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2013 Archived Content

August 13-15, 2013

Eighth Annual
Novel Vaccines: Innovations & Adjuvants

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THURSDAY, August 15

8:00am Morning Coffee


NEW TECHNOLOGIES AND APPROACHES FOR DEVELOPING VACCINES 

8:25 Chairperson's Remarks

Geoffrey Stone, Ph.D., Assistant Professor, Microbiology, and Group Leader, Immunology, HIV Immunotherapy Program, University of Miami Miller School of Medicine


8:30 Featured Presentation

Systematic Dissection of Immune Responses in Humans by Utilizing Natural Variations and Vaccination

John TsangJohn Tsang, Ph.D., Chief, Systems Genomics and Bioinformatics Unit, LSB, Head, Computational Systems Biology, Trans-NIH Center for Human Immunology (CHI), NIAID-NIH

As a first step towards developing systems-biology models of human immunity in health and disease, we have analyzed immune parameters broadly and in depth both at baseline and in response to perturbation using influenza vaccination. Inter-individual variations in peripheral blood transcriptomes, serum titers, cell subpopulation frequencies, and B cell responses were measured both prior to and after vaccination in a cohort of individuals, and used to build predictive models of post-vaccination antibody responses. We found that accurate models could be generated using pre-perturbation parameters alone. Notably, many of the key factors contributing to the predictive model(s) involved the most stable baseline differences across individuals, raising the prospect of immune health monitoring in the clinic before intervention.

9:00 Novel AIDS Vaccine Approaches: Focus on Epitopes Linked to Vaccine Protection

Ruth M. RuprechtRuth M. Ruprecht, M.D., Ph.D., Professor of Medicine, Harvard Medical School and the Dana-Farber Cancer Institute  Biography 

In this study, we developed protection-linked biopanning as universal tool to probe the paratopes of antibodies associated with vaccine protection – regardless of the vaccine target or infectious agent. In a proof-of-concept experiment, we identified anti-HIV-1 Tat neutralizing antibodies as vaccine-specific responses that significantly correlated with complete and partial protection of vaccinated macaques against challenge with a heterologous SHIV. Together, the data from our novel biopanning strategy argue for including HIV-1 Tat in a multi-component vaccine that seeks to induce humoral as well as cellular immunity.

9:30 Messenger RNA-Based RNActive Vaccines – A Universally Applicable, Disruptive Technology for Immunizations 

Karl-Josef KallenKarl-Josef Kallen, M.D., Ph.D., CSO, CureVac GmbH

Here, a novel, nucleotide based immunization technology, RNActive® vaccines, is presented. Modification of wild-type mRNA only with the naturally occuring nucleotides A,G,C,U  achieves largely enhanced protein expression (around 105-fold), while complexation with protamine activates the immune system involving TLR 7. The resulting self-adjuvanted RNActive® vaccines induce strong and balanced immune responses. RNActive® vaccines protect against lethal viral challenges and exert anti-tumor activity in a variety of preclinical models. Clinical experiences demonstrated safety and immunogenicity of RNActive® vaccines in humans. 

Cellular Technology Limited10:00 Adjuvant-Guidance of T Cell Responses   

Magdalena Tary-LehmannMagdalena Tary-Lehmann, M.D., Ph.D., CSO, Cellular Technology Limited (C.T.L.)

Adjuvants are important enhancers of the immune response. The choice of Adjuvant is especially crucial in the context of subunit vaccine approaches. The adjuvants: CFA, CpG, nCpG, ssRNA, poly(I:C), and IFA were studied for their effects on CD8+ T cell, and CD4+ T cell responses.

 

10:15 Coffee Break with Exhibit and Poster Viewing 

11:00 Fungal Antigens that Protect Against Fungal and Bacterial Pathogens 

John HennesseyJohn P. Hennessey, Jr., Ph.D., Vice President, Novadigm Therapeutics, Inc.

Despite the new targets addressed by recently licensed vaccines, there are still no licensed vaccines to address fungal infections.   Recent work in this field has revealed that two well-studied fungal vaccine antigens have also shown preclinical efficacy against specific bacterial pathogens.  This unprecedented cross-kingdom protection was predicted based on an in silico evaluation of sequence and structural homology first advanced by Michael Yeaman and colleagues at UCLA in 2004.  Data to support these claims will be presented and discussed in the context of how we can leverage these findings. 

11:30 Development of Thermostable Vaccine Formulations 

Alex Flood, Ph.D., Program Officer, Technology Solutions, PATH

BIA separations12:00pm Introduction of PAT to Improve the Efficiency and Robustness of Vaccine Development and Manufacturing 

Aleš Štrancar, Ph.D., CEO, BIA Separations

12:15 Sponsored Presentation (Opportunity Available)

12:30 Luncheon Presentation (Opportunity Available) or Lunch on Your Own


PARTICLE TECHNOLOGY 

1:55 Chairperson's Remarks

Aliasger K. Salem, Ph.D., Leader, Cancer Signalling and Experimental Therapeutics, Holden Comprehensive Cancer Center, Pharmaceutical Sciences and Experimental Therapeutics, Chemical and Biochemical Engineering and Biomedical Engineering, College of Pharmacy and Engineering, University of Iowa

2:00 Skin Delivery of Flu Vaccine with Micro Arrays

Derek O'HaganDerek O'Hagan, Ph.D., Global Head, Vaccine Delivery Research, Novartis Vaccines

The coming years will see the introduction of a range of new vaccines against important infectious diseases. It will prove a challenge to incorporate these vaccines into the already crowded schedules for infant immunization. Moreover, many of these vaccines will be targeted at different population groups who may not normally accept regular vaccines, including adolescents and the elderly. It would be preferable for patient compliance if these vaccines could be administered without the use of conventional needles. Although novel rotes of vaccine delivery have been of long term interest, so far there has been limited commercial success. Nevertheless, progress has been made recently on skin delivery in particular. This presentation will review some of the technology concepts under current investigation, including skin delivery technologies.

