The GW Vaccine Research Unit (GW VRU) is a collaboration between the Departments of Medicine and Microbiology, Immunology and Tropical Medicine located at the George Washington University School of Medicine and Health Sciences, and the GW Medical Faculty Associates (GW MFA). The GW VRU conducts clinical trials of experimental products that are being developed for the prevention of infectious diseases such as COVID-19, HIV, Zika virus, and neglected tropical diseases (NTDs), particularly hookworm infection and schistosomiasis.
Clinical Trials Capabilities
The GW VRU is located at the GW School of Medicine and Health Sciences, within state-of-the-art facilities of the Research Center for Neglected Diseases of Poverty.
The GW VRU is committed to providing a full range of research services to facilitate the development, implementation, and successful completion of clinical trials. The GW VRU ensures compliance with federal, state, and institutional regulations, policies, and procedures to protect the interests of study participants.
The GW VRU consists of clinical investigators, with specialty board certification and faculty appointments at the George Washington University, physician assistants, investigational pharmacists, and research coordinators. As a group we have combined experience in translational, Phase I, II, III, and IV clinical trials, and epidemiological studies.
COVID-19 Vaccine Development
The GW VRU is participating as a site for the Phase 2 trial of the Sanofi/GSK COVID-19 vaccine. Enrollment was completed in March 2021.
The GW VRU is also a participating site for the Phase 3 trial of the Moderna mRNA-1273 vaccine (see Moderna Press Release), as part of the CoVPN network. Beginning in August 2020, the GW VRU, in collaboration with the team of Dr. Manya Magnus at the GW Milken Institute of Public Health, enrolled approximately 350 adults aged 18 years and older into this clinical trial assessing the efficacy, safety and immunogenicity of the mRNA-1273 developed to prevent COVID-19. Enrollment was completed in October 2020 and an Emergency Use Authorization for the vaccine was granted by the FDA in December 2020. This vaccine is one of the two authorized vaccines that are currently being used in an unprecedented vaccination effort throughout the US and worldwide.
HIV Vaccine Development
The GW VRU is partnering with the International AIDS Vaccine Initiative (IAVI) to conduct early-phase clinical trials of experimental preventative HIV vaccines.
Hookworm Vaccine Development
The GW VRU is part of the Texas Children's Hospital Center for Vaccine Development (TCH-CVD), a Product Development Partnership (PDP) that is developing and testing novel, low-cost vaccines to help prevent disease caused by hookworm infection. Hookworm infection causes anemia and can lead to problems with physical and cognitive development in children (see Research Interests).
We are currently conducting a clinical trial of the Na-GST-1 hookworm vaccine candidate at GW (see Clinical Trials). In this trial, we are immuning healthy volunteers with our candidate vaccine and we will then give them an effective dose of hookworm larvae in a controlled human infection model (CHIM), to test for the protective effect of the vaccine.
Schistosomiasis Vaccine Development
The GW VRU is also collaborating with the TCH-CVD to develop a novel vaccine to prevent intestinal and hepatic schistosomiasis caused by Schistosoma mansoni. Currently, the GW VRU is conducting a Phase 1 trial of the Sm-TSP-2/Alhydrogel vaccine in healthy adults in collaboration with its partners, the Fundação Oswaldo Cruz (FIOCRUZ) in an endemic area of the Brazilian state of Minas Gerais. This study is being funded by the US National Institute of Allergy and Infectious Diseases (NIAID) through its contract the the Baylor College of Medicine Vaccine and Treatment Evaluation Unit (VTEU).
In addition, the GW VRU has received a 4-year grant from the US Department of Defense to conduct a Phase 1/2 trial of the Sm-TSP-2/Alhydrogel vaccine in partnership with the Makerere University Walter Reed Project in Uganda. Vaccinations in this study are projected to start in November 2019.
Zika Vaccine Development
The GW VRU recently partnered with LEIDOS Biomedical and the National Institutes of Health on a phase II trial of a DNA-based Zika vaccine (VRC-ZKADNA090-00-VP) in Belo Horizonte, Brazil.