Xiao Y H, Chang S Y, Bai S, Zhao R M, Wang J H, Wang X Q, Yang Y K, Ma Y L, Liu X Q, Luo L Y, Lyu M, Chen H P
China National Biotec Group Company Limited, Beijing 100024, China.
Shanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China.
Zhonghua Liu Xing Bing Xue Za Zhi. 2021 Jun 10;42(6):1086-1091. doi: 10.3760/cma.j.cn112338-20200409-00541.
To investigate the immunogenicity and safety of a boost dose of measles, mumps, and rubella combined vaccine (MMR) for children 4 to 6 years old. Children, aged 4 to 6 years old, had vaccinated with 1 dose of measles and rubella combined vaccine(MR) at the age of 8 months and 1 dose of MMR vaccine at 18-months, were recruited in Shanxi, Inner Mongolia, and Beijing, respectively. All children were assigned into 4, 5 and 6-year-old group. The children who met inclusion and exclusion criteria were vaccinated with 1 dose MMR vaccine, and were collected blood samples before vaccination and 35 to 42 d after the vaccination. During the study period, adverse events were collected at 30 min, 1 d, 2 d, 3 d, 4-12 d, and 13 to 42 days after vaccination. Serum was tested for IgG antibodies against measles, mumps and rubella. Geometric mean concentrations (GMC) of measles, mumps, and rubella antibodies were compared among groups by analysis of variance or non-parametric test. Seropositive rates and adverse event rates were compared among groups by Chi-square test or Fisher exact test. A total of 500 children were included in immunogenicity analysis and 535 children were included in safety analysis. The overall adverse event rate was 20.37%, the most of severity for adverse events was mild. The rates of local and systemic adverse events were 0.37% and 20.00%, respectively. Symptoms of local adverse events were redness. The main systemic adverse events were fever, followed by cough, rash and runny nose. Received a dose of MMR vaccine for booster immunization, the seropositive rates of measles antibody, mumps antibody and rubella antibody were above 99% for all 3 age groups, and there was no significant difference between groups. There were significant differences in mumps antibody GMC among groups (=0.042), but no significant differences in measles and rubella antibodies GMC. The immunogenicity and safety of a boosted MMR vaccintion in children aged 4, 5 and 6 years were all similar good.
探讨麻疹、腮腺炎和风疹联合疫苗（MMR）加强剂量对4至6岁儿童的免疫原性和安全性。分别在山西、内蒙古和北京招募4至6岁的儿童，这些儿童在8个月龄时接种过1剂麻疹风疹联合疫苗（MR），在18月龄时接种过1剂MMR疫苗。所有儿童被分为4岁、5岁和6岁组。符合纳入和排除标准的儿童接种1剂MMR疫苗，并在接种前和接种后35至42天采集血样。在研究期间，于接种后30分钟、1天、2天、3天、4至12天以及13至42天收集不良事件。检测血清中针对麻疹、腮腺炎和风疹的IgG抗体。通过方差分析或非参数检验比较各年龄组麻疹、腮腺炎和风疹抗体的几何平均浓度（GMC）。通过卡方检验或Fisher精确检验比较各年龄组的血清阳性率和不良事件发生率。共有500名儿童纳入免疫原性分析，535名儿童纳入安全性分析。总体不良事件发生率为20.37%，不良事件的严重程度大多为轻度。局部和全身不良事件的发生率分别为0.37%和20.00%。局部不良事件的症状为发红。主要的全身不良事件为发热，其次为咳嗽、皮疹和流鼻涕。接种1剂MMR疫苗进行加强免疫后，所有3个年龄组的麻疹抗体、腮腺炎抗体和风疹抗体血清阳性率均高于99%，各年龄组之间无显著差异。各年龄组之间腮腺炎抗体GMC存在显著差异（P = 0.042），但麻疹和风疹抗体GMC无显著差异。4、5和6岁儿童接种加强剂量MMR疫苗的免疫原性和安全性均良好。
