aim of this study was to assess the nurses’ willingness to work and the concerns and persuading factors towards working during infectious influenza pandemics. A cross-sectional study was conducted with 266 nurses; 89 (33.5%) professional nurses working in a tertiary hospital and 43 (16.2%) working in a primary care facility, 105 (50.4%) undergraduate nursing students from the Faculty of Nursing and 29 (10.9%) students from the Secondary Technical Nursing School. None of the studied nurses provided nursing care to H1N1 patients during the 2009 H1N1 pandemic but if forced to do so, 41.5% would not be willing to report to duty. Fear about their families’ health and increased workload were the main concerns of professional and student nurses (p>0.05). Increased rates of infection (OR=3.33) and deaths (OR=2.75) among colleagues and school closure (OR=7.08) were significant concerns for the student compared to professional nurses (p<0.05). Receiving treatment for one self and for family came on top of the persuading factors for all nurses. While vaccination for oneself (OR=2.3) and family (OR=2.0) came on top of the persuading factors for the nursing students (p<0.05). The study concluded that providing nurses with appropriate education, training, supply of adequate protection and psychosocial support should be considered on preparing plans for influenza pandemics.

Speaker
Biography:

Ahdi Amer is an Associate Professor of Pediatrics at Wayne State University School of Medicine, Detroit, USA. He has expertise in the field of general academic pediatrics and pediatric infectious diseases. His main areas of interest are vaccine development, vaccine safety and various pediatric infectious and dermatological disorders. He has conducted clinical research supported by the WHO, Merck and Pfizer regarding vaccines and other topics related to infectious and dermatological diseases in children. He has consulted for UNICEF and WHO on the issue of diarrheal diseases and presented in several international settings on immunization topics.

Abstract:

Background & Aim: Annual vaccination of children against seasonal influenza with trivalent inactivated influenza vaccine (TIV) has shown to be beneficial. However, this yearly practice may have unintended effect. Studies have shown that infection with wild type influenza A viruses can stimulate protective heterotypic immunity against unrelated or new influenza subtypes. We hypothesized that a consequence of yearly TIV vaccination is lack of induction of heterotypic immunity against the recent H1N1 pandemic.

Methods: This was a retrospective case-control study. We reviewed the medical records of polymerase chain reaction confirmed cases of 2009 H1N1 influenza infection in children 6 months to 18 years and a matched control group seen during the pandemic.

Results: We identified 353 polymerase chain reaction confirmed H1N1 cases and 396 matching control subjects. Among the H1N1 group, 202/353 (57%) cases received a total of 477 doses of seasonal TIV compared with 218/396 (55%) in the control group who received a total of 435 doses. Seasonal TIV uptake was significantly higher in the H1N1 group 477/548 (87%) than in the control group, 435/532 (81%) (P=0.017).

Conclusion: Seasonal TIV uptake was significantly higher in H1N1-infected group. The finding suggests that the practice of yearly vaccination with TIV might have negatively affected the immune response against the novel pandemic H1N1 strain. Given the rarity of pandemic novel influenza viruses and the high predictability of seasonal influenza occurrence, the practice of yearly influenza vaccination should be continued. However, the use of live attenuated intranasal vaccine, as opposed to TIV, may allow for the desirable development of a vigorous heterotypic immune response against future pandemics.

Speaker
Biography:

He is a Medical Doctor, Epidemiologist and Immunologist. He has worked at the Ministry of Health of Mexico as Epidemiologist and Head of Research and Training of the National Immunization Program. He was Member of the "Steering Committee on Epidemiology and Field Research" of WHO, and temporary consultant for the Expanded Program on Immunization of WHO/PAHO in Geneva, Washington DC, five Latin American countries, and  Consultant for 10 countries of Southeast Asia (WHO headquarters, New Delhi). He currently serves on the National Institute of Public Health as Researcher, Professor of "Vaccines and Public Health" and visiting professor of Infectious Diseases. He has directed 20 theses of BA, Medical Specialization and Master of Public Health.  He is member of the National System of Researchers and of the National Institutes of Health. He has performed controlled clinical trials of MMR vaccines applied by aerosol and evaluated immune response to other vaccines. He is Technical Secretary of National Commission for Documentation and Verification of Measles-Rubella and Congenital Rubella Syndrome Elimination, and is a member of the PAHO Regional Committee for Certification of Final Eradication of Poliomyelitis.  He has published 49 articles and 16 book chapters or manuals.

Abstract:

Background: Endemic transmisión of measles was interrupted in 1995 in Mexico and in 2002 in Latin American countries, with reintroduction of temporal endemic transmission in Brazil in 2013. In September, 2016 The Americas were declared as free region of endemic transmission of measles, by the International Committee of Experts of PAHO.  

Objective: Describe the role of international travels in the incidence of measles cases in México and in some Latin American countries.

Material and methods: Description and analysis of available information in epidemiological literature and web sites about measles transmisión in the post-elimination era in Mexico and in some Latin American countries.

Results: To achieve measles elimination different strategies have been implemented in Latin American countries. Data from imported cases are presented as well as the consequences of these importations in terms of the occurrence of hot cases, primary cases and secondary cases associated to importations in the post-elimination era of measles. Many of importations and secondary cases have occurred in Brazil, Ecuador and Mexico and have related to international travels to or from different parts of the world. Some characteristics of the molecular epidemiology of the imported cases and risk of transmission to other passengers and the crew are described in this presentation.

Conclusions: International travelers under conditions of susceptibility are at risk of acquiring measles even in countries without endemic transmission. Both epidemiological surveillance of high quality and high immunization coverage could explain the absence of secondary cases in the native population of those countries.

Magdalena Tary-Lehmann

Case Western Reserve University School of Medicine, USA

Title: Challenges and successes of measuring antigen-specific immune responses
Speaker
Biography:

Magdalena Tary-Lehmann is an Adjunct Associate Professor of Case Western Reserve University (CASE) Department of Pathology, Co-Founding Scientist and Chief Scientific Officer for Cellular Technology Limited (CTL). She has published more than 75 papers in peer-reviewed journals. She provides guidance and oversight for technical operations in the GLP laboratory, ensuring the ongoing scientific excellence of CTL. Over the past decade, she has worked with clients and regulatory agencies to develop and validate reference samples and controls for use in regulated immune monitoring assays.

Abstract:

Assessing immunogenicity is a challenge in the biopharmaceutical industry, as an increasing number of new drugs and vaccines aim to elicit a response from the cellular components of the immune system. Antigen specific responses for white blood cells such as T, B, NK and others, is of paramount importance throughout the drug/vaccine development cycle in both the preclinical and clinical phases. It is often the case that cell responses are studied based upon population levels that presume outcomes, but do not clearly enumerate the products individual cells have released. Lack of sensitivity in these assays can lead to misinterpretation of results. Therefore, it may be of key importance to employ an assay that produces high sensitivity based upon single cell responses. For this reason, assays such as ELISA and flow cytometry should be complemented with a single cell assay such as ELISPOT. Measurements of antibodies in bodily fluids (e.g., by ELISA) have provided robust and reproducible results for decades and such assays have been validated for monitoring of B cell immunity. While T cells play a critical role, reliable measurements of antigen specific T cell responses ex vivo remain seemingly problematic, as typically, T cells occur in very low frequencies in test samples, such as peripheral blood with the need to test live cells in functional assays ex vivo. Early considerations to the standardization of specimen processing, cryopreservation, sample management and assay systems are vital steps for the successful design and execution of pre-clinical and clinical trials that deliver consistent and regulatory acceptable immune monitoring data. Examples of such successful T cell monitoring in vaccine evaluations will be presented.