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Enhanced immunity against SARS-CoV-2 in returning Chinese individuals. 提高归国华侨对 SARS-CoV-2 的免疫力。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-01-08 DOI: 10.1080/21645515.2023.2300208
Runyu Yuan, Huimin Chen, Lina Yi, Xinxin Li, Ximing Hu, Xing Li, Huan Zhang, Pingping Zhou, Chumin Liang, Huifang Lin, Lilian Zeng, Xue Zhuang, QianQian Ruan, Yueling Chen, Yingyin Deng, Zhe Liu, Jing Lu, Jianpeng Xiao, Liang Chen, Xincai Xiao, Jing Li, Baisheng Li, Yan Li, Jianfeng He, Jiufeng Sun

Global COVID-19 vaccination programs effectively contained the fast spread of SARS-CoV-2. Characterizing the immunity status of returned populations will favor understanding the achievement of herd immunity and long-term management of COVID-19 in China. Individuals were recruited from 7 quarantine stations in Guangzhou, China. Blood and throat swab specimens were collected from participants, and their immunity status was determined through competitive ELISA, microneutralization assay and enzyme-linked FluoroSpot assay. A total of 272 subjects were involved in the questionnaire survey, of whom 235 (86.4%) were returning Chinese individuals and 37 (13.6%) were foreigners. Blood and throat swab specimens were collected from 108 returning Chinese individuals. Neutralizing antibodies against SARS-CoV-2 were detected in ~90% of returning Chinese individuals, either in the primary or the homologous and heterologous booster vaccination group. The serum NAb titers were significantly decreased against SARS-CoV-2 Omicron BA.5, BF.7, BQ.1 and XBB.1 compared with the prototype virus. However, memory T-cell responses, including specific IFN-γ and IL-2 responses, were not different in either group. Smoking, alcohol consumption, SARS-CoV-2 infection, COVID-19 vaccination, and the time interval between last vaccination and sampling were independent influencing factors for NAb titers against prototype SARS-CoV-2 and variants of concern. The vaccine dose was the unique common influencing factor for Omicron subvariants. Enhanced immunity against SARS-CoV-2 was established in returning Chinese individuals who were exposed to reinfection and vaccination. Domestic residents will benefit from booster homologous or heterologous COVID-19 vaccination after reopening of China, which is also useful against breakthrough infection.

全球 COVID-19 疫苗接种计划有效遏制了 SARS-CoV-2 的快速传播。了解回国人群的免疫状况将有助于了解群体免疫的实现情况和中国 COVID-19 的长期管理。研究人员从中国广州的 7 个隔离检疫站招募人员。采集了参与者的血液和咽拭子标本,并通过竞争性酶联免疫吸附试验、微中和试验和酶联荧光斑点试验确定了他们的免疫状况。共有 272 名受试者参与了问卷调查,其中 235 人(86.4%)为归国华侨,37 人(13.6%)为外国人。从 108 名归国华侨中采集了血液和咽拭子标本。在约 90% 的归国华侨中检测到了 SARS-CoV-2 的中和抗体,无论是初种组还是同种异源加强免疫组。与原型病毒相比,血清中针对 SARS-CoV-2 Omicron BA.5、BF.7、BQ.1 和 XBB.1 的 NAb 滴度明显下降。然而,两组的记忆 T 细胞反应,包括特异性 IFN-γ 和 IL-2 反应,并无差异。吸烟、饮酒、SARS-CoV-2 感染、COVID-19 疫苗接种以及最后一次接种与采样之间的时间间隔是影响针对原型 SARS-CoV-2 和相关变种的 NAb 滴度的独立影响因素。疫苗剂量是 Omicron 亚变种的唯一共同影响因素。在再次感染和接种疫苗的归国华侨中建立了对 SARS-CoV-2 的增强免疫力。中国重新开放后,国内居民将受益于同源或异源 COVID-19 强化接种,这对预防突破性感染也很有用。
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引用次数: 0
Comparative immunogenicity and neutralizing antibody responses post heterologous vaccination with CoronaVac (Sinovac) and Vaxzevria (AstraZeneca) in HIV-infected patients with varying CD4+ T lymphocyte counts. 在不同 CD4+ T 淋巴细胞数量的 HIV 感染者中接种异源疫苗 CoronaVac(希诺威)和 Vaxzevria(阿斯利康)后的免疫原性和中和抗体反应比较。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-01-31 DOI: 10.1080/21645515.2024.2309734
Sorawit Chittrakarn, Pisud Siripaitoon, Sarunyou Chusri, Siripen Kanchanasuwan, Boonsri Charoenmak, Thanaporn Hortiwakul, Phaiwon Kantikit, Narongdet Kositpantawong

