SANARIA INC. — Department of Health and Human Services SBIR Phase II: R

Description

DESCRIPTIONprovided by applicantThe world needs a highly effective malaria vaccineSanaria rPfSPZ Vaccinecomposed of asepticpurifiedcryopreserved radiation attenuated PfSPZprotectedof volunteers in an NIH clinical trialThe vaccine has been administered by direct venous inoculationDVItosubjects in MaliTanzaniaEquatorial GuineaEGand USASafetytolerabilityhigh grade protectionheterologous protection after Controlled Human Malaria Infectiondurable protection in the fieldefficacy withdoses and safety atx theprotective dosehave been establishedSanaria has met with the World Health Organization to plan for pre qualification and establishment of a Technical Advisory Group for PfSPZ Vaccine administered by DVIInthe vaccine will be assessed by DVI in TanzaniaKenyainfantsMaliBurkina FasoEGGermanyand USAThe first licensure submission in USA is planned for lateReduction in the number of PfSPZregimennumber of dosesand or time to complete an immunization regimenand prolongation of efficacy will reduce costs and improve implementationBeing able to immunize by cutaneous or intramuscular routes will increase capacity to immunize young infants and facilitate immunization by less experienced personnelTo these endswe have studied adjuvants that augment prolong immune responsesTraditional and experimental adjuvantsincluding multiple toll like receptor ligandsdo not worklikely because the vaccine is composed of live attenuated organisms and no licensed adjuvants are known to enhance the CDT cell mediated immunity which appears to underlie protective efficacy against PfSPZ VaccineA novel glycolipidDWwhich binds CD d and stimulates iNKT cellshas strong adjuvant effects in mice immunized with irradiated Pyoelii sporozoitesirrPySPZand enabled reduction to one dose when irrPySPZ were administered by DVIprotectionand fromtodoses when administered intradermallyprotectionProtection lasted for at leastweeksFour DVI doses during a week ofxpurifiedcryopreserved irrPySPZ with and withoutDWprotectedandof mice respectivelypraising the possibility of an accelerated immunization regimen that would be ideal for travelers and mass administration campaignsIn non human primatesNHPsDWwith PfSPZ Vaccine was well toleratedgreatly enhancing the magnitude of splenic CDand CDT cell responsesmonths post vaccinationThese findings support development ofDWfor use with PfSPZ Vaccine administered both by intravascular and traditional routes to allow for reduced cost of goodsrapid immunization and increased durability of protectionIn this project we will assessDWwith rodenthumanand simian SPZ in mice and NHPsand manufactureDWin compliance with cGMPsAccomplishing the Specific Aims of this proposal will provide the foundation for the first phaseclinical trial of PfSPZ Vaccine administered withDWand eventual use of this combination for rapid and cost effective immunization of travelers military and for mass malaria elimination campaigns