国产水痘减毒活疫苗初次和加强免疫的免疫原性和安全性观察

Immunogenicity and safety of primary and booster vaccination with domestic varicella attenuated live vaccine

目的观察国产水痘减毒活疫苗（VarV）初次免疫和加强免疫的免疫原性和安全性。方法采用单纯随机抽样方法选择16月龄儿童接种2剂次VarV（16月龄组），选择18月龄儿童接种1剂次VarV（18月龄组）；分别采集受试者免疫前和每剂免疫后35一g2d的血标本，采用膜免疫荧光抗体法（FAMA）检测水痘抗体；观察接种后30d内的不良反应。结果在16月龄组和18月龄组VarV初次免疫中，免疫前水痘抗体阳性率（SPR）分别为89．47％、87．96％（x^2=0．17，P=0．68），抗体几何平均滴度（GMT）分别为1：5．80、1：5．62（t=0．33，P=0．74）；免疫后抗体阳转率（SCR）分别为49．56％、75．00％（x^2=19．44，P=0．00），GMT分别为1：20．16、1：35．23（t=5．94，P=0．00）。在16月龄组VarV加强免疫中，l剂次和2剂次免疫后SCR分别为49．52％和86．19％（z。=64．72，P=0．00），GMT分别比免疫前增加2．53倍和7．01倍（F=453．97，P=0．00）。16月龄组第l剂次和第2剂次VarV、18月龄组1剂次VarV免疫后的局部红肿发生率分别为2．19％、0．95％、2．78％，发热发生率分别为0．88％、0．48％、0．93％，无其他不良反应报告。结论VarV初次和加强免疫的免疫原性和安全性均良好。

Objective To evaluate the immunogenicity and safety of primary and booster vaccination with domestic varicella attenuated live vaccine （VarV）. Methods A simple random sampling method was used to select 16-month-old children for 2-dose VarV vaccination （the 16-month group）, and to select 18-month-old children for 1-dose VarV vaccination （the 18-month group）. We collected blood samples from all subjects before and 35-42 days after each dose of vaccine for testing varicella antibody by the flu- orescent antibody to membrane antigen （FAMA） method. Adverse reactions within 30d of VarV adminis- tration were observed. Results In the 16-month group and the 18-month group, pre-vaccination sero- positivity rates （SPRs） of varicella antibody were 89. 47% and 87.96% （x2 =0. 17, P =0. 68）, re- spectively, and the geometric mean titers （GMTs） were 1：5.80 and 1：5.62 （t =0. 33, P =0. 74）. The post-primary vaccination seroconversion rates （SCRs） were 49.56% and 75.00% （X^2 = 19.44, P = 0. 00） , respectively, and the GMTs were 1： 20. 16 and 1：35.23 （t =5.94, P =0.00）. Following boost- er vaccination of the 16-month group, post-vaccination SCRs for 1-dose and 2-dose VarV were 49.52% and 86. 19% （X^2 =64. 72, P =0. 00）, respectively, and GMTs had increased by 2.53 and 7.01 times compared with the pre-vaccination GMT （F = 433.97, P = 0. 00）. The incidences of injection-site red- ness and swelling following first- and second-dose VarV in the 16-month group and 1 dose of VarV in the 18-month group were 2. 19% , 0. 95% , and 2.78% , respectively, and the incidences of fever were 0. 88% , 0. 48% , and 0. 93% , respectively. No other adverse reactions were reported. Conclusions VarV had a good immunogenicity and safety for both primary and booster vaccination.