The immune response to heterologous coronavirus disease (COVID-19) vaccination in people living with HIV (PLWH) is still unclear. Herein, our prospective cohort study aimed to compare the immune response of heterologous vaccination with CoronaVac (Sinovac) and Vaxzevria (AstraZeneca) between PLWH having CD4 counts ≤ 200 cells/µL (low CD4+) and > 200 cells/µL (high CD4+). Anti-receptor-binding domain (RBD) immunoglobulin G (IgG) levels and the percentage inhibition of neutralizing antibodies (nAbs) were analyzed at 2 and 12 weeks after immunization. Participants in the low and high CD4+ groups had mean CD4+ counts of 139 and 575 cell/µL, respectively. Two and 12 weeks after immunization, in the low CD4 group, the median anti-RBD-IgG levels were 159 IU/mL and 143 IU/mL, respectively, whereas the nAb level was 71% and decreased to 47.2%, respectively. Contrarily, the median anti-RBD-IgG levels in the high CD4+ group were 273 IU/mL and 294 IU/mL, respectively, whereas the nAb levels were 89.3% and relatively stable at 81.6%. However, although immune responses between the two study groups were not significantly different, a decline in nAb levels was observed at 12 weeks in the low CD4+ group. Therefore, a COVID-19 booster vaccine dose is suggested for immunoprotection.

艾滋病病毒感染者(PLWH)对异源冠状病毒病(COVID-19)疫苗接种的免疫反应尚不清楚。在此,我们的前瞻性队列研究旨在比较 CD4 细胞数≤ 200 cells/µL(低 CD4+)和大于 200 cells/µL(高 CD4+)的艾滋病病毒感染者接种冠状病毒(COVID-19)异源疫苗后的免疫反应。免疫2周和12周后,对抗受体结合域(RBD)免疫球蛋白G(IgG)水平和中和抗体(nAbs)抑制百分比进行分析。低 CD4+ 组和高 CD4+ 组参与者的平均 CD4+ 细胞数分别为 139 和 575 cells/µL。免疫2周和12周后,低CD4组的抗RBD-IgG水平中位数分别为159 IU/mL和143 IU/mL,而nAb水平分别为71%和47.2%。相反,高 CD4+ 组的抗 RBD-IgG 水平中位数分别为 273 IU/mL 和 294 IU/mL,而 nAb 水平为 89.3%,相对稳定在 81.6%。不过,虽然两个研究组之间的免疫反应没有显著差异,但在 12 周时,低 CD4+ 组的 nAb 水平出现了下降。因此,建议接种 COVID-19 加强剂量疫苗以获得免疫保护。
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引用次数: 0
Ex vivo observation of Pythium insidiosum-antigen treated neutrophils on three Pythium insidiosum strains isolated from vascular pythiosis patients. 体内观察经脓疱疮抗原处理的中性粒细胞对从血管脓疱病患者体内分离出的三种脓疱疮菌株的影响。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-02-05 DOI: 10.1080/21645515.2024.2304372
Sadeep Medhasi, Apichaya Sriwarom, Nitipong Permpalung, Pattama Torvorapanit, Rongpong Plongla, Ariya Chindamporn, Navaporn Worasilchai

