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Novel Vaccines - Day 1

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Wednesday, August 13

Research: Meeting Medical Needs

7:30am Registration and Morning Coffee


8:25 Chairperson’s Remarks
Camilla Estmer Nilsson, PhD, Scientist, Life Sciences, GE Healthcare
Bio-Sciences AB, Sweden

konstantim Chumakov8:35 New Poliovirus Vaccines for Post-Eradication Period
Konstantin Chumakov, Ph.D., Chief, Laboratory of Method Development, Division of Viral Products, Center for Biologics Evaluation and Research,Food and Drug Administration (FDA)
The twenty-year worldwide campaign to eradicate poliomyelitis may soon succeed in stopping circulation of wild-type polioviruses. However, emergence and circulation of pathogenic vaccine-derived polioviruses demands that use of inactivated poliovirus vaccine (IPV) be continued. To reduce the risk of release of pathogenic poliovirus from vaccine production facilities, it was proposed to switch manufacturing from wild-type strains to attenuated Sabin strains of poliovirus. In addition, combination vaccines that include IPV as one of the components are becoming a standard tool for prevention of infectious diseases. They also require evaluation of their efficacy. Validation of the new vaccines presents a challenge in the absence of significant natural polio morbidity. The presentation will focus on creation of a number of novel approaches for evaluation of efficacy based on surrogate markers such as the use of transgenic animals and detailed immunochemical profiling.

Jan Vinje9:05 The Emergence of Norovirus: Can We Prevent Disease by Vaccination?
Jan Vinjé, Ph.D., Head, National Calicivirus Laboratory, Gastroenteritis & Respiratory Viruses Laboratory Branch, Division of Viral Diseases (DVD), National Center for Immunizations and Respiratory Diseases (NCIRD), Centers for Disease Control and Prevention (CDC) 
This presentation will outline the increased understanding of the disease burden, transmission and evolution of norovirus in the last few years, and new breakthroughs in culture techniques and approaches for vaccine development.  Noroviruses are increasingly recognized as an important cause of gastrointestinal morbidity and even mortality.  In the US, older adults may be particularly at risk, especially those in nursing homes where outbreaks are frequent.  In poorer countries, noroviruses may be an important cause of mortality among children. Along with an increasing appreciation of the disease burden, several recent developments in the understanding of the molecular epidemiology, immunity, and possible culture methods for this virus, have brought the possibility of an effective vaccine closer and generated interest among pharmaceutical companies. 

Ashley J. Birkett9:35 Recent Advances in Malaria Vaccine Development
Ashley J. Birkett, Ph.D., Director, Preclinical Research & Development, The PATH Malaria Vaccine Initiative
Every year 300 to 500 million people suffer from malaria, causing an estimated 1 to 2.7 million deaths. Ninety percent of these deaths occur in sub-Saharan Africa, mostly among children younger than five. An array of candidate vaccines intended to reduce clinical disease and mortality associated with malaria are at various stages of preclinical and clinical development. This presentation will review recent advances in malaria vaccine development, with particular emphasis on novel vaccine candidates that will be entering the clinic in the near future.


10:05 Networking Coffee Break in Exhibit Hall (Sponsorship Available)

10:45 Bioterrorism - Outsmarted! A New Generation of Simultaneously Prophylactic and Therapeutic Anthrax Vaccines
Michael Roehrl, M.D., Ph.D., Pathology and Laboratory Medicine, Massachusetts General Hospital
Anthrax is a highly lethal infectious disease and an attractive bioterrorist weapon. Spores of the causative agent, Bacillus anthracis, are easily produced and dispersed and may lead to mass casualties in unprotected populations. Prophylactic measures are urgently needed. However, the only currently available vaccine is poorly immunogenic, carries significant risks of side effects, and would be unsafe to use widely in a post-exposure scenario. We will discuss the development of a novel generation of anthrax vaccines with significantly enhanced immunogenicity, safety profile, and protective scope. Our vaccines are based on the innovative principle of combining both anti-toxic and anti-bacterial activities in one vaccine, thus rendering the vaccine simultaneously prophylactic and therapeutic. Furthermore, we discovered and beneficially exploit a phenomenon that we termed “endosomal trapping” to render this new anthrax vaccine significantly more immunogenic, yet safe for post-exposure use.

11:15 Potential Role of Toll-like Receptors in the Immune Response and Protection Mediated by the Recombinant Yersina pestis Plague Vaccine
Kei Amemiya, Ph.D., Principal Investigator, Microbiologist, United States Army Medical Institutes of Infectious Diseases (USAMRIID)
We have been studying the immune response to a new recombinant vaccine against Yersinia pestis, the etiological agent of plague. Under normal conditions, plague is transmitted to humans through the bite of an infected flea. But with the potential use of the organism as a biowarfare agent, there is a critical need for an efficacious vaccine. The recombinant vaccine consists of a fusion of two proteins, the F1 capsular protein and the LcrV virulence protein or V antigen. These proteins individually have been shown to protect against one form or another of plague, however, there is a need to better protect the host against the possible exposure to both bubonic and pneumonic forms of the disease. The biparte recombinant vaccine will be replacing the killed whole cell vaccine that was only protective against the bubonic form of the disease. We are evaluating the immune response to the vaccine in the mouse model of plague, and the augmentation of the immune response by Toll-like receptor (TLR) agonists. The V antigen and F1-V fusion protein can activate both TLR2 and 4, and we have demonstrated that the inclusion of other TLR agonists can further augment the immune response to the vaccine. Nevertheless, it is not clear what role, if any, that TLR2 and 4 may play in the protective immune response mediated by the recombinant plague vaccine. We are exploring the involvement of the TLR2 and 4 in the immune response to the vaccine with TLR knockouts. We are also evaluating the immune response to the vaccine in a nonhuman primate model of plague. We have been able to show that Cynomolgus macaques that received the recombinant vaccine were protected against an aerosol challenge of a virulent strain of Y. pestis. We are using a competitive-inhibition ELISA with immune sera from vaccinated mice and nonhuman primates to develop a correlate of immunity against Y. pestis infection that can potentially serve as a surrogate of immune protection in other animal/human species. We would like to discuss the results of these animal studies with the recombinant plague vaccine, and the possible role-played by protective antibodies against plague infection

