Day 1 | Day 2 | Speaker Bios
7:30am Morning Coffee (Breakfast Sponsored Presentation Opportunity Available)
8:25 Chairperson’s Remarks
8:30 Heterologous Prime-Boost Vaccines for HIV Vaccine Development
Shan Lu, M.D., Ph.D., Professor, Medicine, University of Massachusetts Medical School
Development of an HIV vaccine faces some unusual challenges. Two traditional vaccine modalities, the live-attenuated and inactivated vaccines, are considered either too risky or insufficient to elicit strong and broad B and T cell immune responses against a virus with diverse and constant genetic mutations. The failure of a subunit-based protein vaccine further denied HIV vaccine researchers the privilege of using this previously successful vaccination approach. The surprising failure of the “STEP trial,” which focused solely on T cell immune responses, a dramatic shift from the traditional reliance on antibodies for vaccine development, finally closed the door for an attempt towards developing an HIV vaccine based on a single vaccination approach. Our finding that a polyvalent DNA prime-protein boost vaccine can elicit balanced and broadly cross-reactive antibody and T cell immune responses including positive neutralizing antibodies in humans indicated that a combination vaccination approach provides an alternative strategy to allow for the elicitation of complicated protective immune response required for an HIV vaccine. Biography
9:00 Designing Smarter Adenoviral Vector Delivery of Vaccines: What Has Translated Successfully into Humans
Alfredo Nicosia, Ph.D., CSO, Okairos
Okairos develops genetic vaccines for major infectious diseases, including malaria, hepatitis C (HCV) and universal influenza, using a novel proprietary technology. Okairos’ technology platform is based on the development of new, potent, replication-incompetent Adenovirus vectors, derived from strains isolated from chimpanzees and used to encode and deliver prophylactic and therapeutic antigens. These vectors are not neutralized by human sera, and they hold promise for generating effective T cell responses, where existing vectors have failed. Development of these new Adenovirus vectors from preclinical- to clinical stage will be presented along with the generation of an optimised cell substrate for their production. Biography
9:30 SynCon DNA Vaccines for Emerging Infectious Diseases
Niranjan Y. Sardesai, Ph.D., Senior VP, Research & Development, Inovio Pharmaceuticals
The 2009 outbreak of the newly emergent swine origin influenza A/H1N1 and its rapid escalation to a pandemic designation by the WHO, has drawn attention to the need to develop vaccine approaches that are broadly protective against related yet divergent virus strains. DNA vaccines afford many advantages desirable for a rapid response to an emerging pandemic – easy to produce within weeks, store, transport, and deploy; and are considered safer than live virus vaccines. Similarly, current strain-matched influenza vaccine approaches place a severe limitation on their use against emergent strains and results in the need for new vaccines every year. We will discuss the development of Syncon™ DNA vaccine candidates based on consensus antigens to target multiple unmatched but related pandemic and seasonal influenza strains and demonstrate broadly cross-protective immune responses in animal models of disease. The same strategy has been extended to target other emerging infectious diseases such as dengue and chikungunya that also require broadly cross-protective immune responses. Biography
10:00 Networking Coffee Break
10:30 The Pharmajet Needle-Free System for Standard Delivery of H1N1 Flu Vaccines and Future Applications Enabled by Intra-Dermal Delivery
Linda McAllister, M.D., Ph.D., Chief Medical Officer & VP, R&D, PharmaJet, Inc.
PharmaJet’s low cost and robust needleless jet injection system is now FDA, CE and ANVISA cleared for intramuscular and subcutaneous delivery. The initial commercial experience of patients and healthcare workers with H1N1 and seasonal flu vaccinations will be presented. In addition, Intra-dermal delivery can reduce vaccine dose and adjuvant requirements; the future use of this new modality will be discussed. Biography
11:00 Mucosal Immunization against Vaginal Candida Infections Using Sap2 Recombinant Protein Delivered by Influenza Virosomes
Christian Spyr, Ph.D., Head, Project Management and Clinical Development, Pevion Biotech, Ltd.
Vaginal Candida infections have emerged as a significant medical problem during the last few decades. Innovative vaccine approaches are needed to induce local mucosal immunity in order to cure recurrent vulvovaginal candidiasis. In animal challenge studies, recombinant Secreted Aspartyl Proteinases-antigen (Sap2) delivered by influenza virosomes are able to induce protective immune responses. A Phase I clinical study is ongoing.
11:30 Intranasal Nanoemulsion Adjuvanted Influenza Vaccine – Dose Range Efficacy and Toxicity Studies
Tarek Hamouda, M.D., Ph.D., M.B.A., Director of Vaccines, NanoBio Corporation
NB-1008 is a nanoemulsion adjuvanted Fluzone® vaccine. The adjuvant is an oil-in-water emulsion composed of nanometer-sized droplets stabilized by surfactants. Different doses of commercial influenza vaccine (Fluzone®) were mixed with different concentrations of nanoemulsion and administered intranasally to ferrets to determine immune responses. IND-enabling rabbit toxicity studies were performed under GLP conditions. The ferret and rabbit studies demonstrated that administration of NB-1008 resulted in an unprecedented high titer of antibody response without toxic side effects. These studies led to initiation of a first-in-man clinical trial in 2009. Biography
Sponsored by
12:00pm Mimopath™, A New Versatile Vaccine Carrier-Adjuvant Technology
Kees Leenhouts, Chief Scientific Officer, Mucosis B.V.
Mucosis’s vaccine technology Mimopath™ is based on bacteria-like particles derived from the food-grade bacterium Lactococcus lactis. The particles can simply be used as an adjuvant or can also be functionalized as antigen carrier.