The mechanisms of Pythium insidiosum-antigen (PIA) immunotherapy activating a patient's immune system are unknown. We evaluated the interleukin-8 (IL-8) serum levels during P. insidiosum infection and after vaccination with PIA in vascular pythiosis cases. Furthermore, we studied the anti-P. insidiosum activity of neutrophils stimulated with various concentrations of PIA ex vivo in 3 strains of P. insidiosum isolated from vascular pythiosis patients. IL-8 serum levels were evaluated using the ELISA technique. We assessed the effect of PIA-stimulated neutrophils on the viability of zoospores using MTT assay, visualized neutrophil extracellular trap (NET) formation via microscopy, and measured the levels of double-stranded DNA (dsDNA) using PicoGreen dsDNA quantitation assay in 3 strains of P. insidiosum isolated from vascular pythiosis patients. Serum levels of IL-8 gradually lowered from the early to the end phases of vaccination with PIA among the surviving group of vascular pythiosis cases. Neutrophils stimulated with 0.01 µg/ml PIA reduced zoospore viability significantly compared to PIA-unstimulated neutrophils for strain 1 and strain 3 (p < .05). Neutrophils stimulated with 0.01, 0.1, 1, and 10 µg/ml PIA exhibited significantly lower zoospore viability than PIA-unstimulated neutrophils for strain 2 (p < .05). IL-8 can be used as a biomarker for monitoring vascular pythiosis cases treated with the PIA vaccine. Also, anti-P. insidiosum activity of PIA-stimulated neutrophils was probably due to the disruption of cellular activity in zoospores rather than the mechanisms based on the formation of NETs.

脓疱疮抗原(PIA)免疫疗法激活患者免疫系统的机制尚不清楚。我们评估了血管脓疱病病例在感染脓疱疮期间和接种脓疱疮疫苗后的白细胞介素-8(IL-8)血清水平。此外,我们还研究了从血管脓毒血症患者体内分离出的 3 株 P. insidiosum,用不同浓度的 PIA 在体外刺激中性粒细胞的抗 P. insidiosum 活性。使用 ELISA 技术评估了 IL-8 血清水平。我们使用 MTT 试验评估了 PIA 刺激的中性粒细胞对动物孢子活力的影响,通过显微镜观察了中性粒细胞胞外捕获器(NET)的形成,并使用 PicoGreen dsDNA 定量分析法测定了从血管脓疱病患者体内分离出的 3 株 P. insidiosum 的双链 DNA(dsDNA)水平。在血管性脓疱病存活病例组中,IL-8的血清水平从接种PIA初期到末期逐渐降低。与未受 PIA 刺激的中性粒细胞相比,受 0.01 µg/ml PIA 刺激的中性粒细胞可显著降低 1 号菌株和 3 号菌株的虫孢子活力(p p P. insidiosum),PIA 刺激的中性粒细胞的活性可能是由于破坏了虫孢子的细胞活性,而不是基于 NET 的形成机制。
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引用次数: 0
Formulation development of a stable influenza recombinant neuraminidase vaccine candidate. 稳定型流感重组神经氨酸酶候选疫苗的配方开发。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-03-18 DOI: 10.1080/21645515.2024.2304393
Bing Li, Irina V Ustyugova, Lisa Szymkowicz, Shaolong Zhu, Marin Ming, Karen Y Y Fung, Guadalupe Cortés, D Andrew James, Michael Hrynyk, Nausheen Rahman, Roger H Brookes, Salvador F Ausar

Current influenza vaccines could be augmented by including recombinant neuraminidase (rNA) protein antigen to broaden protective immunity and improve efficacy. Toward this goal, we investigated formulation conditions to optimize rNA physicochemical stability. When rNA in sodium phosphate saline buffer (NaPBS) was frozen and thawed (F/T), the tetrameric structure transitioned from a "closed" to an "open" conformation, negatively impacting functional activity. Hydrogen deuterium exchange experiments identified differences in anchorage binding sites at the base of the open tetramer, offering a structural mechanistic explanation for the change in conformation and decreased functional activity. Change to the open configuration was triggered by the combined stresses of acidic pH and F/T. The desired closed conformation was preserved in a potassium phosphate buffer (KP), minimizing pH drop upon freezing and including 10% sucrose to control F/T stress. Stability was further evaluated in thermal stress studies where changes in conformation were readily detected by ELISA and size exclusion chromatography (SEC). Both tests were suitable indicators of stability and antigenicity and considered potential critical quality attributes (pCQAs). To understand longer-term stability, the pCQA profiles from thermally stressed rNA at 6 months were modeled to predict stability of at least 24-months at 5°C storage. In summary, a desired rNA closed tetramer was maintained by formulation selection and monitoring of pCQAs to produce a stable rNA vaccine candidate. The study highlights the importance of understanding and controlling vaccine protein structural and functional integrity.

