关键词: immunogenicity mRNA vaccines pharmacovigilance reactogenicity real-world data

来  源:   DOI:10.3390/vaccines12060665   PDF(Pubmed)

Abstract:
Enhancing our comprehension of mRNA vaccines may facilitate the future design of novel vaccines aimed at augmenting immune protection while minimising reactogenic responses. Before this design is carried out, it is important to determine whether adaptive immunity correlates with the reactogenicity profile of vaccines. We studied a large cohort that was vaccinated with mRNA vaccines to answer this question. This was an observational study with real-world data. Reactogenicity data were obtained from the VigilVacCOVID study. Immunogenicity (humoral and cellular) data were retrieved from health records. One main population (n = 215) and two subpopulations were defined (subpopulation 1, n = 3563; subpopulation 2, n = 597). Sensitivity analyses were performed with subpopulations 1 and 2 to explore the consistency of results. We analysed the association of the intensity and types of adverse reactions with the development and quantity of elicited antibody titres. As an exploratory analysis in subpopulation 1, we assessed the association between reactogenicity and cellular immunogenicity. A higher incidence of fever, malaise, and myalgia including severe cases was significantly associated with the development and quantity of positive antibody titres. No significant findings were observed with cellular immunity. We observed a positive association between immunogenicity and reactogenicity. These findings can be relevant for the future development of our understanding of how mRNA vaccines function.
摘要:
增强我们对mRNA疫苗的理解可能有助于将来设计新型疫苗,旨在增强免疫保护,同时最大程度地减少反应原反应。在进行此设计之前,确定适应性免疫是否与疫苗的反应原性相关是很重要的.我们研究了一个用mRNA疫苗接种的大型队列来回答这个问题。这是一项针对真实世界数据的观察性研究。反应性数据来自VigilVacCOVID研究。从健康记录中检索免疫原性(体液和细胞)数据。定义了一个主要种群(n=215)和两个亚群(亚群1,n=3563;亚群2,n=597)。对亚群1和2进行敏感性分析,以探索结果的一致性。我们分析了不良反应的强度和类型与引发的抗体滴度的发展和数量之间的关系。作为亚群1的探索性分析,我们评估了反应原性与细胞免疫原性之间的关联。发烧的发病率较高,萎靡不振,包括严重病例在内的肌痛与抗体滴度阳性的发展和数量显着相关。细胞免疫没有观察到显著的发现。我们观察到免疫原性和反应原性之间的正相关。这些发现可能与我们对mRNA疫苗功能的理解的未来发展有关。
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