Delem A, Van Rensburg W, Flaskett I
J Hyg (Lond). 1979 Oct;83(2):221-9. doi: 10.1017/s0022172400026000.
A clinical trial was initiated in South Africa before the winter season of 1976. The study involved 253 volunteers divided into three groups of vaccinees and one control group. Two groups of vaccinees were inoculated with either one or two doses at 2 weeks' interval (10(7.2) EID 50/dose) of the RIT 4025 live recombinant strain [A/Scotland/840/74 (H3N2) serotype] and one group received one injection of an inactivated vaccine [A/Port Chalmers/1/73 (H3N2), 360 i.u., A/Scotland/840/74 (H3N2), 300 i.u. and B/Hong Kong/8/73, 300 i.u./dose]. The serum antihaemagglutinin antibody responses against the heterologous A/Victoria/3/75 strain as measured by the single radial haemolysis test were satisfactory and not statistically different in all groups of vaccinees. On the other hand, the antineuraminidase antibody response was better in the group receiving the killed vaccine. At the end of the influenza season, A/Victoria/3/75 infections were confirmed serologically. Only 12% of the infections were symptomatic. The infection rate was significantly reduced in the live vaccine groups, whereas in the killed vaccine group the percentage of infection was lower but not significantly different from that in the placebo group.
1976年冬季来临之前,在南非开展了一项临床试验。该研究涉及253名志愿者,他们被分为三组接种疫苗者和一组对照组。两组接种疫苗者分别以两周的间隔接种一剂或两剂(10(7.2) EID 50/剂)RIT 4025活重组毒株[A/苏格兰/840/74 (H3N2)血清型],一组接受一剂灭活疫苗注射[A/查尔默斯港/1/73 (H3N2),360国际单位,A/苏格兰/840/74 (H3N2),300国际单位,B/香港/8/73,300国际单位/剂]。通过单向辐射溶血试验测定,所有接种疫苗组针对异源A/维多利亚/3/75毒株的血清抗血凝素抗体反应均令人满意,且无统计学差异。另一方面,接受灭活疫苗组的抗神经氨酸酶抗体反应更好。在流感季节结束时,通过血清学方法确认了A/维多利亚/3/75感染情况。只有12%的感染出现症状。活疫苗组的感染率显著降低,而灭活疫苗组的感染百分比虽较低,但与安慰剂组无显著差异。