可以通过加入重组神经氨酸酶(rNA)蛋白抗原来增强目前的流感疫苗,从而扩大保护性免疫并提高疗效。为此,我们研究了优化 rNA 理化稳定性的配制条件。当磷酸钠生理盐水缓冲液(NaPBS)中的 rNA 被冷冻和解冻(F/T)时,四聚体结构会从 "封闭 "构象转变为 "开放 "构象,从而对功能活性产生负面影响。氢氘交换实验确定了开放四聚体底部锚定结合位点的差异,为构象改变和功能活性降低提供了结构机理解释。酸性 pH 值和 F/T 值的双重压力引发了开放构型的变化。所需的封闭构象在磷酸二氢钾缓冲液(KP)中得以保留,最大限度地降低了冷冻时的 pH 值下降,并加入了 10%的蔗糖以控制 F/T 应力。在热应力研究中进一步评估了稳定性,通过酶联免疫吸附试验(ELISA)和尺寸排阻色谱法(SEC)很容易检测到构象的变化。这两项测试都是稳定性和抗原性的合适指标,被认为是潜在的关键质量属性(pCQA)。为了解更长期的稳定性,对 6 个月热应激 rNA 的 pCQA 曲线进行了建模,以预测在 5°C 储存条件下至少 24 个月的稳定性。总之,通过配方选择和 pCQA 监测,可保持理想的 rNA 封闭四聚体,从而生产出稳定的 rNA 候选疫苗。这项研究强调了了解和控制疫苗蛋白质结构和功能完整性的重要性。
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引用次数: 0
Cost-effectiveness analysis of vaccination strategies against meningococcal disease for children under nine years of age in China. 中国九岁以下儿童脑膜炎球菌病疫苗接种策略的成本效益分析。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-02-13 DOI: 10.1080/21645515.2024.2313872
Haonan Zhang, Haijun Zhang, Hai Fang

Meningococcal vaccination strategies in China are intricate, including multiple vaccines targeting different serogroups. The current National Immunization Program (NIP) includes two polysaccharide vaccines for serogroups A and C (MPV-A and MPV-AC), covering limited serogroups and requiring adaptation. This study aims to evaluate the cost-effectiveness of replacing the current strategy with alternative strategies utilizing non-NIP vaccines to inform policy decisions. From a societal perspective, a decision tree-Markov model was constructed to simulate the economic and health consequences of meningococcal disease in a 2019 birth cohort with four vaccination strategies. Epidemiology, vaccine efficacy, cost, and other parameters were derived from previous studies. We conducted sensitivity analyses to assess the robustness of the findings and explored prices for non-NIP vaccines that enable cost-effective strategies. Compared to the current strategy, alternative strategies using quadrivalent polysaccharide vaccine (MPV-4), bivalent conjugate vaccine (MCV-AC), and quadrivalent conjugate vaccine (MCV-4) could avoid 91, 286, and 455 more meningococcal cases. The ICERs were estimated at approximately $250 thousand/QALY, $450 thousand/QALY, and $1.5 million/QALY, all exceeding the threshold of three times GDP per capita. The alternative strategies were not cost-effective. However, if vaccine prices were reduced to $3.9 for MPV-4, $9.9 for MCV-AC, and $12 for MCV-4, the corresponding strategy would be cost-effective. The current meningococcal vaccination strategy in China could effectively prevent the disease at a low cost, but with limited serogroup coverage. Strategies using MPV-4, MCV-AC, or MCV-4 could increase health benefits at a substantial cost, and might become cost-effective if vaccine prices decrease.