11:45 DNA Vaccines: Moving Forward to Human Studies
Shan Lu, M.D., Ph.D., Professor, Department of Medicine, University of Massachusetts Medical School
Fifteen years after the initial introduction of DNA immunization as a novel vaccination technology, recent human clinical studies have demonstrated that DNA vaccines are immunogenic in humans. However, the best human application of DNA vaccines is in a heterologous prime-boost format. Furthermore physical delivery methods are superior over the conventional needle injections. A more accelerated development of DNA vaccines against human pathogens is anticipated.

12:15pm Lunch on Your Own
(Lunch Workshop Sponsorship Available)


1:40 Chairperson’s Remarks

Shan Lu, M.D., Ph.D., Professor, Department of Medicine, University of Massachusetts Medical School

1:45 Universal Influenza Vaccine - Conjugation of Immunostimulatory DNA to Conserved Viral Antigens Generates Broad Immunity
Debbie Higgins, Ph.D., Associate Director, Preclinical Research, Dynavax Technologies
Standard influenza vaccines rely on generating strain specific neutralizing antibody responses to prevent viral infection. A universal vaccine approach makes use of conserved flu antigens to generate broad immunity. Linking conserved nucleoprotein and M2e antigens to immunostimulatory DNA (ISS) generates highly immunogenic materials that can be used alone or in combination with standard flu vaccine to induce potent, broadly reactive immunity. NP-ISS induces strong Th1 and CTL responses that reduce viral titers and provide protection against shift and drift strains in mouse challenge systems. Polymeric presentation of M2e-ISS induces high antibody titers. Co-administration of the ISS-linked flu antigens with TIV also enhances responses to TIV vaccine components.

2:15 A Novel Approach to Produce Glycoconjugated Vaccines using Recombinant Bacterial Cells that Directly Produce Immunogenic Bioconjugates
Michael Kowarik, Ph.D., Head, Research, GlycoVaxyn AG
Chemically synthesized complexes of polysaccharides and proteins have been successfully used as conjugated vaccines to protect against a number of bacterial infections. This report describes a novel bioengineering approach to produce immunogenic conjugated vaccines that provides advantages over classical chemical conjugation methods. This has been first applied to the development of a Shigella dysenteriae O1 glycoconjugate vaccine, using genetically engineered E. coli with simple fermentation and purification methods. A new technology is presented that revolutionizes the development of effective conjugated vaccines against bacterial infections. For the first time it is shown that conjugated vaccines can be completely produced in E. coli, therefore facilitating the production process and opening new applications.

2:45 Poster Spotlights
Molecular Technologies toward Better Molecular Vaccines

Kathryn Sykes, Ph.D., Assistant Professor, Life Sciences, Arizona State University

3:00 Towards a Multi‐strain ETEC Vaccine Using Reverse Vaccinology
Robert Gormley, Ph.D., Medical Officer, Entrerics, NavalMedical Research Center

3:15 Networking Coffee Break in Exhibit Hall (Sponsorship Available)

4:00 RepliVax, a Replication-Defective Approach to Flavivirus Vaccines
Harry Kleanthous, Ph.D., Senior Vice President, Research, Acambis plc

4:30 Non-replicating Adenovirus-Vectored Avian Influenza Vaccines for Mass Immunization of Poultry and People
Kent Van Kampen, Ph.D., CEO, Research & Development, Vaxin Inc.
Even as the fear of an avian influenza (AI) pandemic is waning, a new generation of AI vaccines that can be rapidly produced and mass administered into poultry and man is needed. We have demonstrated that protective immunity against AI virus could be elicited in chickens by in ovo vaccination with a non-replicating human adenovirus (Ad) vector encoding an AI virus hemagglutinin (HA). Vaccinated chickens were protected against both H5N1 and H5N2 highly pathogenic AI virus challenges. This vaccine can be mass-administered using available robotic in ovo injectors; it is compatible with a DIVA (differentiation between infected and vaccinated animals) strategy of vaccination; and the intrinsic problems associated with embryonated eggs for vaccine production are eliminated by propagating Ad vectors in well-characterized cell lines. In addition to mass immunization of poultry, we have also shown that intranasal administration of an Ad-vectored influenza vaccine could induce seroconversion in human volunteers without appreciable side effects, even in subjects with pre-existing immunity to Ad. The RCA-free (replication-competent Ad) AdHigh-vectored AI vaccine may provide a critical tool for generation of AI vaccines in a time- and labor-saving manner within the context of an excellent safety profile.

5:00 Happy Hour in the Exhibit Hall

6:30 End of Day One

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