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目的评价10μg(微克)和5μg剂量A/C群脑膜炎球菌多糖结合疫苗(Group A/C Meningococcal Polysaccharide Conjugate Vaccine,MCV-A/C),在不同年龄组人群中的免疫学效果。方法按随机、盲法的原则,评价各年龄组人群接种不同剂次、剂量MCV-A/C后抗体阳转率、抗体保护率及几何平均滴度(Geometric Mean Titer,GMT)。结果 10μgMCV-A/C免疫后,各年龄组人群不同剂次、剂量A/C群血清杀菌力抗体(Serum Bactericidal Antibody,SBA)同时阳转率均>90.00%,抗体同时≥1:128保护率均>90.00%,A/C群SBAGMT>1:200;5μg MCV-A/C免疫后,各年龄组人群A/C群SBA同时阳转率均<90.00%,抗体同时≥1:128保护率为0,A/C群SBAGMT<1:50。结论不同剂次、剂量MCV-A/C在各年龄组人群中免疫原性有差异,10μgMCV-A/C具有较好的免疫原性。临床试验注册国家食品药品监督管理局《药物临床试验》2005L00830号。
Objective To evaluate the immunological effects of Group A / C Meningococcal Polysaccharide Conjugate Vaccine (MCV-A / C) at 10 μg and 5 μg doses in different age groups. Methods According to the principle of randomization and blindness, the antibody positive rate, antibody protection rate and geometric mean titer (GMT) after vaccination with different dose and dose of MCV-A / C were evaluated in all age groups. Results After immunization with 10μg of MCV-A / C, the positive rate of positive seroconversion rate of Serum Bactericidal Antibody (SBA) was> 90.00% at different doses of different age groups and the antibody protection rate ≥1: 128 A / C group SBAGMT> 1: 200; After 5μg MCV-A / C immunization, the SAC positive rate of A / C group in all age groups were all <90.00% 0, A / C group SBAGMT <1:50. CONCLUSION: The immunogenicity of MCV-A / C in different dose and dose groups is different in all age groups. 10μgMCV-A / C has good immunogenicity. Clinical trials registered with the State Food and Drug Administration “Drug Clinical Trial” 2005L00830.