Clinical safety and efficacy of a powdered Hepatitis B nucleic acid vaccine delivered to the epidermis by a commercial prototype device.
Clinical safety and efficacy of a powdered Hepatitis B nucleic acid vaccine delivered to the epidermis by a commercial prototype device.
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通过商业原型设备将粉末状乙型肝炎核酸疫苗递送至表皮的临床安全性和有效性。
DOI：
10.1016/j.vaccine.2005.05.026
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发表时间：
2005
期刊：
影响因子：
5.5
通讯作者：
Suzanne Jones
中科院分区：
文献类型：
--
作者：
L. Roberts;L. J. Barr;D. Fuller;C. Mcmahon;P. Leese;Suzanne Jones
这项临床递送系统桥接研究评估了一次性使用的商用原型设备(命名为ND5.5)的性能，该设备用于颗粒介导的乙肝核酸疫苗的表皮递送(PMEd)。健康的成年人之前接种了有执照的乙肝疫苗，他们接受了由ND5.5或XR-1接种的单次加强接种乙肝核酸疫苗，XR-1是之前临床试验中使用的临床研究设备。当提供相同有效剂量的疫苗时，ND5.5和XR-1在抗乙肝表面抗原血清抗体效价和细胞免疫反应方面也产生了类似的增加。在ND5.5之前接种两次疫苗而不是四次疫苗的受试者，总体免疫反应强度较低。疫苗注射部位的皮肤反应与两种设备相同。这是首次使用ND5.5设备对核酸疫苗进行安全有效的PMEd的临床演示。
This clinical delivery system bridging study evaluated the performance of a single-use disposable, commercial prototype device (designated ND5.5) for particle-mediated epidermal delivery (PMED) of a nucleic acid vaccine against Hepatitis B virus (HBV). Healthy adults, previously immunized with licensed HBV vaccine, received a single boost vaccination of HBV nucleic acid vaccine administered by ND5.5 or XR-1, the clinical research device used in previous clinical trials. Similar increases in anti-HBV surface antigen serum antibody titers and cell-mediated immune responses were produced by ND5.5 and XR-1 when delivering comparable effective doses of the vaccine. The overall intensity of the immune response was lower in those subjects vaccinated with two, rather than 4 administrations of vaccine delivered by ND5.5. Skin reactions at sites of vaccine administration were equivalent with both devices. This is the first clinical demonstration of the safe and effective PMED of a nucleic acid vaccine with the ND5.5 device.
影响因子：
15.9
作者：
Boni, C;Bertoletti, A;Ferrari, C
通讯作者：
Ferrari, C