Zangwill Kenneth M, Greenberg David P, Chiu Chung-Yin, Mendelman Paul, Wong Victor K, Chang Swei-Ju, Partridge Susan, Ward Joel I
UCLA Center for Vaccine Research, Harbor-UCLA Medical Center, Liu Research Building, 1124 W. Carson Street, Torrance, CA 90502, USA.
Vaccine. 2003 May 16;21(17-18):1894-900. doi: 10.1016/s0264-410x(03)00013-6.
To evaluate the safety and immunogenicity of two lots of a heptavalent Streptococcus pneumoniae conjugate vaccine (PCV) containing seven capsular polysaccharide serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) conjugated to the outer membrane complex of Neisseria meningitidis serogroup B (OMPC) and administered to infants at 2, 4, 6, and 12 months of age.
One hundred twenty infants were randomly assigned to concurrently receive PCV-OMPC and one of two Haemophilus influenzae type b (Hib) conjugate-DTwP combination vaccines: (1) Hib with a heterologous protein carrier (CRM(197), TETRAMUNE, Group 1) or (2) an experimental Hib-hepatitis b combination vaccine with the homologous carrier (OMPC, Group 2). All infants in Groups 1 and 2 received PCV-OMPC (lot 1) at 12 months of age. Another separate group of 120 infants (Group 3) received a different lot of PCV-OMPC concurrently with Hib-CRM(197) (TETRAMUNE) at 2, 4, and 6 months of age and then were randomized to receive either PCV-OMPC or a 23-valent polysaccharide (PS) pneumococcal vaccine at 12 months of age.
Each PCV-OMPC lot was generally well tolerated and no vaccine-related serious adverse events were reported. Following the primary series, serotype-specific anti-pneumococcal geometric mean concentrations (GMC) were highest for serotypes 14, 19F, and 4 and lowest for serotypes 6B and 23F. GMC and seroconversion rates in Group 3 (lot 2) were lower than in Group 1 (lot 1) for serotypes 6B, 14, 18C, and 23F. Antibody responses to serotypes 6B, 14, and 18C were significantly lower in Group 2 compared to Group 1. Following a booster dose of PCV-OMPC at 12 months of age, each lot was immunogenic with at least a 5-10-fold increase in antibody levels, and responses were significantly higher among those who received the PS vaccine.
PCV-OMPC is generally safe in infants, displays variable immune response by serotype, and concomitant receipt of Hib vaccine with homologous carrier may impact on its immunogenicity.
评估两批七价肺炎链球菌结合疫苗（PCV）的安全性和免疫原性，该疫苗包含七种与B群脑膜炎奈瑟菌外膜复合物（OMPC）结合的荚膜多糖血清型（4、6B、9V、14、18C、19F和23F），并在婴儿2、4、6和12月龄时接种。
120名婴儿被随机分配同时接种PCV - OMPC和两种b型流感嗜血杆菌（Hib）结合 - 白喉破伤风全细胞疫苗（DTwP）联合疫苗之一：（1）含异源蛋白载体（CRM(197)，TETRAMUNE，第1组）的Hib或（2）含同源载体（OMPC，第2组）的实验性Hib - 乙肝联合疫苗。第1组和第2组的所有婴儿在12月龄时接种PCV - OMPC（批次1）。另一组120名婴儿（第3组）在2、4和6月龄时同时接种不同批次的PCV - OMPC和Hib - CRM(197)（TETRAMUNE），然后在12月龄时随机接受PCV - OMPC或23价多糖（PS）肺炎球菌疫苗。
每批PCV - OMPC总体耐受性良好，未报告与疫苗相关的严重不良事件。在初次接种系列后，血清型特异性抗肺炎球菌几何平均浓度（GMC）在血清型14、19F和4中最高，在血清型6B和23F中最低。对于血清型6B、14、18C和23F，第3组（批次2）的GMC和血清转化率低于第1组（批次1）。与第1组相比，第2组对血清型6B、14和18C的抗体反应显著降低。在12月龄时接种一剂PCV - OMPC加强针后，每批疫苗均具有免疫原性，抗体水平至少增加5 - 10倍，且在接受PS疫苗的人群中反应显著更高。
PCV - OMPC在婴儿中总体安全，各血清型免疫反应存在差异，同时接种含同源载体的Hib疫苗可能会影响其免疫原性。
