Harvard/Boston/Providence Clinical Trials Unit (Harvard/B/P CTU)

The Harvard/Boston/Providence Clinical Trials Unit (CTU) conducts clinical trials to address research areas ofthree NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN); integrated HIVprevention strategies (HPTN); and adult HIV therapeutic strategies including HIV cure, management of non-infectious co-morbidities and infectious co-morbidities of viral hepatitis and tuberculosis (ACTG). The CTU iscomprised of five clinical research sites (CRSs) at institutions where the clinical trials are conducted. Theseinstitutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham andWomen's Hospital, Fenway Health Center, and The Miriam Hospital. The CTU is led by three highlyexperienced principal investigators, Drs. Raphael Dolin, Kenneth Mayer and Daniel Kuritzkes, and includeshighly accomplished CRS leaders and collaborating investigators. The CTU functions as an integrated, highlycollaborative entity, which has centralized planning, resource allocation, decision-making and financialmanagement through an efficient administration plan. Decisions are driven by a rigorous evaluation processbased on established metrics of performance and robust communication among leadership and staff of theCTU and CRSs. Centralized resources of the CTU include a Clinical Research Laboratory (CRL), a ResearchPharmacy Coordinator (RPC), Data and Quality Management Plans, and a Community Engagement Core. TheCTU has diverse and accessible populations for study, representing communities most affected by HIV/AIDS,hepatitis C virus infection, and tuberculosis, and have well-grounded connections with the communities inwhich they are based. The CTU is well poised and experienced to carry out efficient, high quality clinical trialsto address major questions in HIV clinical research. Its leadership and administrative structure facilitates theconduct of studies which cross traditional network boundaries and that enables rapid responses to newscientific directions as they emerge.Under this Administrative Supplement application, The HBP CTU is responding to NIAID's Notice of SpecialInterest (NOSI) (NOT-AI-20-031) to address the need for research on Severe Acute Respiratory SyndromeCoronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is particularly interested inprojects focusing on viral natural history, pathogenicity, transmission, as well as projects developing/expandingmedical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeuticsagainst SARS-CoV-2/COVID-19. In order to address this urgent public health need, the NIAID-supportednetworks have been charged to serve as a focal point of sponsored trials in COVID-19 vaccines andmonoclonal antibodies (mAbs) for preventing the acquisition of SARS-CoV-2, as well as to increaseunderstanding of and to establish treatments for COVID-19.The HBP CTU and its affiliated CRSs have well established and highly productive relationships with the NIAID-supported networks. Through its existing leadership and administrative structure, the HBP CTU is activatedand prepared to immediately support these efforts.The HBP CTU is based in Boston, Massachusetts, which has been a "hot spot" for SARS-CoV-2 infections andCOVID-19 cases. The HBP CTU is well poised and experienced to support these emerging research needsand interests. In particular, HBP CTU is prepared to support and implement studies needed for expandedSARS-CoV-2 RNA and serology testing at our affiliated Clinical Research Sites (CRSs). The CTU is alsoprepared to rapidly implement other studies related to NIAID's charge to address all aspects of SARS-CoV-2and COVID-19 research, vaccine development and clinical trials, other prevention measures, and potentialtreatments. Studies at the CTU may include: seroepidemiology of SARS-CoV-2 in the Boston/New Englandarea; treatment of COVID-19 with antivirals such as remdesivir and hydroxychloroquine; treament of advancedcases of COVID-19 with anti-IL-6 inhibitors; the conduct of clinical trials of candidate vaccines and mAbs forprevention and/or treatment of disease; and the development of in vitro assays used for making measurementsof SARS-CoV-2 neutralization, which have the ability to distinguish incremental advances in potency, breadth,and durability. The HBP CTU administration will oversee the expansion and implementation of these activitiesat our affiliated CRSs and Clinical Research Laboratories (CRLs).