a Pfizer Vaccine Clinical Research and Development , Pfizer Pharma GmbH , Berlin , Germany.
b Triangle Medical Research Associates , Raleigh , NC , USA.
Hum Vaccin Immunother. 2019;15(3):575-583. doi: 10.1080/21645515.2018.1538618. Epub 2019 Jan 16.
Vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) followed ≥ 1 year by the 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for immunocompetent adults ≥ 65 years of age in the United States. This study assessed antipneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) to PCV13 in PPSV23-naive and PPSV23-preimmunized adults 1 year after a second vaccine dose. Two parent studies were conducted previously: (1) PPSV23 vaccine-naive subjects (60-64 years of age at enrollment) received PCV13 followed by PCV13 or PPSV23 1 year later or PPSV23 followed by PCV13 1 year later; and (2) subjects (≥ 70 years of age at enrollment) vaccinated with PPSV23 ≥ 5 years before study entry received PCV13 or PPSV23 followed by PCV13 1 year later. Overall, 962 subjects (PPSV23-naive, n = 519; PPSV23-preimmunized, n = 443) who received both vaccinations in the parent studies were enrolled. Numerically higher OPA GMTs persisted for at least 1 year after administration of PCV13 as the initial vaccine (PCV13/PPSV23 or PCV13/PCV13) compared with those who received PPSV23 either 1 or 5 years prior (PPSV23/PCV13). This impairment in antibody responses to subsequent PCV13 vaccination produced by initial PPSV23 vaccination persisted for at least 1 year. OPA GMTs were numerically higher for most serotypes 1 year after 2 doses of PCV13 compared with 1 year after the first PCV13 dose. These data suggest PCV13 should be given first if both vaccines are to be administered, higher immune responses were achieved when PCV13 was given first and persisted at least 1 year (ClinicalTrials.gov Identifier: NCT01025336).
在美国,建议免疫功能正常的 65 岁及以上成年人接种 13 价肺炎球菌结合疫苗(PCV13),并在 1 年后接种 23 价肺炎球菌多糖疫苗(PPSV23)。本研究评估了在接种第二剂疫苗 1 年后,PPSV23 初免和未初免的成年人对 PCV13 的肺炎球菌调理吞噬抗体效价(OPA GMT)。此前进行了两项主要研究:(1)PPSV23 疫苗初免组(入组时年龄为 60-64 岁)接种 PCV13 后 1 年接种 PCV13 或 PPSV23,或 1 年后接种 PPSV23;(2)入组时年龄≥70 岁且在研究入组前至少 5 年接种过 PPSV23 的受试者接种 PCV13 或 1 年后接种 PPSV23 后接种 PCV13。总体而言,共有 962 名受试者(PPSV23 初免组,n=519;PPSV23 预免组,n=443)参加了这两项研究。与 1 年前或 5 年前接种 PPSV23 的受试者相比,作为初始疫苗(PCV13/PPSV23 或 PCV13/PCV13)接种 PCV13 后至少 1 年内,OPA GMT 持续升高(PCV13/PCV13)。这种由初始 PPSV23 接种引起的对随后 PCV13 接种的抗体反应受损至少持续了 1 年。与初次接种 PCV13 1 年后相比,2 剂 PCV13 接种 1 年后大多数血清型的 OPA GMT 均较高。这些数据表明,如果要接种两种疫苗,应先接种 PCV13,先接种 PCV13 可获得更高的免疫应答,且至少持续 1 年(临床试验注册号:NCT01025336)。