Scientific Program

Day 1

KEYNOTE SPEAKERS
  • Measles vaccination: Threat from related veterinary viruses and need for continued vaccination post measles eradication

    Queen's University Belfast
    United Kingdom
    Biography

    Professor S. Louise Cosby (SLC) was appointed as Head of Virology Branch at the Agri-Food and Biosciences institute, UK, in 2015. She was Chair of Microbiology in Queen’s University Belfast from 2002 and remains an emeritus professor. SLC is a Fellow of Royal College of Pathologists (London) and Fellow of the Royal Society of Biology, UK. She has served/currently serves on grant/editorial boards: BBSRC, UK; Chair/member, Science Foundation Ireland; Deputy Chair Professional Development Committee, Microbiology Society, UK; Associate Editor, Journal of Neurovirology, USA; Review editor, Frontiers in Microbiology; External Assessor for Appointments and Promotions in Medical Microbiology, University of Malaysia. Research interests: in virus pathogenesis including virus-receptor interactions, virus-induced immunosuppression as well as novel diagnostics and vaccine development. Work has focused on paramyxoviruses of both human and veterinary interest, with publications/grant funding in this area.

    Abstract

    Measles virus (MV) is the only human virus within the morbillivirus genus of the Paramyxoviridae. The virus can cause severe complications such as measles giant cell pneumonia and acute post measles encephalitis. More rarely fatal infections of the CNS, subacute sclerosing panencephalitis (SSPE) and in immunosuppressed individuals measles inclusion body encephalitis (MIBE) occur. The World Health Organization (WHO) has set goals towards the complete eradication of MV in at least five WHO regions by 2020 raising the risk of zoonotic infection. MV is thought to have evolved from the now eradicated cattle morbillivirus, rinderpest, and to have entered the human population during cattle domestication. Lessons have also been learned from other animal to human virus transmission i.e. human immunodeficiency virus (HIV) and more recently avian influenza, severe acute respiratory syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS). This highlights the potential consequences of complete withdrawal of MV vaccination after eradication. This may present presents problems as the closely related veterinary members in the genus share common cell entry receptors. Therefore novel cross reacting vaccines will be required.The current measles vaccine is live attenuated and has very low risk of reversion but is still unlikely to be acceptable in a MV free world raising the need for alternative approaches. A formalin fixed MV vaccine was used for a period in the 1960’s but provided short lived and non-complete immunity with an altered immune response and death of some children following later infection. This has encouraged research into recombinant vaccines for MV and the closely related veterinary viruses using other virus vector systems. The potential for zoonotic infection and approached to vaccination will be discussed.

  • Can mucosal immunity succeed where other systemic immune responses failed? Intranasal immunization using a NanostatTM platform technology protected against respiratory and sexually transmitted diseases in the appropriate animal challenge models

    NanoBio Corporation
    USA
    Biography

    For more than 25 years Dr. Fattom led research in vaccine discovery and development against infectious diseases and addiction. After a 5 years tenure in vaccine research at the NIH, under Dr. John Robbins, Dr. Fattom moved to the biotech industry, he joined Nabi Biopharmaceuticals, to lead bacterial vaccines development. His work on Staphylococcus aureus pathogenesis, determination of virulence factors, and identifying protective antigens for developing a protective vaccine against this pathogen are well recognized in the field. Nicotine vaccine, a second lead vaccine developed by Dr. Fattom for smoking cessation was also developed through phase II clinical trials. In 2010, Dr. Fattom joined NanoBio Corp. as a Sr. VP of vaccine research and development. For the last 6 years, his efforts were focused on developing intranasal vaccines against respiratory (Flu, RSV, Anthrax, and Pertussis), and sexually transmitted diseases (Genital herpes HSV2, Chlamydia, and HIV). Target indication for these vaccines is to protect against disease, carriage, shedding/transmission. Dr. Fattom holds an Adjunct professor at the University of Michigan since 2012. He authored >70 publications and >20 issued patents. He is a reviewer for NIAID and NIDA grant applications and a reviewer for several journals including Vaccine, Infection and Immunity, Human Vaccines & Immunotherapeutics, and NPJ Vaccine.

    Abstract

    The list of failed vaccines against respiratory and sexually transmitted diseases in late clinical development is growing. Recent failures include parenterally administered vaccines against RSV and genital herpes (HSV2). Further, the emerging pertussis infections and outbreaks on the background of a well-established acellular pertussis vaccine is also alarming. Mucosal surfaces are the port of entry for respiratory and sexually transmitted diseases. Yet most vaccines evaluated or licensed to date are parenterally administered and target systemic responses. Targeting and triggering mucosal immunity may bring to the table another efficient arm of the immune response that may prove essential in preventing or treating sexually transited or respiratory infections. NanoBio is developing an intranasal nanoemulsion adjuvant/delivery (NE) that induces mucosal Th17 responses and enhances homing of IgG and IgA -secreting B-cells to localize in the mucosal tissues. Evaluation of intranasal NE-RSV and NE-HSV2 vaccines in primary animal models demonstrated that the vaccinated animals were protected against disease, colonization, shedding, as well as chronic infection in the case of HSV2 challenge. These data suggest that mucosal immunity may be essential for successful development of efficacious vaccines against these mucosal pathogens and maybe improvement and expanding coverage of existing vaccines such as pertussis and flu vaccines. Mucosal Immunization and protection data from HSV2 in guinea pigs, RSV in monkeys, and flu in ferrets will be shared.

  • Recent progress in Human mucosal vaccine development: Role of Mucosal Immunity and Mucosal Microbiome in the outcome of vaccine effectiveness

