重组酵母乙型肝炎疫苗无(或弱)应答者复种远期效果观察

The long-term efficacy of recombinant microzyme hepatitis B revaccination in non-or hypo-responders to vaccination

目的探讨重组酵母乙肝疫苗无(或弱)应答者复种远期效果。方法严格筛选无(或弱)应答者40名,分肌肉和皮内接种,用3针加倍剂量(每次10μg或20μg),以80名同期筛检人群正常应答者作对照,完成30个月随访观察。结果无(或弱)应答者复种后产生抗体应答;第30个月,肌肉和皮内组仍有64.7%和34.8%维持抗体阳性。但无(或弱)应答者抗-HBs阳性率和抗体阳性者的抗体几何平均滴度(GMT)均明显低于正常应答者(P<0.01)。无(或弱)应答者HBV累积感染率(单项抗-HBc阳性)为25.0%(肌肉组17.6%,皮内组30.4%),显著高于正常应答者2.6%(P<0.01)。结论肌肉接种好于皮内接种。无(或弱)应答者复种确实能起到改善应答并在一个相对较长时间里维持抗体水平的作用。

Objective To evaluate long-term efficacy of hepatitis B revaccination in non- or hypo-responders. Methods 40 non- or hypo-responders diagnosed with severe screening were given three 2-fold-dose boosters （ 10 g or 20 g per dose） randomly by intramuscular or intradermal route, and 80 normal responders diag- nosed from the same screening were selected as the controls. A 30-month follow-up was finished after the first booster. Results 39 non- Or hypo-responders produced protective level anti-HBs, and 64.7% of intramuscular vaccines and 34.8% of intradermal vaccines still kept anti-HBs positive till the 30th month. However, the anti- HBs positive rate and the GMT of the antibody positive subjects in non-or hypo-responders were significantly lower than those in normal responders （ P 〈 0.01 ） , and the cumulative HBV infection rate （ isolated anti-HBc positive-conversion as infection marker） in non- or hypo-responders was 25.0% （ 17.6% for intramuscular and 30.4% for intradermal）, dramatically higher than 2.6% in normal responders （P 〈 0.01 ）. Conclusion ntramuscular route was more effective than intradermal route. It is undoubted that revaccination in non- or hypo-responders can improve response to the vaccine and keep protective anti-HBs within a relatively long time, but the efficacy was limited.