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Adjuvants and novel delivery systems have become an integral part of the strategy for creating the next generation of vaccines. These innovations boost vaccines' potency while also cutting costs by decreasing dosage requirements, and offer creative ways to provide vaccine solutions for persistent challenges such as overcoming the cold chain, patient discomfort, and efficacy. Lack of FDA approval for new adjuvants presents a major hurdle for vaccine developers, as do the pressing concerns for safety. In the Adjuvants & Delivery Systems meeting, vaccine leaders will discuss their promising work that is leading the way to a new era of better vaccines.
Wednesday, August 17
12:15 pm Registration
1:45 Chairperson's Remarks
Nathalie Garçon, Pharm.D., Ph.D., VP & Head, Global Adjuvant Center for Vaccines, GlaxoSmithKline Biologicals
Opening Keynote Presentation
1:50 Vaccine Adjuvant Safety from a Regulatory Perspective
Wellington Sun, M.D., Director, Division of Vaccine Review and Product Applications (DVRPA), Office of Vaccine Evaluation and Research (OVRR), CBER, FDA - Biography
The presentation will discuss regulatory principles in assessment of adjuvant safety, and the approach to risk/benefit analysis of safety and effectiveness of vaccine adjuvants.
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2:30 Featured Presentation
Technologies for the Discovery and Development of New Vaccines
Jeffrey Ulmer, Ph.D., Head, External Research, Novartis Vaccines & Diagnostics, Inc. - Biography
This talk will discuss tools for antigen discovery and optimization, rational vaccine design and enhancing the quality and quantity of vaccine responses with adjuvants.
3:00 POSTER HIGHLIGHT
3:30 Ice Cream Bar Refreshment Break with Exhibit and Poster Viewing
4:15 CAF01, A Novel Versatile Liposome Adjuvant in Clinical Trials that Promotes Both Strong Humoral and CMI Responses
Else Marie Agger, M.Sc., Ph.D., Director, Department of Infectious Disease Immunology, Head of Section, TB Vaccine Research, Statens Serum Institut - Biography
The CAF01 adjuvant, consists of cationic liposomes based on dimethyldioctadecylammonium (DDA) and synthetic mycobacterial cordfactor (TDB) that promotes a C-type lectin mediated immune activation through the MINCLE receptor. I will also discuss development aspects of this adjuvant that can now be produced in a format that allow sterile filtration as a final step in manufacturing. Recent data from clinical trials with CAF01 as an adjuvant for TB and HIV vaccines will be presented.
4:45 Vaxfectin®: A Versatile Adjuvant for Plasmid DNA- and Protein-Based Vaccines
John Doukas, Ph.D., Senior Director, Pre-Clinical Safety and Efficacy, Vical, Inc. - Biography
Vaxfectin® is a lipid-based adjuvant initially developed for use with plasmid DNA (pDNA)-based vaccines, but also highly effective with protein and peptide-based vaccines. This presentation will review its pre-clinical and clinical development. In the clinic, Vaxfectin®-adjuvanted pDNA-based H5 influenza vaccines were found to be well-tolerated and to result in durable immune responses, including up to a 65% patient response for viral neutralizing antibodies and a 75-100% response for antigen-specific T cells. In conclusion, Vaxfectin® represents a next-generation adjuvant with potential as a platform technology across multiple vaccine formats.
5:15 All-Trans Retinoic Acid Promotes Increased Effector T Cells at Mucosal Sites and Increased Central Memory Systemic T Cells During Vaccination
Joseph Blattman, Ph.D., Assistant Professor, Immunology, School of Medicine, University of Washington - Biography
We have tested the ability of all-trans retinoic acid (ATRA) used as an adjuvant during vaccination to promote mucosal T cell homing in mice. We observed increased effector-memory phenotype T cells in mucosal sites, including gut, vaginal, and lung tissues in ATRA-treated vaccinated mice compared to control treated vaccinated mice. Given the conserved nature of ATRA signaling in humans and mice, as well as the safety record of ATRA in humans, these results indicate that ATRA should be useful in human vaccine clinical trials against mucosally transmitted pathogens such as HIV.
5:45 Close of Day
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