    The State University of New York
    USA
    Biography

    Dr. Ogra’s career in medicine began in the early 1960’s. His academic leadership has focused on research, teaching and patient care in childhood infections, mucosal vaccine development, and definition of biologic markers of immunity against human infections. His major scientific contributions began with the first functional characterization of secretory IgA and “alimentary” mucosal immunity in natural or vaccine induced infection with poliovirus. In subsequent investigations, he defined the role of secretory IgA and cellular mucosal immune responses to such human infections as rubella, mumps, hepatitis B virus and enteroviruses. His laboratory provided extensive immunologic characterization of human milk, its role in maternal-neonatal interactions and childhood infections, and the association of mammary glands with other components of the common mucosal immune system. Other investigations from his laboratory identified important components of host-pathogen interactions underlying the pathogenesis of mucosal infections, notably in Bronchiolitis due to respiratory syncytial virus (RSV), gastroenteritis due to rotavirus, and immunologic aspects of Otitis media in childhood. These include, demonstration of RSV specific IgE in the respiratory mucosa and its role in viral induced reactive airway disease, identification of rotavirus- specific receptor-binding sites in villous enterocytes in early infancy and the role of Bifidobacteria in modulating rotavirus-mucosal cell interactions, and development of IgA and other aspects of mucosal immune responses in the middle ear mucosa during otitis media. Dr. Ogra served as the chief of Pediatric infectious diseases and Professor of Pediatrics and Microbiology at the University at Buffalo, State University of New York until 1990, when he was appointed as the John Sealy Distinguished Chair Professor and Chairman of the Department of Pediatrics at the University of Texas Medical Branch (UTMB), Pediatrician-in-Chief at the UTMB Children's Hospital, and as Professor of Microbiology and Immunology.. He retired from this position in 2002. Since that time, he has returned to the Children’s Hospital of Buffalo and is currently serving as Professor Emeritus, Department of Pediatrics at the State University of New York at Buffalo. Dr. Ogra has been a member of over 30 prestigious national and international scientific societies, These include election as ; Member, Association of American Physicians, American Society for Clinical Investigation, American Pediatric Society; Fellow ; Royal Society (Medicine) , London, UK . Infectious Diseases Society of America, American Academy of Microbiology. He has received multiple honors and awards, and has served as an honored guest and commencement speaker at medical school graduation events. He has served on many study sections, and national and international advisory panels of World Health Organization, National Institutes of Health (US) Institute of Medicine:, US National academy of Sciences, Federal Drug Administration ,International Vaccine Institute, Seoul, S. Korea, European Union ,Mucosal Vaccine Development Program (MUVAPRED). To date, Dr. Ogra has contributed over 440 peer reviewed original scientific publications and review articles. He has edited, in collaborations with many of his colleagues, 20 full-length books and monographs, has served as the founding editor of the first comprehensive textbook of Mucosal Immunology. During his investigative career, Dr. Ogra has served as the mentor of over 75 post-doctoral fellows and PhD students in Microbiology and Immunology and training of over 500 Pediatric residents. He continues to remain very active as a consultant and a teacher in the diverse areas of vaccine research and development and in the global issues of childhood infectious diseases. He devotes significant amount of his effort in the field in South Asia, towards the control of vaccine preventable diseases of the poor.

    Abstract

    One of the most successful and enduring accomplishments of mankind to date is the prevention or effective control of many infectious diseases through the use of vaccines. Most vaccines have been administered via the systemic (intramuscular/intracutaneous/subcutaneous) route. Such vaccines have resulted in significant decline in the disease burden of systemic infections associated with blood stream involvement, such as diphtheria, tetanus, pertussis, hemophilus influenzae, mumps, measles, rubella, and in the complete eradication of smallpox, Poliovirus type2 infection, and virtual elimination of other poliovirus types in most parts of the world. Systemic immunization has been highly effective in inducing systemic innate and adaptive immune responses, but limited or variable degree of immunity in the mucosal sites. Most human infections are acquired via the external mucosal surfaces of the respiratory, gastrointestinal, urogenital tracts. Human and other mammalian mucosal surfaces are in continuous contact with external environment and exposed to an overwhelming spectrum of microorganisms, dietary agents and other environmental macromolecules. It is estimated that the human intestinal mucosa alone contains >?10?^14 bacterial organisms representing as many as 2000 species , and over ?10?^11 virus -like particles/gm of feces, of nearly 1,000 viral species. In addition to the bacteria and viruses, human mucosal surfaces are the primary portals of entry and sites of initial colonization with many fungi and parasitic agents. However, pathogenic agents represent a very tiny fraction of the entire mucosal microbial repertoire .The mucosal surfaces of the human neonate begin to be colonized with components of maternal microbiome shortly before , during the process of birth and, subsequently within the first 2-3 weeks after birth from maternal and other environmental exposures. Studies over the past 5 decades have demonstrated an extensive and intercommunicative network of innate and adaptive immune mechanisms in the mucosa associated lymphoid tissue(MALT) distributed in the gut(GALT), upper Respiratory and bronchial epithelium (BALT), nose-nasopharynx-waldyers ring(NALT), Sublingual tissue(SLT),Urogenital tissue and mammary glands, and Skin(SALT). These lymphoid elements are collectively referred as the common mucosal Immune system. There is now increasing evidence to suggest that induction of protective immune response in the specific mucosal portals of entry is the most effective approach to regulate local colonization and subsequent disease outcome. Currently available mucosal vaccines include vaccines against, polioviruses,(live attenuated- oral)rotavirus(live attenuated –oral) influenza virus(live attenuated –nasal),vibrio cholera(inactivated-oral)and salmonella typhi (live attenuated-oral). Several other candidate mucosal vaccines are currently undergoing evaluations in human trials. These include, enterotoxigenic E.coli (ETEC), Shigella, Helicobacter, Campylobacter, Salmonella paratyphi, and Norovirus. The composition and the diversity of mucosal microbiome have been shown to have a profound influence on the induction of immune response and efficacy of mucosally introduced vaccines, especially in tropics. Other possible factors which influence the effectiveness of mucosal vaccines include, methods delivery of the infant (vaginal vs C-section) , postnatal feeding practices, malnutrition and carbohydrate consumption, use of antibiotics, and mucosal inflammation. Currently, mucosally delivered vaccines comprise of non- replicating whole organisms, synthetic peptides, inactivated toxins, and recombinant subunit proteins. In order to improve their immunogenicity and protective efficacy, the use of adjuvants has been explored in several clinical trials. These include, adjuvants which facilitate effective delivery of vaccine antigens ( liposomes, nanogels, oil-in-water emulsions); adjuvants directed at targeting vaccine antigens to professional antigen presenting cells (APC) (Virosomes). Finally, several adjuvants which stimulate the immune system itself are being explored currently in different settings. These include molecules binding to specific cellular receptors such as TLR, NOD and RIG1 like receptors, and DNA sensors.

