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Post-marketing safety surveillance of the BBIBP-CorV (Sinopharm) COVID-19 vaccine in Peruvian healthcare workers: A retrospective analysis of a Pharmacovigilance Center 秘鲁卫生保健工作者BBIBP-CorV(国药)COVID-19疫苗上市后安全性监测:药物警戒中心的回顾性分析
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-17 DOI: 10.1016/j.vaccine.2026.128227
L. Yesenia Rodríguez-Tanta , Raquel Delgado-Escalante , Tania del Pilar Solis-Yucra , Enrique Cachay Rojas , Guisela Alva Lozada , Liz E. Veramendi-Espinoza , Vladimir Espinoza-Ildefonso , Violeta Saromo-Meléndez , Anaís Lazarte-Ramos , Juan Carlos Aldave , Mariela Milla Pimentel , Carla Garcia Torres , Claudia Rentería Valdiviezo , Víctor E. Lechuga-Noa

Introduction

The inactivated SARS-CoV-2 vaccine (BBIBP-CorV) was first introduced in Peru among healthcare workers. We evaluated its safety profile by analyzing adverse events following immunization (AEFI) reports and conducting clinical and causality assessments for cases meeting criteria for adverse events of special interest (AESI) and serious adverse events (SAEs).

Methods

We conducted a retrospective analysis using data from the Pharmacovigilance Center of EsSalud. We identified, estimated the overall reporting rate, and described key characteristics of AEFI reports, including differences by gender and age group. Clinicians trained in vaccine safety performed clinical assessments for AESIs and SAEs based on medical records and conducted formal causality assessments.

Results

From February to August 2021, we identified 2280 AEFI reports (1052 per 100,000 doses; 95% CI 1009–1097), corresponding to 4376 adverse event terms. Of these, 22 met AESI criteria, with only two anaphylaxis cases causally linked to the vaccine (A1). The remaining 4354 events were grouped into 14 MedDRA SOC categories, with nervous system disorders (30%) and injection site reactions (11%) most frequent. Gastrointestinal events were more common in women (12.6% vs. 7.9%, p < 0.001), while men reported more general disorders (16% vs. 10.9%, p < 0.001). Adults ≥65 years reported more vascular and eye disorders. Fifteen events were categorized as SAEs and classified as category C.

