Mackenzie J S, Mackenzie I, Lloyd J, Dent V
J Hyg (Lond). 1975 Dec;75(3):425-43. doi: 10.1017/s0022172400024499.
Comparative clinical trials of live attenuated and detergent-split subunit influenza virus vaccines were undertaken with 1048 volunteers in Western Australia. Volunteers were divided into three main groups, each of which received either live virus vaccine or a saline control administered intranasally, or subunit vaccine injected subcutaneously. No differences were recorded between the three groups in their post-vaccination symptoms. Serum samples were collected at various times up to 50 weeks after vaccination, and antibody titres were measured by haemagglutination-inhibition (HI) tests and, for 231 volunteers, by virus neutralization tests. The two vaccines were almost equivalent in inducing seroconversion in vaccinees with pre-trial HI titres of 96 or less, but the subunit vaccine stimulated a higher geometric mean HI antibody titre. The longevity of the HI antibody response was greater for the live virus vaccine. The height of the response and the longevity of neutralizing antibody were the same for both vaccines. Both vaccines provided a high degree of protection against epidemic A/England/42/72 influenza, and some protection against A/Port Chalmers/1/73 influenza.
在西澳大利亚,对1048名志愿者进行了减毒活流感病毒疫苗和去污剂裂解亚单位流感病毒疫苗的比较临床试验。志愿者被分为三个主要组,每组分别接受鼻内接种的活病毒疫苗或生理盐水对照,或皮下注射的亚单位疫苗。三组接种疫苗后的症状没有差异。在接种疫苗后长达50周的不同时间采集血清样本,并通过血凝抑制(HI)试验以及对231名志愿者通过病毒中和试验来测量抗体滴度。对于试验前HI滴度为96或更低的接种者,两种疫苗在诱导血清转化方面几乎等效,但亚单位疫苗刺激产生的几何平均HI抗体滴度更高。减毒活疫苗的HI抗体反应持续时间更长。两种疫苗的中和抗体反应高度和持续时间相同。两种疫苗都对A/England/42/72流感大流行提供了高度保护,并对A/Port Chalmers/1/73流感提供了一定保护。