Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial.
Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial.
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DOI：
10.1093/infdis/jiw024
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发表时间：
2016-06-01
期刊：
影响因子：
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通讯作者：
Neuzil KM
中科院分区：
文献类型：
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作者：
Zaman K;Fleming JA;Victor JC;Yunus M;Bari TI;Azim T;Rahman M;Mowla SM;Bellini WJ;McNeal M;Icenogle JP;Lopman B;Parashar U;Cortese MM;Steele AD;Neuzil KM
背景。在发展中国家，5岁以下儿童中轮状病毒发病率和死亡率的负担很高，评估表明第二年轮状病毒免疫保护作用减弱。额外一剂轮状病毒疫苗可增强免疫反应并延长疾病保护期，但同时接种这一剂量不应干扰对同时接种疫苗的免疫反应。方法。来自孟加拉国Matlab的480名9个月大的参与者被纳入一项研究，其主要目的是确定与单独接种MR相比，同时接种麻疹-风疹疫苗（MR）和第三剂人轮状病毒疫苗（HRV; MR + HRV）的非劣效性。次要目标包括风疹抗体血清转化的非劣效性和评估MR + HRV受体中轮状病毒IgA/IgG血清反应。结果。接种2个月后，MR + HRV和MR接种者的血清麻疹病毒抗体水平分别为75.3%和74.3%；抗风疹病毒免疫球蛋白G （IgG）血清保护率分别为100.0%和99.6%。MR + HRV组抗轮状病毒免疫球蛋白A和IgG血清阳性率接种前分别为52.7%和66.3%，接种后分别为69.6%和88.3%。结论。疫苗诱导的麻疹和风疹抗体反应不受同时施用HRV的负面影响。HRV剂量增加抗轮状病毒血清抗体滴度和可检测到抗轮状病毒抗体的婴儿比例。临床试验注册，NCT01700621。
Background. The burden of rotavirus morbidity and mortality is high in children aged <5 years in developing countries, and evaluations indicate waning protection from rotavirus immunization in the second year. An additional dose of rotavirus vaccine may enhance the immune response and lengthen the period of protection against disease, but coadministration of this dose should not interfere with immune responses to concurrently given vaccines. Methods. A total of 480 9-month-old participants from Matlab, Bangladesh, were enrolled in a study with a primary objective to establish noninferiority of concomitant administration of measles-rubella vaccine (MR) and a third dose of human rotavirus vaccine (HRV; MR + HRV), compared with MR given alone. Secondary objectives included noninferiority of rubella antibody seroconversion and evaluating rotavirus IgA/IgG seroresponses in MR + HRV recipients. Results. Two months after vaccination, 75.3% and 74.3% of MR + HRV and MR recipients, respectively, had seroprotective levels of measles virus antibodies; 100.0% and 99.6%, respectively, showed anti–rubella virus immunoglobulin G (IgG) seroprotection. In the MR + HRV group, antirotavirus immunoglobulin A and IgG seropositivity frequencies before vaccination (52.7% and 66.3%, respectively) increased to 69.6% and 88.3% after vaccination. Conclusions. Vaccine-induced measles and rubella antibody responses are not negatively affected by concomitant administration of HRV. The HRV dose increases antirotavirus serum antibody titers and the proportion of infants with detectable antirotavirus antibody. Clinical Trials Registration. NCT01700621.