| 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].Chinese journal of Epidemiology,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 |
| Received:May 26, 2022 |
| DOI：10.3760/cma.j.cn112338-20220526-00467 |
| KeyWord: b型流感嗜血杆菌 疫苗 免疫持久性 |
| English Key Word: Haemophilus influenzae type b Vaccine Immunity persistence |
| FundProject: |
| Author Name | Affiliation | E-mail | | Wei Mingwei | Vaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China | | | Li Jingxin | Vaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China | | | Chu Kai | Vaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China | | | Zhu Jiahong | Program Office, Lianshui County Center for Disease Control and Prevention, Huai'an 223499, China | | | Zhu Fengcai | Vaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China | jszfc@vip.sina.com |
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| Abstract: |
| 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。 |
| English Abstract: |
| 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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