Conclusions

This first post-marketing safety evaluation of BBIBP-CorV among Peruvian healthcare personnel found a low AEFI reporting rate, with mostly mild events. Access to medical records enabled accurate assessment, supporting local pharmacovigilance and public health decision-making.
灭活SARS-CoV-2疫苗(BBIBP-CorV)首先在秘鲁的卫生保健工作者中引入。我们通过分析免疫后不良事件(AEFI)报告,并对符合特殊不良事件(AESI)和严重不良事件(SAEs)标准的病例进行临床和因果关系评估,来评估其安全性。方法回顾性分析山东省药物警戒中心的资料。我们确定、估计了总体报告率,并描述了AEFI报告的关键特征,包括性别和年龄组的差异。接受过疫苗安全培训的临床医生根据医疗记录对aesi和SAEs进行临床评估,并进行正式的因果关系评估。从2021年2月至8月,我们共发现2280例AEFI报告(1052 / 10万剂;95% CI 1009-1097),对应4376例不良事件。其中22例符合AESI标准,只有2例过敏反应与疫苗有因果关系(A1)。其余4354例事件分为14个MedDRA SOC类别,其中神经系统疾病(30%)和注射部位反应(11%)最为常见。胃肠道事件在女性中更常见(12.6%对7.9%,p < 0.001),而男性报告更多的一般疾病(16%对10.9%,p < 0.001)。≥65岁的成年人报告了更多的血管和眼部疾病。结论首次对秘鲁医护人员进行的BBIBP-CorV上市后安全性评估发现,AEFI报告率较低,且大多为轻度事件。获得医疗记录有助于进行准确的评估,支持当地的药物警戒和公共卫生决策。
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引用次数: 0
Primary evaluation of immune responses in mice after a single mRNA immunization with Echinococcus granulosus Eg95 and Coenurus cerebralis TM16 细粒棘球绦虫Eg95和脑棘球绦虫TM16单mRNA免疫小鼠免疫应答的初步评价
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-21 DOI: 10.1016/j.vaccine.2026.128232
Chun-Ni Meng , Ting-Ting Li , Wen-Hui Li , Meng Wang , Wei-Gang Chen , Hong-Bin Yan , Li Li , Xiao-Lin Sun , Bao-Quan Fu , Nian-Zhang Zhang
Echinococcus granulosus and Taenia multiceps cause zoonotic cystic diseases. Studies have shown that Eg95 from E. granulosus is highly conserved, exhibits excellent immunogenicity, and serves as a critical candidate antigen. In recent years, the TM16 recombinant protein antigen has been one of the most studied antigens for preventing C. cerebralis and demonstrates optimal experimental immunogenicity. This study developed both recombinant protein and mRNA-LNP vaccines targeting the Eg95 and TM16 antigens. Immunization of BALB/c mice showed that both vaccines significantly increased specific antibody levels (IgG, IgG1, IgG2a) and cytokines (IFN-γ, IL-4) (P < 0.001), inducing a predominant Th1-type immune response. The mRNA-LNP vaccine demonstrated superior efficacy in enhancing IgG2a levels and CD8+ T cell responses compared to the protein vaccine. These results indicate strong immunogenicity and support further evaluation of the Eg95-TM16 mRNA-LNP vaccine in intermediate hosts like sheep and goats.
细粒棘球绦虫和多头带绦虫引起人畜共患囊性疾病。研究表明,颗粒棘球绦虫Eg95具有高度保守性,具有良好的免疫原性,是一种重要的候选抗原。TM16重组蛋白抗原是近年来研究最多的预防脑棘球蚴病的抗原之一,具有较好的实验免疫原性。本研究开发了针对Eg95和TM16抗原的重组蛋白和mRNA-LNP疫苗。BALB/c小鼠免疫结果显示,两种疫苗均显著提高特异性抗体(IgG、IgG1、IgG2a)和细胞因子(IFN-γ、IL-4)水平(P
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引用次数: 0
Safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive healthy adults: Results from 2 randomised, controlled clinical trials 25价肺炎球菌结合疫苗在未接种肺炎球菌疫苗的健康成人中的安全性和免疫原性:来自2个随机对照临床试验的结果
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-22 DOI: 10.1016/j.vaccine.2026.128236
Joanne M. Langley , Manish Sadarangani , Christian Ockenhouse , Luis Barreto , Lingyun Ye , Yuxiao Tang , Janis L. Breeze , Jodi Feser , Nancy A. Hosken , Indah Andi-Lolo , Sybil A. Tasker , Scott A. Halperin , the Canadian Immunization Research Network

Background

Pneumococcus causes substantial morbidity and mortality worldwide in children under 5. IVT PCV-25 is a 25-valent pneumococcal conjugate vaccine (PCV25) designed to prevent invasive pneumococcal disease from the serotypes predominant in children, particularly in low and middle income countries (LMICs).

Methods

We completed 2 randomised, parallel-group, double-blind clinical trials in Canada to evaluate the safety and immunogenicity of a single IM dose of PCV25 in healthy adults who had no history of pneumococcal vaccination or microbiologically confirmed IPD. PCV20 (Prevnar 20) was the control. In CVIA 096, 30 participants per group were randomised to PCV25 at a dose similar to PCV 20 (2.2 μg for each serotype polysaccharide (except 4.4 μg for serotype 6B) with 125 μg aluminium as aluminium phosphate (2.2/125)) or PCV20. Potentially more immunogenic formulations with higher polysaccharide and/or aluminium phosphate dose were evaluated in CVIA105, where 40 participants were randomised to PCV25 (2.2/125), 60 to PCV25 (2.2/250), 80 to PCV25 (4.4/250), and 40 to PCV20.

Results

Most participants were female and white. All participants were included in the safety analyses. One participant in CVIA 096 and 6 participants in CVIA 105 were excluded from the immunogenicity analyses because of protocol deviations that might interfere with immune response. Solicited and unsolicited AE profiles were similar for PCV25 and PCV20. No Grade 4 events were reported. At the highest dose, PCV25 elicited IgG and OPA responses with GMFRs of ≥2 for all 25 serotypes and for serotype 6A except for OPA response to 35B.

