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目的观察A、C群脑膜炎球菌-b型流感嗜血杆菌(Meningococcal group A&C/Haemophilus influenzae type b,ACHib)多糖结合疫苗的免疫原性。方法采用开放、完全随机、盲态观察的方法,将1 800名观察对象分为临床试验组和对照组,每组各900名,两组又按3个年龄段分为3～5、6～11和12～71月龄组。试验组仅经上臂三角肌肌内注射试验疫苗(ACHib多糖结合疫苗),对照组分别经左右上臂同时注射两种对照疫苗(A、C群脑膜炎球菌多糖结合疫苗和Hib结合疫苗)。3～5月龄组免疫3针,每针间隔1个月;6～11月龄组免疫2针,每针间隔1个月;12～71月龄组免疫1针。分别于免疫前、全程免疫后30～35 d采集静脉血,分离血清,采用功能性抗体杀菌力法检测A、C群脑膜炎球菌血清杀菌抗体滴度,间接ELISA法检测Hib抗体水平,并计算抗体阳转率及抗体增长倍数。结果免疫后,3个年龄段的试验组与对照组血清A、C群脑膜炎球抗体和Hib抗体阳转率差异均无统计学意义(P>0.05)。3个年龄段试验组与对照组易感和非易感人群A、C群脑膜炎球菌抗体滴度差异均无统计学意义(P均>0.05),而试验组Hib抗体水平低于对照组,且差异有统计学意义(P<0.001)。结论 ACHib多糖结合疫苗具有良好的免疫原性,可作为上述3种病原菌的预防制剂推广使用。
Objective To investigate the immunogenicity of Meningococcal group A and C / Haemophilus influenzae type b (ACHib) polysaccharide conjugate vaccine. Methods A total of 1 800 subjects were divided into clinical trial group and control group with 900 cases in each group by open, completely random and blind observation. The two groups were divided into 3 ~ 5, 6 ~ 11 and 12 to 71 months of age group. The experimental group was given intramuscular injection of the upper arm muscle only (ACHib polysaccharide conjugate vaccine), and the control group was injected with two control vaccines (Group A, Group C meningococcal polysaccharide conjugate vaccine and Hib conjugate vaccine) simultaneously via the upper and right arms respectively. 3 to 5 months old group immunized 3 needles, each needle interval of 1 month; 6 to 11 months group immunized 2 needles, each needle interval of 1 month; 12 to 71 months group immunized 1 needle. Venous blood was collected 30 ~ 35 days after immunization before immunization and serum was separated. The antibody titer of meningococcal serogroup A and C was tested by functional antibody bactericidal assay. The level of Hib antibody was measured by indirect ELISA Antibody positive rate and antibody growth fold. Results After immunization, there was no significant difference in the positive rate of meningococcal antibody and Hib antibody in serum of group A and C between the three age groups and the control group (P> 0.05). There was no significant difference in the antibody titers of meningococcal serogroups A and C between the three test groups and the control group (P> 0.05), while the level of Hib antibody in the test group was lower than that of the control group And the difference was statistically significant (P <0.001). Conclusion ACHib polysaccharide conjugate vaccine has good immunogenicity and can be used as a preventive agent for the above three pathogenic bacteria.