First human trials of a preventive human papillomavirus cervical cancer vaccine (HPV 16). This virus-like particle (VLP) vaccine was the progenitor of the HPV vaccine (Gardasil) recently licensed by the FDA, & of a second vaccine (Cervarix) currently in phase III trials.
Lead clinical trial site in first phase III HIV vaccine trial. Lead clinical trial site for first human studies of live attenuated recombinant RSV vaccines. Leading single dose, oral cholera (Peru-15) & typhoid vaccines (MICRO-TY/ZH9) shown to be safe & immunogenic in early Phase I/II trials performed in Baltimore & Vermont (typhoid only). Established efficacy of whole cell ETEC vaccine in field trials in Guatemala & Mexico. Multicenter clinical trials that led to licensure of Rifamixin for treatment of traveler's diarrhea. First human trial of a recombinant dengue virus vaccine; additional trials are ongoing. First human trial of intranasal Shigella vaccine demonstrated short-term protection against Shigella flexneri in an experimental challenge model. Lead clinical trial site for 1st human study of HIV vaccine using Venezuelan Equine Encephalitis vector. Challenge studies evaluating ETEC vaccines demonstrated that anti-CS3 serum IgA titer is a marker for protection against strains sharing this colonization factor. Lead site for the first human testing of a live-attenuated adenovirus vectored HIV vaccine. First human trial of malaria transmission blocking vaccine. Pre-clinical study finds that immune complexes play a role in enhanced RSV disease. New recombinant anthrax vaccine (rPA-102) shown to be safe & immunogenic in multi-center trials carried out in Baltimore & other U.S. cities. First human trial to evaluate the protective efficacy of an ETEC vaccine delivered transcutaneously by an arm patch. Lead clinical trial site for first human studies of a preventive S. aureus vaccine. First human trials of a live attenuated West Nile virus vaccine. First human trials of a live attenuated H9N2 A/AA ca avian influenza virus vaccine. First human trials of a live attenuated H5N1 A/AA ca avian influenza virus vaccine. Phase II field study finds an ETEC vaccine delivered transcutaneously by arm patch protects travelers to Guatemala and Mexico. Developed and validated low-inoculum ETEC challenge model in human volunteers that enabled 2 log reduction in challenge strain while maintaining consistently high attack rates. Principal Investigators and lead site in a large multicenter trial of a pandemic H1N1 influenza vaccine.
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