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一项评估伤寒Vi疫苗和23价肺炎球菌多糖疫苗在健康成年人中免疫反应的随机、三盲、安慰剂对照临床试验:PREP研究。

A randomized, triple-blinded, placebo-controlled clinical trial evaluating immune responses of Typhim Vi and PPSV23 vaccines in healthy adults: The PREP study.

作者信息

Wang Chunxue, Damiano Robert J, Ruebush Laura E, Engelen Mariёlle P K J, Mariani Sara, Liu Luoluo, Silva Ikaro, Borhani Soheil, Cote Gerard L, Conroy Bryan, McFarlane Daniel, Deutz Nicolaas E P

机构信息

Philips North America, Cambridge, MA, USA.

Philips North America, Cambridge, MA, USA.

出版信息

Vaccine. 2024 Dec 2;42(26):126292. doi: 10.1016/j.vaccine.2024.126292. Epub 2024 Sep 7.

Abstract

Rapid and early identification of emergent infections is essential for delivering prompt clinical care. To advance the development of algorithms for the clinical management of infection identification, we performed a vaccination clinical trial to investigate the potential of using vaccination as a model for studying mild inflammation responses associated with different infections (NCT05346302). We collected data at various time points over 4 weeks from blood samples, wearable devices, and questionnaires. Following a 2-week baseline period, 210 healthy participants, aged 18-40 years, were administered either a Pneumococcal Polysaccharide vaccine (PPSV23), Typhoid Vi Polysaccharide vaccine (Typhim Vi), or placebo. In longitudinal analyses of blood biomarkers, we found that CRP was significantly higher at 2 days post-vaccination, whereas basophils, IL-10, IL-12p40, and MIG were significantly higher at 7 days post-vaccination in the PPSV23 group compared to both other groups (all p < 0.05). MIP-1β was significantly lower in the PPSV23 group than in the placebo group, while monocytes and MPV were significantly lower in the Typhim Vi group than in the placebo group at 7 days post-vaccination (all p < 0.05). The PPSV3 group showed a higher inflammatory profile, suggesting that PPSV23 induces a stronger immune response compared to Typhim Vi. The distinct immune responses induced by the two vaccines indicate the potential for utilizing vaccines as models for studying inflammation responses associated with different infectious pathogens.

摘要

快速且早期识别新发感染对于提供及时的临床护理至关重要。为推动感染识别临床管理算法的发展,我们开展了一项疫苗临床试验,以研究将疫苗接种作为研究与不同感染相关的轻度炎症反应模型的潜力(NCT05346302)。我们在4周内的不同时间点从血液样本、可穿戴设备和问卷中收集数据。在为期2周的基线期后,210名年龄在18至40岁之间的健康参与者分别接种了肺炎球菌多糖疫苗(PPSV23)、伤寒Vi多糖疫苗(Typhim Vi)或安慰剂。在血液生物标志物的纵向分析中,我们发现接种疫苗后2天,PPSV23组的CRP显著升高,而与其他两组相比,PPSV23组接种疫苗后7天嗜碱性粒细胞、IL-10、IL-12p40和MIG显著升高(所有p<0.05)。接种疫苗后7天,PPSV23组的MIP-1β显著低于安慰剂组,而Typhim Vi组的单核细胞和MPV显著低于安慰剂组(所有p<0.05)。PPSV3组显示出更高的炎症特征,表明与Typhim Vi相比,PPSV23诱导更强的免疫反应。两种疫苗诱导的不同免疫反应表明,利用疫苗作为研究与不同感染病原体相关的炎症反应模型具有潜力。

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