  • Colon cancer stem cell-based vaccine reduces efficiently both tumor growth and cancer stem cell subpopulation in a mouse colon carcinoma model

    Southeast University
    China
    Biography

    Dr. Jun Dou now is a Director, Professor of Department of Pathogenic Biology and Immunology, School of Medicine, Southeast University. He got his Medicine Doctor degree (MD, PhD) in 1997 at Zhejiang University of China. Dr. Jun Dou visited the Ulm University School of Medicine, Germany as a Visiting Scholar from Jun 1999 to Sept.1999, and then visited the CDC, USA as a senior visiting fellow from Oct. 2001 to Feb.2004. And Dr. Jun Dou visited the Georgia State University, USA as a visiting fellow from Sept. 2006 to Dec. 2006. Recently, Dr. Dou visited the Yale University School of Medicine, USA twice as a senior visiting fellow in 2014 and in 2015. Currently Dr. Dou’s research has focused on the cancer stem cells (CSCs), the targeted CSCs by manipulation of nc-RNAs to treat breast, ovarian, colon cancers, and melanoma, as well as the CSC vaccines and CSC nanotheranostics.

    Abstract

    Statement of the Problem: Colon cancer is the most common malignant gastrointestinal cancers that are still the most frequent cause of cancer-related mortality in China. Colon cancer stem cells (CCSCs) are the main reasons that result in the drug and radiation resistance, invasive growth, metastasis, and cancer relapse. Though many factors involving immunosurveillance and immunosuppression were recently validated as important for patient prognosis, a lot of experimental immunotherapies to fight unresectable metastatic colorectal cancer, only few cases, have successfully induced antitumor immune response against malignancies. The goal of this work was to investigate the effects on the inhibition of colon cancer growth by vaccination of CCSC vaccines. The CD133+CSCs were isolated from human LOVO and mouse CT26 cell lines by using a magnetic-activated cell sorting system, respectively. The xenograft or syngeneic mice were subcutaneously inoculated with the LOVO or CT26 CD133+CSC vaccine inactivated with again and again freeze thawing three times before the mice were challenged subcutaneously with LOVO or CT26 cells. The inhibition tumor efficacy was assessed by the tumorigenicity, immune efficient analysis by flow cytometer, and enzyme-linked immunosorbent assays, respectively. The results showed that, compared with the non-CSC vaccine, the inhibition tumor growth efficacy of LOVO or CT26 CSC vaccine was significantly increased in the xenograft or syngeneic mice. Vaccination of LOVO or CT26 CD133+CSC vaccine resulted in increasing cytotoxic activity of natural killer cells, enhancing serum IFN-?, and decreasing TGF-? levels in the mice. The LOVO and CT26 CD133+CSC vaccines significantly reduced the CSC subpopulations in the colon cancer tissues. Conclusion & Significance: The data provided the first evidence that the human LOVO or mouse CT26 CD133+CSC-based vaccine may be an attractive therapeutic approach to excitation of anti-tumor immunity for treatment of colon cancer.

Advanced vaccine technology and engineering | Vaccine Production | DNA Vaccines | Human and Bovine Tuberculosis vaccine | Classification Vaccines | Bioinformatics in Vaccine Design | Synthetic Genomics-Based Vaccines | Profiling Immune Responses to Infection and Vaccines | New Approaches to Viral Vaccines | Measles Vaccine | The Challenge of Helminth Vaccines | Market revenue from Vaccines
Speaker
  • Autoimmunity in Breast Carcinogenesis. Implications for Vaccination in Solid Tumors
    Speaker
    Félix Fernández Madrid
    Wayne State University
    USA
    Biography

    Félix Fernández Madrid is a Professor of Internal Medicine at Wayne State University in Detroit Michigan. His affiliations are Department of Internal Medicine,Center for Molecular Medicine and Genetics, Karmanos Cancer Institute. Based on the established role of autoantibodies as diagnostic and prognostic biomarkers in the rheumatic autoimmune diseases [RADs] and on their involvement in disease pathogenesis I became interested on a novel biomarker discovery approach which may contribute to the diagnosis of BC and other solid tumors. We demonstrated that autoantibodies in BC are not epiphenomena and that anti-mitochondrial antibodies targeting subunits of mitochondrial electron transfer chain complexes I, IV and V encoded by mtDNA are BC autoantigens, suggesting that these autoantibodies are the expression of mitochondrial autoimmunity in BC. There are established links between chronic inflammation and cancer and autoimmune tissue damage is an accepted concept in the pathogenesis of RADs. A major goal of my research program is to establish the role of tissue damage produced by autoimmunity to breast antigens as contributors to creating a chronic inflammatory milieu promoting the progression of BC, and other solid tumors.

    Abstract

    Our findings of anti-mitochondrial and anti-centrosome antibodies as well as autoantibodies targeting, RNA and RNA-protein complexes, histones, idiotypes and molecules involved in remodeling of the microenvironment in breast cancer [BC] sera, support our proposal that autoimmunity to tumor associated [TAA] and stromal associated antigens [SAA] is involved in breast carcinogenesis. Autoimmunity is mechanistically involved in the pathogenesis of rheumatic autoimmune and organ-specific autoimmune diseases by triggering chronic inflammation with consequent end-organ tissue damage. It is generally accepted that chronic inflammation may lead to the development of cancer. The most effective anti-tumor immune responses in animal models as well as in humans have relied on the efficient generation of TH1-cell immunity that promotes CTL responses that would favor tumor regression, while TH2 responses, ie, autoantibodies and cytokines have failed to provide a vigorous anti-tumor effect. In this context, efforts to prevent and/or eradicate solid tumors with the use of vaccination, although promising have been largely disappointing. We have proposed that autoimmunity to TAAs and SAAs is responsible for autoimmune breast tissue damage, fueling chronic inflammation with generation of tumorigenic signals providing the rationale for the reported paradoxical association of B-cell hyperactivity and BC progression. The proposed model of cancer progression based on mitochondrial autoimmunity implies a vicious cycle of mitochondria/ER stress, immune recognition of accumulated unfolded or misfolded mitochondrial, centrosome and other proteins by auto-reactive immune cells, autoimmune damage of the target organ and chronic inflammation with generation of tumorigenic signals. Autoantibodies in BC do identify autoantigens participating in breast carcinogenesis. Some autoantibodies and cytokines involved in immune surveillance may have anti-tumor effects while others may be tumorigenic and promote cancer progression. This model has the potential ability of identifying protective and tumorigenic responses as well as new candidate biomarkers for targeted immunotherapy and for cancer vaccination in solid tumors.

  • Development of a bovine papillomavirus VLP vaccine in bacterial host
    Speaker
    Diego Grando Módolo
    Butantan Institute
    Brazil
    Biography

    Diego Grando Módolo has a PhD degree in Genetics and Molecular Biology, and many years of experience in production of recombinant antigens in plants and bacteria. Has his expertise in expression and characterization of recombinant vaccines, including the production of papillomavirus virus-like particles. Actually, he is working at Butantan Institute, in the Research and Development of innovative solutions in the area of animal or human health. Using his experience in biotechnology to produce biomolecules of pharmaceutical interest.

