Rottinghaus Scott T, Poland Gregory A, Jacobson Robert M, Barr Lori J, Roy Mike J
Department of Internal Medicine, Mayo Clinic, Rochester, MN 55905, USA.
Vaccine. 2003 Nov 7;21(31):4604-8. doi: 10.1016/s0264-410x(03)00447-x.
A novel DNA vaccine against hepatitis B virus was administered intraepidermally by particle-mediated epidermal delivery (PMED) to 16 human subjects who demonstrated absent or non-sustainable responses to conventional hepatitis B vaccination. Eleven subjects received three doses of vaccine at 56-day intervals, and five subjects received only a single vaccination. Each dose of vaccine contained 4 microg of plasmid DNA encoding the hepatitis B surface antigen (HBsAg). The vaccine was safe and well tolerated. Remarkably, the DNA vaccine elicited antibody responses in 12 of the 16 subjects after a licensed subunit vaccine failed to induce a lasting response after >/=3 vaccinations. This study provides evidence in humans for protective immunogenicity of a particle-mediated DNA vaccine in subjects who have responded suboptimally to conventional vaccination.
一种新型的抗乙型肝炎病毒DNA疫苗通过粒子介导的表皮递送(PMED)皮内注射给16名对常规乙型肝炎疫苗接种表现出无反应或反应不可持续的人类受试者。11名受试者每隔56天接受三剂疫苗,5名受试者仅接受一次接种。每剂疫苗含有4微克编码乙型肝炎表面抗原(HBsAg)的质粒DNA。该疫苗安全且耐受性良好。值得注意的是,在一种已获许可的亚单位疫苗在≥3次接种后未能诱导出持久反应的情况下,这种DNA疫苗在16名受试者中的12名中引发了抗体反应。这项研究为粒子介导的DNA疫苗在对常规疫苗接种反应欠佳的受试者中的保护性免疫原性提供了人体证据。