Yonsei University Health System-Severance Hospital, Seoul, Korea.
Pediatr Infect Dis J. 2013 Mar;32(3):266-73. doi: 10.1097/INF.0b013e3182748bb6.
The immunogenicity and safety of 13-valent and 7-valent pneumococcal conjugate vaccines (PCV13 and PCV7) were compared when administered with routine vaccines in Korea.
Healthy infants (n = 180) were randomly assigned (1:1) to receive PCV13 or PCV7 at 2, 4, 6 (infant series) and 12 months (toddler dose). Immune responses 1 month after the infant series and toddler dose were measured by enzyme-linked immunosorbent assay and opsonophagocytic activity (OPA) assay. IgG antibody geometric mean concentrations and OPA functional antibody geometric mean titers were calculated. Safety was assessed.
After the infant series, for the 7 common serotypes, proportions of responders with IgG concentrations ≥0.35 µg/mL were comparable (≥97.6%) between groups; IgG geometric mean concentrations and OPA geometric mean titers were generally similar, but tended to be lower in the PCV13 group for some serotypes. For the 6 serotypes unique to PCV13, IgG geometric mean concentrations and OPA geometric mean titers were notably higher in the PCV13 group. Importantly, although PCV7 elicited IgG antibodies to PCV13 serotypes 5 and 19A, OPA responses were minimal, whereas serotype 6A elicited both IgG and OPA responses. These observations are consistent with at least some protection by PCV7 against 6A-mediated invasive pneumococcal disease, but no cross-protection for serotypes 5 and 19A. The toddler dose elicited higher IgG and OPA responses than postinfant series responses for most serotypes; however, for serotypes 3 and 14 only OPA responses were increased posttoddler dose. Vaccine safety profiles were similar.
PCV13 is safe and immunogenic in Korean children. PCV13 should provide broader protection than PCV7.
在韩国，将 13 价和 7 价肺炎球菌结合疫苗（PCV13 和 PCV7）与常规疫苗联合使用时，对其免疫原性和安全性进行了比较。
健康婴儿（n=180）按 1:1 随机分配接受 PCV13 或 PCV7，于 2、4、6 月龄（婴儿系列）和 12 月龄（幼儿剂量）接种。婴儿系列和幼儿剂量接种后 1 个月，通过酶联免疫吸附试验和调理吞噬活性（OPA）试验检测免疫应答。计算 IgG 抗体几何平均浓度和 OPA 功能抗体几何平均滴度。评估安全性。
婴儿系列接种后，7 种常见血清型中，各血清型 IgG 浓度≥0.35μg/mL 的应答者比例在各组间相当（≥97.6%）；IgG 几何平均浓度和 OPA 几何平均滴度通常相似，但某些血清型 PCV13 组较低。PCV13 特有的 6 种血清型中，PCV13 组 IgG 几何平均浓度和 OPA 几何平均滴度明显较高。重要的是，虽然 PCV7 诱导针对 PCV13 血清型 5 和 19A 的 IgG 抗体，但 OPA 反应很小，而血清型 6A 则同时诱导 IgG 和 OPA 反应。这些观察结果表明，PCV7 至少对 6A 介导的侵袭性肺炎球菌病有一定的保护作用，但对血清型 5 和 19A 无交叉保护作用。幼儿剂量接种后，大多数血清型的 IgG 和 OPA 反应均高于婴儿系列接种后，而仅在血清型 3 和 14 中仅 OPA 反应增加。疫苗安全性特征相似。
PCV13 在韩国儿童中安全且具有免疫原性。PCV13 应提供比 PCV7 更广泛的保护。
