Kawakami Kenji, Kishino Hiroyuki, Kanazu Shinichi, Toshimizu Nobuhito, Takahashi Kenichi, Sterling Tina, Wang Meihua, Musey Luwy
Department of Respiratory Medicine, National Hospital Organization Nagasaki Kawatana Medical Center, Kawatana, Nagasaki, Japan.
Japan Development, MSD K.K., Tokyo, Japan.
Vaccine. 2016 Jul 19;34(33):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10.
Following primary vaccination of adults ⩾65years of age with 23-valent pneumococcal polysaccharide vaccine (PPSV23), immune responses increase and thereafter appear to decrease over time. With increased life expectancy worldwide, revaccination with PPSV23 may be required for continued protection of the elderly population against pneumococcal disease. The present study evaluated the immunogenicity and safety of revaccination with PPSV23 in the Japanese elderly.
Depending on prior history of PPSV23 vaccination, adults aged ⩾70years were given a first dose (primary group; N=81) or second dose (revaccination group; N=161, at least 5years after first dose) of PPSV23 intramuscularly. Subjects were matched for gender, age, and number and type of comorbidity across both groups. Blood samples were collected before and 4weeks postvaccination to measure serotype-specific immunoglobulin G (IgG) concentrations and opsonophagocytic killing activity (OPA) antibody titers to serotypes included in the vaccine. Injection-site and systemic adverse events (AEs) were collected for 14days postvaccination.
Baseline serotype-specific IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) were generally higher in subjects with a prior history of PPSV23 vaccination than in PPSV23-naïve subjects. The levels of IgG GMCs and OPA GMTs after revaccination were generally comparable to those observed after primary vaccination. Incidences of systemic AEs were comparable between the 2 groups. Although incidences of injection-site AEs were higher following revaccination than primary vaccination, the difference was not clinically significant as most AEs were mild to moderate in intensity and resolved within 5days after revaccination without treatment.
Revaccination with PPSV23 was well tolerated and associated with increases in serotype-specific IgG concentrations and OPA titers in the elderly who received a prior PPSV23 dose at least 5years before. Revaccination with PPSV23 can be safely implemented in the elderly for continued prevention against pneumococcal disease.
NCT02260882.
65岁及以上成年人接种23价肺炎球菌多糖疫苗(PPSV23)进行初次免疫后,免疫反应增强,随后似乎会随时间下降。随着全球预期寿命的增加,可能需要再次接种PPSV23,以持续保护老年人群免受肺炎球菌疾病的侵害。本研究评估了日本老年人再次接种PPSV23的免疫原性和安全性。
根据PPSV23疫苗接种史,对70岁及以上成年人肌肉注射PPSV23第一剂(初次接种组;N = 81)或第二剂(再次接种组;N = 161,在第一剂接种至少5年后)。两组在性别、年龄、合并症数量和类型方面进行匹配。在接种前和接种后4周采集血样,以测量血清型特异性免疫球蛋白G(IgG)浓度以及针对疫苗中所含血清型的调理吞噬杀伤活性(OPA)抗体滴度。在接种后14天收集注射部位和全身不良事件(AE)。
PPSV23疫苗接种史阳性的受试者,其基线血清型特异性IgG几何平均浓度(GMC)和OPA几何平均滴度(GMT)通常高于未接种过PPSV23的受试者。再次接种后的IgG GMC水平和OPA GMT水平通常与初次接种后观察到的水平相当。两组全身AE的发生率相当。虽然再次接种后注射部位AE的发生率高于初次接种,但差异无临床意义,因为大多数AE的严重程度为轻度至中度,且在再次接种后5天内未经治疗即消退。
对于至少5年前接受过PPSV23剂量接种的老年人,再次接种PPSV23耐受性良好,且与血清型特异性IgG浓度和OPA滴度升高相关。再次接种PPSV23可在老年人中安全实施,以持续预防肺炎球菌疾病。
NCT02260882。