    Abstract

    Bovine papillomatosis (BP) is an infectious disease, presenting multiple benign epithelial proliferative lesions. BP causes economic losses, since affected animals usually show delayed development, weight loss, reduction of milk flow and leather quality. There are not yet commercial vaccines against BPV available up to date. Here, we developed an integrated study about the L1 capsid protein of BPV-1, obtained from bacterial expression system, concerning its purification, biosafety, thermo-stability and immunogenicity. The recombinant protein was expressed in bacteria and purified by Affinity and Ion Exchange chromatography. Circular dichroic (CD) spectra analysis indicated the correct folding of the recombinant L1 protein, suggesting a predominantly ?-sheet structure. The thermostability of the recombinant L1 was accessed through the CD signal. Provided data revealed a TM value of 55.7oC. The biosafety of the recombinant L1 protein was evaluated by the cytokinesis-blocked micronucleus test. This test detected a high frequency of micro nucleated cells in the positive control, which was not verified in both the negative control and in the cells treated with the L1 recombinant protein. Complementally, comet assay indicated similar results. A heterogenic complex of structures was observed with Transmission Electron Microscopy, with a consistent conformation of both incomplete and complete VLPs, with approximately 45 and 55 nm, respectively. Structural capsomeres were also found nearby the virus-like particles. For prophylactic test, we inoculated by intradermal injection young calves. After 30 days of the booster dose, antibody levels in control group did not increase. On the other hand, the group that received two vaccine doses showed a significant high production of specific antibodies against recombinant L1 of BPV-1. Our strategy can be useful to evaluate the efficacy and the safety of different recombinant vaccine candidates. Moreover, described recombinant VLPs has proved to be a viable approach for designing new vaccines against other PVs species, including the human papillomavirus.

  • Anti- energy based unconventional prophylactic HIV/AIDS vaccine provide proof of concept in human
    Speaker
    Bandana Uniyal
    Shri Radheykrishna Oaj (AIDS) Vaccine Organization
    India
    Biography

    The prime aim of my life is to prepare preventive vaccine against HIV/AIDS. I am working on my unconventional anti – energy based hypothesis. To fulfill my dream I was developed an organization. I am a young researcher and struggling for developing my aim in reality. I was got young scientist B fellowship in 2008 by the Department of Science and Technology, New Delhi.

    Abstract

    Statement of the Problem: The human immunodeficiency virus (HIV) pandemic is now in its fourth decade. With more than 35 million infected in over thirty years, the HIV pandemic has been an unique challenge to the scientific community. The development of effective anti-retroviral therapy has decreased morbidity and mortality of those infected with HIV, but a comprehensive approach that includes effective preventive strategies will be needed to curb this unique pandemic. Vaccine remains the best option, but the development of a safe and effective preventive HIV vaccine has defied decades of research. Over 30 products have been tested in more than 85 trials, but no safe and effective vaccine has been developed yet. Despite these setbacks, these decades of research have broadened the understanding of HIV immunopathogenesis and closer to the goal of a successful HIV vaccine. Understanding the unique obstacles in HIV vaccine development has been key in creating breakthroughs and tracing a path forward. The complexity of this challenge has required innovative approach to vaccine development. Prototype HIV -1 vaccine candidates aimed at eliciting humoral and cellular immune responses have so far failed to protect against HIV -1 infection or to reduce viral loads after infection in clinincal efficacy studies. A new unconventional basic research study finds a proof of concept in human when 1:2 dilutions of HIV -1 infected (positive) serum with anti-energy substance lost its infectivity when left for two weeks. This vaccine strategy based on energy utilized by the HIV -1 virus for replication inside host rather than proteinious nature of virus. No chemical treatment for inactivation and killing of HIV -1 virus. Vaccine was administered intramuscularly to HIV negative individual. After 3.5 years of follow up study, vaccine subject do not show any symptoms of HIV – 1 infection but does not show humoral antibody response. Protection was occurred due to cellular immunity. Sexual transmission of virus does not occur in study subject while no prevention methods were used during sexual relationship. In vaccine subject general parameters of blood (Complete Blood Count) is normal in range. The nature of HIV infections argues strongly that an effective vaccine must block infection such that it never becomes established in vaccinated individuals (i.e., sterilizing protection). The basic research study provides proof of concept for prophylactic HIV – 1 vaccine in human. The study vaccine is safe and effective.

  • Presence of cellular components in vaccines
    Speaker
    Valentina Divocha
    Ukrainian Research Institute for Medicine of Transport of Ministry of Health
    Ukraine
    Biography

    Valentina Divocha in 1967 graduated from I.I. Mechnikov Odessa State University, Faculty of Biology (Department of Virology). In 1973 continued her postgraduate study ate Odessa Institute of Virology and Epidemiology (specialty virology). In 1974 she was awarded her candidate degree with the thesis "Interaction of Coxsackie B viruses with sensitive cell cultures and their antigenic relationships." In 2009 she was awarded her doctoral degree with the thesis entitled "Biological basis antiproteinase therapy of influenza". Under her leadership performed a doctoral and two master's theses. Scientific experience is 35 years. She has more than 190 scientific publications, 3 monographs, textbook "Virology" (2012), 10 patents, 3 innovations. She has currently working as the head of the Laboratory of Experimental and Clinical Pathology for Ukrainian Research Institute of Transport Medicine, is the supervisor of the nine research programs in virology and biochemistry.

    Abstract

    Now preventive maintenance of a flu by means of vaccination is conventional and is supported by experts of all world. To check presence of trypsin-like proteinase and its inhibitor in antiflu and other vaccines and in immunobiological blood preparations of domestic and foreign manufacture. In work following commercial preparations have been used:" Interferon leukocytic human"," the Immunoglobulin of human placental, donor 10 %, a gonococcal vaccine a herpetic vaccine (Odessa), vaccines for preventive maintenance of a flu, a season 2002/2003 -"Influvac" which consists of hemagglutinins and a neuraminidase of a virus of a flu, strains: ?/Moscow/10/99 (H3N2), ?/New Caledonia/20/99 (H/N), B/Hong Kong/330/2001, "Fluarix" which consists of hemagglutinins of strains (H1N1) A/New Caledonia (H3N2), ?/Panama and ?/Shandont 17/97 and "Vaxigrip" which consists of three strains of a flu virus, a vaccine for preventive maintenance of a hepatitis A - "Avaxim", a blood preparation received from a heparin (the antifactor of Ha) - "Fraxiparine", a preparation from a blood of calfs for a hemodialysis - "Solcoseryl". Preparations were investigated before the termination of a period of validity. Resuits.Work is devoted to study presence of components of a cell-owner and its inhibitor in vaccines and blood preparations and to define presence trypsin-like proteinase and its inhibitor in vaccines and blood preparations. It is revealed that anti influenza vaccines (influvac, vaxigrip, fluarix), herpetic and tularemic vaccines contained an inhibitor of trypsin-like proteinase in considerable quantity. Commercial preparations from a human donor blood (an immunoglobulin, interferon, fraxiparine and solcoseryl) contained as trypsin-like proteinase, and its inhibitor. The immunoglobulin contained in 4,0 times more inhibitor, than interferon. Conclsions. Hence, the modern vaccines applied to prophilaxis and treatment, are insufficiently cleared. Presence of cellular components (enzymes and inhibitors) could lead to allergization and follow complication which is not very known.