Conclusions

Multiple formulations of IVT PCV-25, a vaccine designed to cover pneumococcal serotypes prevalent in LMICs, were well tolerated and immunogenic in healthy adults. As adult immunogenicity is not fully predictive for infants, further development will evaluate safety and immunogenicity in the target infant population.
ClinicalTrials.gov NCT05540028, NCT06077656
肺炎球菌在全球5岁以下儿童中引起大量发病率和死亡率。IVT PCV-25是一种25价肺炎球菌结合疫苗(PCV25),旨在预防儿童中主要的血清型侵袭性肺炎球菌疾病,特别是在中低收入国家(LMICs)。方法:我们在加拿大完成了2项随机、平行组、双盲临床试验,以评估PCV25单剂量IM在没有肺炎球菌疫苗接种史或微生物学证实的IPD的健康成人中的安全性和免疫原性。PCV20 (Prevnar 20)作为对照。在CVIA 096中,每组30名参与者被随机分配到PCV25,剂量与PCV20相似(每种血清型多糖2.2 μg(血清型6B 4.4 μg除外),125 μg铝为磷酸铝(2.2/125))或PCV20。在CVIA105中评估了具有更高多糖和/或磷酸铝剂量的潜在免疫原性配方,其中40名参与者随机分配到PCV25(2.2/125), 60名到PCV25(2.2/250), 80名到PCV25(4.4/250)和40名到PCV20。结果大多数参与者是女性和白人。所有参与者都被纳入安全性分析。CVIA 096的1名参与者和CVIA 105的6名参与者因可能干扰免疫应答的方案偏差而被排除在免疫原性分析之外。PCV25和PCV20的主动和非主动AE配置文件相似。未报告4级事件。在最高剂量下,PCV25在所有25种血清型和6A血清型中均引起IgG和OPA应答,GMFRs≥2,但对35B血清型的OPA应答除外。结论IVT PCV-25疫苗是一种设计用于覆盖低收入国家流行的肺炎球菌血清型的疫苗,多种配方在健康成人中具有良好的耐受性和免疫原性。由于成人免疫原性不能完全预测婴儿的免疫原性,因此进一步的研究将评估该药物在目标婴儿人群中的安全性和免疫原性
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引用次数: 0
Preclinical immunogenicity studies of Haemophilus influenzae type a glycoconjugate vaccine 流感嗜血杆菌a型糖结合疫苗的临床前免疫原性研究。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-18 DOI: 10.1016/j.vaccine.2026.128242
Gowri Chellappan , Florence Seal , Winston Umakanth Balasundaram , Yutai Zhao , Giriraj Chalke , Shangdong Guo , Gowthami Jagruthi Penumaka , Geetha Karengil , Amandeep Grewal , Rashmi Ghayal , Jen Gan , Richa Puri , Dimple Reshma Machado , Aakriti Bajracharya , Pradip Ghate , Anup Datta , Subhash V. Kapre
Haemophilus influenzae type a (Hia) disease is associated with fatality and morbidity, predominantly in children from Northern indigenous communities in Canada and Alaska. Symptoms include but are not limited to meningitis, sepsis, pneumonia, otitis media and bacteremia. A key virulence factor associated with Hia pathogenesis is the bacterial capsular polysaccharides. Prophylactic vaccines targeting the capsular polysaccharide (CPS) antigens is considered a promising intervention strategy given the effectiveness of polysaccharide-protein conjugate vaccines against diverse bacterial pathogens. In the same vein, we in this study have presented the development of Hia conjugate vaccine involving hydrazide-polyethylene glycol-hydrazide linker with rCRM197 as a carrier protein. Preclinical immunogenicity data indicated induction of robust serum bactericidal antibody responses at a 10-μg CPS antigen dose in rabbits like the PedvaxHIB® comparator, leading to evaluation of the Hia vaccine candidate in Phase I clinical trials.
甲型流感嗜血杆菌病与死亡率和发病率相关,主要发生在加拿大和阿拉斯加北部土著社区的儿童中。症状包括但不限于脑膜炎、败血症、肺炎、中耳炎和菌血症。与Hia发病机制相关的一个关键毒力因子是细菌荚膜多糖。考虑到多糖-蛋白结合疫苗对多种细菌病原体的有效性,针对荚膜多糖(CPS)抗原的预防性疫苗被认为是一种有前途的干预策略。同样,我们在本研究中提出了以rCRM197为载体蛋白的含肼-聚乙二醇-肼连接体的Hia结合疫苗的开发。临床前免疫原性数据表明,PedvaxHIB®比较物在10 μg CPS抗原剂量下可在兔体内诱导强大的血清杀菌抗体反应,从而在I期临床试验中对Hia候选疫苗进行评估。
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引用次数: 0
Inflammatory mechanisms of menstrual cycle changes following COVID-19 vaccination in adolescents 青少年COVID-19疫苗接种后月经周期变化的炎症机制
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-18 DOI: 10.1016/j.vaccine.2026.128226
Ariel B. Handy , Boyu Ren , Laura C. Seidman , Steven W. Granger , Laura A. Payne

