RESUMO
Bridging study in vaccine clinical trials means a series of small-scale additional tests on the basis that the original safety and effectiveness of a vaccine have been confirmed in clinical trials, to prove that the characteristics of safety, immunogenicity and effectiveness of a vaccine are similar or consistent after component, population and immunization procedure change to other types which can extrapolate data from existing clinical trials. Compared with traditional vaccine clinical trials, bridging trials can promote the approval of vaccines to the market, accelerate the expansion of vaccine application, and promote the use of vaccines across regions and populations. In recent years, the application of bridge study design in vaccine clinical research has become more and more common. In order to better guide and promote the application of bridging trial design in the field of vaccine clinical research, we reviewed the design characteristics and application examples of bridging study design in vaccine clinical trials, and systematically elaborated the design ideas, key points and statistical evaluation methods of bridging study.
Assuntos
Humanos , Projetos de Pesquisa , Pesquisa Biomédica , Imunização , Vacinas/uso terapêuticoRESUMO
Bridging study in vaccine clinical trials means a series of small-scale additional tests on the basis that the original safety and effectiveness of a vaccine have been confirmed in clinical trials, to prove that the characteristics of safety, immunogenicity and effectiveness of a vaccine are similar or consistent after component, population and immunization procedure change to other types which can extrapolate data from existing clinical trials. Compared with traditional vaccine clinical trials, bridging trials can promote the approval of vaccines to the market, accelerate the expansion of vaccine application, and promote the use of vaccines across regions and populations. In recent years, the application of bridge study design in vaccine clinical research has become more and more common. In order to better guide and promote the application of bridging trial design in the field of vaccine clinical research, we reviewed the design characteristics and application examples of bridging study design in vaccine clinical trials, and systematically elaborated the design ideas, key points and statistical evaluation methods of bridging study.
Assuntos
Humanos , Projetos de Pesquisa , Pesquisa Biomédica , Imunização , Vacinas/uso terapêuticoRESUMO
OBJECTIVES@#This study was performed to evaluate the occlusion of monetite paste on dentine tubule and provide a new potential method for treating dentine hypersensitivity.@*METHODS@#Calcium oxide, strontium chloride, and polyethylene glycol phosphate were mixed in a certain proportion and ground in a planetary ball mill. The reaction was carried out by adjusting the pH to obtain monetite and hydroxyapatite paste. The morphological characteristics of the paste were observed through scanning electron microscope (SEM). The structure and composition were analyzed through X-ray diffraction (XRD) and Fourier transform infrared spectrometer (FTIR). The extracted third molar was selected to undergo demineralization to establish the @*RESULTS@#XRD and FTIR showed that the composition of the paste was mainly monetite, and the composition of hydroxyapatite paste was mainly composed of hydroxyapatite. SEM revealed that the size of the crystal particles of the synthesized paste was tens to hundreds of nanometers. Monetite and hydroxyapatite paste could produce a thicker mineralization layer on the dentin surface, and the mineralization of the dentin tubules of monetite was deeper than that of hydroxyapatite paste. The microhardness of the monetite paste group was significantly less than those of the hydroxyapatite paste groups (@*CONCLUSIONS@#Monetite paste could effectively block the exposed dentin tubules and be used for treating dentin hypersensitivity.