中国的脑膜炎球菌疫苗接种策略错综复杂,包括针对不同血清群的多种疫苗。目前的国家免疫规划(NIP)包括针对 A 和 C 血清群的两种多糖疫苗(MPV-A 和 MPV-AC),覆盖的血清群有限,需要进行调整。本研究旨在评估利用非 NIP 疫苗替代现行战略的成本效益,为政策决策提供依据。从社会角度出发,我们构建了一个决策树-马尔科夫模型,模拟在 2019 年出生队列中使用四种疫苗接种策略对脑膜炎球菌疾病造成的经济和健康后果。流行病学、疫苗疗效、成本和其他参数均来自先前的研究。我们进行了敏感性分析,以评估研究结果的稳健性,并探讨了非国家免疫规划疫苗的价格,以实现具有成本效益的策略。与目前的策略相比,使用四价多糖疫苗 (MPV-4)、二价结合疫苗 (MCV-AC) 和四价结合疫苗 (MCV-4) 的替代策略可分别避免 91 例、286 例和 455 例脑膜炎球菌病例。ICER 估计约为 25 万美元/QALY、45 万美元/QALY 和 150 万美元/QALY,均超过人均 GDP 三倍的临界值。替代战略不具有成本效益。然而,如果疫苗价格降至 MPV-4 3.9 美元、MCV-AC 9.9 美元和 MCV-4 12 美元,相应的策略将具有成本效益。中国目前的脑膜炎球菌疫苗接种策略可以低成本有效预防疾病,但血清群覆盖率有限。使用 MPV-4、MCV-AC 或 MCV-4 的接种策略可增加健康效益,但成本较高,如果疫苗价格下降,这种策略可能具有成本效益。
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引用次数: 0
Reconsidering the inclusion of Ladapo's work in the meta-analysis: Validity concerns and implications. 重新考虑将拉达波的工作纳入荟萃分析:有效性问题及影响
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-02-15 DOI: 10.1080/21645515.2024.2315711
Borja Somovilla Del Saz

This is a response to Marchand & Masoud's response letter regarding my criticism "Response to Dr. Somovilla del Saz's letter to the editor regarding "Risk of all-cause and cardiac-related mortality after vaccination against COVID-19: A meta-analysis of self-controlled case series studies."" The response is a defense of the initial criticism to the paper regarding the validity of the inclusion of Ladapo´s paper.

这是对 Marchand 和 Masoud 就我的批评所写的回信的回应,"回应 Somovilla del Saz 博士写给编辑的关于 "接种 COVID-19 疫苗后的全因和心脏相关死亡风险:自我对照病例系列研究的荟萃分析""。该回复是对最初对该论文提出的关于纳入拉达波论文的有效性的批评的辩护。
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引用次数: 0
Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season. 德国和芬兰在 2022/23 流感季节加强对高剂量和标准剂量四价灭活分裂病毒流感疫苗的被动安全性监测。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-03-06 DOI: 10.1080/21645515.2024.2322196
Marina Amaral de Avila Machado, Sonja Gandhi-Banga, Sophie Gallo, Tathyana Giannotti Cousseau, Reddappa Maniganahally Byrareddy, Markku Nissilä, Jörg Schelling, Celine Monfredo

Enhanced Passive Safety Surveillance (EPSS) was conducted for quadrivalent inactivated split-virion influenza vaccines (IIV4) in Germany (high dose [HD]) and Finland (standard dose [SD]) for the northern hemisphere (NH) 2022/23 influenza season. The primary objective was to assess adverse events following immunization (AEFI) occurring ≤7 days post-vaccination. In each country, the EPSS was conducted at the beginning of the NH influenza season. Exposure information was documented using vaccination cards (VC), and AEFI were reported via an electronic data collection system or telephone. AEFI were assessed by seriousness and age group (Finland only). The vaccinee reporting rate (RR) was calculated as the number of vaccinees reporting ≥ 1 AEFI divided by the total vaccinees. In Germany, among 1041 vaccinees, there were 31 AEFI (ten vaccinees) during follow-up, including one serious AEFI. Of 16 AEFI (six vaccinees) with reported time of onset, 15 occurred ≤7 days post-vaccination (RR 0.58%, 95% confidence interval [CI] 0.21, 1.25), which was lower than the 2021/22 season (RR 1.88%, 95% CI: 1.10, 3.00). In Finland, among 1001 vaccinees, there were 142 AEFI (51 vaccinees) during follow-up, none of which were serious. Of 133 AEFI (48 vaccinees) with time of onset reported, all occurred ≤7 days post-vaccination (RR 4.80%, 95% CI: 3.56, 6.31), which was similar to the 2021/22 season (RR 4.90%, 95% CI: 3.65, 6.43). The EPSS for HD-IIV4 and for SD-IIV4 in the 2022/23 influenza season did not suggest any clinically relevant changes in safety beyond what is known/expected for IIV4s.

