Velocity Clinical Research, Omaha, NE, USA.
CenExel RCA, Hollywood, FL, USA.
Hum Vaccin Immunother. 2024 Dec 31;20(1):2408863. doi: 10.1080/21645515.2024.2408863. Epub 2024 Oct 18.
This phase 1, open-label, dose-escalation, multi-center study (NCT05477186) assessed the safety and immunogenicity of a booster dose of an mRNA COVID-19 vaccine (CV0501) encoding the SARS-CoV-2 Omicron BA.1 spike protein. Participants aged ≥ 18 years previously vaccinated with ≥ 2 doses of an mRNA COVID-19 vaccine received CV0501 doses ranging from 12 to 200 μg. After assessment of safety and immunogenicity of the 12 μg dose in 30 adults, 30 adults ≤ 64 years were randomized to receive either a 3 or 6 μg dose. Solicited adverse events (AEs) were collected for 7 days, unsolicited AEs for 28 days, and serious AEs (SAEs), medically attended AEs (MAAEs), and AEs of special interest (AESIs) until day (D) 181 post-vaccination. Serum neutralizing titers specific to SARS-CoV-2 BA.1, wild-type, Delta, and additional Omicron subvariants were assessed at D1, D15, D29, D91, and D181. Of 180 vaccinated participants (mean age: 49.3 years; 57.8% women), 70.6% had prior SARS-CoV-2 infection. Most solicited local (98.1%) and systemic (96.7%) AEs were of mild-to-moderate severity; the most common were injection site pain (57.5%; 33.3-73.3% across groups) and myalgia (36.9%; 13.3-56.7%). Unsolicited AEs were reported by 14.4% (6.7-26.7%) of participants (mild-to-moderate severity in 88.5% of the participants). Three participants (1.7%) reported SAEs, 16.7% (6.7-30.0%) reported MAAEs, and 8.3% (0.0-13.3%) reported AESIs (15 COVID-19 cases), none related to vaccination. Geometric means of serum neutralizing titers increased from baseline to D15 and D29 (dose-dependent), and then decreased over time. The safety and immunogenicity results supported advancement to a phase 2 trial.
本研究为一项 1 期、开放标签、剂量递增、多中心研究（NCT05477186），评估了编码 SARS-CoV-2 Omicron BA.1 刺突蛋白的 mRNA COVID-19 疫苗（CV0501）加强针的安全性和免疫原性。先前接种过≥2 剂 mRNA COVID-19 疫苗的年龄≥18 岁的参与者接受了 12 至 200μg 的 CV0501 剂量。在 30 名成年人中评估了 12μg 剂量的安全性和免疫原性后，30 名≤64 岁的成年人被随机分为接受 3μg 或 6μg 剂量组。在 7 天内收集了有针对性的不良事件（AE），在 28 天内收集了无针对性的 AE，在接种后第 181 天（D）之前收集了严重 AE（SAE）、需要医疗处理的 AE（MAAE）和特别关注的 AE（AESI）。在 D1、D15、D29、D91 和 D181 时，评估了针对 SARS-CoV-2 BA.1、野生型、Delta 和其他 Omicron 亚变体的血清中和滴度。在 180 名接种疫苗的参与者（平均年龄：49.3 岁；57.8%为女性）中，70.6%有既往 SARS-CoV-2 感染史。大多数有针对性的局部（98.1%）和全身（96.7%）AE 为轻至中度严重程度；最常见的是注射部位疼痛（57.5%；各组 33.3-73.3%）和肌痛（36.9%；13.3-56.7%）。14.4%（6.7-26.7%）的参与者报告了无针对性的 AE（88.5%的参与者为轻至中度严重程度）。3 名参与者（1.7%）报告了 SAE，16.7%（6.7-30.0%）报告了 MAAE，8.3%（0.0-13.3%）报告了 AESI（15 例 COVID-19 病例），均与疫苗接种无关。血清中和滴度的几何平均值从基线到 D15 和 D29 增加（剂量依赖性），然后随时间下降。安全性和免疫原性结果支持推进到 2 期试验。