  • Comparability of biosimilar products: insulin as a model
    Speaker
    Maely Peçanha Favero-Retto
    National Cancer Institute and Hospital Municipal Miguel Couto
    Brazil
    Biography

    Maely Peçanha Favero-Retto is Graduated in Pharmacy from the Federal University of Rio de Janeiro (1995), Master in Biological Chemistry from UFRJ (1999) and PhD in Pharmaceutical Sciences from UFRJ (2013). Specialist in Hospital Pharmacy (2007) and Clinical Pharmacy (2015) by SBRAFH, with Executive MBA by the COPPEAD Institute (2008). He is currently a Technologist in Hospital Pharmacy at the National Cancer Institute and at the Hospital Municipal Miguel Couto. Professor of the Multiprofessional Residency in Oncology at INCA and postgraduate courses. President of the Brazilian Society of Hospital Pharmacy and Health Services (SBRAFH). Has experience in the field of biological metrology with emphasis on the study of biosimilar products.

    Abstract

    Government initiatives at several nations have motivated the development of biosimilar products. In contrast to generics, biosimilar regulations require comparative preclinical and clinical data because of uncertainties regarding the level of characterization achievable, and the possible clinical consequences of differences in physical–chemical characteristics, such as amount of impurities. Protein therapeutics are a class of products which have a complex three-dimensional structure in solution whose integrity determines the biological activity, clinical efficacy, and safety. Thus, it is highly desirable that products from this class meet well-defined requirements for structural integrity. The characterization of conformational and oligomeric distribution of proteins is of paramount importance. Methodology: We have studied regular acting, wild-type human insulin, and insulin analogues from different pharmaceutical products directly from their final finished formulation by the combined use of mass spectrometry, dynamic light scattering, small-angle X-ray scattering, nuclear magnetic resonance, single-crystal protein crystallography and electrospray ionization-mass spectrometry coupled to ion mobility spectrometry with the aim to analyze structural information. Findings: We have made the combined use of modern state-of-the-art structural techniques for the detailed characterization of the chemical and structural integrity, accessing the correct folding through the evaluation of the secondary, tertiary, and quaternary structural arrangement of the human insulin and insulin analogues. Conclusion & Significance: These structural methods are currently well-established, and they can be accessed in most countries, in special those for the main pharmaceutical markets, the Americas, Europe and Japan. It could be used in routine evaluation of structural integrity and identity, as a part of current or evolving methods aiming the minimization of animals’ requirement in routine quality control, in the development of novel insulin products, or in future protocols for a thorough comparability exercises between follow-on protein product and a reference product.

Day 2

KEYNOTE SPEAKERS
  • Feasibility of Monitoring Cell Mediated Immunity during Vaccine Trials

    Cellular Technology Ltd
    USA
    Biography

    Dr. M. Tary-Lehmann is a Co-Founding Scientist and Chief Scientific Officer for Cellular Technology Limited (CTL) and an Adjunct Associate Professor of Case Western Reserve University (CASE) Department of Pathology. She has published more than 75 papers in peer-reviewed journals. She provides guidance and oversees technical operations of the performance of immunology assays in CTL’s GLP- and CLIA compliant contract laboratory for various pharmaceutical and biotechnology clients, 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

    An increasing number of new vaccines aim to elicit a response from the cellular components of the immune system, in addition to the classical establishment of an antibody-based immunity. T cell immunity is critically involved in combating infections and cancer, and plays a pathogenic roles in autoimmune diseases and allergies. Therefore, monitoring antigen-specific T cells and their effector functions is crucial for the understanding of these diseases and for proper assessments of the efficacy of specific immune therapies such as vaccines in preclinical and clinical trials. Yet, unlike the detection of antibodies, reliable measurement of T cell-mediated immunity has remained a major challenge, due to several factors. One such factor is that the antigen-specific T cells of interest typically occur at very low frequencies in test samples, such as peripheral blood. Another factor is that for the reliable measurement of T cell function(s) it is necessary that the test conditions don’t change the functionality of T cells in vitro as compared to the one in vivo. The many variables that can affect T cell functionality have earned T cell assays the reputation of being rather fragile, with even minor changes of test conditions potentially having a major impact on the test results. A major breakthrough in the field of T cell monitoring has been the introduction of protocols that facilitate cryopreservation of PBMC such that, upon thawing, the cells retain their full functionality. This has enabled the generation of “reference PBMC” as ideal tools for assay development and standardization. Examples of successful T cell monitoring using the ELISPOT assay will be presented.

  • Universal viral vectors for prophylactic vaccines against infectious diseases and for therapeutic vaccines against persistent viral infections

    The University of Western Ontario
    Canada
    Biography

    Dr. Chil-Yong (Yong) Kang received his Ph.D. from McMaster University in Canada in 1971 and his D.Sc. degrees from McMaster University and from Carleton University. He took his three year postdoctoral training at the University of Wisconsin, Madison, USA. He has served as a Professor of Microbiology at the University of Texas, Southwestern Medical School in Dallas, Professor and Chairman of the Department of Microbiology and Immunology at University of Ottawa, Faculty of Medicine, Dean of Science at the University of Western Ontario, and currently is serving as Professor of Virology in the Department of Microbiology and Immunology, Schulich School of Medicine and Dentistry at the University of Western Ontario. His research in molecular virology includes the development of antiviral therapeutic agents and efficacious vaccines against various human viral diseases. He has published 297 scientific papers in fields of virology, medicine, and molecular biology. He holds nine international patents. Dr. Kang has received numerous prizes including Ho-Am Prize in Medicine in 1999 and Queen Elizabeth II Diamond Jubilee Medal of the Governor General of Canada in 2012. Dr. Kang is an elected Life-time Fellow of the Royal Society of Canada, Academy of Science and an elected Life-time Member of the Korean Academy of Science and Technology.

