Dahl-Hansen E, Siebke J C, Frøland S S, Degré M
Department of Internal Medicine, National Hospital of Norway, Oslo.
Epidemiol Infect. 1990 Feb;104(1):143-9. doi: 10.1017/s0950268800054625.
The immunogenicity and reactogenicity of two preparations of yeast-derived hepatitis B vaccines were compared in healthy adult populations. The two groups were vaccinated in parallel, but they were not matched for age and sex. All subjects seroconverted, and 9 months after the first vaccine dose, all had anti HBs titres of at least 10 IU/l. The anti-HBs titres were higher in the group of subjects given 20 micrograms vaccine antigen made by Smith Kline & RIT (GMT 2943 at 9 months) compared to those who received 10 micrograms of vaccine made by Merck, Sharp & Dohme (GMT 729 at 9 months). Adverse effects were recorded in 32.0 and 44.7% of the participants, but these were limited to minor local and general reactions. In the present study both preparations were safe and efficient.
在健康成年人群中比较了两种酵母源乙肝疫苗制剂的免疫原性和反应原性。两组同时接种疫苗,但未按年龄和性别进行匹配。所有受试者均发生血清转化,在首剂疫苗接种9个月后,所有人的抗-HBs滴度均至少为10 IU/l。与接受默克公司10微克疫苗(9个月时几何平均滴度为729)的受试者相比,接种史克必成公司20微克疫苗抗原的受试者组抗-HBs滴度更高(9个月时几何平均滴度为2943)。32.0%和44.7%的参与者记录到不良反应,但这些仅限于轻微的局部和全身反应。在本研究中,两种制剂均安全有效。