Background OVX836 is a recombinant protein vaccine targeting the highly conserved influenza nucleoprotein (NP), which could confer broad-spectrum protection against this disease. Methods A randomized, placebo-controlled, double-blind, dose-escalating, single- center, first-in-human study was conducted in 36 healthy adults aged 18–49 years. Twelve subjects per cohort (9 vaccine and 3 placebo) received 2 OVX836 intramuscular administrations on days 1 and 28 at the dose level of 30 µg, 90 µg, or 180 µg. Safety and immunogenicity were assessed after each vaccination and for 150 days in total. Results OVX836 was safe and well tolerated at all dose levels, with no difference in solicited local and systemic symptoms, and unsolicited adverse events between the first and second administration, or between dose levels. All subjects presented pre-existing NP-specific immunity at baseline. OVX836 induced a significant increase in NP-specific interferon-gamma T cells and anti-NP immunoglobulin G at all dose levels after the first vaccination. The second vaccination did not further increase the response. There was a trend for a dose effect in the immune response. Conclusions The safety and reactogenicity profile, as well as the humoral and cellular immune responses, encourage further evaluation of OVX836 in a larger Phase 2a study.

中文翻译：

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评估 OVX836（一种基于核蛋白的流感疫苗）的 1 期随机、安慰剂对照、剂量递增研究：肌肉注射结果

背景 OVX836 是一种针对高度保守的流感核蛋白 (NP) 的重组蛋白疫苗，可提供针对这种疾病的广谱保护。方法 在 36 名 18-49 岁的健康成年人中进行了一项随机、安慰剂对照、双盲、剂量递增、单中心、首次人体研究。每组 12 名受试者（9 名疫苗和 3 名安慰剂）在第 1 天和第 28 天接受 2 次 OVX836 肌肉注射，剂量水平为 30 µg、90 µg 或 180 µg。每次接种疫苗后评估安全性和免疫原性，总共评估 150 天。结果 OVX836 在所有剂量水平下都是安全且耐受性良好的，在第一次和第二次给药之间或剂量水平之间的请求的局部和全身症状以及非请求的不良事件没有差异。所有受试者在基线时都表现出预先存在的 NP 特异性免疫。在第一次接种疫苗后，OVX836 在所有剂量水平上均诱导 NP 特异性干扰素-γ T 细胞和抗 NP 免疫球蛋白 G 显着增加。第二次接种并没有进一步增加反应。在免疫反应中存在剂量效应的趋势。结论 安全性和反应原性特征，以及体液和细胞免疫反应，鼓励在更大的 2a 期研究中进一步评估 OVX836。