幽門螺旋桿菌疫苗

號外：幽門螺旋桿菌疫苗

NEW: Helicobacter pylori VACCINE

耗時1/4世紀，經過無數的嘗試，已製造出有效對抗幽門螺旋桿菌的疫苗。For a quarter of a century, countless attempts have been made to produce an effective vaccine against Helicobacter pylori. Zeng與他的同事發表 "口服三劑量，重組幽門螺桿菌疫苗" 新研究成果。Zeng and colleagues present the results of NEW research into a three-dose oral recombinant H pylori vaccine.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60310-5/fulltext

口服三劑量，重組幽門螺旋桿菌疫苗，是中國大陸研發，發表在LANCET知名期刊：（中國大陸生物科技快追上歐美，厲害！）

在中國兒童的一項隨機，雙盲，安慰劑對照組，3期臨床試驗口服重組幽門螺旋桿菌疫苗的療效，安全性和免疫抗原性。Efficacy, safety, and immunogenicity of an oral recombinant Helicobacter pylori vaccine in children in China: a randomised, double-blind, placebo-controlled, phase 3 trial

在中國江蘇省，贛榆縣的一個中心，以過去或現在均未感染幽門螺旋桿菌的6〜15歲健康兒童，做這項隨機、雙盲、安慰劑對照組、3期的口服重組幽門螺桿菌疫苗試驗。 We did this randomised, double-blind, placebo-controlled, phase 3 trial at one centre in Ganyu County, Jiangsu Province, China. Healthy children aged 6–15 years without past or present H pylori infection

從2004年12月2日到2005年3月19日期間，我們隨機分配4464位受試者，其中口服三劑重組幽門螺旋桿菌疫苗組有2232位受試者，和安慰劑對照組有2232位受試者，其中有4403位（99％）受試者完成口服三劑量，重組幽門螺桿菌疫苗計劃，並列入了方案的有效性分析。Between Dec 2, 2004, and March 19, 2005, we randomly assigned 4464 participants to either the vaccine group (n=2232) or the placebo group (n=2232), of whom 4403 (99%) participants completed the three-dose vaccination schedule and were included in the per-protocol efficacy analysis.

延長追蹤3年。We extended follow-up to 3 years. 在追蹤第一年，記錄了64例幽門螺旋桿菌感染（口服三劑重組幽門螺旋桿菌疫苗組，在2074.3人-年的幽門螺旋桿菌感染風險有14例比較安慰劑對照組在2089.6人-年的幽門螺旋桿菌感染風險有50例）， We recorded 64 events of H pylori infection within the first year (14 events in 2074·3 person-years at risk in the vaccine group vs 50 events in 2089·6 person-years at risk in the placebo group), 實驗結果口服三劑重組幽門螺旋桿菌疫苗有71·8％的功效（95％信賴區間48·2-85·6）。resulting in a vaccine efficacy of 71·8% (95% CI 48·2–85·6).

至少報告有一個口服疫苗不良反應症狀：在口服重組幽門螺旋桿菌疫苗組有157例（7％），和在安慰劑對照組有161例（7％）。157 (7%) participants in the vaccine group and 161 (7%) participants in the placebo group reported at least one adverse reaction. 口服疫苗嚴重不良反應的報告：在口服重組幽門螺旋桿菌疫苗組有5例   <1%  ，和在安慰劑對照組有7例   <1%  ，在安慰劑組的參與者，但沒有一例不良反應被認為是與口服疫苗有關。Serious adverse events were reported in five    < 1%  participants in the vaccine group and seven   <1%  participants in the placebo group, but none was considered to be vaccination related.

對天真的孩子施予口服重組幽門螺旋桿菌疫苗是有效，安全，和具幽門螺旋桿菌免疫抗原性。The oral recombinant H pylori vaccine was effective, safe, and immunogenic in H pylori-naive children. 這種疫苗可以顯著降低幽門螺旋桿菌感染的發生率; This vaccine could substantially reduce the incidence of H pylori infection; 然而，需長時間追蹤來確認疫苗對抗幽門螺桿菌相關疾病的保護力。however, follow up over a longer period is needed to confirm the protection of the vaccine against H pylori-associated diseases.

口服三劑量，重組幽門螺桿菌疫苗中國大陸研發公司：重慶康威生物科技有限公司，研發和行銷幽門螺旋桿菌診斷試劑盒。Chongqing Kangwei Biotech Co. Ltd. develops and markets H. pylori diagnostic kits. 此外，該公司從事研究與幽門螺旋桿菌疫苗的研製。

In addition, the company engages in research and development of H. pylori vaccine. 重慶康威生物科技有限公司成立於2000年，總部設在中國。Chongqing Kangwei Biotech Co. Ltd. was founded in 2000 and is based in China. 該公司是岳陽興長石化股份有限公司的子公司。The company is a subsidiary of Yueyang Xingchang Petro-Chemical Co., Ltd.