Chotpitayasunondh Tawee, Sohn Young Mo, Yoksan Sutee, Min J, Ohrr Heechoul
Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.
J Med Assoc Thai. 2011 Aug;94 Suppl 3:S195-203.
The authors aimed to evaluate the safety and immunogenicity of a live attenuated SA14-14-2 Japanese Encephalitis (JE) vaccine in healthy Thai infants. One hundred and fifty subjects aged 9-15 months were vaccinated with one dose of this vaccine. Regarding the vaccine safety, during the 28-day post-vaccination follow-up, no vaccine-related serious adverse events were reported. In terms of immunogenicity, the sero-conversion rate of a single dose vaccination was 95% (95% CI, 90.0-97.6%) within 90 days after vaccination and the geometric mean titer (GMT) was 66.1. Eight subjects with JE seronegative on days 28-35 post-vaccination became sero-positive on day 90. Seven subjects who remained sero-negative during days 28-35 and day 90 post-vaccination were successfully sero-converted after receiving a second dose 3 months later. Thus, two doses of this JE vaccine resulted in a 100% (95% CI, 97.3-100%) sero-conversion rate with the GMT of 260.8. Eight children with GMTs lower than protective level after a single vaccination demonstrated a booster response with GMT of 1237 after the second dose of JE vaccination. In conclusion, the live attenuated SA14-14-2 vaccine was safe, well tolerated and highly immunogenic with 95% and 100% sero-conversion rate after one and two doses, respectively. Nevertheless, its long-term immune response and possible influences from natural dengue infection requires further evaluation.
作者旨在评估一种减毒活SA14-14-2日本脑炎(JE)疫苗在泰国健康婴儿中的安全性和免疫原性。150名年龄在9至15个月的受试者接种了一剂这种疫苗。关于疫苗安全性,在接种疫苗后的28天随访期间,未报告与疫苗相关的严重不良事件。在免疫原性方面,单剂量接种后的血清转化率在接种后90天内为95%(95%置信区间,90.0 - 97.6%),几何平均滴度(GMT)为66.1。8名在接种后第28至35天JE血清学阴性的受试者在第90天转为血清学阳性。7名在接种后第28至35天以及第90天仍为血清学阴性的受试者在3个月后接受第二剂接种后成功实现血清转化。因此,两剂这种JE疫苗导致血清转化率达到100%(95%置信区间,97.3 - 100%),GMT为260.8。8名单次接种后GMT低于保护水平的儿童在第二剂JE疫苗接种后表现出增强反应,GMT为1237。总之,减毒活SA14-14-2疫苗安全、耐受性良好且免疫原性高,单剂和两剂接种后的血清转化率分别为95%和100%。然而,其长期免疫反应以及自然登革热感染可能产生的影响需要进一步评估。