Siegel M, Olsen D, Critchlow C, Buchanan T M
J Infect Dis. 1982 Mar;145(3):300-10. doi: 10.1093/infdis/145.3.300.
In a phase I clinical trial, 39 volunteers received an initial and booster subcutaneous injection of 100 or 112 microgram of a pili vaccine prepared from Neisseria gonorrhoeae strain F62 in Tris buffer with an aluminum phosphate adjuvant (alum) or 220 microgram of the F62 pili vaccine prepared in ethanolamine, with or without alum. Antibody responses were quantitated with an enzyme-linked immunosorbent assay. All four groups had significant (P less than 0.0001) responses to the vaccine preparations with peak mean antibody responses one to three weeks after the booster. Differences in antibody responses among the groups were due to the administration of alum and not to use of Tris buffer vs. ethanolamine. In vitro, postimmunization sera enhanced phagocytosis of piliated strain F62 organisms by human polymorphonuclear leukocytes; preabsorption of the sera with strain F62 pili blocked this activity. Thus, gonococcal pili given subcutaneously are immunogenic and lead to production of functional serum antibodies.
在一项I期临床试验中，39名志愿者接受了初始和加强皮下注射，注射的是100或112微克由淋病奈瑟菌F62菌株在含磷酸铝佐剂（明矾）的Tris缓冲液中制备的菌毛疫苗，或220微克在乙醇胺中制备的F62菌毛疫苗，有无明矾均可。用酶联免疫吸附测定法定量抗体反应。所有四组对疫苗制剂均有显著（P小于0.0001）反应，加强注射后1至3周出现平均抗体反应峰值。各组间抗体反应的差异是由于明矾的使用，而非Tris缓冲液与乙醇胺的使用。在体外，免疫后的血清增强了人多形核白细胞对有菌毛的F62菌株的吞噬作用；用F62菌株菌毛对血清进行预吸收可阻断这种活性。因此，皮下注射的淋病菌毛具有免疫原性，并导致产生功能性血清抗体。
