Vaccines-2013 - OMICS Group

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Jessica M.H. Thrall et al., J Vaccines Vaccin 2013, 4:5http://dx.doi.org/10.4172/2157-7560.S1.0173 rd International Conference onVaccines & VaccinationJuly 29-31, 2013 Embassy Suites Las Vegas, NV, USAStabilizing micronized particles boosts sterility and safety of vaccinesJessica M.H. Thrall 1,2 , Stephen P. Cape 1,2 , Nisha K. Shah 1,2 , Scott Winston 1 , David H. McAdams 2 , Diane E. Griffin 3 , Wen-Hsuan Lin 3 andRobert E. Sievers 1,21Aktiv-Dry LLC, 2100 Central Avenue, USA2University of Colorado Boulder, USA3Johns Hopkins Bloomberg School of Public Health, Molecular Microbiology and Immunology, USACurrent vaccine delivery methods for prevention of global childhood diseases carry a high risk for needle contamination, vaccinewastage, and transportation and storage difficulties. Aktiv-Dry LLC’s focus is on R&D of safe and effective microparticles ofvaccines and pharmaceuticals for easier storage, greater thermal stability, and ease of use. We utilize our patented CO 2-AssistedNebulization with a Bubble Dryer® (CAN-BD) system to create stable dry microparticles of compounds for administration byneedle-free aerosol inhalers, sublingual solid formulations, or safer unit-dose, all-in-one auto-reconstitution syringe devices.Recently, our work has focused on vaccine prevention of measles and hepatitis B. Aktiv-Dry has developed inhalable andsublingual vaccines for measles along with a human-powered, active dry powder inhaler called the PuffHaler® for intrapulmonarydelivery of the dry powder measles vaccine. CAN-BD processed measles vaccine shelf-life stability has been shown for 4 yearsat 2-8 o C, protective immunity after intrapulmonary delivery to rhesus macaques, and no serious adverse events reported to dateduring on-going clinical Phase I safety trials in 60 adult males in India.We have also demonstrated stability of CAN-BD processed and dried microparticles of hepatitis B vaccine for use in a preloaded,single-dose, field-reconstitution device for parenteral delivery. Aktiv-Dry-formulated hepatitis-B vaccine was stabilizedwith trehalose, processed, and determined to retain stability using in-house stability assays. Our immunogenicity results fromintrapulmonary mucosal membrane delivery of measles vaccine dry powder aerosols and fundamental project goals may beextended to prevention and treatment (e.g., antibiotics and antivirals) of other pulmonary diseases (e.g., tuberculosis andinfluenza).BiographyJessica Thrall earned her Ph.D. in Biochemistry from the University of Colorado in 2012. Jessica spent nearly three years researching MycobacteriumTuberculosis initial and chronic infection stages, and testing novel vaccines and drugs using small animal models at the Mycobacteria ResearchLaboratories at Colorado State University. As part of the Aktiv-Dry LLC’s science team, Jessica drives the biological assay development sector forstability and effi cacy testing of dry powders produced using the CAN-BD process. Jessica brings to Aktiv-Dry her background in vaccine and drugtesting in animal models and her previous work involving innovative assay development and protein formulation.jthrall@aktiv-dry.comJ Vaccines Vaccin 2013ISSN: 2157-7560, JVV an open access journalVaccines-2013July 29-31, 2013Volume 4 Issue 5Page 96
Regina Heidenreich et al., J Vaccines Vaccin 2013, 4:5http://dx.doi.org/10.4172/2157-7560.S1.0173 rd International Conference onVaccines & VaccinationJuly 29-31, 2013 Embassy Suites Las Vegas, NV, USARNAdjuvant ® : A novel, highly-potent, RNA-based adjuvant for prophylactic and therapeuticvaccinesRegina Heidenreich, Benjamin Petsch, Mariola Fotin-Mleczek, Patrick Baumhof, Birgit Scheel, Söhnke Voss, Edith Jasny, Thomas Krampsand Karl-Josef KallenCureVac GmbH, Tübingen, GermanyGiven the important role of adjuvants in prophylactic vaccines as well as tumor immunotherapy, identification anddevelopment of new adjuvants with enhanced efficacy and safety is necessary. CureVac has recently developed a novel RNAbasedadjuvant with strong immunostimulatory properties. RNAdjuvant® is physically and chemically well-defined and exhibits avery good safety profile. RNAdjuvant® is well tolerated even at high doses and does not induce splenomegaly in mice as describedfor standard adjuvants such as CpG-DNA. In vitro, RNAdjuvant® induced activation of APC leading to an increased expressionof specific activation markers and secretion of cytokines driving a pronounced Th1 response.In vivo, RNAdjuvant® boosted even very immunogenic influenza vaccines inducing balanced Th1/Th2 T cell responses.Vaccination with RNAdjuvant® accelerated onset of protective antibody responses to approved influenza vaccines, enhancedvaccine specific T cell responses and enabled significant dose sparing.In addition, RNAdjuvant® combined with human papillomavirus (HPV)-derived recombinant peptides elicited strongantigen-specific cytotoxic T-cell responses, which are barely induced by vaccination with peptide alone. Vaccination withRNAdjuvant® with HPV-derived peptides mediated complete tumor protection in a prophylactic setting, as well as significantgrowth inhibition of already established tumors after therapeutic vaccination.Taken together our data demonstrate that RNAdjuvant® represents a novel breakthrough technology that can be combinedwith almost any type of antigen that requires safe and potent adjuvants.bm@curevac.deJ Vaccines Vaccin 2013ISSN: 2157-7560, JVV an open access journalVaccines-2013July 29-31, 2013Volume 4 Issue 5Page 97
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