Purpose

Changes in menstrual cycle characteristics following COVID-19 vaccination have been reported in women and adolescent girls, yet the biological mechanisms underlying these changes remain poorly understood. Inflammation, though frequently hypothesized as a possible mechanism underlying this finding, has yet to be explicitly studied. Thus, the present study examined the relationships of ovarian hormones and inflammatory processes pre- and post-COVID-19 booster vaccination to menstrual changes among adolescent girls.

Methods

47 adolescent girls aged 13–20 who received a COVID-19 booster vaccination provided saliva samples and completed self-reported measures at five time points across the menstrual cycle. Saliva samples were assayed for inflammatory markers IL-1β, IL-6, TNF-α and ovarian hormones estradiol (E2) and progesterone.

Results

Higher levels of IL-1β, measured 24 h post-vaccination, were significantly associated with shorter cycle length in the cycle during which the booster was administered. No significant effects were found for ovarian hormones or other inflammatory markers. Cluster analyses based on anti-spike immunoglobulin G (IgG) levels identified two distinct immune response profiles (high and low responders), though this was not significantly associated with menstrual cycle changes.

Conclusions

Pro-inflammatory cytokine IL-1β plays a significant role in explaining the shortening of the menstrual cycle following COVID-19 vaccination in adolescent girls, primarily impacting the cycle in which the vaccine was received This finding suggests that vaccine-induced inflammation can influence menstrual cycle regulation in adolescents, possibly due to the immaturity of the HPO-axes during adolescence.
目的:有报道称,妇女和少女接种COVID-19疫苗后月经周期特征发生了变化,但对这些变化背后的生物学机制仍知之甚少。炎症虽然经常被假设为这一发现背后的可能机制,但尚未得到明确的研究。因此,本研究调查了青春期女孩在covid -19加强疫苗接种前后卵巢激素和炎症过程与月经变化的关系。方法:47名接受COVID-19加强疫苗接种的13-20岁少女在月经周期的五个时间点提供唾液样本并完成自我报告。检测唾液中炎症标志物IL-1β、IL-6、TNF-α和卵巢激素雌二醇(E2)、黄体酮。结果:接种24小时后测量的较高水平的IL-1β与注射增强剂的周期长度较短显著相关。卵巢激素或其他炎症标志物没有发现明显的影响。基于抗刺突免疫球蛋白G (IgG)水平的聚类分析确定了两种不同的免疫反应谱(高反应和低反应),尽管这与月经周期变化没有显著关联。结论:促炎细胞因子IL-1β在青春期女孩接种COVID-19疫苗后月经周期缩短中发挥重要作用,主要影响疫苗接种周期。这一发现表明,疫苗诱导的炎症可以影响青少年月经周期调节,可能是由于青春期hpo轴不成熟所致。
{"title":"Inflammatory mechanisms of menstrual cycle changes following COVID-19 vaccination in adolescents","authors":"Ariel B. Handy ,&nbsp;Boyu Ren ,&nbsp;Laura C. Seidman ,&nbsp;Steven W. Granger ,&nbsp;Laura A. Payne","doi":"10.1016/j.vaccine.2026.128226","DOIUrl":"10.1016/j.vaccine.2026.128226","url":null,"abstract":"<div><h3>Purpose</h3><div>Changes in menstrual cycle characteristics following COVID-19 vaccination have been reported in women and adolescent girls, yet the biological mechanisms underlying these changes remain poorly understood. Inflammation, though frequently hypothesized as a possible mechanism underlying this finding, has yet to be explicitly studied. Thus, the present study examined the relationships of ovarian hormones and inflammatory processes pre- and post-COVID-19 booster vaccination to menstrual changes among adolescent girls.</div></div><div><h3>Methods</h3><div>47 adolescent girls aged 13–20 who received a COVID-19 booster vaccination provided saliva samples and completed self-reported measures at five time points across the menstrual cycle. Saliva samples were assayed for inflammatory markers IL-1β, IL-6, TNF-α and ovarian hormones estradiol (E2) and progesterone.