Conne P, Gauthey L, Vernet P, Althaus B, Que J U, Finkel B, Glück R, Cryz S J
Hôpital de Loëx, Hôpitaux Universitaires de Genève, Switzerland.
Vaccine. 1997 Oct;15(15):1675-9. doi: 10.1016/s0264-410x(97)00087-x.
The safety and immunogenicity of a commercial trivalent subunit influenza vaccine and an experimental virosome-formulated influenza vaccine were evaluated among geriatric patients in a double-blind, randomized manner. The virosome vaccine was produced by incorporating hemagglutinin (HA) into the membrane of liposomes composed of phosphatidylcholine. Both vaccines elicited a significant (P < 0.01) rise in the geometric mean anti-HA antibody titer to all three vaccine components 1 month after immunization. However, significantly (P < 0.005) more subjects vaccinated with the virosome preparation mounted a more than fourfold rise to the A/Singapore and A/Beijing strains compared with those who received subunit vaccine. The percentage of patients who attained protective levels (anti-HA titer > or = 40) of anti-A/Beijing antibody was also significantly (P < 0.005) higher in the virosome group. Subjects who possessed non-protective baseline antibody levels to the A/Singapore and A/Beijing strains were more likely (P < 0.005-0.030) to achieve protective levels after immunization with the virosome vaccine than with the subunit vaccine. Of particular clinical significance was the fact that 68.4% of subjects immunized with the virosome vaccine attained protective levels of antibody to all three vaccine components versus 38% for the subunit vaccine (P = 0.010).
以双盲、随机方式在老年患者中评估了一种商业化三价亚单位流感疫苗和一种实验性病毒体配方流感疫苗的安全性和免疫原性。病毒体疫苗是通过将血凝素（HA）掺入由磷脂酰胆碱组成的脂质体膜中制备的。两种疫苗在免疫后1个月均使针对所有三种疫苗成分的几何平均抗HA抗体滴度显著（P < 0.01）升高。然而，与接受亚单位疫苗的受试者相比，接种病毒体制剂的受试者中，对A/新加坡株和A/北京株抗体滴度升高超过四倍的人数显著更多（P < 0.005）。病毒体组中达到抗A/北京抗体保护水平（抗HA滴度>或 = 40）的患者百分比也显著更高（P < 0.005）。与亚单位疫苗相比，对A/新加坡株和A/北京株基线抗体水平无保护作用的受试者在用病毒体疫苗免疫后更有可能（P < 0.005 - 0.030）达到保护水平。具有特别临床意义的是，接种病毒体疫苗的受试者中有68.4%达到了针对所有三种疫苗成分的抗体保护水平，而亚单位疫苗组为38%（P = 0.010）。
