Kwak Byung Ok, Ma Sang Hyuk, Park Su Eun, Shin Seon Hee, Choi Kyung Min, Lee Taek-Jin, Eun Byung Wook, Hong Young Jin, Kim Dong Hyun
Department of Pediatrics, Hallym University Kangnam Sacred Heart Hospital, Seoul 07441, Korea.
Department of Pediatrics, Changwon Fatima Hospital, Changwon 51394, Korea.
Vaccines (Basel). 2020 Apr 26;8(2):200. doi: 10.3390/vaccines8020200.
The enhanced inactivated poliovirus vaccine was first introduced in 2002, and several inactivated poliovirus vaccines are licensed in Korea. Reliable data by a prospective study on the immunogenicity and safety of the inactivated poliovirus vaccines in Korean infants are required. Normal healthy infants aged 6-12 weeks received three doses of the vaccine (IPVAX™, Imovax Polio™ or Poliorix™) in intervals of 2 months. Neutralizing antibody (NTAb) titers were measured before and 4-6 weeks after three-dose primary vaccination. Immunogenicity was evaluated by seroconversion rates and geometric mean titers obtained by analyzing NTAb titers. Local and systemic adverse events were recorded during 7 days after each vaccination. A total of 150 infants were included: 40 in IPVAX™, 52 in Imovax Polio™, and 58 in Poliorix™. The seroconversion rates for the group vaccinated with IPVAX™ were 100% in types 1, 2 and 3, while those of Imovax Polio™ were 98.1%, 96.2%, 96.2% and those of Poliorix™ were 98.3%, 100%, 100%, respectively. In all groups, injection site redness and irritability were the most common local and systemic adverse events. Neither serious adverse events nor adverse events above grade 2 were reported throughout the study. The currently used inactivated poliovirus vaccines was demonstrated to be safe and immunogenic in healthy Korean infants.
强化灭活脊髓灰质炎疫苗于2002年首次引入,韩国有几种灭活脊髓灰质炎疫苗获得许可。需要通过前瞻性研究获得关于韩国婴儿中灭活脊髓灰质炎疫苗免疫原性和安全性的可靠数据。6至12周龄的正常健康婴儿每隔2个月接种三剂疫苗(IPVAX™、Imovax Polio™或Poliorix™)。在三剂基础疫苗接种前和接种后4至6周测量中和抗体(NTAb)滴度。通过分析NTAb滴度获得的血清转化率和几何平均滴度评估免疫原性。每次接种后7天记录局部和全身不良事件。共纳入150名婴儿:40名接种IPVAX™,52名接种Imovax Polio™,58名接种Poliorix™。接种IPVAX™组1型、2型和3型的血清转化率均为100%,而接种Imovax Polio™组的血清转化率分别为98.1%、96.2%、96.2%,接种Poliorix™组的血清转化率分别为98.3%、100%、100%。在所有组中,注射部位发红和易激惹是最常见的局部和全身不良事件。在整个研究过程中,未报告严重不良事件或2级以上不良事件。目前使用的灭活脊髓灰质炎疫苗在健康的韩国婴儿中被证明是安全且具有免疫原性的。