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Development of a bioconjugate vaccine against Group B Streptococcus

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI142928-01A1
Agency Tracking Number: R41AI142928
Amount: $300,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-03-12
Award End Date (Contract End Date): 2021-02-28
Small Business Information
4447 MCPHERSON AVE, Saint Louis, MO, 63108-2505
DUNS: 080343938
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (314) 747-4473
Business Contact
Phone: (843) 331-9533
Research Institution
ATHENS, GA, 30602-1589
 Nonprofit college or university
PROJECT SUMMARY Streptococcus agalactiaecommonly referred to as Group B StreptococcusGBSis a leading cause of neonatal meningitis and sepsis worldwide as well as an agent of invasive disease in both pregnant and non pregnant adultsGBS neonatal disease manifests as early onsetdefined as disease within the first six days after birthor late onsetdefined as disease occurring after the first week of lifeboth of which are life threateningIn some instancesearly onset disease is preventable with intrapartum antibiotic prophylaxishoweverthis treatment strategy is not practical for lowand middle income countries nor does it prevent late onset disease or themillion preterm andstillbirths attributed to GBS each yearMolecularlyGBS produces one of ten different capsular polysaccharidesfive of whichserotype IaIbIIIIIand Vare associated withof all invasive neonatal GBS disease eventsIn additionprevious studies have demonstrated that placental transfer of maternal antibodies are able protect neonates from invasive GBS infectionThereforea vaccine targeting these five serotypes is of high societal and commercial valueIn order to make an efficacious vaccine targeting GBS capsulesthe polysaccharide must be covalently linked to an immunogenic carrier protein generating what s termed a conjugate vaccineConjugate vaccines are considered some of the most effective vaccines to dateas they are highly protective and generate immunological memory across all age groupsHowevertheir synthesis is complexcostlyand not conducive for all polysaccharideswhich has hindered development of novel conjugate vaccines against life threatening bacteria like GBSAs an alternative manufacturing platformVaxNewMo is developing conjugate vaccines using an innovative in vivo conjugation technologywhich eliminates the dependency on intricate chemical conjugation methods currently employed to synthesize these vaccinesUsing VaxNewMo s proprietary bioconjugating enzyme technologywe will therefore generate the most broadly covering GBS vaccine against five of the most prevalent GBS serotypes causingof all neonatal invasive disease eventsThe proposed research in this phase I application will focus onAimdeveloping five glycoengineered strains of Ecoli for the scalablerecombinant expression of GBS capsular polysaccharides in conjunction with VaxNewMo s conjugating enzyme technologygenerating the first bioconjugate vaccine against GBSSubsequentlyAimwe will demonstrate that a monovalent GBS bioconjugate vaccine is immunogenically non inferior to a traditionally prepared chemical GBS conjugate vaccineWe will also demonstrate the versatility of VaxNewMo s bioconjugating platform by providing preliminary immunogenicity data on a pentavalent GBS bioconjugateLastwe will test for correlates of immunity by determining bacterial burden and or survival of newborn pups infected with GBS born from vaccinated miceOur next step for Phase II funding will be to develop and optimize a purification protocol for large scale quantities of GBS bioconjugate vaccines and provide sufficient safetytolerability and immunogenicity data for Fast Track FDA approval PROJECT NARRATIVE Group B Streptococcus is a leading cause of neonatal infections worldwide and the causative agent of invasive disease in pregnant and non pregnant adultsCurrentlyprophylactic antibiotic therapy is the only treatment strategy available to at risk pregnant women and their newborn infantsThis proposal focuses on the development a bioconjugate vaccine to prevent the five most prevalent GBS serotypeswhich are responsible forof all neonatal GBS invasive disease events

* Information listed above is at the time of submission. *

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