Lim Sang-Min, Jung Hahn-Sun, Kim Min Ja, Park Dae-Won, Kim Woo-Joo, Cheong Hee-Jin, Park Seung-Chul, Lee Kwang-Chul, Shin Young-Kyoo, Tan Hyun Kwang, Kim Sang-Lin, Sohn Jang Wook
Central Research Institute, Boryung Pharm. Co. Ltd., Ansan 425-120, Korea.
J Microbiol Biotechnol. 2007 Apr;17(4):611-5.
The purpose of this study was to evaluate the immunogenicity and safety of Salmonella Typhi Vi capsular polysaccharide vaccine (Vi vaccine) in Korea. The immunogenicity of a single dose of Vi vaccine was evaluated in 157 subjects (75 children and 82 adults) before and at 1, 6, and 12 months after vaccination. Immunogenicity was measured with a passive hemagglutination assay (PHA), quantified as geometric mean titers (GMTs) and seroconversion rates. The safety of the vaccine was investigated by determining adverse reactions occurring within 4 h, 3 days, and 1 month after injection. The seroconversion rate for children and adults 1 month after vaccination was 96.92% and 89.02%, respectively. In the case of children, the GMTs of Vi antibodies before vaccination were 5.87 +/- 1.34 and 142.59 +/- 2.39 at one month after vaccination. For adults, the GMTs before and one month after vaccination were 5.58 +/- 1.28 and 58.56 +/- 3.67, respectively. Vi antibodies persisted for as long as 6 and 12 months after vaccination. All adverse reactions in adults and children were minor and did not require treatment. The Vi CPS vaccine was safe and immunogenic in adults and children older than 5 years.
本研究的目的是评估伤寒Vi多糖疫苗(Vi疫苗)在韩国的免疫原性和安全性。对157名受试者(75名儿童和82名成人)在接种疫苗前以及接种后1个月、6个月和12个月评估单剂量Vi疫苗的免疫原性。采用被动血凝试验(PHA)测量免疫原性,以几何平均滴度(GMT)和血清转化率进行量化。通过确定注射后4小时、3天和1个月内发生的不良反应来研究疫苗的安全性。接种疫苗1个月后儿童和成人的血清转化率分别为96.92%和89.02%。对于儿童,接种疫苗前Vi抗体的GMT为5.87±1.34,接种后1个月为142.59±2.39。对于成人,接种疫苗前和接种后1个月的GMT分别为5.58±1.28和58.56±3.67。接种疫苗后Vi抗体持续长达6个月和12个月。成人和儿童的所有不良反应均较轻微,无需治疗。Vi CPS疫苗在成人和5岁以上儿童中安全且具有免疫原性。