针对北半球(NH)2022/23流感季节,在德国(高剂量[HD])和芬兰(标准剂量[SD])对四价灭活分裂病毒流感疫苗(IIV4)进行了强化被动安全监测(EPSS)。首要目标是评估接种后7天内发生的免疫接种不良事件(AEFI)。在每个国家,EPSS都是在北半球流感季节开始时进行的。暴露信息通过疫苗接种卡(VC)记录,AEFI则通过电子数据收集系统或电话报告。AEFI 按严重程度和年龄组进行评估(仅芬兰)。接种者报告率 (RR) 的计算方法是:报告 AEFI ≥ 1 例的接种者人数除以接种者总人数。在德国的 1041 名接种者中,有 31 人(10 名接种者)在随访期间发生了 AEFI,其中包括 1 例严重 AEFI。在报告发病时间的 16 例 AEFI(6 名接种者)中,15 例发生在接种后 7 天以内(RR 0.58%,95% 置信区间 [CI] 0.21,1.25),低于 2021/22 季度(RR 1.88%,95% 置信区间:1.10,3.00)。在芬兰的 1001 名接种者中,有 142 例 AEFI(51 名接种者)在随访期间发生,其中没有一例是严重的。在报告了发病时间的 133 例 AEFI(48 例接种者)中,全部发生在接种后 7 天以内(RR 4.80%,95% CI:3.56, 6.31),与 2021/22 季度(RR 4.90%,95% CI:3.65, 6.43)相似。在2022/23流感季节,HD-IIV4和SD-IIV4的EPSS表明,除了已知/预期的IIV4之外,安全性没有任何临床相关变化。
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引用次数: 0
A phase 3, single-arm, open-label study to evaluate the safety, tolerability, and immunogenicity of a 15-valent pneumococcal conjugate vaccine, V114, in a 3+1 regimen in healthy infants in South Korea (PNEU-PED-KOR). 一项 3 期、单臂、开放标签研究,旨在评估 15 价肺炎球菌结合疫苗 V114 在韩国健康婴儿中采用 3+1 方案的安全性、耐受性和免疫原性 (PNEU-PED-KOR)。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-03-18 DOI: 10.1080/21645515.2024.2321035
Alvino Maestri, Su Eun Park, Fiona Fernandes, Zhongyi Lucy Li, Yae-Jean Kim, Yun-Kyung Kim, Jin Lee, Ji Young Park, Dong Hyun Kim, GyongSeon Yang, Hyunjung Lim, Jin Oh Kim, Robert Lupinacci, Tina M Sterling, Marissa Wilck, Alejandra Esteves-Jaramillo, Natalie Banniettis

There is an ongoing burden of pneumococcal disease in children despite the use of pneumococcal conjugate vaccines (PCVs). This phase 3, open-label, single-arm, multisite, descriptive study was designed to evaluate the safety and immunogenicity of a 3 + 1 regimen of V114 (VAXNEUVANCE™), a 15-valent PCV, in South Korean infants and toddlers. Adverse events (AEs) were reported for 14 d following any vaccination, and throughout the study period for serious AEs. Serotype-specific immunoglobulin G (IgG) response rates (proportion of participants meeting an IgG threshold value of ≥0.35 μg/mL) and geometric mean concentrations (GMCs) for the 15 serotypes at 30 d postdose 3 (PD3) and at 30 d postdose 4 (PD4) were evaluated as endpoints. Healthy infants enrolled at 42-90 d after birth were vaccinated with V114 (N = 57). The most commonly reported AEs were those solicited in the trial. The majority of reported AEs were transient and of mild or moderate intensity. Few serious AEs were reported; none were vaccine related. No participants died nor discontinued the study vaccine because of an AE. V114 was immunogenic for all 15 serotypes contained in the vaccine, as assessed by IgG response rates at 30 d PD3 and IgG GMCs at 30 d PD3 and at 30 d PD4. V114 was well tolerated and immunogenic when administered as a 3 + 1 regimen in healthy South Korean infants and toddlers.

