Objective: To grope for an ideal immune strategy in grown-ups via comparison of immunological effects under 4 different vaccination schemes. Methods: Study population was selected by stratified random cluster sampling. A total of 4 different vaccination proposals, including Strategy A (3 doses, 10 μg, administrated repeatedly into the unilateral deltoid muscle at 0-1-6 months), Strategy B (2 doses, 20 μg, administrated into the bilateral deltoid muscles simultaneously), Strategy C (3 doses, 10 μg, administrated repeatedly into the unilateral deltoid muscle at 0-1-2 months) and Strategy D (2 doses, 10 μg, administrated to the bilateral deltoid muscles at the same time), were conducted in Liangzhou, Minqin Gulang, and the Tianzhu Tibetan Autonomic county respectively, in Wuwei city, Gansu province. Under 4 different strategies, post-vaccination immunological effectiveness was evaluated when blood samples of participants collected in the eighth months, post-first injection and in the third year, and tested by enzyme-linked immunoassays and electro-chemiluminescence immunoassay. Chi-squared test and Fisher exact test were used to evaluate the immunological differences between the 4 strategies. Wilcoxon' s signed rank test and Kruskal-Waillis H test were conducted to compare the differences of the geometric mean titers (GMTs) of antibody against HBV surface antigen (anti-HBs) titers. Results: A total of 1 621 eligible participants aged 16 to 60 years old, were recruited for the study. Numbers of administration and gender were testified as the presuming factors for influencing immune effectiveness. The vaccination completion rates were 53.97% and 79.82% in Strategy A and C, respectively, and the difference statistically significant (P<0.05). In the first year, the protective antibody sero-conversion rates (standardization rate) were 89.21%, 54.88%, 92.11%, and 41.63%, in Strategy A, B, C and D, respectively, and the significant statistically differences emerged (P<0.05) if Strategy B, C and D were compared with Strategy A (as the gold standard). Over a 3-year follow-up period, the levels of GMTs on protective antibody declined from 179.2 IU/L, 51.6 IU/L, 277.1 IU/L and 10.1 IU/L to 61.3 IU/L, 21.2 IU/L, 31.8 IU/L and 6.0 IU/L in Strategy A, B, C and D, respectively, and the differences of declination on GMTs showed statistically significant differences (P<0.05) when compared within or between the 4 strategies. Conclusion: The 0-1-2 months' prophylactic schedules (Strategy C) seemed superior to the others, in terms of effectively inducing the protective antibody, with shorter duration of vaccination, persisting longer immunity and having higher rate of completive vaccination, so is worth to be recommended as a feasible immune programme for adults, especially for migrants from the rural regions.
目的： 比较成年人乙型肝炎（乙肝）疫苗4种接种方案的免疫学效果。 方法： 通过整群分层随机抽样方法，对来自甘肃省农村人口流动性高的地区武威市凉州区、民勤县、古浪县及天祝藏族自治县HBsAg、抗-HBs和抗-HBc均阴性的成年人分别采用4种方案（A ：10 μg " 0-1-6"方案；B: 20 μg"两点一次"方案；C ：10 μg"0-1-2"方案；D: 10 μg"两点一次"方案）接种乙肝疫苗。分别于接种第一针后的第8个月和第3年收集血样，通过ELISA及电化学发光法（ECLIA）检测，使用χ(2)检验或Fisher精确检验比较各方案间的免疫学差异；使用Wilcoxon' s signed rank test及Kruskal-Waillis H test比较抗-HBs的平均抗体滴度（GMT）变化差异。 结果： 共有1 621名16~ 60岁合格的志愿者参与了此次研究。方案A及C的疫苗接种完成率分别为53.97%及79.82%。方案C的全程接种完成率明显高于方案A（P<0.05）。第1年，方案A、B、C及D的血清保护性抗体阳转率（标准化率）分别为89.21%、54.88%、92.11%及41.63%；以方案A作为金标准，方案B、C及D分别与之比较，差异均有统计学意义（P<0.05）；3年随访结束，在方案A、B、C及D中，保护性抗体的GMT （IU/L）分别由第1年的179.2、51.6、277.1及10.1，下降到第3年的61.3、21.2、31.8及6.0，各免疫方案内比较，抗体滴度的变化均有统计学意义（P<0.05）；4个不同方案间比较，抗体滴度变化差异亦有统计学意义（P<0.05）。性别和接种次针与乙肝疫苗的免疫效果相关。 结论： 方案C (10 μg"0-1-2"方案）对调查地区的成年人具有血清保护性抗体阳转率高、免疫持久性好、接种周期短及完成全程接种率高的优势，尤其适合于人口流动性高的农村地区。.
Keywords: Adult; HBV; Immunogenicity; Persistence; Vaccine.