低剂量皮内注射乙肝疫苗的疗效：医护人员随机试验结果

Efficacy of low dose intradermal hepatitis B vaccine: results of a randomized trial among health care workers.

作者信息

Das H S, Sawant P, Shirhatti R G, Vyas K, Vispute S, Dhadphale S, Patrawalla V, Desai N

机构信息

Department of Gastroenterology, LTMMC and LTMGH, Sion, Mumbai.

出版信息

Trop Gastroenterol. 2002 Jul-Sep;23(3):120-1.

PMID:12693152

Abstract

BACKGROUND

Hepatitis B virus (HBV) infection is an occupational health hazard among the healthcare workers. Vaccination against HBV has been established to be the most effective preventive strategy. The present study was designed to assess the efficacy of low dose intradermal HBV vaccine among the nursing staff in a tertiary care hospital setting.

PATIENTS AND METHODS

Staff nurses working in our hospital were included in the study as vaccine recipients. Each staff nurse was tested for HBsAg and anti-HBs (commercial ELISA). Those who tested negative for both the above markers were randomized to receive either three doses of intramuscular (i.m.) HBV vaccine (20 micrograms m each dose) at 0, 1 and 6 month interval or three doses of intradermal HBV vaccine (2 micrograms m each dose) at similar intervals. Each vaccine recipient was tested for the presence of anti HBs (commercial ELISA) at the end of 1 month and 1 year after the last dose of the vaccine. The anti-HBs titres were also estimated simultaneously in them.

RESULTS

Out of 153 staff nurses screened, 19 were either positive for HBsAg (n = 1) or anti HBs (n = 18). 96(72%) of the remaining 134 nurses agreed to receive HBV vaccine (i.m.--48, intradermal--48). At the end of 1 month after last dose of the vaccine, all vaccinees in both the group tested positive for anti-HBs. However the anti-HBs titres at 1 month were significantly higher among intramuscular vaccinees than the nurses receiving the vaccine through intra-dermal route (253 +/- 127.7 mIU/ml vs 151.3 +/- 92.8 mIU/ml, P < 0.001). Eighty four (85.5%) of these 96 vaccine recipient were available for evaluation of anti-HBs titre at the end of 1 year after the last dose of vaccine (1M group = 40, Intradermal group = 44). All the nurses continued to be positive for anti-HBs at the end of 1 year but the anti HBs-titre among i.m. vaccine recipient continued to remain at a significantly higher level than the similar titre among the intradermal vaccine recipients (256.4 +/- 124.7 mIU/ml vs 121.6 +/- 122.4 mIU/ml p < 0.001).

CONCLUSION

Intradermal route for HBV vaccine had similar immunogenic efficacy as the conventional intramuscular route, but the dose required in the former route is one tenth of the intramuscular route. Therefore intradermal route may reduce the cost of HBV vaccine markedly.

摘要

背景

乙型肝炎病毒（HBV）感染是医护人员面临的职业健康风险。接种HBV疫苗已被确立为最有效的预防策略。本研究旨在评估低剂量皮内注射HBV疫苗在三级医院护理人员中的疗效。

患者与方法

在我们医院工作的注册护士被纳入研究作为疫苗接种对象。对每位注册护士进行HBsAg和抗-HBs检测（采用商用ELISA法）。上述两种标志物检测均为阴性的人员被随机分为两组，一组接受3剂肌内注射（i.m.）HBV疫苗（每剂20微克），接种时间间隔为0、1和6个月；另一组接受3剂皮内注射HBV疫苗（每剂2微克），接种时间间隔相同。每位疫苗接种对象在最后一剂疫苗接种后1个月和1年时检测抗-HBs（采用商用ELISA法）。同时测定他们的抗-HBs滴度。

结果

在筛查的153名注册护士中，19名HBsAg呈阳性（n = 1）或抗-HBs呈阳性（n = 18）。其余134名护士中有96名（72%）同意接种HBV疫苗（肌内注射组48名，皮内注射组48名）。在最后一剂疫苗接种后1个月时，两组所有接种者抗-HBs检测均呈阳性。然而，肌内注射疫苗接种者1个月时的抗-HBs滴度显著高于皮内注射疫苗的护士（253±127.7 mIU/ml比151.3±92.8 mIU/ml，P < 0.001）。这96名疫苗接种对象中有84名（85.5%）在最后一剂疫苗接种后1年时可用于评估抗-HBs滴度（肌内注射组 = 40名，皮内注射组 = 44名）。在1年时所有护士抗-HBs仍为阳性，但肌内注射疫苗接种者的抗-HBs滴度仍显著高于皮内注射疫苗接种者的相似滴度（256.4±124.7 mIU/ml比121.6±122.4 mIU/ml，p < 0.001）。