</div></div><div><h3>Results</h3><div>Higher levels of IL-1β, measured 24 h post-vaccination, were significantly associated with shorter cycle length in the cycle during which the booster was administered. No significant effects were found for ovarian hormones or other inflammatory markers. Cluster analyses based on anti-spike immunoglobulin G (IgG) levels identified two distinct immune response profiles (high and low responders), though this was not significantly associated with menstrual cycle changes.</div></div><div><h3>Conclusions</h3><div>Pro-inflammatory cytokine IL-1β plays a significant role in explaining the shortening of the menstrual cycle following COVID-19 vaccination in adolescent girls, primarily impacting the cycle in which the vaccine was received This finding suggests that vaccine-induced inflammation can influence menstrual cycle regulation in adolescents, possibly due to the immaturity of the HPO-axes during adolescence.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"75 ","pages":"Article 128226"},"PeriodicalIF":4.5,"publicationDate":"2026-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146004808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Needle-free intradermal delivery of a recombinant PRRSV-vectored CSFV E2 vaccine enhances humoral immunity and growth performance in piglets 重组prrsv载体CSFV E2疫苗的无针皮内注射增强了仔猪的体液免疫和生长性能。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-03-07 Epub Date: 2026-01-20 DOI: 10.1016/j.vaccine.2026.128247
Wenna Shuai , Qi Sun , Jiale Li , Wei Shen , Junrui Zhu , Ziqiang Guo , Meng Luo , Yifan Zeng , Jinbin Wang , Guangzhi Tong , Yanjun Zhou , Fei Gao
Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) and Classical Swine Fever Virus (CSFV) remain among the most economically devastating pathogens of swine worldwide. Needle-free intradermal vaccination has emerged as a promising alternative to conventional injection, potentially improving animal welfare, biosecurity, and antigen delivery efficiency within high-density swine production systems. A recombinant PRRSV-vectored live vaccine expressing the CSFV E2 protein (rPRRSV-E2) was evaluated in fifteen 30-day-old healthy piglets. Animals were randomly assigned to three groups: intramuscular injection of rPRRSV-E2 vaccine(needle-based rPRRSV-E2 immunization), intradermal injection of rPRRSV-E2 vaccine (needle-free rPRRSV-E2 immunization), or mock control. Piglets were tracked for clinical signs, growth, and rectal temperature to 63 dpv (Days Post Vaccination). PRRSV/CSFV antibodies were assayed by Enzyme linked immunosorbent assay (ELISA); viral RNA in serum, swabs, and tissues by RT-qPCR. Gross and histopathology were done at 63 dpv. Both vaccination routes induced seroconversion to PRRSV and CSFV by 14 dpv, with the intradermal injection group exhibiting significantly higher antibody level for both antigens (*p < 0.05). No PRRSV RNA was detected in samples from either vaccinated group. Compared to intramuscular injection, intradermal injection significantly improved the average daily weight gain, while causing no fever or notable clinical symptoms, no macroscopic or microscopic lesions, and no differences in gross pathology were noted relative to controls. Intradermal injection of rPRRSV-E2 vaccine elicited robust humoral responses against PRRSV and CSFV, matched pathogen clearance capacity of conventional injection, improved growth performance, and reduced the need for invasive handling. These findings support intradermal injection as a viable, welfare-oriented strategy for integrated control of PRRSV and CSFV in swine herds, with potential application in biosecurity-driven and high-throughput vaccination programs.
