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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02955-2

摘要内容如下：

在此，我们进行了一项多中心、开放标签、随机的2期和3期研究，以评估重症急性呼吸综合征冠状病毒2（SARS-CoV-2）特异性（BA.1/B.1.1.529）、单价、热稳定、自我扩增mRNA疫苗GEMCOVAC-OM作为加强剂在接受两剂BBV152或CHADOX1 NCoV-19的健康成人中皮内给药时的安全性和免疫原性。GEMCOVAC-OM在第2阶段和第3阶段均耐受良好，无相关严重不良事件。在第2阶段，在140名参与者中比较了GEMCOVAC-OM与我们的原型mRNA疫苗GEMCOVAC-19（D614G变异特异性）的安全性和免疫原性。在接种后第29天，GEMCOVAC-OM（p<0.0001）和GEMCOVAC-19（p<0.0001）的抗刺突（BA.1）IgG抗体显著升高。然而，Gemcovac-OM的IgG滴度（主要终点）和血清转换较高（P<0.0001）。在第3阶段，在3，140名参与者（安全性队列）中，将GEMCOVAC-OM与CHADOX1 NCoV-19进行比较，其中包括420名参与者的免疫原性队列。在第29天，抗SARS-CoV-2的BA.1变体的中和抗体滴度在GEMCOVAC-OM组中显著高于基线（p<0.0001），但在CHADOX1 NCoV-19组中没有（p=0.1490）。GEMCOVAC-OM在中和抗体滴度和血清转换率方面（最小二乘几何均数比的下限95%置信区间>1，血清转换差异>0%）不劣于CHADOX1 NCoV-19（主要终点）且优于CHADOX1 NCoV-19。在第29天，Gemcovac-OM的抗尖峰IgG抗体和血清转换（次要终点）显著更高（p<0.0001）。这些结果表明，GEMCOVAC-OM是安全的，并能增强针对B.1.1.529变异体的免疫反应。印度临床试验注册标识符：CTRI/2022/10/046475。

英文原文如下：

Abstracts

Here we conducted a multicenter open-label, randomized phase 2 and 3 study to assess the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron-specific (BA.1/B.1.1.529), monovalent, thermostable, self-amplifying mRNA vaccine, GEMCOVAC-OM, when administered intradermally as a booster in healthy adults who had received two doses of BBV152 or ChAdOx1 nCoV-19. GEMCOVAC-OM was well tolerated with no related serious adverse events in both phase 2 and phase 3. In phase 2, the safety and immunogenicity of GEMCOVAC-OM was compared with our prototype mRNA vaccine GEMCOVAC-19 (D614G variant-specific) in 140 participants. At day 29 after vaccination, there was a significant rise in anti-spike (BA.1) IgG antibodies with GEMCOVAC-OM (P < 0.0001) and GEMCOVAC-19 (P < 0.0001). However, the IgG titers (primary endpoint) and seroconversion were higher with GEMCOVAC-OM (P < 0.0001). In phase 3, GEMCOVAC-OM was compared with ChAdOx1 nCoV-19 in 3,140 participants (safety cohort), which included an immunogenicity cohort of 420 participants. At day 29, neutralizing antibody titers against the BA.1 variant of SARS-CoV-2 were significantly higher than baseline in the GEMCOVAC-OM arm (P < 0.0001), but not in the ChAdOx1 nCoV-19 arm (P = 0.1490). GEMCOVAC-OM was noninferior (primary endpoint) and superior to ChAdOx1 nCoV-19 in terms of neutralizing antibody titers and seroconversion rate (lower bound 95% confidence interval of least square geometric mean ratio >1 and difference in seroconversion >0% for superiority). At day 29, anti-spike IgG antibodies and seroconversion (secondary endpoints) were significantly higher with GEMCOVAC-OM (P < 0.0001). These results demonstrate that GEMCOVAC-OM is safe and boosts immune responses against the B.1.1.529 variant. Clinical Trial Registry India identifier: CTRI/2022/10/046475 .

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