grant

Core A: Administration

Organization BOSTON UNIVERSITY MEDICAL CAMPUSLocation BOSTON, UNITED STATESPosted 14 Sept 2018Deadline 31 Aug 2026
NIHUS FederalResearch GrantFY2025A vaginaeA. vaginaeAb responseAchievementAchievement AttainmentAdherenceAnti-sperm antibodyAnti-spermatozoa antibodyAnti-spermatozoa autoantibodyAntibodiesAntibody FormationAntibody ProductionAntigen TargetingAtopobium vaginaeAwardBiologicalBloodBlood Reticuloendothelial SystemBostonCannot achieve a pregnancyClinicalClinical DataClinical ManagementClinical Treatment MoabClinical TrialsClinical Trials DatabaseCommunicationContraceptionContraceptive AgentsContraceptive methodsContraceptivesDataDevelopmentDevelopment and ResearchDifficulty conceivingEarly-Stage Clinical TrialsElectronicsEnsureEnvironmentExperimental DesignsFertility ControlFilmFundingGoalsGrantGuidelinesHHV-2HHV2HIV-1HIV-IHIV1HSV-2HSV2Herpes Simplex Virus 2Herpes Simplex Virus Type 2Herpesvirus 2 (alpha), HumanHerpesvirus progenitalisHumanHuman (alpha) herpes virus 2Human Herpesvirus 2Human Immunodeficiency Virus Type 1Human herpes simplex virus type 2Human immunodeficiency virus 1IgG1ImmobilizationIndividualIndustrializationIndustryInfertilityInfrastructureInhibition of FertilizationInstitutionIntravaginal AdministrationInvestigatorsLeadershipLibrariesLiquid substanceMethodsModern ManMonitorMonoclonal AntibodiesMultipurpose prevention technologyNIAIDNICHDNational Institute of Allergy and Infectious DiseaseNational Institute of Child Health and Human DevelopmentNational Institutes of HealthNicotianaPerformancePhase 1 Clinical TrialsPhase I Clinical TrialsPositionPositioning AttributePreclinical TestingProgram ReviewsPublicationsR & DR&DR-Series Research ProjectsR01 MechanismR01 ProgramReagentResearchResearch GrantsResearch PersonnelResearch Project GrantsResearch ProjectsResearchersResource AllocationSafetyScheduleScientific PublicationScientistSexually Transmitted DiseasesSexually Transmitted DisorderSexually Transmitted InfectionSiteSpecificitySpermSperm AgglutinationSperm antibodySperm autoantibodySpermatozoaSpermatozoa antibodyStatistical Data AnalysesStatistical Data AnalysisStatistical Data InterpretationTestingTranslational ResearchTranslational ScienceUnited States National Institutes of HealthUniversitiesVaginaVaginal AdministrationVaginal Drug AdministrationVaginal InstillationsVaginal Route of Drug AdministrationVaginal filmVenereal DiseasesVenereal DisordersVenereal InfectionsWomanantibody biosynthesisapply vaginallybiologicclinical databaseconferenceconventiondata acquisitiondata acquisitionsdata managementdata sharingdevelopmentalelectronicelectronic deviceexperiencefertility cessationfertility lossfluidherpes simplex iihuman alphaherpesvirus 2immunoglobulin biosynthesisinfertileinnovateinnovationinnovativeintravaginal applicationliquidmAbsmedical collegemedical schoolsmeetingmeetingsmonoclonal Absmultipurpose preventionorthopedic freezingpathogenphase I protocolpre-clinicalpre-clinical testingpreclinicalprogramsresearch and developmentschool of medicinesexually acquired infectionsperm cellspermatozoa Abstatistical analysisstatistical servicestatisticssuccesssummitsymposiasymposiumtranslation researchtranslational investigationvaginal applicationvaginal drug deliveryweb sitewebsitezoosperm
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Full Description

ADMINISTRATIVE CORE – ABSTRACT
The Contraception Research Center at Boston University School of Medicine (BUSM-CRC) brings together an

experienced team of clinical, industrial and basic scientists to develop and test a new contraceptive product, ZB-

06, a vaginal film that releases an antisperm antibody, Human Contraception Antibody (HCA). HCA was

originally isolated from the blood of an infertile but otherwise healthy woman and targets an antigen on sperm to

effect rapid sperm agglutination and immobilization. Success of the BUSM-CRC relies upon an Administrative

Core that provides scientific and administrative leadership in coordinating the two contraception development

research projects and one contraceptive translational research project that make up the program. The

Administrative Core will also maintain the clinical database and provide statistical services, and coordinate data

and materials acquisition and sharing so that the research progresses in an integrated iterative fashion to meet

individual project and programmatic milestones,

The Specific Aims of the Administrative Core are:

1. To provide scientific leadership and administrative oversight. Specifically, the Administrative Core will

establish an Executive Committee (EC) for ongoing assessment of project and core milestones, resource

allocation and changes to the experimental design. The Administrative Core will also convene an external

Scientific Advisory Panel (SAP) to review the program annually. The Administrative Core will facilitate

communication through scheduled conference calls and investigator meetings, provide financial and

administrative support, and insure adherence to institutional and federal guidelines.

2. To coordinate data and materials acquisition and sharing to insure that project and program

milestones are met. The Administrative Core will be responsible for the reagent/research material and data

management and sharing plan, and for monitoring milestone achievements.

3. To manage the clinical database and statistical analysis for the two clinical trials.

Grant Number: 5P50HD096957-08
NIH Institute/Center: NIH

Principal Investigator: Deborah Anderson

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