■在成人随机对照社区获得性肺炎免疫试验(CAPITA)中,在≥65岁的成人中,13价肺炎球菌结合疫苗(PCV13)对首次发作的疫苗型社区获得性肺炎的有效率为46%.作为CAPiTA的一部分,研究了PCV13在未接种肺炎球菌疫苗的老年人中的长期免疫原性。
我们测定了1006名PCV13受者和1005名对照者在接种前和接种后1、12和24个月时对PCV13的免疫应答和3个年龄分层研究参与者队列。测定PCV13血清型特异性调理吞噬活性(OPA)滴度和免疫球蛋白G(IgG)浓度。
■在每个时间点样品收集完整性为至少93.4%。在所有三个年龄段中,在安慰剂组中,单剂量PCV13引起的所有13种血清型的OPA滴度和IgG浓度在所有时间点都显著高于基线和相应的缓解.在年龄最大的受试者(接种疫苗时年龄≥80岁)中,OPA滴度和IgG浓度保持在基线以上,并且在有自我报告的合并症的人和健康老年人之间,OPA滴度和IgG浓度没有明显差异。然而,该研究无法确定不同年龄和合并症组之间的统计学意义,因此,这些结果是探索性的。
■对于年龄≥65岁的有免疫能力的成年人,PCV13引起OPA滴度和IgG浓度显著增加,在所有13种血清型疫苗接种后2年持续存在,无论年龄和合并症。
■NCT00744263。
UNASSIGNED: In the randomized controlled Community-Acquired Pneumonia Immunization
Trial in Adults (CAPiTA), the efficacy of the 13-valent pneumococcal conjugate vaccine (PCV13) against first episodes of vaccine-type community-acquired pneumonia in adults aged ≥65 years was 46%. The long-term immunogenicity of PCV13 in pneumococcal vaccine-naive older adults was investigated as part of CAPiTA.
UNASSIGNED: We determined the immune responses to PCV13 before and at 1, 12, and 24 months after vaccination in 1006 PCV13 recipients and 1005 controls with 3 age-stratified
study participant cohorts. PCV13 serotype-specific opsonophagocytic activity (OPA) titers and immunoglobulin G (IgG) concentrations were determined.
UNASSIGNED: Sample collection completeness was at least 93.4% at each time point. In all 3 age categories, a single dose of PCV13 elicited
OPA titers and IgG concentrations for all 13 serotypes that were significantly higher than baseline and the corresponding responses in the placebo group at all time points. In the eldest subjects (≥80 years of age at vaccination),
OPA titers and IgG concentrations remained above baseline and there was no apparent difference in OPA titers and IgG concentrations between those with self-reported comorbidities and healthy older adults. However, the
study was not powered to determine statistical significance between different age and comorbidity groups, and thus these results are exploratory.
UNASSIGNED: In immunocompetent adults ≥65 years of age, PCV13 elicits significant increases in OPA titers and IgG concentrations that persist 2 years postvaccination for all 13 serotypes, regardless of age and comorbidity.
UNASSIGNED: NCT00744263.