Microneedles LOG(TCID 50 ) per array Vaccine Stability
Smith, Chris, Morning Show Host has reference to this Academic Journal, PHwiki organized this Journal DEPARTMENT OF HEALTH AND HUMAN SERVICESCENTERS FOR DISEASE CONTROL AND PREVENTIONMeasles Vaccination: Alternative Delivery Methods GLOBAL MEASLES AND RUBELLA MANAGEMENT MEETING 15-17 March 2011Salle B, WHO Headquarters, Geneva, Switzerl in addition to Paul A. Rota, Ph.D.Measles, Mumps, Rubella in addition to Herpes Viruses Laboratory BranchDivision of Viral DiseasesDry Powder in addition to Microneedle VaccinesDemonstrate that dry measles vaccine can be reconstituted in vivo in addition to produce an immune responseLong-Term ObjectiveTo develop a microneedle-based patch that can successfully immunize an individual against measles virus
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MicroneedlesMicron-scale needlesBiologically inert: Stainless steel or titaniumCoated with dry vaccineVaccine rapidly dissolves in the skinThe ouch factor is significantly decreased
Excipient SelectionCMC in addition to F68 were added to increase coating effectivenessThey negatively affect vaccine stability:2% CMC + 1% F68 creates 2.48 logTCID50 loss after 1 dayThe addition of 15% trehalose reduces loss to 1.11 log unitsReplacing trehalose with 2.5% pig gelatin or 15% myo-inositol did not have a significant effect on stabilityLOG(TCID50) per array
Immunogenicity in Cotton Rats: 1000 TCID50 Microneedle in addition to 1000 TCID50 SQPlaque Neutralization Titer Against Measles Virus: 1000 TCID50 Microneedle in addition to 1000 TCID50 SQChallenge study planned as long as April, 2011Primate protocol is being writtenTest in rhesus macaques in 2011Dry Powder Vaccine as long as Measles
Retention of Dry Powder Measles Vaccine PotencyAt 25 ºC the dry vaccine can be stored as long as 6 monthsGMP CAN-BD powder manufacturing equipment installed at the Serum Institute of India (Pune, India) as long as the production of inhalable dry powder measles vaccine as long as the NHP toxicity study in addition to Phase I clinical trial.
Conclusions from GLP toxicology study of MVDP in Rhesus macaquesNo test article-related effects on:Clinical pathology including blood chemistry, hematology, coagulation, in addition to urinalysisGross pathologyOrgan weightsHistopathologyThe no-observed adverse effect level of MVDP is 50 mg when administered once or twice with PuffHaler or BD Solovent
Status of Regulatory Submission The results of the pre-clinical animal studies demonstrate that the Measles Vaccine Dry Powder can be delivered by inhalation using two novel, inexpensive, dry powder inhalers, is safe in addition to non-toxic, in addition to can induce protective immune responses against measles virus infection.A Clinical Trial Application was submitted to the Drugs Controller General of India in July, 2010 to conduct a Phase 1 clinical trial of MVDP.
Design of Phase 1 Clinical StudyStudy is sponsored by the Serum Institute of India, Ltd in addition to will be conducted at a single hospital in Pune, India. Study Objectives:Primary: to compare the safety of a single administration of 10 mg of inhaled MVDP aerosol given by PuffHaler or BD Solovent to a licensed Edmonston Zagreb measles vaccine given subcutaneouslySafety will be determined by the incidence of solicited in addition to unsolicited adverse events, physical examination, clinical laboratory testing, in addition to concomitant medication useSecondary: to compare the immune responses, as measured by ELISA in addition to PRNT, induced by the three delivery methodsAcknowledgementsMMRHLB, CDC: Marcus Collins, Mark PapaniaGeorgia Tech: Mark Prausnitz in addition to Chris EdensCDC ARB: Jessica AyersSupport from Georgia Research AllianceAktiv-Dry, University of Colorado: Bob Sievers, Brian QuinnSII: R DhereJHU: Diane GriffinSupport from Bill in addition to Melinda Gates FoundationExtra slides
Structure of myo-inositolSEM of dry powder containing myo-inositol (rice-derived) manufactured by CAN-BD. Formulation of Measles Vaccine Dry PowderParticles as long as med at <60 °C from an aqueous solution containing 11% total dissolved solids (50 g/L myo-inositol, 25 g/L gelatin, 16 g/L arginine-HCl, 1 g/L alanine, 2.1 g/L histidine, 3.5 g/L lactalbumin hydrolysate, 8.3 g/L MEM constituents, 3 g/L tricine, pH 6.5 - 7.0). Microparticles averaged 1 µm in diameter in addition to encased spherical virus particles averaged 120 nm.Mean viral potency of measles vaccine powder samples was 4.6 log CCID50 / 10 mg.FREEZE-FRACTURE SEM OF E-Z SUB-MICRON MEASLES VIRUS ENCASED IN MYO-INOSITOL-STABILIZED EXCIPIENT MICROPARTICLESVaccine StabilityCurrent WHO recommendations:Store lyophilized vaccine at 2-8oCRequired stability is 7 days at 37oCAfter reconstitution of multidose vial, if not used within 8 hours, discardDry StabilityTraditional vaccine rapidly loses titer after drying0.43 logTCID50 units lost after 1 dayAddition of 15% trehalose reduces loss
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