Li Xiao-mei, Zhang Zhu-jia-zi, Wang Hai-hong, Liu Fang, Zhang Li-wen, Chu Ping, Xu Ying, Zhang He-run, Li Juan, Liu Dong-lei, Lu Li
Department of Immunization,Beijing Centre for Disease Control and Prevention,Beijing 100013, China.
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Zhonghua Yu Fang Yi Xue Za Zhi. 2013 Oct;47(10):905-9.
To evaluate the immunogenicity and safety of a boost dose of inactivated polio vaccine (IPV) among children aged 18 months who had been administered with primary doses of IPV.
Form 2011 to 2012, a total of 97 children were enrolled in the present study who were vaccinated with IPV at 2, 3, 4 months of age and boosted with the same vaccine at 18 months of age. Anti-poliovirus neutralizing antibody titers in serum were measured before and after booster vaccination, geometric mean titers (GMT) and seroprotection rate were calculated. Adverse events occurring within 30 days after booster vaccination were observed, including pain, redness/swelling and induration at the injection site, fever, vomit, abnormal crying, drowsiness, loss of appetite, irritability, and all other physical discomfort and related medications were also recorded. A descriptive analysis was performed for the safety assessment.
Immunogenicity was assessed in 84 subjects. The pre-booster seropositivity rates of neutralizing antibody against poliovirus type 1, 2, 3 before booster were all 100% (84/84) and the corresponding GMT (95% CI) was 1: 148.5 (116.49-189.29) , 1: 237.68 (178.39-316.67) and 1: 231.87 (181.27-296.58) , respectively. The seropositivity rates of neutralizing antibody against the three types of poliovirus after booster were all 100% (84/84) and the corresponding GMT (95% CI) was 1: 1612.14 (1470.57-1767.34) , 1: 1854.92 (1715.83-2005.29) and 1: 1625.50 (1452.12-1819.58) , respectively. The pre-booster titer of neutralizing antibody against poliovirus type 1, 2, 3 mainly ranged 1: 128-1: 512, which accounted for 65% (55/84) , 55% (46/84) , 74% (62/84) in each type. After the booster immunization, titers of neutralizing antibody against type 1, 2, 3 were increased as subjects with titer ≥ 1: 1024 accounted for 94% (78/84) , 95% (80/84) , 92% (77/84) , respectively.Safety was evaluated in 96 subjects, of which 16 subjects reported adverse events with the rate of 17%. The observed local events were mainly tenderness 3% (3/96) , redness/swelling and induration were not reported. The systemic adverse events included loss of appetite (8%, 8/96) , irritability (8%, 8/96) , fever (7%, 7/96) , abnormal crying (6%, 6/96) , drowsiness (6%, 6/96) and vomit (1%, 1/96) . All reported adverse events were mild or moderate. All of the local events occurred in the day of vaccination and lasted for 1-2 days, while systemic events almost developed within 2 days after vaccination and last less than 3 days.
IPV booster dose has good immunogenicity and safety profile, which provides effective protection against poliovirus.
评估在已接种过基础剂量灭活脊髓灰质炎疫苗（IPV）的18月龄儿童中给予一剂IPV加强针后的免疫原性和安全性。
2011年至2012年，本研究共纳入97名儿童，这些儿童在2、3、4月龄时接种了IPV，并在18月龄时接种了同一疫苗的加强针。在加强免疫前后测量血清中的抗脊髓灰质炎病毒中和抗体滴度，计算几何平均滴度（GMT）和血清保护率。观察加强免疫后30天内发生的不良事件，包括注射部位的疼痛、发红/肿胀和硬结、发热、呕吐、异常哭闹、嗜睡、食欲不振、易激惹，所有其他身体不适及相关用药情况也予以记录。对安全性评估进行描述性分析。
对84名受试者进行了免疫原性评估。加强免疫前，针对脊髓灰质炎病毒1型、2型、3型的中和抗体血清阳性率均为100%（84/84），相应的GMT（95%CI）分别为1:148.5（116.49 - 189.29）、1:237.68（178.39 - 316.67）和1:231.87（181.27 - 296.58）。加强免疫后，针对三种脊髓灰质炎病毒的中和抗体血清阳性率均为100%（84/84），相应的GMT（95%CI）分别为1:1612.14（1470.57 - 1767.34）、1:1854.92（1715.83 - 2005.29）和1:1625.50（1452.12 - 1819.58）。加强免疫前，针对脊髓灰质炎病毒1型、2型、3型的中和抗体滴度主要在1:128 - 1:512之间，各型分别占65%（55/84）、55%（46/84）、74%（62/84）。加强免疫后，针对1型、2型、3型的中和抗体滴度升高，滴度≥1:1024的受试者分别占94%（78/84）、95%（80/84）、92%（77/84）。对96名受试者进行了安全性评估，其中16名受试者报告了不良事件，发生率为17%。观察到的局部事件主要为压痛3%（3/96），未报告发红/肿胀和硬结。全身不良事件包括食欲不振（8%，8/96）、易激惹（8%，8/96）、发热（7%，7/96）、异常哭闹（6%，6/96）、嗜睡（6%，6/96）和呕吐（见1%，1/96）。所有报告的不良事件均为轻度或中度。所有局部事件均发生在接种当天，持续1 - 2天，而全身事件几乎在接种后2天内出现，持续时间少于3天。
IPV加强针具有良好的免疫原性和安全性，能提供有效的脊髓灰质炎病毒防护。
