魏明伟,李靖欣,储凯,朱加宏,朱凤才.b型流感嗜血杆菌结合疫苗接种后5年的免疫持久性观察[J].中华流行病学杂志,2022,43(11):1768-1772 |
b型流感嗜血杆菌结合疫苗接种后5年的免疫持久性观察 |
Five-year immunity persistence following immunization with haemophilus influenzae type b conjugate vaccine |
收稿日期:2022-05-26 出版日期:2022-11-22 |
DOI:10.3760/cma.j.cn112338-20220526-00467 |
中文关键词: b型流感嗜血杆菌 疫苗 免疫持久性 |
英文关键词: Haemophilus influenzae type b Vaccine Immunity persistence |
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中文摘要: |
目的 评价国产b型流感嗜血杆菌(Hib)结合疫苗在我国3月龄至5岁健康婴幼儿接种后5年的免疫持久性。方法 选择江苏省涟水县Ⅲ期临床试验(试验疫苗组)中完成全程免疫接种者作为研究对象,2019年11-12月开展接种后5年的采血工作,并采用ELISA法检测血清抗b型流感嗜血杆菌-荚膜多糖(Hib-PRP)抗体,计算血清抗Hib-PRP抗体长期保护率和短期保护率、几何平均浓度(GMC)和几何平均浓度增长倍数(GMFI)。结果 共纳入研究对象580例,其中3~5月龄组、6~11月龄组以及1~5岁组分别有158、207和215例,各年龄组接种后5年的血清抗PRP抗体的短期保护率(≥0.15 μg/ml)和长期保护率(≥1.0 μg/ml)均分别为89.24%、90.34%和98.60%,GMC分别为3.95、3.11和10.01 μg/ml,GMFI分别为29.04、11.01和3.26。结论 在3月龄至5岁的婴幼儿中Hib结合疫苗接种后5年仍具有良好的免疫持久性。 |
英文摘要: |
Objective To evaluate the immunity persistence five years later after immunization with Haemophilus influenzae type b (Hib) conjugate vaccine in healthy infants/children aged 3 months to 5 years in China. Methods The children were subjects who completed the whole-schedule immunization in the phase Ⅲ clinical trial in Lianshui county of Jiangsu povince was selected for the collection of blood samples at 5 years after vaccination from November to December, 2019. The enzyme-linked immunosorbent assay (ELISA) was used to detect Hib polyribosyl-ribitol-phosphate antibody (anti-Hib-PRP), and the long-term/short-term protection rate, geometric mean concentration (GMC) and geometric mean concentration increase fold (GMFI) of serum anti-Hib-PRP were calculated. Results A total of 580 children were enrolled in this study, of which 158, 207 and 215 belonged to 3-5 month age group, 6-11 month age group and 1-5 year age group, respectively. The short-term (≥ 0.15 μg/ml)/long-term (≥ 1.0 μg/ml) protection rates of serum anti-PRP in the three groups after immunization were 89.24%, 90.34% and 98.60%, respectively; the GMC were 3.95 μg/ml, 3.11 μg/ml and 10.01 μg/ml respectively, and the GMFI were 29.04, 11.01 and 3.26 respectively. Conclusions Hib conjugate vaccine can still have good immunogenicity after 5 years of primary immunization in healthy infants/children aged 3 months to 5 years in China. |
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