Comparative tolerability and immunogenicity of Typherix™ or Typhim Vi™ in healthy adults -: 0, 12-month and 0, 24-month administration
Comparative tolerability and immunogenicity of Typherix™ or Typhim Vi™ in healthy adults -: 0, 12-month and 0, 24-month administration
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DOI：
10.2165/00063030-200115001-00002
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发表时间：
2001-01-01
期刊：
影响因子：
6.8
通讯作者：
Lebacq, E
中科院分区：
文献类型：
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作者：
Lebacq, E
背景资料：进行这项研究是为了比较Typherix（TM）（一种最近开发的伤寒Vi多糖疫苗）与Typhim Vi（TM）（第一种可用的Vi多糖疫苗）在健康成人中的免疫原性和耐受性。三个不同的生产批次的Typherix（TM）也compared.Methods：所有受试者随机接受初始剂量的Typhim VI（TM），或三个生产批次的Typherix（TM）之一，随后随机接受第二剂疫苗在12或24个月。接种后6天内，患者记录不良事件。在第0、7、14和28天，第6、12和24个月，以及第二次接种后1个月（第13或25个月）测定血清中的抗Vi抗体。三个Typherix（TM）组中报告不良事件的患者明显少于Typhim Vi（TM）组（分别为17 - 21%和44%）。在第14天，三个Typherix（TM）组的受试者中的血清阳性率为95.7%至97.9%，Typhim Vi（TM）组为96.8%（组间无显著差异）。在第7天观察到疫苗之间血清阳性的唯一显著差异（Typherix（TM）为71.8%，Typhim Vi（TM）为86.4%）。在12和24个月时接受第二剂Typherix（TM）的受试者中，77%和61%在再接种前血清阳性，而Typhim Vi（TM）为69%和46%（无显著差异）。在接种第二剂疫苗（12或24个月）后，两种疫苗之间的血清阳性率或不良事件无显著差异。结论：Typherix（TM）的初始剂量与比Typhim Vi（TM）更少的不良事件相关。基于血清Vi滴度，两种疫苗在0、12个月和0、24个月给药时表现出相同的免疫原性。Typherix（TM）的三个不同生产批次之间无差异。
Background: This study was carried out to compare the immunogenicity and tolerability of Typherix(TM), a recently developed typhoid Vi polysaccharide vaccine, with Typhim Vi(TM), the first available Vi polysaccharide vaccine, in healthy adults. Three different production lots of Typherix(TM) were also compared.Methods: All subjects were randomised to receive an initial dose of Typhim Vi(TM), or one of three production lots of Typherix(TM), and subsequently randomised to receive a second dose of vaccine at 12 or 24 months. Adverse events were recorded by patients for 6 days after vaccination. Anti-Vi antibodies were measured in serum on days 0, 7, 14 and 28, at months 6, 12 and 24, and 1 month after the second dose (month 13 or 25).Results: A total of 400 healthy subjects aged between 18 and 50 years received the first dose of vaccine. Significantly fewer patients in the three Typherix(TM) groups than in the Typhim Vi(TM) group reported adverse events (17 to 21% vs 44%, respectively). Seropositivity rates were 95.7 to 97.9% among subjects in the three Typherix(TM) groups at day 14, and 96.8% in the Typhim Vi(TM) group (no significant between-group differences). The only significant difference between the vaccines in seropositivity was observed at day 7 (71.8% for Typherix(TM) vs 86.4% for Typhim Vi(TM)). Of subjects receiving the second dose of Typherix(TM) at 12 and 24 months, 77% and 61% were seropositive before revaccination, compared with 69% and 46% for Typhim Vi(TM) (no significant difference). There were no significant differences in seropositivity or adverse events between the two vaccines after administration of the second dose (12 or 24 months).Conclusions: The initial dose of Typherix(TM) was associated with fewer adverse events than Typhim Vi(TM). On the basis of serum Vi titres, the two vaccines demonstrated equivalent immunogenicity, with 0, 12-month and 0, 24-month administration. There were no differences between the three different production lots of Typherix(TM).