人二倍体细胞狂犬病疫苗免疫8年后加强免疫效果研究

Investigation on the effects of booster immunization of human diploid cell rabies vaccine after eight years of primary vaccination

目的揭示人二倍体细胞狂犬病疫苗（human diploid cell rabies vaccine，HDCV）免疫8年后加强免疫的效果。方法选取参加过冻干HDCV临床Ⅲ期全程免疫的对象60例，在初次免疫8年后进行单剂加强免疫。观察加强免疫后的不良反应情况，在加强免疫前和加强免疫后14d分别采集血清，采用快速荧光灶抑制试验（rapid fluorescent focus inhibition test，RFFIT）检测狂犬病病毒中和抗体（rabies virus neutralizing antibody，RVNA）。对加强免疫前后的RVNA阳性率和几何均值（geometric mean titer，GMT）进行比较。结果54例受试者完成随访和RVNA检测。受试者在加强免疫后30min及随访15d期间未发生不良反应。加强免疫前和加强免疫后RVNA阳性率为51．85％（28／54）、96．30％（52／54）。加强免疫前和加强免疫后RVNA的GMT为1．42IU／ml、30．61IU／ml。结论冻干HDCV免疫8年后单剂加强免疫效果良好。

Objective To disclose the effects of booster immunization of human diploid cell rabies vaccine （HDCV） after eight years of primary vaccination. Methods Sixty subjects who had participated the phase Ⅲ clinical trial of freeze-dried HDCV were selected and gaven booster immunization after eight years of primary vaccination. The side effects of booster immunization were observed. The serum before and after 14 days of booster immunization were collected and detected the rabies virus neutralizing antibody （RVNA） by rapid fluorescent focus inhibition test （RFFIT）. The positive rate and geometric mean titer （GMT） of RVNA before and after booster immunization were made statistical analysis. Results Total 54 subjects finished the follow-up and RVNA detection. No sever side-effects were observed in 30 min or 15 days of follow-up after booster immunization. The positive rate of RVNA before and after booster immunization were 51.85% （28/54） and 96.30% （52/54）. The GMT of RVNA before and after booster immunization were 1.42 IU/ml and 30. 61 IU/ml. Conclusions The freeze-dried HDCV has good immune effects with one-dose of booster immunization after eight years of primary vaccination.