2:30 Tuning Innate Immune Activation by Surface Texturing of Polymer Microparticles: The Role of Shape in Inflammasome Activation

Evelyn A. Kurt-JonesEvelyn A. Kurt-Jones, Ph.D., Professor of Medicine, University of Massachusetts Medical School  Biography 

Polymeric microparticles have been widely investigated as platforms for drug delivery, vaccination, and as medical imaging contrast agents. Two key elements to consider in such applications are phagocytosis of microparticles by immune cells and the activation of innate immune responses. The efficiency with which a particle is engulfed, the specific pathway that it enters, its intracellular fate (recycling, endosomal or lysosomal) and the secretion of extracellular signals (cytokines) by the cell, all have important consequences for the ultimate fate of the particle and the downstream immune response. Our colleague Dr. Ryan Hayward (UMass Amherst) has used a novel manufacturing process to synthesize microparticles with either smooth or textured surfaces. We demonstrate that complex surface of the textured particles has a pronounced impact on both immune cell uptake and on inflammasome activation.

3:00 Replicating Adenovirus Serotype 4 Vector Vaccine for H5N1 Influenza: Phase I Clinical Study Results and Proof-of-Concept

Marc GurwithMarc Gurwith, M.D., CMO, PaxVax

We conducted a multi-center, randomized, placebo-controlled study of a novel, oral replication-competent Ad4 vector vaccine expressing H5N1 influenza hemagglutinin (HA). 166 volunteers in five ascending dosage cohorts from 107 viral particles (vp) to 1011 vp received Ad4-H5 vector vaccine or placebo X3; and, subsequently, volunteers were boosted subvirion inactivated H5N1 vaccine. There was not significant toxicity and no evidence for transmission to household contacts. HA-specific cellular immune responses were noted, and, following the inactivated H5N1 subvirion boost, there were robust HAI antibody responses. Pre-existing immunity to Ad4 was overcome at the higher dosage levels.  The replication-competent Ad4 vector appears to have broad applicability.  Ad4 vectors expressing HIV Gag and HIV Env, and Ad4 expressing anthrax Protective Antigen have completed animal testing, and are scheduled to start phase 1 trials in August-September, 2013.

3:30 Refreshment Break

3:45 The Versatile Utility of Biodegradable Particles in Vaccinations 

Aliasger SalemAliasger K. Salem, Ph.D., Leader, Cancer Signalling and Experimental Therapeutics, Holden Comprehensive Cancer Center, Pharmaceutical Sciences and Experimental Therapeutics, Chemical and Biochemical Engineering and Biomedical Engineering, College of Pharmacy and Engineering, University of Iowa Biography 

Antigen-loaded or antigen-coated biodegradable particles are capable of being actively taken up by antigen-presenting cells (APCs), and they have shown promising potential in immunotherapy by initiating a strong immunostimulatory cascade that results in potent antigen-specific immune responses against the target antigen. Such particle based carrier systems offer versatility in that they can simultaneously co-deliver adjuvants with the antigens to enhance APC activation and maturation. Antigen coated biodegradable particles have also shown strong potential as a prime for heterologous prime-boost adenovirus based vaccines generating antigen-specific CD8+ T cell responses that were equally as effective as homologous adenovirus vaccine prime-boosts but with reduced risk of formation of therapy suppressive anti-adenovirus antibodies and other potential adverse effects.

4:15 Delivery of TLR Agonists in Synthetic Vaccine Particles (SVP) Induces Strong Local Immune Activation without Systemic Cytokine Release and Augments the Immune Response to Encapsulated Antigen

Petr IlyinskiiPetr Ilyinskii, Ph.D., Senior Staff Scientist, Selecta Biosciences, Inc. 

Selecta Biosciences is a clinical stage company utilizing self-assembling nanoparticles to induce antigen-specific immune activation or tolerance. We developed a synthetic vaccine particle (SVP) technology that enables co-encapsulation of antigen with potent TLR agonists resulting in augmentation of immune responses with minimal systemic production of inflammatory cytokines. Conversely, local immune stimulation is more pronounced and sustained when adjuvants are SVP-encapsulated.We have optimized formulations for expansion of CD8+T cell effector memory cells and sustained in vivo CTL activity resulting in superior survival following therapeutic dosing in various mouse cancer models. The SVP technology is a flexible and modular platform that enables the use of potent TLR agonists for the development of therapeutic vaccines against cancer and chronic infections.

4:45 Close of ImVacS 



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