Walter Reed Army Institute of Research, Infectious Diseases-Viral Diseases Branch
The Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) has a primary mission to conduct clinical trials testing new medical and prophylactic countermeasures against emerging infectious disease threats to the Warfighter, including malaria, Ebola, and Zika virus. CTC physician investigators serve as advisors and/or investigators on clinical trials involving an average of 4,000 patient visits annually, including first-in-human phase 1 vaccine trials. WRAIR’s CTC partners with federal, academic, and industry entities to conduct clinical trials.
Physician research fellows working at the WRAIR CTC will initially be added as associate investigators to ongoing or upcoming clinical trials; they will need to have a current license to practice medicine in the United States. They will see study patients, contribute to research management meetings, and complete administrative and regulatory requirements with regard to the studies. As they gain experience over the first 1-2 years, they will have the opportunity to apply for independent funding with mentorship from the CTC Chief. Research fellows at the CTC will also have the benefit of a full complement of expert research staff, to include nine clinical research coordinators, a team of three patient recruitment specialists, a biostatistician, a program manager, a laboratory, administrative staff, as well as four physician investigators as colleagues.
Recent notable work from the WRAIR CTC includes the phase 1 testing of an Ebola vaccine, whose results were published in the New England Journal of Medicine (Regules et al., NEJM 2017; https://www.ncbi.nlm.nih.gov/pubmed/25830322); this vaccine has now gone on to successful Phase 3 testing in over 11,000 patients in Africa with 100% efficacy (Henao-Restrepo et al., Lancet 2017; https://www.ncbi.nlm.nih.gov/pubmed/28017403), and will likely be licensed by Merck this year. The Phase 1/2 testing done at the WRAIR CTC influenced the dosing regimen of this Ebola vaccine, and provided the safety and efficacy evidence to conduct the Phase 3 trial. Another recent study from the WRAIR CTC includes a new promising dosing regimen for a leading malaria vaccine candidate, the RTS,S vaccine. This vaccine showed 86.7% efficacy in a recent trial of 30 participants (Regules et al., J. Infect. Diseases 2017; https://www.ncbi.nlm.nih.gov/pubmed/27296848), which has led to the largest clinical trial involving controlled human malaria infection, currently ongoing at the WRAIR CTC. There are also ongoing research studies involving another Ebola vaccine candidate, a Zika vaccine candidate, and a Dengue vaccine candidate. Studies planned to start in the next two to three years include vaccine trials for Marburgvirus, E. Coli, Yellow Fever, multiple Shigella studies, another malaria vaccine candidate, campylobacter, and four new HIV vaccine trials. Additionally, the research fellow will have an opportunity to explore his or her research interests.
The WRAIR CTC is an ideal venue to gain significant experience in the conduct and design of vaccine and drug early phase clinical trials. Alumni of the CTC have gone on to leadership positions of greater responsibility in the military, in academia, and in the corporate sector.