目的 评价≥2岁健康人群接种23价肺炎球菌多糖疫苗(Pneumococcal polysaccharide vaccine,PPV23)的安全性和免疫原性.方法 采用开放性Ⅳ期临床试验,招募2-5岁、6-15岁、16-59岁和≥60岁健康受试者,观察1剂次PPV23接种后30 d内不良事件,分析发生率;检测接种前和接种后30 d血清标本23种肺炎链球菌(Strepiococcus pneumoniae,Spn)血清型IgG抗体,评价接种后抗体阳转率、几何平均浓度(Geometric mean concentration,GMC)和几何平均增长倍数(Geometric mean increase,GMI).结果 在2 997例受试者中,PPV23接种后与疫苗有关的不良事件发生率为10.84％(325例),其中1级、2级、3级、4级不良事件分别为9.94％、0.77％、0.13％、0.00％;接种部位疼痛、发热分别为4.50％、1.40％.在273例受试者中,PPV23接种后23种Spn血清型IgG抗体阳转率在92.83％-99.66％之间,GMC在2.00-63.34 μg/mL之间,GMI在6.82-171.24之间.结论 ≥2岁健康人群接种1剂次PPV23具有良好的安全性和免疫原性.
The safety and immunogenicity of one dose of 23-valent pneumococcal polysaccharide vaccine in a healthy population aged ≥ 2 years:a phase Ⅳ clinical trial
Objective To evaluate safety and immunogenicity of one dose of 23-valent pneumococcal polysaccharide vaccine(PPV23)in a healthy population aged ≥2 years.Methods We recruited healthy subjects aged 2-5,6-15,16-59,and ≥60 years into an open-label phase Ⅳ clinical trial and observed for adverse events 0-30 days after one dose of PPV23 vaccination to determine incidence of adverse events.We tested serum samples for IgG antibodies against each of 23 Streptococcus pneumoniae(Spn)serotypes before and 30 days after vaccination to determine seroconversion rates,geometric mean concentrations(GMC),and geometric mean increases(GMI).Results Among the 2 997 subjects who received one dose of PPV23,the overall incidence of vaccine-related adverse events was 10.84％(325 cases).Incidences for grade 1,2,3,and 4 adverse events were 9.94％,0.77％,0.13％,and 0.00％;and for injection-site pain and fever were 4.50％and 1.40％.Among 273 subjects,seroconversion rates,GMCs,and GMIs of IgG antibodies against 23 Spn serotypes after vaccination ranged from 92.83％to 99.66％,from 2.00 to 63.34 μg/mL,and from 6.82 to 171.24.Conclusions One dose of PPV23 showed good safety and immunogenicity profiles among healthy individuals ≥2 years of age.
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