    Abstract

    Vaccination against infectious agents has proven to be the best way to prevent infectious diseases. We have created genetically modified recombinant M gene mutants of the Indiana serotype of vesicular stomatitis virus (VSVInd) and of the New Jersey serotype of VSV (VSVNJ) as universal vectors for the development of recombinant virus vaccines. The priming vaccine vector should be antigenically distinct from the boost vaccine vector in order to maximize the boost effects. rVSVInd with the mutations of G21E/M51R/L111A in the M protein (VSVIndGML) and rVSVNJ with the mutations of G22E/M48R+M51R in the M protein (rVSVNJGMM) was attenuated to a degree that mice injected with one million of these genetically modified infectious viruses directly into the brain showed no neurological signs or any other adverse effects. In contrast, 1,000 infectious wild-type VSV kills mouse within 4 days. Foreign genes inserted into these VSV vectors elicit strong B cell and T cell immune responses against the inserted gene products when we prime animals with rVSVInd(GML) followed by boost immunization with rVSVNJ(GMM) carrying the same genes of interest. Animals can tolerate over 109 PFU of recombinant infectious VSVInd(GML) and recombinant infectious rVSVNJ(GMM) and showed high levels of gene expression and adaptive immune responses. Our results show clearly that rVSVInd(GML) priming and rVSVNJ(GMM) boosting is the best way to induce ultimate humoral and cellular immune responses. I will describe the advantages of these dual serotype VSV vectors for future vaccine development against infectious diseases. This is a platform technology applicable for many types of vaccine development.

  • The Brazilian National Immunization Program and its challenges for modernization and improvement

    Universidade do Grande Rio - Unigranrio
    Brazil
    Biography

    Dr. Ricardo Bordinhão received his Bachelor degree in Pharmacy from the Universidade do Grande Rio - Unigranrio in 2001 and is currently obtaining a degree in Logistics Management & Pharmaceutical Distribution from the Institute of Science, Technology and Quality - ICTQ. He has worked in the pharmaceutical department of a number of renowned hospitals in Rio de Janeiro, developing great expertise in integration and consultancy for ANVISA regulatory matters. He is a member of the Ethics Committee and of the Technical Chamber for Pharmaceutical Logistics of the Regional Pharmacy Council of Rio de Janeiro. He currently works at BRL - DISTRIBUIDORA DE VACINAS LTDA, a Pharmaceutical and Drug distributor where he holds the position of Logistics Manager and Head Pharmacy Technician.

    Abstract

    Statement of the Problem: Although the decision making for vaccination strategies is done individually, it is influenced by social and public policies. Over the last years, the Brazilian National Immunization Program (PNI) has registered a 95% rate of national vaccination coverage, which is similar to the rates observed in developed countries. The current challenges to be overcome by the program in order to preserve its excellence are to maintain its high rates of vaccination coverage, access equality, vaccination coverage monitoring, and safety, among others. The aim of this work is to analyze the development of the PNI program over the last decades along with its challenges and prospects for modernization and improvement. Methodology & Theoretical Orientation: The research methodology used in this work was of descriptive and bibliographical survey based on the Brazilian population data. The collection of data occurred between May and June of 2017 in the city of Rio de Janeiro - RJ - Brazil. Over the last years there has been a decrease in the rate of hospital admissions for the following diseases: measles, meningitis, tetanus, influenzas, pneumonia and others. Nevertheless, the access to information remains fragmented due to low informatization levels of the processes. Conclusions: The investments made in immunization generates countless benefits to the healthcare system and, consequently, to the health of Brazilians. Despite the high vaccination rates, the PNI program still needs improvements, especially in terms of modernization and informatization of the healthcare system. Nevertheless, its effective implementation demands investments for the acquisition and maintenance of new technologies, training of professionals, an organizational change, certification criteria and interoperability standards. Additionally, one of the main challenges for the PNI program is to align the strategies of verification and monitoring of disease risk perception and adverse events following vaccination (AEFV) among the different agents involved.

  • Targeting conserved broadly Neutralizing Epitopes within HIV-1 Envelope gp41 MPER as vaccine immunogens for seronegative partners of HIV-1 discordant couples.

    Centre International de Reference Chantal Biya (CIRCB)
    Cameroon
    Biography

    Dr. Godwin W Nchinda (Ph.D) is Senior Immunologist CIRCB and Deputy Director General Head of CIRCB Vaccinology Laboratory Head of CIRCB Biobanking Laboratory For the last twenty four years I have focused my attention to developing model vaccines that could be easily translated into clinics against infectious diseases and tumors. I studied Microbiology in the University of Calabar, Nigeria and then spent four years thereafter in the University of Nigeria, Nsukka, Nigeria working on an NIH Grant where we developed a feed based vaccine against Newcastle disease virus infections in free range Chickens. During my Ph.D thesis (1998-2001) I learned how to design and evaluate model SIV/HIV vaccines under the mentorship of Dr. K. Überla, Professor of Molecular Virology in the University of Leipzig Germany. I next did a two year postdoc in the Ruhr University Bochum, Germany where we continued characterizing HIV/SIV vaccines. During the next 7 years (2003-2010), I worked under the mentorship of Dr. Ralph Steinman (2011 Nobel prize for Medicine) of the Rockefeller University USA, where we developed new forms of HIV, TB, Malaria and Tumor vaccines by harnessing Dendritic cells. In 2008 I was certified as a clinical and translational research scientist by the Rockefeller University. In 2010 I relocated to CIRCB, Yaounde Cameroon where we are now optimizing dendritic cell targeted vaccines for clinical evaluation in Africa. The first in human evaluation of a Cameroon developed HIV-1 vaccine is envisaged in 2017. In addition we are also studying the phenotypic and functional properties of various immune’s cells in the context of co-morbidies with HIV-1 infection. We are looking particularly at the impact of malaria, HBV, HCV, HPV and TB in the long term management of HIV-1 especially in remote areas of Africa. We are also actively training young research scientists at the Msc and Ph.D level to perform cutting edge science. Our work has been funded by TWAS, EDCTP, Canada grand challenge, Italy, Germny, Korea and Norway. Never the less the the Cameroonian government has remain our greatest funder.

