U19AI189178

CENTER FOR IMMUNOLOGICAL INTERVENTIONS AGAINST GONORRHEA (CIIG) - MODIFIED PROJECT SUMMARY/ABSTRACT SECTION SUMMARY OVER 82 MILLION NEISSERIA GONORRHOEAE (NG) INFECTIONS OCCUR GLOBALLY AND GONORRHEA RANKS SECOND AMONG NOTIFIABLE INFECTIONS REPORTED TO THE CDC. NG HAS A MAJOR IMPACT ON REPRODUCTIVE HEALTH, THE WELL-BEING OF NEWBORNS, AND THE TRANSMISSION OF THE HUMAN IMMUNODEFICIENCY VIRUS. CONTROL RELIES ON SAFE-SEX COUNSELING AND IDENTIFICATION AND TREATMENT OF INFECTED INDIVIDUALS, THE LATTER OF WHICH IS SERIOUSLY CHALLENGED BY THE RAPID EVOLUTION OF ANTIBIOTIC RESISTANCE IN NG. NEW INTERVENTIONS ARE NEEDED TO REDUCE THE NUMBER OF INFECTIONS AND CURB THE SPREAD OF RESISTANT STRAINS. THE OVERALL GOAL OF THE CENTER FOR IMMUNOLOGICAL INTERVENTIONS AGAINST GONORRHEA (CIIG) IS TO ADVANCE A PROMISING VACCINE CANDIDATE THROUGH FURTHER PRECLINICAL DEVELOPMENT AND INTO CLINICAL TRIALS. THIS GOAL WILL BE ACCOMPLISHED BY THREE RESEARCH PROJECTS THAT ARE FOCUSED ON DEVELOPING I.) A COMBINATION MENINGOCOCCAL OUTER MEMBRANE VESICLE (OMV) VACCINE (VESIVAX® IAMS-OMV-NGAG) CONTAINING PROMISING RECOMBINANT NG ANTIGENS USING THE VESIVAX® LIPOSOME VACCINE PLATFORM. THE OMV PORTION OF THE VACCINE IS DESIGNED TO INDUCE BROADER REACTIVITY AGAINST NG STRAINS; CO-DELIVERY OF SELECTED ADJUVANTS (IAMS) AND INTRADERMAL IMMUNIZATION THROUGH A PATENTED MICRONEEDLE PATCH WILL BE OPTIMIZED TO INDUCE ROBUST PROTECTIVE RESPONSES (PROJECTS 1 AND 3); II.) A PEPTIDE/VIRUS-LIKE PROTEIN IMMUNOGEN TO AUGMENT THE VESIVAX® IAMS-OMV-NGAG VACCINE BY INDUCING EPITOPE-TARGETED ANTIBODIES THAT INCREASE NG SUSCEPTIBILITY TO HOST IMMUNE DEFENSES BY BLOCKING MECHANISMS BY WHICH NG TO EVADES COMPLEMENT ACTIVATION (PROJECT 2). THREE COLLABORATIVE SCIENTIFIC CORES WILL SUPPORT THE PROJECTS BY PROVIDING STATE-OF-THE ART MEASUREMENTS OF IMMUNE RESPONSES (CORE B), IN VIVO EFFICACY TESTING IN MOUSE MODELS OF NG REPRODUCTIVE TRACT INFECTION (CORE C), AND CENTRALIZED SYSTEMS FOR DATA MANAGEMENT, STUDY DESIGN, DATA ANALYSIS, AND PRE-IND ACTIVITIES (CORE D). AN ADMINISTRATIVE CORE (CORE A) WILL PROVIDE THE INFRASTRUCTURE NEEDED TO FACILITATE COMMUNICATIONS BETWEEN THE CIIG AND NIH, AND COORDINATE TELECONFERENCES AMONG THE PROJECT AND CORE LEADERS TO FOSTER DATA EXCHANGE, INTERNAL PEER REVIEW AND INTRA-CENTER COLLABORATIONS. A STANDING SCIENTIFIC ADVISORY BOARD WILL REVIEW SCIENTIFIC PROGRESS EACH YEAR AND DETERMINE WHICH PRODUCTS WILL BE ADVANCED FOR FURTHER PRE-CLINICAL DEVELOPMENT. PRE-IND ACTIVITIES WILL BEGIN IN YEAR 4 UNDER A REGULATORY STRATEGY PROVIDED BY CORE D.

The Henry M. Jackson Foundation For The Advancement Of Military Medicine

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Maryland United States

State-Wide

Centers of Excellence for Translational Research (CETR) (U19 Clinical Trial Not Allowed) (RFA-AI-23-065)