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越南农村地区出生剂量在冷链外储存的本地生产乙肝疫苗的免疫原性

Immunogenicity of a locally produced hepatitis B vaccine with the birth dose stored outside the cold chain in rural Vietnam.

作者信息

Hipgrave David B, Tran Trung Nam, Huong Vu Minh, Dat Do Tuan, Nga Nguyen Tuyet, Long Hoang Thuy, Van Nguyen Thu, Maynard James E, Biggs Beverley-Ann

机构信息

International Health Unit, Burnet Institute, Alfred Medical Research and Education Precinct, Prahran, Victoria, Australia.

出版信息

Am J Trop Med Hyg. 2006 Feb;74(2):255-60.

PMID:16474080
Abstract

The heat stability of hepatitis B vaccine (HepB vaccine) should enable its storage outside the cold chain (OCC), increasing access to the birth dose in areas lacking refrigeration. We compared the immunogenicity of a locally produced vaccine among infants who received three doses stored within the cold chain (n = 358) or for whom the first dose was stored OCC for up to one month (n = 748). Serum was collected from these infants at age 9-18 months. The vaccine was protective in 80.3% of all infants. There were no differences in the prevalence of a protective level of antibody or antibody titer among groups of infants according to storage strategy. Differences in antibody titer between certain groups of infants could be explained by different vaccination schedules. Where birth dose coverage will be improved, HepB vaccine can be taken OCC for up to one month without affecting its immunogenicity.

摘要

乙肝疫苗(HepB疫苗)的热稳定性应使其能够在冷链之外储存(OCC),从而增加在缺乏冷藏条件地区首剂疫苗的可及性。我们比较了在冷链内储存三剂疫苗的婴儿(n = 358)或首剂疫苗在OCC条件下储存长达一个月的婴儿(n = 748)中,一种本地生产疫苗的免疫原性。在这些婴儿9至18个月龄时采集血清。该疫苗对所有婴儿的保护率为80.3%。根据储存策略分组的婴儿中,抗体保护水平或抗体滴度的患病率没有差异。某些婴儿组之间抗体滴度的差异可以通过不同的接种程序来解释。在首剂疫苗接种覆盖率将得到提高的情况下,乙肝疫苗可以在OCC条件下储存长达一个月而不影响其免疫原性。

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