Mimopath™ has been shown to activate the innate immune system through TLR2. Vaccines based on Mimopath™ raise balanced Th1/Th2 type responses that are protective as demonstrated in several models for viral, bacterial and parasitic diseases. The Mimopath™-based vaccines are suitable for mucosal and parental routes of administration.
12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:45 Chairperson’s Remarks
1:50 How VLPs Develop Their Efficacy
Mario Amacker, Ph.D., Head, Process Development & Manufacturing, Pevion Biotech, Ltd.
Virosome are a clinically and commercially validated VLP technology. They are used for several marketed and currently developed subunit vaccines. Despite their use in licensed vaccines, little is known about how they act. We present how this carrier/adjuvant system generates its effect and how this will affect the future development of subunit vaccines. We are able to describe a clear mode of action that may be applicable to other VLP’s. This is the first time that a novel adjuvant/carrier system is described in such detail. This information is key for future regulatory approval processes, not only for the virosome VLP but for VLPs in general. Biography
2:20 Synthetic Virus-Like Particle (SVLP) Technology in Synthetic Vaccine Design
Arin Ghasparian, Ph.D., CSO, Virometix AG
A new approach to vaccine delivery has been developed that is based on artificial nanoscale biological assemblies in the 20–30 nm size range. The assemblies resemble small viruses and VLPs in their shape and composition (i.e. they contain lipid and protein), and harness their excellent immunostimulatory properties, but are made entirely by chemical synthesis. Antigens of choice, including drug-like haptens, small synthetic proteins and synthetic antigen mimetics (SAMs), can be coupled to these “Synthetic Virus-like particles” (SVLPs) for multivalent presentation in an ordered repetitive format. The properties of SVLPs can be tailored using a myriad of chemical methods to include pathogen associated molecular patterns, such as toll-like receptor ligands, as well as universal T-helper epitopes and pathogen-specific T-cell and B-cell epitopes. The talk will illustrate the SVLP approach with artificially designed SVLPs that combine B-cell epitope mimetics and a universal T-helper epitope from the malaria parasite P. falciparum that are strongly immunogenic in animal models without use of an adjuvant. Biography
2:50 Lecithin Nanoparticles as an Adjuvant for Vaccines
Zhengrong Cui, Ph.D., Associate Professor, College of Pharmacy, The University of Texas at Austin
An accumulation of research over the years has demonstrated the utility of nanoparticles as antigen carriers with adjuvant activity. We engineered novel nanoparticles from lecithin/glyceryl monostearate-in-water emulsions. Using bovine serum albumin (BSA), ovalbumin (OVA), or Bacillus anthracis protective antigen (PA) protein as model antigens, we defined the adjuvanticity of the nanoparticles when the antigens were covalently conjugated onto their surface and evaluated the effect of the size of the nanoparticles on the resultant immune responses. The potent adjuvant activity of the nanoparticles was likely due to their ability to move the antigens into local draining lymph nodes, to enhance the uptake of the antigens by antigen-presenting cells, and to activate the antigen-presenting cells. This novel nanoparticle system has the potential to serve as a universal protein-based vaccine carrier capable of inducing strong immune responses. Biography
3:20 Networking Refreshment Break
3:35 Adjuvantation of a Vaccine without Adjuvant Injection
Mei X. Wu, M.D., Ph.D., Associate Professor, Wellman Center for Photomedicines, MGH/Harvard Medical School
We develop a laser-based vaccine “adjuvant” capable of enhancing and prolonging immune responses against both model and clinic vaccines, with few side effects locally or systemically. Brief illumination (2 min) of a small area (< 0.7 cm2) of the skin with a non-destructive safe laser boosted the production of ovalbumin (OVA)-specific antibody by 300~500% over intradermal OVA injection. Similarly, the level of flu-specific antibody was 9-folds higher after two vaccinations with a season flu vaccine each following laser illumination as compared to the vaccine alone. Moreover, immunization of monophosphoryl lipid A (MPL)-adjuvanted OVA followed by laser illumination of the administration site increased the amount of OVA-specific antibody from 11-folds with MPL to 22-folds with MPL plus laser illumination. Thus, in comparison with all current vaccine adjuvants that are either chemical compounds or biological agents, laser-based adjuvant platform is a potent, long-term risk-free vaccine “adjuvant” as it can adjuvantate a vaccine without injection of any self or foreign substance into one’s body. Biography
4:05 Clinical Safety of the ISCOMATRIX Adjuvant
Marli Watt, M.D., Clinical Safety Physician, Clinical Safety, CSL Limited
ISCOMATRIX™ adjuvant is a novel saponin based adjuvant which can be administered with various antigens to induce a targeted immune response. It is a component of a number of vaccines undergoing clinical investigation. The challenge is to manage an integrated approach to patient safety across a diverse range of programs, and evaluate the adjuvant-specific risk benefit profile. The development program for a novel vaccine adjuvant has many distinctive features compared to that of conventional products in clinical development, which include the associated unique challenges faced in managing a range of evolving safety data in order to analyze an adjuvants’ clinical risk – benefit profile. This is particularly pertinent in our current climate, with new technologies, ever increasing scrutiny over vaccine constituents, and evolving expectations from both Regulators and the Public regarding potential undesirable side effects. This presentation will address these challenges and describe CSL’s proactive approach to evaluating and managing the safety profile of our novel adjuvant. Biography
4:35 End of ImVacS
Day 1 | Day 2 | Speaker Bios