Safety of revaccination with pneumococcal polysaccharide vaccine

Safety of revaccination with pneumococcal polysaccharide vaccine
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DOI:
10.1001/jama.281.3.243
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发表时间:
1999-01-20
影响因子:
120.7
通讯作者:
Williams, WW
Williams, WW
中科院分区:
医学1区
文献类型:
--
作者:
Jackson, L;Benson, P;Williams, WW

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健康成人首次接种肺炎球菌多糖疫苗(PPV)后几年内再次接种与局部注射部位反应的频率和严重程度高于预期相关。根据目前的建议,老年人和慢性病患者在首次接种疫苗后5年或更长时间再次接种疫苗所带来的不良事件风险尚未得到很好的界定。目的确定首次接种后至少5年再次接种PPV是否与首次接种后更频繁或更严重的不良事件相关。设计于1996年4月至1997年8月进行比较干预研究。参与者年龄在50至74岁之间,从未接种过PPV疫苗(n= 901)或在入组前至少5年接种过一次疫苗(n=513)。干预措施PPV疫苗接种。主要观察指标:疫苗接种后局部注射部位反应和疫苗接种前型特异性抗体浓度。结果再次接种疫苗者比首次接种疫苗者更有可能在接种后2天内报告直径至少为10.2 cm (4 in)的局部注射部位反应:11% (55/513)vs 3%(29/901)(相对危险度[RR], 3.3; 95%可信区间[CI], 2.1-5.1)。这些反应在接种疫苗后平均3天消退。发生率最高的是在免疫能力强且无慢性疾病的再次接种疫苗的患者中:15%(33/228),而在首次接种疫苗的可比患者中为3% (10/337)(RR, 4.9; 95% CI, 2.4-9.7)。这些局部反应的风险与接种疫苗前的几何平均抗体浓度显著相关。结论医师和患者应注意,与首次接种相比,再次接种后发生自限性局部注射部位反应的频率更高;然而,这种风险并不代表推荐人群再次接种PPV的禁忌症。
Context Revaccination of healthy adults with pneumococcal polysaccharide vaccine (PPV) within several years of first vaccination has been associated with a higher than expected frequency and severity of local injection site reactions. The risk of adverse events associated with revaccination of elderly and chronically ill persons 5 or more years after first vaccination, as is currently recommended, has not been well defined.Objective To determine whether revaccination with PPV at least 5 years after first Vaccination is associated with more frequent or more serious adverse events than those following first vaccination.Design Comparative intervention study conducted between April 1996 and August 1997.Participants Persons aged 50 to 74 years either who had never been Vaccinated with PPV (n = 901) or who had been vaccinated once at least 5 years prior to enrollment (n=513).Intervention PPV vaccination.Main Outcome Measures Postvaccination local injection site reactions and prevaccination concentrations of type-specific antibodies.Results Those who were revaccinated were more likely than those who received their first vaccinations to report a local injection site reaction of at least 10.2 cm (4 in) in diameter within 2 days of vaccination: 11 % (55/513) vs 3% (29/901) (relative risk [RR], 3.3; 95% confidence interval [CI], 2.1-5.1). These reactions resolved by a median of 3 days following vaccination. The highest rate was among revaccinated patients who were immunocompetent and did not have chronic illness: 15% (33/228) compared with 3% (10/337) among comparable patients receiving their first vaccinations (RR, 4.9; 95% CI, 2.4-9.7), The risk of these local reactions was significantly correlated with prevaccination geometric mean antibody concentrations.Conclusions Physicians and patients should be aware that self-limited local injection site reactions occur more frequently following revaccination compared with first vaccination; however, this risk does not represent a contraindication to revaccination with PPV for recommended groups.