Wijesinghe Pushpa Ranjan, Abeysinghe M R Nihal, Yoksan Sutee, Yao Yafu, Zhou Benli, Zhang Lei, Yaich Mansour, Neuzil Kathleen M, Victor John C
Epidemiological Unit, Ministry Of Healthcare and Nutrition, Colombo, Sri Lanka.
Mahidol University, Bangkok, Thailand.
Vaccine. 2014 Aug 20;32(37):4751-7. doi: 10.1016/j.vaccine.2014.06.036. Epub 2014 Jun 18.
To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine at 9 months of age. Serum immune responses were evaluated post-vaccination on days 28, 180, and 365 using JE neutralization test and anti-measles IgG ELISA.
278 infants received one dose of LJEV and measles vaccine. Of these, 257 were eligible for the per-protocol analysis. On Day 0, 14 infants (5.5%) were seropositive for JE, but none were seropositive for measles. At Day 28, seropositivity rates were 90.7% (95% CI, 86.4-93.9%) for JE and 84.8% (95% CI, 79.8-89.0%) for measles. The geometric mean titer for JE neutralizing antibodies was 111 (95% CI, 90-135), and the geometric mean concentration (GMC) for anti-measles IgG was 375 mI U/mL (95% CI, 351-400 mI U/mL). Over the next year, JE neutralizing antibody responses declined only slightly, with seropositivity at 87.4% (95% CI, 82.6-91.2%) at Day 365. In contrast, measles antibody levels continued to increase over time. Seropositivity for anti-measles IgG reached 97.2% (95% CI, 94.4-98.9%) at Day 365, and the GMC rose to 1202 mI U/mL (95% CI, 1077-1341 mI U/mL). Co-administration of LJEV and measles vaccine was also safe. Most adverse reactions were mild, and no serious adverse events were related to study vaccinations.
The safety and immunogenicity of LJEV co-administered with measles vaccine in Sri Lankan infants is similar to that seen in other populations, and our results support use of LJEV at 9 months of age. Live SA 14-14-2 vaccine is now prequalified by the WHO for use in infants in Asia, and other countries may wish to introduce LJEV to combat this devastating disease.
为推动减毒活SA 14-14-2日本脑炎疫苗（LJEV）纳入斯里兰卡国家免疫规划，我们评估了9月龄婴儿同时接种LJEV和麻疹疫苗的安全性和免疫原性。在接种疫苗后的第28天、180天和365天，采用日本脑炎中和试验和抗麻疹IgG ELISA评估血清免疫反应。
278名婴儿接种了一剂LJEV和麻疹疫苗。其中，257名符合符合方案分析的条件。在第0天，14名婴儿（5.5%）日本脑炎血清学呈阳性，但麻疹血清学均未呈阳性。在第28天，日本脑炎血清学阳性率为90.7%（95%CI，86.4-93.9%），麻疹血清学阳性率为84.8%（95%CI，79.8-89.0%）。日本脑炎中和抗体的几何平均滴度为111（95%CI，90-135），抗麻疹IgG的几何平均浓度（GMC）为375 mI U/mL（95%CI，351-400 mI U/mL）。在接下来的一年里，日本脑炎中和抗体反应仅略有下降，在第365天血清学阳性率为87.4%（95%CI，82.6-91.2%）。相比之下，麻疹抗体水平随时间持续升高。抗麻疹IgG的血清学阳性率在第365天达到97.2%（95%CI，94.4-98.9%），GMC升至1202 mI U/mL（95%CI，1077-1341 mI U/mL）。同时接种LJEV和麻疹疫苗也是安全的。大多数不良反应较轻，且没有严重不良事件与研究疫苗接种相关。
在斯里兰卡婴儿中，LJEV与麻疹疫苗同时接种的安全性和免疫原性与其他人群相似，我们的结果支持在9月龄时使用LJEV。减毒活SA 14-14-2疫苗现已获得世界卫生组织预认证，可用于亚洲婴儿，其他国家可能希望引入LJEV来对抗这种毁灭性疾病。