尽管使用了肺炎球菌结合疫苗 (PCV),但儿童肺炎球菌疾病的负担仍在持续。这项 3 期、开放标签、单臂、多站点、描述性研究旨在评估 15 价 PCV V114 (VAXNEUVANCE™) 3 + 1 方案在韩国婴幼儿中的安全性和免疫原性。在接种任何疫苗后的 14 天内报告不良事件 (AE),在整个研究期间报告严重不良事件。血清型特异性免疫球蛋白 G (IgG) 反应率(达到 IgG 阈值≥0.35 μg/mL 的参与者比例)和 15 种血清型的几何平均浓度 (GMC) 作为终点进行评估,评估时间为接种后 30 天(PD3)和接种后 30 天(PD4)。出生后 42-90 天的健康婴儿接种了 V114 疫苗(57 人)。最常报告的AE是试验中征集的AE。大多数报告的不良反应是一过性的,属于轻度或中度。报告的严重不良反应很少;没有一起不良反应与疫苗有关。没有参与者死亡,也没有参与者因不良反应而停止接种疫苗。根据30 d PD3的IgG应答率以及30 d PD3和30 d PD4的IgG GMCs评估,V114对疫苗所含的全部15种血清型均具有免疫原性。在健康的韩国婴幼儿中以 3+1 方案接种 V114 疫苗,其耐受性和免疫原性良好。
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引用次数: 0
Correction. 更正。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-07-16 DOI: 10.1080/21645515.2024.2379689
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引用次数: 0
Utility of cell-based vaccines as cancer therapy: Systematic review and meta-analysis. 细胞疫苗作为癌症疗法的效用:系统回顾和荟萃分析。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2024-12-31 Epub Date: 2024-03-27 DOI: 10.1080/21645515.2024.2323256
Ankur Tiwari, Karl Alcover, Elizabeth Carpenter, Katryna Thomas, Julia Krum, Alexander Nissen, Spencer Van Decar, Todd Smolinsky, Franklin Valdera, Timothy Vreeland, Markus Lacher, Giuseppe Del Priore, William Williams, Alexander Stojadinovic, George Peoples, Guy Clifton

Cell-based therapeutic cancer vaccines use autologous patient-derived tumor cells, allogeneic cancer cell lines or autologous antigen presenting cells to mimic the natural immune process and stimulate an adaptive immune response against tumor antigens. The primary objective of this study is to perform a systematic literature review with an embedded meta-analysis of all published Phase 2 and 3 clinical trials of cell-based cancer vaccines in human subjects. The secondary objective of this study is to review trials demonstrating biological activity of cell-based cancer vaccines that could uncover additional hypotheses, which could be used in the design of future studies. We performed the systematic review and meta-analysis according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The final review included 36 studies - 16 single-arm studies, and 20 controlled trials. Our systematic review of the existing literature revealed largely negative trials and our meta-analysis did not show evidence of clinical benefit from cell-based cancer-vaccines. However, as we looked beyond the stringent inclusion criteria of our systematic review, we identified significant examples of biological activity of cell-based cancer vaccines that are worth highlighting. In conclusion, the existing literature on cell-based cancer vaccines is highly variable in terms of cancer type, vaccine therapies and the clinical setting with no overall statistically significant clinical benefit, but there are individual successes that represent the promise of this approach. As cell-based vaccine technology continues to evolve, future studies can perhaps fulfill the potential that this exciting field of anti-cancer therapy holds.

基于细胞的治疗性癌症疫苗使用源自患者的自体肿瘤细胞、异体癌细胞系或自体抗原呈递细胞来模拟自然免疫过程并激发针对肿瘤抗原的适应性免疫反应。本研究的主要目的是对所有已发表的以细胞为基础的癌症疫苗人体 2 期和 3 期临床试验进行系统的文献综述和嵌入式荟萃分析。本研究的次要目的是回顾证明细胞癌症疫苗具有生物活性的试验,从而发现更多的假设,用于未来研究的设计。我们根据《系统综述和元分析首选报告项目》(Preferred Reporting Items for Systematic Reviews and Meta-Analyses,PRISMA)指南进行了系统综述和元分析。最终的综述包括 36 项研究--16 项单臂研究和 20 项对照试验。我们对现有文献进行的系统性回顾发现,大部分试验结果都是负面的,我们的荟萃分析也没有显示细胞癌症疫苗有临床益处的证据。不过,我们在系统综述的严格纳入标准之外,还发现了细胞癌症疫苗生物活性的重要实例,值得重点关注。总之,关于细胞癌症疫苗的现有文献在癌症类型、疫苗疗法和临床环境方面存在很大差异,总体上没有统计学意义上的显著临床获益,但也有个别成功案例代表了这种方法的前景。随着细胞疫苗技术的不断发展,未来的研究或许能实现这一令人兴奋的抗癌疗法领域所蕴含的潜力。
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Human Vaccines & Immunotherapeutics
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