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, 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.
The GW VRU is participating as a site for a Phase 2 dose-sparing evaluation study (DoSES) for the Jynneos monkeypox vaccine (see NIH press release). The study will evaluate two intradermal (ID) regimens for Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine compared to the standard subcutaneous (SC) regimen in healthy, vaccinia-naïve adults 18 to 50 years of age.
COVID-19 Vaccine Development
The GW VRU will be investigating the safety, efficacy, and immunogenicity of Pfizer bivalent vaccines updated with an Omicron subvariant in adults aged 18-49. Stage 3 of this study, enrolled 107 adults aged 18 years and older to receive the Sanofi/GSK vaccine and completed enrollment in February 2022. The GW VRU is also a participating site for the Phase 3 trial of the Moderna mRNA-1273 vaccine, 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 vaccine, developed to prevent COVID-19. Enrollment was completed in October 2020 and the FDA granted an Emergency Use Authorization for the vaccine in December 2020. This vaccine is one of two vaccines that were FDA-authorized in 2021 and 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 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 recently completed a clinical trial of the Na-GST-1 hookworm vaccine candidate at GW (see Clinical Trials). In this trial, we immunized healthy volunteers with our candidate vaccine, then gave them a 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 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. The study enrolled 290 volunteers between November 2019 and July 2022.
Zika Vaccine Development
The GW VRU 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.