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Principal Investigator: Angela Ramona Branche
Organization: UNIVERSITY OF ROCHESTER
Fiscal Year: 2024
Award: $932,430
Funding agency: National Institute of Allergy and Infectious Diseases
The Vaccine and Treatment Evaluation Units (VTEUs) are a critical resource for the NIAID Infectious Diseases
Clinical Research Consortium to conduct clinical research and trials to evaluate vaccines, preventive biologics,
therapeutics, diagnostics, predictive markers, and devices for the treatment and prevention of infectious
diseases in people of all ages and risk categories. The VTEU network sites must flexible and respond to
emerging threats and changing NIAID priorities. To this end, the University of Rochester VTEU (UR VTEU) will
collaborate with NIAID and the VTEU leadership group (VTEU LG) to address and prioritize initiatives for
infectious diseases such as respiratory, enteric, sexually transmitted infections and antibiotic resistant
organisms as well as maintain flexibility to switch focus to emerging threats as the need arises. The University
of Rochester is fortunate to enjoy a community with a very positive attitude towards clinical research and
collaborative relationships between the major healthcare providers in the city providing access to all the
hospitals, clinics and practices in the area. The UR VTEU offers a very experienced administrative and clinical
group with a proven track record of successful multicenter clinical trial work. With the support of the VTEU LG,
the UR VTEU will be well positioned to develop as well as implement concepts and projects that address
important NIAID priorities and formulate best practices, efficiencies and standard operating procedures among
VTEU sites. UR VTEU investigators have expertise in adult and pediatric clinical research as well as
recruitment of vulnerable populations into clinical trials and thus can anticipate successful recruitment of young
and older adults, infants, young children and adolescents, and pregnant women. Additionally, the close
relationship of the Monroe County Health Department with the University provides access to patients with
sexually transmitted diseases for study participation. We will provide capacity to perform phase 1-3 clinical
trials and pharmacokinetic studies as well as surge capacity in terms of personnel and clinical research sites to
rapidly respond to urgent NIAID demands. Importantly, our investigators have experience conducting challenge
and isolation studies and can provide VTEU facilities for such projects. Our research laboratory expertise will
provide the VTEU network with a variety of state of the art technologies to interrogate the host response to
infection and immunization as well as develop a deeper understanding of pathogenesis for many infectious
diseases. Specifically, core faculty have expertise in a wide range of novel immunologic assays as well as
transcriptional and microbiome analysis. In addition, the UR VTEU will provide research opportunities and
education for junior faculty to train the next generation of physician scientists. All clinical trials will adhere to
NIAID/NIH requirements and comply with Good Clinical Practice. In summary, the UR VTEU site will offer an
enthusiastic and diverse group of investigators with a track record of participating in collaborative research and
the necessary scientific, clinical, administrative and organizational structure to support NIAID activities.
Terms: <0-11 years old><21+ years old><Acute Poliomyelitis><Address><Adolescent><Adolescent Youth><Adult><Adult Human><Age><Antibiotic Agents><Antibiotic Drugs><Antibiotic-resistant organism><Antibiotics><Area><B pertussis infection><B. pertussis infection><Biological Agent><Biological Products><Bordetella pertussis infection><Categories><Child><Child Youth><Childhood><Children (0-21)><Cities><Clinic><Clinical><Clinical Research><Clinical Study><Clinical Trials><Collaborations><Communicable Diseases><Communities><County><Data><Data Analyses><Data Analysis><Development><Devices><Diagnostic><Disease><Disease Outbreaks><Disorder><Drug Kinetics><Drug resistant bacterium><Education><Educational aspects><Enrollment><Ensure><Enteral><Enteric><Epidemic Parotitis><Evaluation><Faculty><GCP standard><Gene Transcription><Genetic Transcription><Good Clinical Practice><Grippe><Health><Health Care Providers><Health Personnel><Healthcare Providers><Healthcare worker><Hospitals><Human Resources><Humanities><Immune response><Immunization><Immunological response><Immunology procedure><Infant><Infection><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Influenza><Intervention><Intervention Strategies><Investigation><Investigators><Laboratories><Laboratory Research><Leadership><M tuberculosis infection><M. tb infection><M. tuberculosis infection><M.tb infection><M.tuberculosis infection><MTB infection><Malaria><Manpower><Measles><Methods><Miscellaneous Antibiotic><Multi-Institutional Clinical Trial><Multi-center clinical trial><Multi-center trial><Multi-site clinical trial><Multicenter Trials><Multicenter clinical trial><Multisite clinical trial><Mumps><Mycobacterium tuberculosis (MTB) infection><Mycobacterium tuberculosis infection><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><Organization Charts><Outbreaks><Paludism><Pathogenesis><Patients><Persons><Pertussis><Pharmacies><Pharmacokinetics><Pharmacy facility><Phase><Physicians><Plasmodium Infections><Policies><Polio><Poliomyelitis><Position><Positioning Attribute><Pregnant Women><Preparation><Prevention><Preventive><Procedures><Protocol><Protocols documentation><RNA Expression><Reporting><Research><Research Personnel><Research Resources><Researchers><Resources><Risk><Rubeola><Sampling><Scientist><Secure><Sexually Transmitted Diseases><Sexually Transmitted Disorder><Sexually Transmitted Infection><Site><Surgeon><TB infection><Target Populations><Technology><Testing><Therapeutic><Training><Transcription><Tuberculosis><United States><United States National Institutes of Health><Universities><Vaccination><Vaccines><Venereal Diseases><Venereal Disorders><Venereal Infections><Vulnerable Populations><War><Whooping Cough><Work><access to vaccination><access to vaccines><adult youth><adulthood><ages><analyze microbiome><biologics><biopharmaceutical><biotherapeutic agent><clinical research site><clinical site><combat><data interpretation><data management><design><designing><developmental><disseminated TB><disseminated tuberculosis><drug resistant bacteria><emergent virus><emerging virus><enroll><epidemic parotiditis><evaluate vaccines><expectant mother><expecting mother><experience><fighting><flexibility><flexible><health care personnel><health care worker><health provider><health workforce><healthcare personnel><host response><immune system response><immunologic assay><immunologic assay/test><immunoresponse><improved><infected with B pertussis><infected with B. pertussis><infected with Burkholderia pertussis><infection due to Mycobacterium tuberculosis><innovate><innovation><innovative><interventional strategy><juvenile><juvenile human><kids><medical personnel><microbiome analysis><morbilli><new drug treatments><new drugs><new pharmacological therapeutic><new therapeutics><new therapy><new vaccines><next generation><next generation therapeutics><next generation vaccines><novel><novel drug treatments><novel drugs><novel pharmaco-therapeutic><novel pharmacological therapeutic><novel therapeutics><novel therapy><novel vaccines><older adult><older adulthood><optimism><organizational structure><pathogen><pediatric><personnel><positive attitude><pre-clinical research><preclinical research><predictive biomarkers><predictive marker><predictive molecular biomarker><pregnant mothers><premature><prematurity><preparations><preservation><recruit><respiratory><sexually acquired infection><treatment provider><tuberculosis infection><tuberculous spondyloarthropathy><vaccination access><vaccination availability><vaccine access><vaccine availability><vaccine evaluation><vaccine screening><vaccine testing><viral emergence><vulnerable group><vulnerable individual><vulnerable people><young adult><young adulthood><youngster>