猪繁殖与呼吸综合征病毒(PRRSV)和猪瘟病毒(CSFV)仍然是世界范围内最具经济破坏性的猪病原体。无针皮内疫苗接种已成为传统注射的一种有希望的替代方法,可能改善高密度猪生产系统中的动物福利、生物安全性和抗原递送效率。用15头30日龄健康仔猪对表达猪瘟病毒E2蛋白的重组prrsv载体活疫苗(rPRRSV-E2)进行了评价。动物随机分为3组:肌肉注射rPRRSV-E2疫苗(基于针的rPRRSV-E2免疫)、皮内注射rPRRSV-E2疫苗(无针免疫)和模拟对照组。跟踪仔猪的临床体征、生长情况和直肠温度至63 dpv(接种后天数)。采用酶联免疫吸附法(ELISA)检测PRRSV/CSFV抗体;RT-qPCR检测血清、拭子和组织中的病毒RNA。肉眼和组织病理学检查在63 dpv。两种疫苗接种途径均诱导血清转化为PRRSV和CSFV 14 dpv,皮内注射组对这两种抗原的抗体水平均显著提高(*p
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引用次数: 0
Comprehensive characterization of multivalent mRNA vaccines functionality by flow cytometry and mass spectrometry 流式细胞术和质谱技术对多价mRNA疫苗功能的综合表征
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-02-27 Epub Date: 2026-01-07 DOI: 10.1016/j.vaccine.2025.128180
Thibaut Willemin , Fabien Guinchard , Jauris Marmey , Audrey Chareyre , Audrey Aguesse , Sebastien Peronin , Mynel Bouhired , Camille Malburet , Philippe Talaga , Eric Abachin , Stéphanie Fertier-Prizzon
The number of clinical trials involving mRNA vaccines has increased considerably over the past few years, increasing the demand for analysis and quantification of their biological activity in vitro. This present challenges due to mRNA vaccines' complex mechanism of action. As the mRNA platform requires minimal adaptations between projects, analytical methods should be quickly adaptable to maximize the technology's benefits. In the literature, mRNA vaccines biological activity is assessed using antibody-based methods that compare percentages of positive cells. However, these methods do not allow quantification of different antigen expression levels between samples, and require using specific antibodies, limiting platform applicability. This study aimed to identify the most relevant read-out using an antibody-based method, and to compare it with an antibody-independent quantifiable method (liquid chromatography coupled with mass spectrometry; LCMS). Both approaches were used to analyze multivalent mRNA samples in stability studies. Results showed that reporting transfection efficiency by percentage of positive cells does not capture differences in protein expression between samples. Integrated median fluorescence intensity (iMFI) highlights these differences and shows trends consistent with antigens quantification by LCMS, confirming the relevance of the latter. However, the LCMS method does not allow relative potency analyses, as the parallelism between samples' dose-responses can be lost due to sample degradation. In summary, iMFI can provide a more comprehensive view of mRNA vaccine's in vitro functionality than the percentage of positive cells. Additionally, this work demonstrates that LCMS is indeed a viable antibody-free alternative to quantify mRNA vaccine functionality. However, neither method allows for calculating relative potencies as prescribed in the US pharmacopeias guidelines.
