Kunz C, Hofmann H
Wien Klin Wochenschr. 1976 Aug 13;88(15):504-8.
In a field trial a new influenza subunit vaccine was tested in parallel with a vaccine prepared from the whole virus. The subunit vaccine essentially contained only the proteins of the viral envelope, haemagglutinin and neuraminidase, which had been selectively solubilized by treatment with cetyl trimethylammonium bromide. Both vaccines contained 700 IU of strain A/Port Chalmers/73 in 0.5 ml. They were given to volunteers by the subcutaneous route with and without the addition of Al (OH)3 as adjuvant. Blood samples were taken on days 0, 28 and 90. Development of antibodies was assayed in the haemagglutination-inhibition (HI) and neuraminidase-inhibition (NI) test. All vaccines exhibited a very good immunogenic effect as judged from the number of volunteers with at least a four-fold rise in antibodies in the HI-test and those reaching titres that are considered to be sufficiently high for protection against disease. The best results were obtained with the aqueous subunit vaccine. All four vaccines also stimulated the formation of neuraminidase-inhibiting antibodies. The vaccines were well tolerated by the volunteers. The incidence of minor local reactions such as redness, swelling and pain varied according to the vaccine used, as shown on statistical evaluation. The aqueous subunit vaccine clearly proved to be superior in this respect.
在一项现场试验中,一种新型流感亚单位疫苗与一种由全病毒制备的疫苗进行了平行测试。亚单位疫苗基本上只含有病毒包膜的蛋白质、血凝素和神经氨酸酶,这些蛋白质已通过用十六烷基三甲基溴化铵处理而被选择性地溶解。两种疫苗在0.5毫升中均含有700国际单位的A/查尔姆斯港/73毒株。它们通过皮下途径给予志愿者,添加或不添加氢氧化铝作为佐剂。在第0、28和90天采集血样。通过血凝抑制(HI)和神经氨酸酶抑制(NI)试验检测抗体的产生。从HI试验中抗体至少有四倍升高的志愿者数量以及达到被认为足以预防疾病的高滴度的志愿者数量来看,所有疫苗都表现出非常好的免疫原性效果。水性亚单位疫苗取得了最佳结果。所有四种疫苗还刺激了神经氨酸酶抑制抗体的形成。志愿者对这些疫苗耐受性良好。如统计评估所示,轻微局部反应如发红、肿胀和疼痛的发生率因所用疫苗而异。在这方面,水性亚单位疫苗明显被证明更具优势。