    Abstract

    Introduction: The membrane proximal external region (MPER) of HIV-1 envelope glycoprotein-41 (gp41) is targeted by several broadly neutralizing antibodies whose conserved linear epitopes are promising targets for vaccine design. However, a formidable challenge has remained the difficulty to design and deliver MPER based immunogens for the efficient induction of such broadly neutralizing HIV-1 specific antibodies (bnAb). This is mainly because the linear bnAb MPER epitopes are poorly accessible to the immune system. The overall objective of this study therefore was the development and validation of an RNA coliphage Q? display system for efficient presentation of conserved bnAb epitopes to the immune system Method: To overcome the challenge of effective presentation of MPER to the immune system we have selectively engineered the surface of the RNA coliphage Q? to to display 12 molecules of MPER per phage particle. The expression cassettes were used for the production of Q?MPER recombinant hybrid phages after transformation of E. coli HB101 strain. Results: Specific recognition of all the linear MPER based bnAb epitopes were confirmed in ELISA with Q?MPER VLP as antigen and the bnAb 2F5, Z13, 4E10 and 10E8 as antibodies. Next the prevalence of MPER specific antibodies was determined in plasma from antiretroviral naïve HIV infected participants of the CIRCB AFRODEC cohort. The greater majority (84%) of participants’ plasma showed MPER peptide specific reactivity with antibody titers rangings ranging from 200 to 409600 comparative to background values with Q? empty as antigen. Conclusion: Thus, this novel Q?MPER VLP can be used to monitor MPER- specific immune responses in clinical samples. In addition the Q?MPER VLP can be used as immunogens either alone or in combination with other strategies for the induction of MPER specific immunity against HIV-1.

Advanced vaccine technology and engineering | Vaccine Production | DNA Vaccines | Human and Bovine Tuberculosis vaccine | Classification Vaccines | Bioinformatics in Vaccine Design | Synthetic Genomics-Based Vaccines | Profiling Immune Responses to Infection and Vaccines | New Approaches to Viral Vaccines | Measles Vaccine | The Challenge of Helminth Vaccines | Market revenue from Vaccines
Speaker
  • Tumor liberated protein (TLP) as potential vaccine for lung cancer patients
    Speaker
    Giulio Filippo Tarro
    Foundation T. and L. de Beaumont Bonelli for Cancer Research
    Italy
    Biography

    Dr. Giulio Tarro graduated from Medicine School, Naples University (1962). Research Associate, Division of Virology and Cancer Research, Children’s Hospital (1965-1968), Assistant Professor of Research Pediatrics, College Medicine (1968-1969), Cincinnati University, Ohio. Oncological Virology Professor, Naples University (1972-1985). Chief Division Virology (1973-2003), Head Department Diagnostic Laboratories, (2003-2006). D. Cotugno Hospital for Infectious Diseases, Naples; Emeritus, 2006 -. Since 2007 Chairman Committee of Biotechnologies and VirusSphere, World Academy Biomedical Technologies, UNESCO, Adjunct Professor Department Biology, Temple University, College of Science and Technology, Philadelphia, recipient of the Sbarro Health Research Organization lifetime achievement award (2010). His researches have been concerned with the characterization of specific virus-induced tumour antigens, which were the "finger-prints" left behind in human cancer. Achievements include patents in field; discovery of Respiratory Syncytial Virus in infant deaths in Naples and of tumor liberated protein as a tumor associated antigen, 55 kilodalton protein overexpressed in lung tumors and other epithelial adenocarcinomas.

    Abstract

    Tumor liberated protein (TLP) has been previously described as a TAA (complex) present in the sera from lung cancer patients with early stage disease. Since early detection improves overall survival in lung cancer, identification of screening biomarkers for patients at risk for the development of this disease represents an important target. Starting from the peptide epitope RTNKEASI previously isolated from TLP complexes, we generated a rabbit anti-RTNKEASI serum. This antiserum detected and immunoprecipitated a 55kDa protein band in the lysate of the lung cancer cell line A549. This protein band was identified as aldehyde dehydrogenase isoform 1A1 through mass spectrometry, revealing the molecular nature of at least one component of the previously described TLP complex. Next, we screened a cohort of 29 lung cancer patients (all histologies), 17 patients with non-neoplastic lung pathologies and 9 healthy donors for the presence of serum ALDH1A1 and global serum ALDH by enzyme-linked immunosorbent assay. This analysis indicated that the presence of ALDH was highly restricted to patients with lung cancer. Interestingly, the global ALDH test detected more lung cancer patients compared to the ALDH1A1-specific test, suggesting that other ALDH isoforms might add to the sensitivity of the assay. Our data suggest that ALDH levels may therefore be evaluated as part of a marker panel for lung cancer screening. Finally, the ability of the immune system to recognize a TAA, enables the development of a vaccine approach for preventive and therapeutic application and represents a main target of this field of research.

  • Community Engagement in HIV Vaccine Research as a Treatment Strategy among Men who have Sex with Men (MSM)
    Speaker
    Kelvin Owange Otieno
    Community Healthcare Consultant, Kenya
    Kenya
    Biography

    Kelvin OwangeOtieno is a Community Healthcare Consultant with inclination on Social Research. He has extensive experience in conducting research and training on organizational capacity, particularly on Tuberculosis and HIV/AIDS. His experience in psychosocial development has positioned him to work in multisectoral setups including Mental Hospitals, Rehabilitation centers and leading Social research institutions in Kenya. He is passionate about creating a nexus between medical research and social research and further making medical research language more palatable to the end-user. Kelvin is currently developing curriculum guiding food producers on the production of healthy foods in Kenya.

    Abstract

    One of the challenges HIV vaccine researchers face is the grapple with the practical need to recruit, engage and sustain the research participants in the HIV vaccine trials and a broader social good regarding the safety of the participants and community perception on clinical research. Understanding the disjunction between the study concepts and participants level of clinical research literacy will pave the way for a successful HIV vaccine research. A meaningful and extensive engagement of the community is not only dependent on how researchers address the challenges associated with the participants’ protection and involvement but also their engagement in the research process. Community engagement on HIV vaccine unearths salient implication of the research, with the potential to inform HIV prevention and treatment policy frameworks. Purpose: This study aims to identify how the meaningful community engagement in HIV vaccine research affects the vaccine trial outcomes among the MSM in Kenya. Methodology: The study was qualitative. Kenya Medical Research Institute (KEMRI) researchers were engaged as key informants. The MSM, who are volunteers to the trials, also responded to questionnaires. Findings: The study established that men who have sex with men (MSM) and those living with HIV in particular, face rampant discrimination and high levels of social stigma. For a long time, such situations compounded the challenges of the disclosure which have significant effects on their participation in the HIV vaccine trials. However, there was a gradual realization of some change in perception among the trial participants after research literacy training by the KEMRI. Conclusion and Significance: Research on HIV vaccine is, therefore, an investment whose benefits transcends a promise of prevention and should uphold community engagement strategies. In Kenya, the vaccine science contributes to an array of research driven discoveries; and such breakthrough incrementally empowers the HIV affected communities to a new narrative, which allows their voices to influence health care policies. Recommendations are made to researchers to engage the community.

