Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, Yunnan 650118, China.
Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong 510440, China.
Vaccine. 2022 Aug 5;40(33):4709-4715. doi: 10.1016/j.vaccine.2022.06.027. Epub 2022 Jun 24.
To evaluate the immunogenicity and safety of simultaneous administration of the enterovirus 71 (EV71) vaccine with the measles and rubella (MR) combined vaccine.
In this phase 4, randomized, open-label and noninferiority study, a total of 680 infants aged 8 months were enrolled and assigned to the simultaneous administration group (infants received the first dose of EV71 vaccine and MR vaccine on Day 0, and the second dose of EV71 vaccine on Day 28), or the separate administration groups (EV71 group: infants received two doses of EV71 vaccine on Day 0 and Day 28, respectively; MR group: infants received MR vaccine on Day 0). Blood sample was obtained on Day 0 and Day 56 to measure antibody responses to each of the antigens in terms of antibody titer or concentration, respectively. Local and systemic adverse reactions (ARs) and other adverse events (AEs) following each dose were monitored and compared among groups.
After vaccination, simultaneous administration group showed similar seroconversion rates of antibody against EV71(97.9%), measles (97.4%), and rubella (94.3%) compared to EV71 group (99.6% for anti-EV71) or MR group (98.4% for anti-measles and 98.9% for anti-rubella, respectively). Noninferiority was demonstrated for all antibodies as the lower limits of two-sided 97.5% confidence intervals (CIs) of the difference in seroconversion rates between simultaneous administration group and separate administration groups were above the predefined margin of -10%. Additionally, the adverse reaction rates were comparable among groups (54.4% in the simultaneous group versus 43.9% in the MR group versus 52.6% in the EV71 group).
Antibody responses induced by simultaneous administration of EV71 vaccine with MR vaccine were robust and noninferior to those by single administration alone. Like the previous findings by single administration alone, simultaneous administration demonstrated comparable reactogenicity and safety profiles.
评估肠道病毒 71 型（EV71）疫苗与麻疹风疹（MR）联合疫苗同时接种的免疫原性和安全性。
在这项 4 期、随机、开放标签、非劣效性研究中，共纳入 680 名 8 月龄婴儿，分为同时接种组（婴儿于第 0 天接种首剂 EV71 疫苗和 MR 疫苗，第 28 天接种第 2 剂 EV71 疫苗）或单独接种组（EV71 组：婴儿分别于第 0 天和第 28 天接种 2 剂 EV71 疫苗；MR 组：婴儿于第 0 天接种 MR 疫苗）。于第 0 天和第 56 天采集血样，分别以抗体滴度或浓度来衡量每种抗原的抗体反应。监测并比较各组中每次接种后的局部和全身不良反应（AR）和其他不良事件（AE）。
接种后，同时接种组 EV71（97.9%）、麻疹（97.4%）和风疹（94.3%）抗体的血清转化率与 EV71 组（抗-EV71 为 99.6%）或 MR 组（抗麻疹为 98.4%，抗风疹为 98.9%）相似。所有抗体均显示非劣效性，同时接种组和单独接种组之间血清转化率差异的双侧 97.5%置信区间（CI）下限均高于预设的-10%边界。此外，各组的不良反应发生率相当（同时接种组为 54.4%，MR 组为 43.9%，EV71 组为 52.6%）。
EV71 疫苗与 MR 疫苗同时接种诱导的抗体反应强劲，且不劣于单独单次接种。与单独单次接种的先前发现一样，同时接种显示出相似的反应原性和安全性特征。
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