Immunogenicity in humans of an edible vaccine for hepatitis B

Immunogenicity in humans of an edible vaccine for hepatitis B
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DOI:
10.1073/pnas.0409899102
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发表时间:
2005-03-01
影响因子:
11.1
通讯作者:
Mason, HS
Mason, HS
中科院分区:
综合性期刊1区
文献类型:
--
作者:
Thanavala, Y;Mahoney, M;Mason, HS

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一项双盲安慰剂对照临床试验评估了在土豆中表达并口服给以前接种过疫苗的人的乙肝表面抗原(HBs)的免疫原性。土豆积累的乙肝表面抗原约为8.5微克/克土豆块茎,摄入剂量为100克块茎。乙肝病毒是一种非肠道病原体,其保护作用与血清中抗HBs Ag抗体滴度有关。在志愿者食用生土豆后,16名志愿者中有10名(62.5%)吃了三剂土豆,其中9名(52.9%)吃了两剂转基因土豆,没有一名志愿者吃了非转基因土豆。这些结果是在没有共同给予粘膜佐剂或需要缓冲胃pH的情况下实现的。我们的结论是,预防乙肝病毒的植物来源口服疫苗应被视为全球免疫计划的一个可行组成部分。
A double-blind placebo-controlled clinical trial evaluated the immunogenicity of hepatitis B surface antigen (HBsAg) expressed in potatoes and delivered orally to previously vaccinated individuals. The potatoes accumulated HBsAg at approximate to8.5 mug/g of potato tuber, and doses of 100 g of tuber were administered by ingestion. The correlate of protection for hepatitis B virus, a nonenteric pathogen, is blood serum antibody titers against HBsAg. After volunteers ate uncooked potatoes, serum anti-HBsAg titers increased in 10 of 16 volunteers (62.5%) who ate three doses of potatoes; in 9 of 17 volunteers (52.9%) who ate two doses of transgenic potatoes; and in none of the volunteers who ate nontransgenic potatoes. These results were achieved without the coadministration of a mucosal adjuvant or the need for buffering stomach pH. We conclude that a plant-derived orally delivered vaccine for prevention of hepatitis B virus should be considered as a viable component of a global immunization program.