  • B. subtilis spores as mucosal adyuvants
    Speaker
    Verónica Donato
    National University of Rosario
    Argentina
    Biography

    My name is Veronica Donato. I have a PhD in Biological Sciences. I am finishing my second postdoc studying B. subtilis, a probiotic bacteria, that can help us to improve the human lifespan and health span. I am also finishing a bachelors degree in Law. I study law because I am interested in writing laws related with Science and Technology. I also have other passions: teaching, mentoring, peer-reviewing, writing and coaching. I work in Argentina and almost every year I spend time in USA increasing my knowledge and exchanging science ideas. My next step is continuing my career as part of a clinical researcher team so I would like to start a Master to obtain my certification.

    Abstract

    Even though B. subtilis spores have received growing attention because of their potential in biotechnology, including vaccine development, there are only a few studies using this probiotic bacteria as a vaccine delivery system or as an adjuvant itself. For this reason, with my lab team, I decided to study B. subtilis spores as a potential candidate to solve some of the problems of current vaccines such a as the need of refrigeration systems, needles and syringes and booster dose.

  • Stability modeling to predict vaccine shelf-life and evaluate impact of temperature excursions from the “cold chain”
    Speaker
    Didier Clenet
    Sanofi Pasteur
    France
    Biography

    Didier has joined R&D Formulation & Stability platform of Sanofi-Pasteur in 2011. He focuses his work on high throughput screening formulations, stability prediction using advanced kinetics, vaccine activity – structure relationship, particulate matter in vaccines and adjuvants process optimization and physic-chemical characterization. For more than 15 years in Sanofi R&D, Didier was dedicated on physical and biophysical characterization of active ingredients, freeze-dried products and monoclonal antibodies (mAbs, ADC). He developed novel X-ray diffraction and thermal analysis tools to study polymorphism and amorphous state in solid materials. His research interests are structural characterization and aggregation state determination using a variety of biophysical techniques (light scattering, flow-imaging, DSC and thermokinetics, fluorescence and infra-red spectroscopy, …. ). Didier implemented Biophysical lab and a lab-automation platform for bioproduct formulations. He is coatching young scientists and performed courses in several Universities.

    Abstract

    The stability of vaccines is of great interest industries and government institutions. Accelerated stability studies are designed to determine the rate of vaccine degradation over time as a result of exposure to temperatures higher than those recommended for product storage. However, commonly applied stability predictions based on application of zero- or first-order kinetics are very often too simplified for description of the degradation of biological products, which frequently undergo complex and multistep degradation reactions. We used an advanced kinetic approach mixing with statistical analysis to fit the forced degradation ELISA data by computed kinetic parameters, and finally, to predict valuable the long term stability of vaccine containing several variants in a freeze-dried form. The modeling approach is based on the selection of the most appropriate kinetic equations which fit the degradation rate of compounds subjected to elevated temperatures, accelerating the rate of the reaction. According to 6 months data obtained at elevated storage temperatures, “two-step” models were identified to conveniently describe antigenicity of variants. We have predicted 2 years antigenicity, in agreement with real long term stability data. The stability modeling procedure was also successfully applied for the prediction of antigenicity during several temperature excursions, thereby demonstrating the accuracy of the kinetic models. To the best of our knowledge, this is the first procedure mixing a global kinetic approach and modern statistical analyses to accurately determine a vaccine degradation rate able to predict shelf-life of bio-products stored in refrigerated condition and suffered temperature excursions from the “cold chain”.

  • Impact of vaccination on the socioeconomic risk factors for cholera in an endemic setting of Bangladesh
    Speaker
    Amit Saha
    University of Sydney
    Australia
    Biography

    Dr Amit Saha is an epidemiologist with special interest in the epidemiology of vaccine-preventable diseases and promoting the implementation of vaccines in resource-poor settings. He is a medical graduate and holds Master of Medicine (M.Med.) in Infection and immunity from the University of Sydney. Amit is an Associate Scientist in the group of Infectious Disease Division at icddr,b in Bangladesh and currently a doctoral candidate with the School of Public Health and Community Medicine, UNSW. He has over fifteen years of professional experience in a wide range of fields in infectious diseases epidemiology and large field-based clinical studies on enteric vaccines in low and middle income countries.

    Abstract

    Background: Cholera continues to be a threat in many developing countries. Socioeconomic factors play an important role in transmitting the disease. Killed whole-cell oral cholera vaccines (OCV) are now considered an important tool to control cholera. This study aims to investigate the impact of vaccination on the socioeconomic risk factors of the disease. Methods: The study was conducted in Dhaka, Bangladesh . The study area was divided into 90 geographic clusters; 30 in each of the three arms of the study: vaccine (VAC), vaccine plus behavioural change (VBC), and a non-intervention arm. Socio-demographic data of each individual were linked to vaccination and cholera surveillance using a unique ID given to each individual in the study population. The data were analysed for the three populations: 1) recipients of two-doses of OCV in the intervention arm (VAC and VBC arms), 2) OCV non-recipients within the intervention arm, and 3) all participants in the non-intervention arm. A generalized estimating equation with logit link function was used to estimate the risk for cholera among these different populations adjusting for household level correlation in the data. Results: Vaccine was associated with significant protection of cholera. A total of 528 cholera and 226 cholera with severe dehydration (CSD) cases in 268,896 participants were observed in the two-year follow-up. For population 1, no socioeconomic factors were found to be risk for cholera; however CSD was less likely among participants living in a household having ?4 members (aOR=0.55, 95% CI=0.32-0.96). Among population 2, younger people and individuals having diarrhoea during baseline census were more likely to have cholera than their counterpart. In this population, females and individuals with diarrhoea at baseline census were at increased risk of CSD. Among population 3, participants living in a household without a concrete floor, or in an area with high population density, or closer to the icddr,b hospital, or not treating drinking water were at significantly higher risk for cholera and CSD. Conclusion: A cholera vaccination eliminates the risk for cholera due to socioeconomic disparities among population in an economically disadvantage setting.

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