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Thursday, August 18
7:30 am Morning Coffee (Breakfast Sponsored Presentation – Opportunity Available)
8:25 Continental Breakfast in the Meeting Room
Please join us for a light breakfast and chance to chat with colleagues
8:55 Chairperson's Remarks
Christian Spyr, Ph.D., Head, Clinical Development & Project Management, Pevion Biotech Ltd.
9:00 Development of a Novel Therapeutic Vaccine Against Vulvovaginal Candidiasis
Christian Spyr, Ph.D., Head, Clinical Development & Project Management, Pevion Biotech Ltd. - Biography
Infections of the genital tract by Candida spp., mainly caused by the Candida albicans species, is a common phenomenon among the female population worldwide. About 5-8% of women suffer from the recurrent form of the disease (recurrent vulvovaginal candidiasis RVVC). Existing treatment options have drawbacks among which the most significant is a relapse rate of up to 50% after treatment. Pevion Biotech is developing a novel therapeutic vaccine to prevent the recurrence of vulvovaginal candidiasis. The presentation will give an overview of the design and development of the candidate vaccine PEV7 with a summary of the latest clinical phase I results.
9:30 A Nutritive Immune-Enhancing Delivery System for Vaccines Against Infectious Diseases
Michael Vajdy, Ph.D., Co-Founder, President and CSO, EpitoGenesis, Inc. - Biography
Since the dawn of modern vaccines, vaccinologists have attempted to mimic the pathogens in their immune-enhancing capacity and thus to induce danger signals. This led to the development of life-saving vaccines based on live attenuated viruses and bacteria as well as toxoids. In keeping with the same dogma of mimicking pathogens' danger signals in host cells, intense research in vaccine adjuvant discovery has focused on toll like receptors, mutant toxins and viral and bacterial vectors. However, recent evidence suggests that nutritive components such as vitamins and a subclass of polyphenols also possess immunomodulating properties without the potential toxic side effects of mimicking danger signals in traditional adjuvant research. We have designed a nutritive immune-enhancing delivery System (NIDS) composed of combination of a rubefacient-based delivery system, i.e. mustard seed oil, formulated with immune-enhancing components comprising select vitamins, and a flavonoid. We have generated impressively significant enhancement of both local and systemic responses in a mouse model following mucosal and systemic vaccinations against HIV and influenza. This approach promises to open a new era in the design and development of safe and effective vaccines.
10:00 Networking Coffee Break
10:30 Design and Characterization of Recombinant DNA and MVA Vectored HIV/SIV Vaccines with GM-CSF as the Adjuvant
Mark J. Newman, Ph.D., Vice President, Research and Development, Geovax, Inc. - Biography
The GeoVax DNA and MVA-vectored HIV vaccines are recombinant moieties designed to express non-infectious, immature virus-like-particles bearing "native" Env protein. This vaccine design was tested using the rhesus macaque model and SIVsm239 prototype vaccines, with and without GM-CSF and a heterologous (DNA + MVA) vaccination regimen. This vaccine design is currently being developed for Phase 1 clinical testing.
11:00 Cytokine Profiles Elicited by Different Adjuvants as Part of the DNA Prime-Protein Boost HIV Vaccines
Shan Lu, M.D., Ph.D., Professor, Medicine, University of Massachusetts Medical School - Biography
We have conducted studies on the effects of several key representative adjuvant (QS-21, Alum and MPL) in the context of our previously tested DNA prime-protein boost HIV vaccines in regular and selected innate immunity signal pathway knock-out mouse models. Our data indicated that different adjuvants may generate unique patterns of biomarkers. This screening provided useful guidance in selecting an adjuvant for inclusion in future prime-boost vaccines to maximize the desired immunological effects and minimize the adverse events.
Sponsored by
11:30 BLPs and their Role in Mucosal Vaccines
Bert Jan Haijema, Ph.D., Preclinical Development Director, Mucosis BV
In recent years exciting progress has been made on a new versatile vaccine platform technology, called Mimopath™. This technology is based on a bacterium-like particle (BLP) that is derived from Lactococcus lactis, a bacterium that is widely used in the food industry for the manufacture of cheeses. L. lactis bacteria are easy to grow to large scale and can be processed into BLPs by a robust and straight forward procedure. Most importantly, L. lactis is a Generally Recognized As Safe (GRAS) organism; millions of people consume L. lactis daily without any negative health effects.
In vaccine development, BLPs can be used as carrier particles for antigens. BLPs can easily be loaded with any antigen of choice, including antigens from bacterial, parasitic or viral origin, but also tumor antigens. The loaded BLPs efficiently deliver the antigen to the antigen presenting cells of the innate immune system. In addition, BLPs activate the innate immune cells via specific activation of toll-like receptors, thereby enhancing not only the quantity, but also the quality of the immune response against the pathogen. Mimopath™-based vaccines raise high serum IgG titers, a well balanced Th1/Th2 immune response, as well as a robust mucosal immunity. The latter is evidenced by high titers of antigen specific IgA immunoglobulins in the mucosal layer of the respiratory tract of the vaccinee. Vaccines based on BLPs can be administered parenterally, or as a non-invasive spray in the nose or oral capsule obviating the need for needles.
