Johnson County Clin-Trials, Department of Clinical Safety & Risk Management, Lenexa, Kansas.
Optimal Research, LLC, Peoria, Illinois.
J Infect Dis. 2024 Sep 23;230(3):e668-e678. doi: 10.1093/infdis/jiae114.
This phase 1 trial evaluated the safety, reactogenicity, and immunogenicity of mRNA-1647, a messenger RNA (mRNA)-based cytomegalovirus (CMV) vaccine, in CMV-seronegative and -seropositive adults.
Participants were randomly assigned to receive 30, 90, 180, or 300 µg of mRNA-1647 or placebo on a 0-, 2-, and 6-month schedule and followed for 12 months after the last dose.
A total of 154 (80 CMV-seronegative and 74 CMV-seropositive) participants were enrolled; 118 participants were randomized to mRNA-1647 and 36 to placebo. Mean (standard deviation) age was 32.5 (8.6) and 35.1 (8.9) years in the placebo and mRNA-1647 groups, respectively, in phase B (63% and 64% female) and 42.5 (6.2) and 33.3 (8.7) years, respectively, in phase C (2% and 16% female). No deaths, related serious adverse events, or adverse events of special interest were reported. Most adverse reactions were grade ≤2 severity. Increased neutralizing antibody, binding antibody, and antigen-specific cell-mediated responses were observed across mRNA-1647 treatment groups, regardless of CMV serostatus.
This phase 1, first-in-human trial demonstrated that mRNA-1647 has an acceptable safety profile in adults and elicits humoral and cellular immune responses. Clinical Trials Registration. NCT03382405.
这项 1 期临床试验评估了信使 RNA（mRNA）型巨细胞病毒（CMV）疫苗 mRNA-1647 在 CMV 阴性和阳性成人中的安全性、反应原性和免疫原性。
参与者按 0、2 和 6 个月的时间表随机分配接受 30、90、180 或 300μg 的 mRNA-1647 或安慰剂，并在最后一次给药后随访 12 个月。
共纳入 154 名（80 名 CMV 阴性和 74 名 CMV 阳性）参与者；118 名参与者被随机分配至 mRNA-1647 组，36 名参与者被分配至安慰剂组。在 B 期（63%和 64%为女性）中，安慰剂组和 mRNA-1647 组的参与者平均（标准差）年龄分别为 32.5（8.6）和 35.1（8.9）岁，在 C 期（2%和 16%为女性）中分别为 42.5（6.2）和 33.3（8.7）岁。没有死亡、相关严重不良事件或不良事件。大多数不良反应为 1 级或 2 级严重程度。无论 CMV 血清状态如何，mRNA-1647 治疗组均观察到中和抗体、结合抗体和抗原特异性细胞介导的反应增加。
这项 1 期首次人体试验表明，mRNA-1647 在成人中具有可接受的安全性，并能引发体液和细胞免疫反应。临床试验注册。NCT03382405。
