Clinical trials protein strategy

Alzheimer s Disease The vaccine being tested contains a small protein called jS-amyloid (AjS). This protein forms abnormal deposits, or plaques, in the brains of people with Alzheimer s disease. Researchers believe that Kji deposition causes loss of mental function by killing the brain neurons. The strategy of Aji vaccination is to stimulate the immune system to clean up plaques and prevent further A deposits. Although preclinical and Phase I studies showed the potential of the vaccine, the Phase II clinical trial was halted because 15 of 360 patients developed severe brain inflammation. Further studies showed that the A did generate the desired... 

Structural proteins derived from viruses such as HBV have the ability to spontaneously assemble into particles called virus-like particles (VLPs).These VLPs are similar to virions and consist of highly repetitive and ordered structures, but unlike recombinant protein vaccines, VLPs can elicit both humoral and cellular responses [16]. In addition these particles are easily purified and can be produced in large quantities [16]. Several VLPs are in clinical trials and have shown to be effective. This strategy has been particularly successful for HPV, and one product has been recently approved by the FDA for prophylactic use [17]. 

Surfactant replacement therapy (SRT) is widely accepted as the most clinically acceptable and cost-effective approach to the treatment of RDS. Clinical trials have been carried out worldwide using an array of artificial, modified natural, and natural surfactants. Natural surfactants are either processed extracts of minced lungs or extracts of lavaged surfactant, which affects the surfactant protein makeup of the preparation. The differences in preparations can be discerned from key components and dosing strategies, which are summarized in Table 28-6. 

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