Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL 35294, USA.
Clin Infect Dis. 2012 Sep;55(5):e35-44. doi: 10.1093/cid/cis513. Epub 2012 May 31.
Although the 23-valent pneumococcal polysaccharide vaccine (PPSV23) protects against invasive disease in young healthy persons, randomized controlled trials in chronic obstructive pulmonary disease (COPD) have demonstrated no benefit in the intention-to-treat population. We previously reported that the 7-valent diphtheria-conjugated pneumococcal polysaccharide vaccine (PCV7) is safe and induced greater serotype-specific immunoglobulin G (IgG) and functional antibody than did PPSV23 1 month after vaccination. We hypothesized that these advantages would persist at 1 and 2 years.
One hundred eighty-one patients with moderate to severe COPD were randomized to receive PPSV23 (n = 90) or PCV7 (1.0 mL; n = 91). We measured IgG by enzyme-linked immunosorbent assay and assessed functional antibody activity by a standardized opsonophagocytosis assay, reported as a killing index (OPK). We determined differences in IgG and OPK between vaccine groups at 1 and 2 years.
Relative to PPSV23, PCV7 induced greater OPK at both 1 and 2 years for 6 of 7 serotypes (not 19F). This response was statistically greater for 5 of 7 serotypes at 1 year and 4 of 7 at 2 years. Comparable differences in IgG were observed but were less often statistically significant. Despite meeting Centers for Disease Control and Prevention criteria for PPSV23 administration, almost 50% of individuals had never been vaccinated. No differences in the frequency of acute exacerbations, pneumonia, or hospitalization were observed.
PCV7 induces a greater functional antibody response than PPSV23 in patients with COPD that persists for 2 years after vaccination. This superior functional response supports testing of conjugate vaccination in studies examining clinical end points.
NCT00457977.
虽然 23 价肺炎球菌多糖疫苗（PPSV23）可预防年轻健康人群发生侵袭性疾病，但在慢性阻塞性肺疾病（COPD）患者中进行的随机对照试验表明，在意向治疗人群中并无获益。我们先前报道称，7 价白喉类毒素结合肺炎球菌多糖疫苗（PCV7）在接种后 1 个月时比 PPSV23 更安全，并诱导产生更高的血清型特异性免疫球蛋白 G（IgG）和功能性抗体。我们假设这些优势在接种后 1 年和 2 年时仍将持续存在。
181 例中至重度 COPD 患者被随机分为接受 PPSV23（n = 90）或 PCV7（1.0 mL；n = 91）治疗。我们通过酶联免疫吸附测定法测量 IgG，并通过标准化调理吞噬作用测定法评估功能性抗体活性，结果以杀伤指数（OPK）表示。我们在接种后 1 年和 2 年时比较了两组之间 IgG 和 OPK 的差异。
与 PPSV23 相比，PCV7 在 1 年和 2 年均诱导了 7 个血清型中的 6 个（而非 19F）的更大 OPK。在 1 年时，5 个血清型和 2 年时 4 个血清型的反应均具有统计学意义。观察到 IgG 方面的相似差异，但通常不具有统计学意义。尽管符合接种 PPSV23 的疾病控制与预防中心标准，但近 50%的患者从未接种过疫苗。未观察到急性加重、肺炎或住院的频率存在差异。
在 COPD 患者中，PCV7 诱导的功能性抗体反应强于 PPSV23，且在接种后 2 年内仍持续存在。这种更优的功能反应支持在研究临床终点的试验中测试结合疫苗接种。
NCT00457977。
