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新型真皮和表皮微针给药系统在健康成年人中狂犬病疫苗接种的安全性和有效性。

Safety and efficacy of novel dermal and epidermal microneedle delivery systems for rabies vaccination in healthy adults.

机构信息

BD Medical - Pharmaceutical Systems, rue Aristide Bergès, Le Pont de Claix, France.

出版信息

Vaccine. 2010 Aug 16;28(36):5850-6. doi: 10.1016/j.vaccine.2010.06.062. Epub 2010 Jun 30.

Abstract

In the present pilot study, intradermal ID delivery systems with a BD microneedle from 1 to 3mm in length, and epidermal delivery (BD skin abrader) through abraded skin surface relative to standard intramuscular injection were evaluated. Circulating neutralizing antibodies were measured against the rabies virus after the Vero cells rabies vaccine was administered at D0, D7, D21 and D49. This clinical evaluation in 66 healthy volunteers shows that ID delivery using BD microneedle technology of 1/4 the IM antigen dose is safe, efficient and reliable, resulting in a protective seroconversion rate. In contrast, the epidermal delivery route did not produce an immune response against the rabies vaccine.

摘要

在本初步研究中,评估了长度为 1 至 3 毫米的 BD 微针的皮内 ID 给药系统和表皮给药(BD 皮肤磨皮器)通过磨蚀皮肤表面与标准肌内注射的相对效果。在vero 细胞狂犬病疫苗于 D0、D7、D21 和 D49 给药后,针对狂犬病病毒测量了循环中和抗体。这项针对 66 名健康志愿者的临床评估表明,使用 BD 微针技术的皮内给药途径,使用 IM 抗原剂量的四分之一,是安全、有效和可靠的,可产生保护效力的血清转化率。相比之下,表皮给药途径未产生针对狂犬病疫苗的免疫反应。

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