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60-64 岁未曾接种过肺炎球菌疫苗的成年人中序贯接种 13 价肺炎球菌结合疫苗和 23 价肺炎球菌多糖疫苗。

Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age.

机构信息

University of Kentucky School of Medicine, Department of Medicine, Room MN-663, 800 Rose Street, Lexington, KY 40536-0084, United States.

Pfizer Vaccines Research, Pfizer Inc., 401 N Middletown Road, Pearl River, NY 10965, United States.

出版信息

Vaccine. 2014 Apr 25;32(20):2364-74. doi: 10.1016/j.vaccine.2014.02.002. Epub 2014 Mar 5.

Abstract

BACKGROUND

Unlike free pneumococcal polysaccharide vaccines (PPSVs), pneumococcal conjugate vaccines (PCVs) induce a T-cell-dependent immune response. The study assessed potential influence of initial 13-valent PCV (PCV13) or 23-valent PPSV (PPSV23) on subsequent vaccine administrations.

METHODS

We conducted a randomized, modified double-blind study in 720 pneumococcal vaccine-naïve adults 60-64 years of age. Subjects received either PCV13 at year 0 and PCV13 at year 1; PCV13 at year 0 and PPSV23 at year 1; or PPSV23 at year 0 and PCV13 at year 1. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and 1 month after each vaccination.

RESULTS

OPA titers following PPSV23 given 1 year after PCV13 (PCV13/PPSV23) (a) were noninferior for the 12 common serotypes and significantly higher for 6 of 12 common serotypes than those following only an initial PPSV23; and (b) were significantly higher for 11 of 12 common serotypes compared with PPSV23 followed by PCV13 (PPSV23/PCV13). In addition, PPSV23 followed 1 year later by PCV13 (PPSV23/PCV13) elicited significantly lower OPA titers than after only an initial dose of PCV13 for all 13 serotypes. Responses after a second vaccination with either PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for 9 of 13 and 8 of 12 common serotypes compared with the initial PCV13 dose.

CONCLUSION

In pneumococcal vaccine-naïve adults 60-64 years of age, an initial PCV13 augmented the antipneumococcal response to subsequent administration of PPSV23 for many of the serotypes in common to both vaccines. In contrast, an initial PPSV23 resulted in a diminished response to subsequent administration of PCV13 for all serotypes. With a relatively short 1-year interval between doses, responses after a second vaccination with PCV13 (PCV13/PCV13) or PPSV23 (PCV13/PPSV23) were noninferior for a majority of serotypes compared with the initial PCV13 dose, probably reflecting the need for a longer interval between vaccine administrations. ClinicalTrials.gov Identifier: NCT00574548.

摘要

背景

与非结合型肺炎球菌多糖疫苗(PPSV)不同,肺炎球菌结合疫苗(PCV)可诱导 T 细胞依赖性免疫应答。本研究评估了初始 13 价 PCV(PCV13)或 23 价 PPSV(PPSV23)接种对后续疫苗接种的潜在影响。

方法

我们在 720 名 60-64 岁的肺炎球菌疫苗初免成年人中进行了一项随机、改良的双盲研究。受试者在第 0 年接受 PCV13,在第 1 年接受 PCV13;在第 0 年接受 PCV13,在第 1 年接受 PPSV23;或在第 0 年接受 PPSV23,在第 1 年接受 PCV13。在每次接种前和接种后 1 个月测量抗肺炎球菌调理吞噬活性(OPA)效价。

结果

PCV13 接种 1 年后接种 PPSV23(PCV13/PPSV23)(a)对于 12 种常见血清型的 OPA 效价非劣效于仅接种初始 PPSV23,且对于 12 种常见血清型中的 6 种 OPA 效价显著高于仅接种初始 PPSV23;且(b)对于 12 种常见血清型中的 11 种 OPA 效价显著高于 PPSV23 后接种 PCV13(PPSV23/PCV13)。此外,在 PPSV23 接种 1 年后再接种 PCV13(PPSV23/PCV13),对于所有 13 种血清型的 OPA 效价均显著低于仅接种初始剂量的 PCV13。对于 9 种和 8 种常见血清型中的 13 种和 12 种常见血清型,接种第 2 剂 PCV13(PCV13/PCV13)或 PPSV23(PCV13/PPSV23)后的反应均非劣效于初始 PCV13 剂量。

结论

在 60-64 岁的肺炎球菌疫苗初免成年人中,PCV13 初始接种增强了对后续接种 PPSV23 的肺炎球菌反应,对于两种疫苗中许多共同的血清型都是如此。相比之下,初始接种 PPSV23 导致对所有血清型的后续接种 PCV13 的反应减弱。由于两剂疫苗的间隔时间相对较短(1 年),接种第 2 剂 PCV13(PCV13/PCV13)或 PPSV23(PCV13/PPSV23)后的反应在大多数血清型中与初始 PCV13 剂量相比非劣效,可能反映出需要更长的疫苗接种间隔时间。临床试验.gov 标识符:NCT00574548。

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