Wiedermann G, Jovanovic D, Georges A M, Hauser P, Ambrosch F
Zentralbl Bakteriol Mikrobiol Hyg A Med Mikrobiol Infekt Parasitol. 1982 Apr;251(4):494-504.
In a study conducted in two phases at one month's interval, 22 healthy adult volunteers received a tetravalent (1, 3, 4, 12F) polysaccharide pneumococcal vaccine; 21 other subjects received another tetravalent (14, 18C, 19F, 23F) vaccine and 25 received a pentadecavalent vaccine (1, 3, 4, 6A, 7F, 8, 9N, 11A, 12F, 14, 15F, 18C, 19F, 23F). Placebo was given under single blind conditions to eleven subjects in the first phase of the study and to 24 subjects in the second phase of the study. The vaccines were well tolerated giving rise to transient local reactions in a small proportion of subjects. Results obtained indicate that all 15 polysaccharides are satisfactorily immunogenic. Results so far obtained can be described as encouraging. Further studies to investigate the reactogenicity and immungenicity of multivalent pneumococcal polysaccharide vaccines with a greater number of serotypes are under way.
在一项分两个阶段进行、间隔一个月的研究中,22名健康成年志愿者接种了四价(1、3、4、12F)肺炎球菌多糖疫苗;另外21名受试者接种了另一种四价(14、18C、19F、23F)疫苗,25名受试者接种了十五价疫苗(1、3、4、6A、7F、8、9N、11A、12F、14、15F、18C、19F、23F)。在研究的第一阶段,对11名受试者进行单盲安慰剂给药,在研究的第二阶段,对24名受试者进行单盲安慰剂给药。疫苗耐受性良好,仅在一小部分受试者中引起短暂的局部反应。所得结果表明,所有15种多糖都具有令人满意的免疫原性。目前所获结果可谓鼓舞人心。正在开展进一步研究,以调查更多血清型的多价肺炎球菌多糖疫苗的反应原性和免疫原性。