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Development of Biomedical Devices to Elicit Durable Protective Immunity against HIV


Background: Substantial progress has been made recently towards identifying effective HIV prevention strategies. The RV144 trial demonstrated that an HIV vaccine comprised of a recombinant ALVAC prime + gp120 boost regimen was partially efficacious (VE=31.2%), although it’s protective effects waned over the study period and study volunteers faced barriers related to transportation to clinic for the required multiple injections with vaccine. Thus, there is an urgent need to identify innovative approaches to elicit or to boost HIV vaccine-elicited immunity, via simplified immunization regimens. If identified, these approaches have the potential to increase the durability of vaccine-mediated protection against HIV acquisition. Use of platforms to sustainably deliver HIV vaccine antigens, which could also incorporate delivery of antiretroviral drugs, would potentially allow for co-delivery of biomedical preventions for HIV. Project Goal: The goal of this project is to stimulate research and development of biomedical devices that elicit durable protective immunity against HIV. Specific areas of research interest include the development of novel devices to achieve sustained delivery of HIV vaccine antigens to mucosal surfaces for the purpose of priming antiviral immune responses and/or boosting prior vaccine-elicited immune responses with the goal of increasing the duration of protective immunity against HIV as well as reducing the need for multiple visits to a provider. Development of products based upon platforms that have (1) demonstrated high levels of safety, acceptance and adherence in human usage for sustained delivery (e.g. implants, vaginal rings) and (2) intrinsic flexibility for advanced development to incorporate co-delivery of antiretroviral compounds, other HIV microbicides, vaccine adjuvants, or hormonal contraceptives are highly encouraged. The expected end-product is the design and construction of a device that could be used in humans to achieve sustained delivery of HIV vaccine antigens to mucosal surfaces and that is suitable for efficacy assessment in a relevant non-human primate model. It would be expected that there would be documentation providing a detailed description of all testing results, including ex vivo characterization of the device as well as pre-clinical assessment protocols and a preliminary efficacy trial design (including statistical power estimates). Impact: Globally, more than 2.6 million new HIV infections occur each year (>50,000 in the US). As such, the need for efficacious biomedical preventions is needed to complement existing behavioral interventions. Products determined to be efficacious under this proposed evaluation have enormous market potential in HIV prevention.
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