On March 11, 2020, the World Health Organization declared that the rapid spread of the novel coronavirus, SARS-CoV-2, and its associated disease, COVID-19, had become a global pandemic. The ongoing crisis calls for the involvement of clinical research sites (CRSs) to work rapidly and efficiently toward therapeutic and preventative measures to control the epidemic. Our CRS, the Seattle Vaccine Trials Unit (VTU), has vast prior experience conducting observational cohort studies and phase 1-2b clinical trials of preventative HIV vaccines and other HIV prevention modalities. We propose bringing this infrastructure and experience to the field of SARS- CoV-2 clinical research. Our proposal is both to expand the scope of research activity at our CRS and to involve new venues for protocol conduct. Onsite CRS activity will encompass natural history studies of recovered COVID-19 patients, as well as early to late phase vaccine protocols. New venues will be opened and developed in order to effectively conduct COVID-19 research with appropriate infection prevention procedures to prevent SARS-CoV-2 transmission. Such new venues will include temporary structures that will provide capability to conduct clinical research in areas with continued SARS-CoV-2 transmission as specific areas with outbreaks are noted during the course of the epidemic.

Public Health Relevance

The ongoing COVID-19 global health crisis necessitates immediate work toward further understanding the pathogenesis of SARS-CoV-2 infection and development of agents to treat and prevent COVID-19 disease. Our clinical research site will contribute to this effort by expanding our focus from HIV immunology and prevention to the corresponding goals in understanding and preventing SARS-CoV-2 infection and disease. We propose enrolling participants in observational cohorts and in clinical trials of candidate preventive agents, both vaccines and monoclonal antibodies.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Program Officer
Pouliot, Eileen M
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Fred Hutchinson Cancer Research Center
United States
Zip Code
Torres, Thiago S; Harrison, Linda J; La Rosa, Alberto M et al. (2018) Quality of life among HIV-infected individuals failing first-line antiretroviral therapy in resource-limited settings. AIDS Care 30:954-962
Fong, Youyi; Shen, Xiaoying; Ashley, Vicki C et al. (2018) Modification of the Association Between T-Cell Immune Responses and Human Immunodeficiency Virus Type 1 Infection Risk by Vaccine-Induced Antibody Responses in the HVTN 505 Trial. J Infect Dis 217:1280-1288
Stockdale, Alexander J; Saunders, Matthew J; Boyd, Mark A et al. (2018) Effectiveness of Protease Inhibitor/Nucleos(t)ide Reverse Transcriptase Inhibitor-Based Second-line Antiretroviral Therapy for the Treatment of Human Immunodeficiency Virus Type 1 Infection in Sub-Saharan Africa: A Systematic Review and Meta-analysis. Clin Infect Dis 66:1846-1857
Li, Binglan; Verma, Shefali S; Veturi, Yogasudha C et al. (2018) Evaluation of PrediXcan for prioritizing GWAS associations and predicting gene expression. Pac Symp Biocomput 23:448-459
Riddler, Sharon A; Zheng, Lu; Durand, Christine M et al. (2018) Randomized Clinical Trial to Assess the Impact of the Broadly Neutralizing HIV-1 Monoclonal Antibody VRC01 on HIV-1 Persistence in Individuals on Effective ART. Open Forum Infect Dis 5:ofy242
Torres, Thiago S; Harrison, Linda J; La Rosa, Alberto M et al. (2018) Quality of life improvement in resource-limited settings after one year of second-line antiretroviral therapy use among adult men and women. AIDS 32:583-593
Nixon, Daniel E; Bosch, Ronald J; Chan, Ellen S et al. (2017) Effects of atorvastatin on biomarkers of immune activation, inflammation, and lipids in virologically suppressed, human immunodeficiency virus-1-infected individuals with low-density lipoprotein cholesterol <130 mg/dL (AIDS Clinical Trials Group Study A52 J Clin Lipidol 11:61-69
Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048
Gulick, Roy M; Wilkin, Timothy J; Chen, Ying Q et al. (2017) Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial. Ann Intern Med 167:384-393
Gandhi, Rajesh T; McMahon, Deborah K; Bosch, Ronald J et al. (2017) Levels of HIV-1 persistence on antiretroviral therapy are not associated with markers of inflammation or activation. PLoS Pathog 13:e1006285

Showing the most recent 10 out of 59 publications