Huebner Robin E, Mbelle Nontombi, Forrest Bruce, Madore Dace V, Klugman Keith P
MRS/NHLS/Wits Pneumococcal Diseases Research Unit, Johannesburg, South Africa.
Pediatr Infect Dis J. 2002 Nov;21(11):1004-7. doi: 10.1097/00006454-200211000-00006.
Children <6 months of age are at increased risk of pneumococcal disease. The early immunogenicity of conjugate vaccines therefore may be important to prevent disease in young children.
To determine the immunogenicity of a nonavalent pneumococcal conjugate vaccine after one dose, two doses and three doses and its impact on the antibody response to coadministered antigens.
A total of 500 infants from Soweto were immunized at 6, 10 and 14 weeks of age with either placebo (n = 250) or 9-valent pneumococcal conjugate vaccine (n = 250) containing serotypes 1, 4, 5, 6B, 9V, 14, 18C, 19F and 23F conjugated to CRM(197) mutant diphtheria protein. Blood was taken for determination of serotype-specific IgG before the first dose and 1 month after each dose.
Before the first dose at 6 weeks of age >80% of infants had >0.15 microg/ml antibody to six of the nine antigens, >70% to serotypes 18C and 23F and >50% to serotype 4. Geometric mean concentrations (GMCs) after one dose ranged from 0.27 microg/ml for serotype 23F to 2.98 microg/ml for serotype 1; >90% of infants had serotype-specific antibody >0.15 microg/ml except for serotypes 23F (70%) and 6B (80%). After two doses GMCs ranged from 1.14 microg/ml for serotype 23F to 5.68 microg/ml for serotype 1; >95% of infants had serotype-specific antibody >0.15 microg/ml and >75% had >0.5 microg/ml for all nine serotypes. GMCs after three doses ranged from 2.73 microg/ml for serotype 23F to 6.18 microg/ml for serotype 5; >98% of infants had serotype-specific antibody >0.15 microg/ml and >92% had >0.5 microg/ml for all nine serotypes. Antibody concentrations after three doses were significantly higher to Haemophilus influenzae type b-polyribosylribitol phosphate vaccine in children who received pneumococcal conjugate vaccine, but they had lower antibodies to pertussis toxin than controls.
A single dose of this pneumococcal conjugate vaccine produces a potentially protective antibody response to most serotypes in the majority of children in this population.
6个月以下儿童患肺炎球菌疾病的风险增加。因此，结合疫苗的早期免疫原性对于预防幼儿疾病可能很重要。
确定一剂、两剂和三剂九价肺炎球菌结合疫苗的免疫原性及其对同时接种抗原的抗体反应的影响。
总共500名来自索韦托的婴儿在6、10和14周龄时分别接种安慰剂（n = 250）或九价肺炎球菌结合疫苗（n = 250），该疫苗包含与CRM(197)突变白喉蛋白结合的1、4、5、6B、9V、14、18C、19F和23F血清型。在第一剂之前以及每剂之后1个月采集血液，用于测定血清型特异性IgG。
在6周龄第一剂之前，超过80%的婴儿对九种抗原中的六种具有>0.15μg/ml的抗体，对18C和23F血清型的抗体>70%，对4血清型的抗体>50%。一剂后的几何平均浓度（GMC）范围从23F血清型的0.27μg/ml到1血清型的2.98μg/ml；除了23F血清型（70%）和6B血清型（80%）外，超过90%的婴儿具有>0.15μg/ml的血清型特异性抗体。两剂后GMC范围从23F血清型的1.14μg/ml到1血清型的5.68μg/ml；超过95%的婴儿具有>0.15μg/ml的血清型特异性抗体，并且对于所有九种血清型，超过75%的婴儿具有>0.5μg/ml的抗体。三剂后的GMC范围从23F血清型的2.73μg/ml到5血清型的6.18μg/ml；超过98%的婴儿具有>0.15μg/ml的血清型特异性抗体，并且对于所有九种血清型，超过92%的婴儿具有>0.5μg/ml的抗体。接种肺炎球菌结合疫苗的儿童对b型流感嗜血杆菌-多聚核糖磷酸疫苗三剂后的抗体浓度显著更高，但他们对百日咳毒素的抗体低于对照组。
单剂量的这种肺炎球菌结合疫苗对该人群中的大多数儿童的大多数血清型产生了潜在的保护性抗体反应。