A number of new high-value vaccines are currently being developed based on the Mimopath™ platform; an innovative intranasal vaccine to prevent influenza which will be tested in humans in early 2011, a broad-spectrum vaccine to prevent pneumococcal diseases and vaccines against Respiratory Syncytial Virus and diarrheal diseases. These Mimopath™-based vaccines raise a more natural immune response, provide a broader base of protection and show the versatility of the platform for the development of novel vaccines.
12:00pm Lunch on Your Own or Luncheon Presentation (Sponsorship Opportunity Available)
1:45 Chairperson's Remarks
Mark J. Newman, Ph.D., Vice President, Research and Development, Geovax, Inc.
1:50 Development of Novel Forms of Flagellin that Improve Vaccine Performance
Lynda Tussey, Ph.D., Vice President, R&D, VaxInnate - Biography
A major unsolved challenge in the use of TLR ligands as vaccine adjuvants is how to achieve a potent adjuvant effect on the adaptive immune response while avoiding systemic reactogenicity. Over the last decade, the ability of Toll-like receptor (TLR) ligands to promote adaptive immune responses and serve as vaccine adjuvants has been recognized. We have developed several novel forms of the TLR5 agonist flagellin which successfully separate immunogenicity from systemic reactogencity. These forms have led to a wider safety window in the clinic. Potential mechanisms will be discussed.
2:20 A TLR7-Specific Phospholipid-Conjugated Small Molecule Ligand as Highly Effective Adjuvant
Alcide Barberis, Ph.D., Head, Research and Collaborations, Telormedix SA - Biography
A phospholipid-conjugated small molecule ligand of Toll-like receptor 7 (TLR7) has been selected and characterized for its properties as a vaccine adjuvant in animal models. This novel molecule showed mucosal adjuvanticity, induced strong cellular immune responses, including TH1 and TH17, and had a protective effect in a mouse model of Anthrax infection. The phospholipid-TLR7 agonist conjugate promoted rapid and long-lasting humoral immune responses upon mouse immunization, which was significantly superior in comparison to the known TLR9 adjuvant CpG ISS-ODN 1018.
2:50 Development of a VLP Based Vaccine for Chikungunya Virus
Indresh Srivastava, Ph.D., Director, Purification and Analytical Development, Staff Scientist Vaccine Production Program Laboratory, Vaccine Research Center, NIAID, NIH - Biography
Co-Authored by Mridul Ghosh, Xin Wang and Richard M. Schwartz
Our focus is to develop effective vaccines against different diseases caused by pathogens such as HIV, Influenza, Chikungunya, Ebola, Marburg and others. We have developed the process for the purification of ChikV VLPs, and purified them to homogeneity. Regarding characterization, there are several state of the art analytical tools are available for the characterization of vaccines such as Circular Dichroism (CD) Spectral Analysis, Tryptophanyl Fluorescence Emission, Differential Scanning Calorimetric (DSC) Analysis, Carbohydrate Profiling and Sequencing Analysis, Capillary Electrophoresis (CE); high resolution Mass Spectrometric Analysis, and for the immunological characterization one may use surface Plasmon resonance technique or Octet system. In addition, some of these same assays can also be used for the accelerated stability testing, stress studies, and forced degradation studies of the vaccines. These assays may help in performing in-depth biophysical characterization of vaccines. Some of these assays may be used for screening optimal formulation conditions for a given vaccine. We will present the data on purification and characterization of Chikungunya virus VLP based vaccine.
3:20 Networking Refreshment Break
3:35 Dermal Electroporation for DNA Vaccine Delivery: Translating the Promise to Prophylactic Vaccination
Niranjan Y. Sardesai, Ph.D., SVP, Research & Development, Inovio Pharmaceuticals - Biography
DNA vaccination with in vivo electroporation has emerged as a viable strategy to tackle emerging pathogens and diseases with a high unmet need. Recent immunogenicity data from human clinical trials as well as immunogenicity and efficacy data in animal models of pathogen challenge have highlighted the potency of the platform in addressing infectious diseases and cancer. We have extended the use of in vivo electroporation to dermal tissue to improve upon ease of delivery for prophylactic settings. We will present data discussing the application of the DNA-EP platform to develop candidate vaccines for foot and mouth disease, chikungunya, and malaria.
4:05 Helicobacter pylori Platform Technology (HPPT) for Vaccine Delivery: Phase I Safety and Immunogenicity Data of Candidate H. pylori Recipient Strains
Alma Fulurija, Ph.D., Head, Immunology, Ondek Pty Ltd. - Biography
HPPT is an oral delivery platform based on live Helicobacter pylori allowing for needle-free delivery of vaccines and biologics. This bacterium infects about half the human population and most infected individuals remain asymptomatic despite the presence of a robust immune response. By taking advantage of these characteristics we can elicit a mucosal immune response in the gut. The first step in the design of Helicobacter-based live vaccines is the identification of H. pylori recipient strains that would be suitable for the oral HPPT, meaning they would be genetically modifiable, immunogenic and safe for use in humans. Pre-clinical and clinical data on the selection of recipient H. pylori strains for use in humans will be presented, with special focus on results from a randomized, double-blind, placebo-controlled Phase I human challenge study, where 5 candidate strains were evaluated in healthy volunteers.
4:35 End of NOVEL VACCINES: Adjuvants & Delivery Systems
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