Safety and immunogenicity of SpiN-Tec, a T-cell based RBD-Nucleocapsid chimeric vaccine for COVID-19

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-09-19 DOI:10.1016/j.vaccine.2025.127756

Gregório Guilherme Almeida , Jorge Andrade Pinto , Patrícia Machado Pinto , Ludmila Bezerra da Silva , Luis Adan Flores Andrade , Bruno Vinícius Santos Valiate , Nathália Zini , Flávia Fonseca Bagno , Graziella Gomes Rivelli , Karine Lima Lourenço , Jéssica Pauline Coelho Souza , Isabela Pereira Gomes , Natália Salazar de Castro , Ana Luiza Chaves Maia , Alex Fiorini de Carvalho , Júlio Castro Alves , Júlia Teixeira de Castro , Guangzhao Li , Gabriel da Rocha Fernandes , Pedro Augusto Alves , Helton da Costa Santiago

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引用次数: 0

Abstract

The SpiN-Tec MCTI UFMG is a chimeric recombinant protein (SpiN) containing the RBD region from the Spike protein (S) fused with the Nucleocapsid protein (N), adjuvanted with a squalene-based emulsion (CTVad1), which was developed as booster COVID-19 vaccine. This is a phase I clinical trial to evaluate safety and reactogenicity. Thirty-six healthy adults aged 18–54, previously vaccinated with two doses of CoronaVac™ (Sinovac) and a booster with the Comirnaty™ Bivalent BA.4/BA.5 (Pfizer-BioNTech), were randomized to receive either SpiN-Tec (20 μg, 60 μg, or 100 μg) or CoviShield™(AstraZeneca). SpiN-Tec was safe and showed a reactogenic profile comparable to CoviShield. Immunogenicity results showed a dose-dependent increase in IgG levels against N and SpiN, peaking at day 28 post-vaccination and declining by day 180. Neutralizing antibody levels against both the Wuhan ancestral and BA1.88 strains showed similar curves presenting no differences between SpiN-Tec and CoviShield. Importantly, SpiN-Tec induced robust IFN-γ production up to 270 days, particularly by CD4⁺ effector memory T cells, indicating a durable immune response memory. These results indicate the potential of SpiN-Tec as a viable COVID-19 booster vaccine.

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基于t细胞的rbd -核衣壳嵌合疫苗SpiN-Tec的安全性和免疫原性

SpiN- tec MCTI UFMG是一种嵌合重组蛋白（SpiN），内含刺突蛋白(S)与核衣壳蛋白(N)融合的RBD区域，以角鲨烯基乳剂（CTVad1）为佐剂，被开发为COVID-19加强疫苗。这是一项评估安全性和反应原性的I期临床试验。36名年龄在18-54岁的健康成年人，先前接种了两剂CoronaVac™（Sinovac）和一剂Comirnaty™双价BA.4/BA.5增强剂SpiN-Tec （20 μg、60 μg或100 μg）或CoviShield™（AstraZeneca）。SpiN-Tec是安全的，并显示出与covisshield相当的反应性。免疫原性结果显示，抗N和自旋IgG水平呈剂量依赖性升高，在接种后第28天达到峰值，到第180天下降。对武汉祖株和BA1.88株的中和抗体水平曲线相似，SpiN-Tec和CoviShield之间无差异。重要的是，SpiN-Tec诱导了长达270天的强大的IFN-γ产生，特别是CD4+效应记忆T细胞，表明持久的免疫反应记忆。这些结果表明SpiN-Tec作为一种可行的COVID-19加强疫苗的潜力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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