CoVPN - COVID Countermeasures

The Vaccine and Treatment Evaluation Units (VTEUs) are a critical resource for the NIAID Infectious DiseasesClinical 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 infectiousdiseases in people of all ages and risk categories. The VTEU network sites must flexible and respond toemerging threats and changing NIAID priorities. To this end, the University of Rochester VTEU (UR VTEU) willcollaborate with NIAID and the VTEU leadership group (VTEU LG) to address and prioritize initiatives forinfectious diseases such as respiratory, enteric, sexually transmitted infections and antibiotic resistantorganisms as well as maintain flexibility to switch focus to emerging threats as the need arises. The Universityof Rochester is fortunate to enjoy a community with a very positive attitude towards clinical research andcollaborative relationships between the major healthcare providers in the city providing access to all thehospitals, clinics and practices in the area. The UR VTEU offers a very experienced administrative and clinicalgroup 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 addressimportant NIAID priorities and formulate best practices, efficiencies and standard operating procedures amongVTEU sites. UR VTEU investigators have expertise in adult and pediatric clinical research as well asrecruitment of vulnerable populations into clinical trials and thus can anticipate successful recruitment of youngand older adults, infants, young children and adolescents, and pregnant women. Additionally, the closerelationship of the Monroe County Health Department with the University provides access to patients withsexually transmitted diseases for study participation. We will provide capacity to perform phase 1-3 clinicaltrials and pharmacokinetic studies as well as surge capacity in terms of personnel and clinical research sites torapidly respond to urgent NIAID demands. Importantly, our investigators have experience conducting challengeand isolation studies and can provide VTEU facilities for such projects. Our research laboratory expertise willprovide the VTEU network with a variety of state of the art technologies to interrogate the host response toinfection and immunization as well as develop a deeper understanding of pathogenesis for many infectiousdiseases. Specifically, core faculty have expertise in a wide range of novel immunologic assays as well astranscriptional and microbiome analysis. In addition, the UR VTEU will provide research opportunities andeducation for junior faculty to train the next generation of physician scientists. All clinical trials will adhere toNIAID/NIH requirements and comply with Good Clinical Practice. In summary, the UR VTEU site will offer anenthusiastic and diverse group of investigators with a track record of participating in collaborative research andthe necessary scientific, clinical, administrative and organizational structure to support NIAID activities.