Document text
Principal Investigator: Raphael Dolin
Organization: BETH ISRAEL DEACONESS MEDICAL CENTER
Fiscal Year: 2020
Award: $900,000
Funding agency: National Institute of Allergy and Infectious Diseases
Harvard/Boston/Providence Clinical Trials Unit (H/B/P CTU)
Administrative Supplement (06/01/20-11/30/20)
PROJECT SUMMARY
The Harvard/Boston/Providence Clinical Trials Unit (CTU) conducts clinical trials to address research areas of
three NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN); integrated HIV
prevention 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 is
comprised of five clinical research sites (CRSs) at institutions where the clinical trials are conducted. These
institutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and
Women’s Hospital, Fenway Health Center, and The Miriam Hospital. The CTU is led by three highly
experienced principal investigators, Drs. Raphael Dolin, Kenneth Mayer and Daniel Kuritzkes, and includes
highly accomplished CRS leaders and collaborating investigators. The CTU functions as an integrated, highly
collaborative entity, which has centralized planning, resource allocation, decision-making and financial
management through an efficient administration plan. Decisions are driven by a rigorous evaluation process
based on established metrics of performance and robust communication among leadership and staff of the
CTU and CRSs. Centralized resources of the CTU include a Clinical Research Laboratory (CRL), a Research
Pharmacy Coordinator (RPC), Data and Quality Management Plans, and a Community Engagement Core. The
CTU 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 in
which they are based. The CTU is well poised and experienced to carry out efficient, high quality clinical trials
to address major questions in HIV clinical research. Its leadership and administrative structure facilitates the
conduct of studies which cross traditional network boundaries and that enables rapid responses to new
scientific directions as they emerge.
Under this Administrative Supplement application, The HBP CTU is responding to NIAID’s Notice of Special
Interest (NOSI) (NOT-AI-20-031) to address the need for research on Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is particularly interested in
projects focusing on viral natural history, pathogenicity, transmission, as well as projects developing/expanding
medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics
against SARS-CoV-2/COVID-19. In order to address this urgent public health need, the NIAID-supported
networks have been charged to serve as a focal point of sponsored trials in COVID-19 vaccines and
monoclonal antibodies (mAbs) for preventing the acquisition of SARS-CoV-2, as well as to increase
understanding 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 activated
and 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 and
COVID-19 cases. The HBP CTU is well poised and experienced to support these emerging research needs
and interests. In particular, HBP CTU is prepared to support and implement studies needed for expanded
SAR-CoV-2 RNA and serology testing at our affiliated Clinical Research Sites (CRSs). The CTU is also
prepared to rapidly implement other studies related to NIAID’s charge to address all aspects of SARS-CoV-2
and COVID-19 research, vaccine development and clinical trials, other prevention measures, and potential
treatments. Studies at the CTU may include: seroepidemiology of SARS-CoV-2 in the Boston/New England
area; treatment of COVID-19 with antivirals such as remdesivir and hydroxychloroquine; treament of advanced
cases of COVID-19 with anti-IL-6 inhibitors; the conduct of clinical trials of candidate vaccines and mAbs for
prevention and/or treatment of disease; and the development of in vitro assays used for making measurements
of 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 activities
at our affiliated CRSs and Clinical Research Laboratories (CRLs).
Terms: <2019 novel coronavirus><2019-nCoV><21+ years old><AACTG><ACTG><AIDS Virus><AIDS clinical trial group><AIDS prevention><AIDS/HIV><AIDS/HIV problem><AZU1 Protein><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Address><Administrative Supplement><Adult><Adult Human><Affect><Animal Model><Animal Models and Related Studies><Antiviral Agents><Antiviral Drugs><Antivirals><Area><B cell differentiation factor><B cell stimulating factor 2><B-Cell Differentiation Factor><B-Cell Differentiation Factor-2><B-Cell Stimulatory Factor-2><BCDF><BSF-2><BSF2><Boston><CAP 37><CAP37><COVID-19><COVID-19 vaccine><COVID19><COVID19 vaccine><Charge><Clinical Research><Clinical Study><Clinical Treatment Moab><Clinical Trials><Clinical Trials Unit><Communication><Communities><Conduct Clinical Trials><Data><Decision Making><Development><Disease><Disorder><Dolin><Evaluation><Financial Management><GS-5734><General Hospitals><HBP><HCV infection><HIV><HIV Infections><HIV Prevention><HIV Vaccine Trials Network><HIV/AIDS><HIV/AIDS prevention><HIV/AIDS problem><HPGF><HTLV-III Infections><HTLV-III-LAV Infections><HVTN><Health><Heparin Binding Protein><Hepatitis C><Hepatitis C virus infection><Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted><Hepatitus C><Hepatocyte-Stimulating Factor><Hospitals><Hot Spot><Human Immunodeficiency Viruses><Human T-Lymphotropic Virus Type III Infections><Hybridoma Growth Factor><Hydroxychlorochin><Hydroxychloroquine><IFN-beta 2><IFNB2><IL-6><IL6 Protein><Infection><Institution><Interleukin-6><Investigators><Israel><LAV-HTLV-III><Laboratory Research><Leadership><Lymphadenopathy-Associated Virus><M tuberculosis infection><M. tb infection><M. tuberculosis infection><M.tb infection><M.tuberculosis infection><MGI-2><MTB infection><Massachusetts><Measurement><Medical center><Monoclonal Antibodies><Mycobacterium tuberculosis (MTB) infection><Mycobacterium tuberculosis infection><Myeloid Differentiation-Inducing Protein><NIAID><National Institute of Allergy and Infectious Disease><Natural History><New England><Non-Polyadenylated RNA><Northeastern United States><Occupational activity of managing finances><Oxychlorochin><Oxychloroquine><Pathogenicity><Performance><Pharmacies><Pharmacy facility><Plasmacytoma Growth Factor><Population><Preclinical Testing><Preventative strategy><Prevention><Prevention Measures><Prevention strategy><Preventive strategy><Principal Investigator><Process><Public Health><RNA><RNA Gene Products><Research><Research Personnel><Research Resources><Researchers><Resource Allocation><Resources><Ribonucleic Acid><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Serologic tests><Serological Tests><Severe acute respiratory syndrome coronavirus 2><Structure><TB infection><Testing><Therapeutic><Transmission><Tuberculosis><Vaccines><Viral><Viral hepatitis><Virus-HIV><Woman><Wuhan coronavirus><acquired immunodeficiency syndrome clinical trial group><adulthood><anti-viral agents><anti-viral drugs><anti-virals><base><cationic antimicrobial protein CAP 37><clinical research site><clinical site><co-morbid><co-morbidity><comorbidity><corona virus disease 2019><corona virus disease 2019 vaccine><coronavirus disease 2019><coronavirus disease 2019 vaccine><develop a vaccine><development of a vaccine><developmental><disseminated TB><disseminated tuberculosis><experience><hep C><hepatitis non A non B><hepatitis virus infection><in vitro Assay><infection due to Mycobacterium tuberculosis><inhibitor><inhibitor/antagonist><interest><interferon beta 2><mAbs><medical countermeasure><model of animal><model organism><non A, non B hepatitis><non-A, non-B hepatitis><pre-clinical testing><prevent><preventing><remdesivir><response><serology><support network><transmission process><tuberculosis infection><tuberculous spondyloarthropathy><vaccine candidate><vaccine development><vaccine evaluation><vaccine formulation><vaccine screening><vaccine testing>