钩端螺旋体疫苗的接种反应和血清学效果观察

Observation on the Inoculated Reaction and Serological Effect of Leptospira Vaccine

为统一中国钩体疫苗的菌数 (浓度 ) ,保障人群预防接种的安全与有效 ,用上海、武汉和成都生物制品研究所生产钩体疫苗 ,观察了 4种不同菌数、4种不同接种剂量 8个不同组别对 2 0 37人的免疫效果。所有接种者全身反应轻微 ,中强反应不超过 3%。局部反应各所间有差别 ,上海所最轻 (9.6 8% ) ,武汉所居中(17.93% ) ,成都所最重 (38.78% )。血清阳转率和GMT水平 1个月达高峰 ,3个月似有下降。随着钩体疫苗接种总量的增大 ,人群抗体的阳转率和GMT水平有所提高 ,尤其是赖型抗原。 3个所疫苗的抗体阳转率和GMT有明显差别 ,以成都所为最高。根据实验结果 ,建议 :① 5价 (含 5价 )以下钩体疫苗 ,每型菌数不低于1.5亿 /mL ;② 6价 (含 6价 )以上 ,每型含菌数不应低于 1亿 /mL ,但疫苗的总菌数不超过 12 .5亿 /mL ;③全程接种 2次 ,首次 0 .5mL ,再次 1mL ,间隔 5～ 7d。该建议已被 1990版《中国生物制品规程》(钩体疫苗制检规程 )所采纳 ,并一直沿用至今。

In order to unify concentration of Leptospira vaccines in China for more safety and efficiency, we observed the immune effects of three different Leptospira vaccines respectively produced by Shanghai, Wuhan and Chengdu institutes in {2 037} healthy individuals, which was divided into 8 groups including 4 different concentrations of Leptospira and 4 different doses of inoculation. The results indicated that all the vaccinated individuals displayed slight systemic reaction and only 3% of the individuals showed moderate or severe reaction. In comparison with the local reactions ca used by the three Leptospira vaccines, the vaccine from Shanghai institute is relatively mild (9.68%), the vaccine from Wuhan institute is moderate ({17.93%}) and the vaccine from Chengdu institute is more serious (38.78%). The specific antibody positive conversion rates and GMT levels were up to highest in the 30th d after vaccination, and then showed a little down after three months. The specific antibody positive conversion rates and GMT levels became higher when the vaccines containing more concentrations of Leptospira used, especially for antigen of serovars lai. Among the three vaccines, the specific antibody positive conversion rate and GMT level caused by the vaccine from Chengdu institute were the highest. According to the results in this study, we suggested: a) For the vaccine with pentavalent or below, each the serovars should contain at least higher than 1.5×108 Leptospira/mL; b) For the vaccine with hexavalent or above, each the serovars should contain not less than 1.0×108 Leptospira/mL; but lower than 1.25×109/mL; c) The vaccine should be injected twins for adults, 0.5 mL of the vaccine for the first injection of and 1.0 mL for the second with an interval of 5～7 d between the two injections. These suggestions had been accepted by the requirements for biologics of the people's republic of China, published in 1990, and until used to now.;