Abstract：
We conducted a phase I, randomized, double-blind, placebo-controlled trial including healthy adults in Sui County, Henan Province, China. Ninety-six adults were randomly assigned to one of three groups (high-dose, medium-dose, and low-dose) at a 3:1 ratio to receive one vaccine dose or placebo. Adverse events up to 28 days after each dose and serious adverse events up to 6 months after all doses were reported. Geometric mean titers and seroconversion rates were measured for anti-rotavirus neutralizing antibodies using microneutralization tests. The rates of total adverse events in the placebo group, low-dose group, medium-dose group, and high-dose group were 29.17 % (12.62 %-51.09 %), 12.50 % (2.66 %-32.36 %), 50.00 % (29.12 %-70.88 %), and 41.67 % (22.11 %-63.36 %), respectively, with no significant difference in the experimental groups compared with the placebo group. The results of the neutralizing antibody assay showed that in the adult group, the neutralizing antibody geometric mean titer at 28 days after full immunization in the low-dose group was 583.01 (95 % confidence interval [CI]: 447.12-760.20), that in the medium-dose group was 899.34 (95 % CI: 601.73-1344.14), and that in the high-dose group was 1055.24 (95 % CI: 876.28-1270.75). The GMT of serum-specific IgG at 28 days after full immunization in the low-dose group was 3444.26 (95 % CI: 2292.35-5175.02), that in the medium-dose group was 6888.55 (95 % CI: 4426.67-10719.6), and that in the high-dose group was 7511.99 (95 % CI: 3988.27-14149.0). The GMT of serum-specific IgA at 28 days after full immunization in the low-dose group was 2332.14 (95 % CI: 1538.82-3534.45), that in the medium-dose group was 4800.98 (95 % CI: 2986.64-7717.50), and that in the high-dose group was 3204.30 (95 % CI: 2175.66-4719.27). In terms of safety, adverse events were mainly Grades 1 and 2, indicating that the safety of the vaccine is within the acceptable range in the healthy adult population. Considering the GMT and positive transfer rate of neutralizing antibodies for the main immunogenicity endpoints in the experimental groups, it was initially observed that the high-dose group had higher levels of neutralizing antibodies than the medium- and low-dose groups in adults aged 18-49 years. This novel inactivated rotavirus vaccine was generally well-tolerated in adults, and the vaccine was immunogenic in adults (ClinicalTrials.gov number, NCT04626856).
摘要：
我们进行了第一阶段，随机化，双盲,安慰剂对照试验，包括隋县的健康成年人，河南省,中国。96名成年人被随机分配到三组中的一组(高剂量，中等剂量,和低剂量）以3：1的比例接受一次疫苗剂量或安慰剂。报告每个剂量后28天的不良事件和所有剂量后6个月的严重不良事件。使用微中性测试测量抗轮状病毒中和抗体的几何平均滴度和血清转化率。安慰剂组的总不良事件发生率，低剂量组,中剂量组,高剂量组为29.17%(12.62%-51.09%),12.50%（2.66%-32.36%），50.00%（29.12%-70.88%），和41.67%（22.11%-63.36%），分别,实验组与安慰剂组相比无显着差异。中和抗体测定结果表明，在成虫组中，低剂量组完全免疫后28天的中和抗体几何平均滴度为583.01（95％置信区间[CI]：447.12-760.20），中剂量组为899.34（95％CI：601.73-1344.14），高剂量组为1055.24（95％CI：876.28-1270.75）。低剂量组完全免疫后28天血清特异性IgG的GMT为3444.26（95％CI：2292.35-5175.02），中剂量组为6888.55（95％CI：4426.67-10719.6），高剂量组为7511.99(95%CI:3988.27-14149.0)。低剂量组完全免疫后28天血清特异性IgA的GMT为2332.14（95％CI：1538.82-3534.45），中剂量组为4800.98（95％CI：2986.64-7717.50），高剂量组为3204.30(95%CI:2175.66-4719.27)。在安全方面,不良事件主要为1级和2级,表明该疫苗在健康成人人群中的安全性在可接受范围内.考虑到实验组主要免疫原性终点的GMT和中和抗体的阳性转移率，最初观察到,在18~49岁的成年人中,高剂量组的中和抗体水平高于中剂量组和低剂量组.这种新型的灭活轮状病毒疫苗在成人中通常具有良好的耐受性，并且该疫苗在成人中具有免疫原性(ClinicalTrials.gov编号，NCT04626856)。
