This proposal describes a plan for an HIV Vaccine Trial Unit (HVTU) at Johns Hopkins University. The HVTU will be a consortium with its core at the Johns Hopkins Center for Immunization Research (CIR) in Baltimore, Maryland. There will be a local urban sub-site at Morgan State University and international sub-sites in China, India, and Thailand. The HVTU will contribute to the scientific research agenda of the NIH HIV Vaccine Trials Network, will enroll 60 volunteers into Phase I trials per year and 40 volunteers into Phase II per year, and will prepare to rapidly enroll 1000 volunteers into a Phase III efficacy trial. The HVTU also will increase participation of minorities in HIV vaccine research, establish international HIV vaccine trial sites, and provide training opportunities to affiliated researchers. The experienced Hopkins CIR team is already proven to be highly proficient in vaccine trials. As an NIH AIDS Vaccine Evaluation Unit, the Johns Hopkins CIR has conducted 35 HIV vaccine trials, administered 1,817 immunizations of investigational HIV vaccines, and collected over 13,000 clinical specimens for research analyses. 95% of volunteers in Johns Hopkins CIR HIV vaccine Phase I and II trials, and 100% of volunteers in Phase III HIV vaccine trials, have completed all scheduled vaccinations. In the past 5 years the Hopkins CIR has also conducted successful Phase I/Il trials of investigational vaccines for hepatitis B, hepatitis C, papillomavirus, influenza, parainfluenza, respiratory syncytial virus, and rotavirus, involving over 1600 volunteer subjects and 20,000 study visits. The planned HVTU will build on this extensive experience. A new collaboration with Morgan State University, a historically black university, will explore methods to improve community understanding about HIV and vaccines among urban African-Americans. International collaborations will examine the effects of differing viral strains, human immunogenetics, routes of infection, cultural practices, and other factors on HIV vaccine safety and immunogenicity. All of the scientific expertise at Johns Hopkins on HIV/AIDS, vaccinology, ethics, and other relevant disciplines will be coordinated through the proposed HVTU. Training opportunities will be available to HVTU-affiliated researchers through the Fogarty AIDS program at Johns Hopkins and through internet-based courses.
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