在过去几年中,涉及mRNA疫苗的临床试验数量大幅增加,增加了对其体外生物活性分析和量化的需求。由于mRNA疫苗具有复杂的作用机制,这是目前的挑战。由于mRNA平台需要在项目之间进行最小程度的调整,因此分析方法应该能够快速适应,以最大限度地发挥该技术的优势。在文献中,使用基于抗体的方法比较阳性细胞的百分比来评估mRNA疫苗的生物活性。然而,这些方法不允许定量样品之间不同的抗原表达水平,并且需要使用特异性抗体,限制了平台的适用性。本研究旨在使用基于抗体的方法确定最相关的读数,并将其与不依赖抗体的定量方法(液相色谱-质谱联用法;LCMS)进行比较。在稳定性研究中,这两种方法都被用于分析多价mRNA样本。结果表明,以阳性细胞百分比报告转染效率并不能反映样品之间蛋白质表达的差异。综合中位荧光强度(iMFI)突出了这些差异,并显示出与LCMS抗原定量一致的趋势,证实了后者的相关性。然而,LCMS方法不允许相对效价分析,因为样品的剂量反应之间的平行性可能由于样品降解而丢失。综上所述,与阳性细胞百分比相比,iMFI可以更全面地了解mRNA疫苗的体外功能。此外,这项工作表明LCMS确实是一种可行的无抗体替代方法来量化mRNA疫苗的功能。然而,这两种方法都不允许计算美国药典指南规定的相对效价。
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引用次数: 0
A novel calcium influx inducer and a TLR7 agonist are synergistic co-adjuvants that enhance cross-reactive immunity against influenza in young and aged mice 一种新的钙内流诱导剂和TLR7激动剂是协同佐剂,可增强年轻和老年小鼠对流感的交叉反应性免疫
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-02-27 Epub Date: 2026-01-08 DOI: 10.1016/j.vaccine.2025.128189
Yumi Yokoyama , Shiyin Yao , Renna Cozza , Fernando Gil , Ian Mclaughlin , Paola Anguiano Quiroz , Tyler Brown , Nikunj M. Shukla , Michael Chan , Karen Messer , Minya Pu , Maripat Corr , Dennis A. Carson , Tomoko Hayashi
Vaccine adjuvants play a crucial role in the efficacy of vaccines, particularly in immunocompromised populations. Newer agents and combination strategies are needed for adequate defense against emerging pathogens and their evolving variants. Here we report the benefit of a synergistic combination of two adjuvants: a Toll-like receptor 7 agonist, 1V270, and a calcium influx inducer, 2G272, that elicit Th1 and Th2 biased immune responses, respectively. In vitro, 2G272 significantly enhanced cytokine production induced by 1V270 in human and mouse primary cells, compared to a low activity analog, 2E281, identified from structure-activity relationship studies. Using A/California/07/2009 (H1N1) inactivated influenza A virus (IIAV) as the antigen, the combination adjuvant (2G272 + 1V270) magnified IgG1 and IgG2a responses against hemagglutinin (HA) accompanied by greater hemagglutinin inhibition titers and increased germinal center formation in the draining lymph nodes of immunized BALB/c mice at comparable levels to FDA-approved comparators, MF59 and AS01B. The combination adjuvant also enhanced H1 HA-specific T cell responses, augmenting antigen-specific IFNγ secretion. Importantly, the 2G272 + 1V270 combined adjuvant promoted cross-reactive antibody and cellular immune responses against other HAs in phylogenic Group 1: H5, H11, and in Group 2: H3. C57BL/6 aged mice immunized with H1N1 IIAV and 2G272 + 1V270 generated significant anti-H1 IgG1 responses and IFNγ splenic T cell responses to H1 which were cross-reactive with H5 and H3. Collectively, our findings suggest that 2G272 + 1V270 may be a versatile vaccine co-adjuvant system for promoting a larger breadth of cross reactive Th1/Th2 immune responses and robust GC B cell formation, including in the elderly population.
疫苗佐剂在疫苗的效力中起着至关重要的作用,特别是在免疫功能低下的人群中。需要更新的药物和联合策略来充分防御新出现的病原体及其进化变体。在这里,我们报告了两种佐剂协同组合的益处:toll样受体7激动剂1V270和钙内流诱导剂2G272,它们分别引发Th1和Th2偏向性免疫反应。在体外,与低活性的类似物2E281相比,2G272在人和小鼠原代细胞中显著增强了1V270诱导的细胞因子的产生。以A/California/07/2009 (H1N1)灭活甲型流感病毒(IIAV)为抗原,联合佐剂(2G272 + 1V270)增强了免疫BALB/c小鼠的IgG1和IgG2a对血凝素(HA)的应答,同时提高了血凝素抑制滴度,并增加了引流淋巴结中生发中心的形成,其水平与fda批准的比较剂MF59和AS01B相当。联合佐剂还增强H1 ha特异性T细胞反应,增加抗原特异性IFNγ分泌。重要的是,2G272 + 1V270联合佐剂促进了系统发育组1:H5、H11和组2:H3中针对其他ha的交叉反应抗体和细胞免疫应答。经H1N1 IIAV和2G272 + 1V270免疫的C57BL/6老龄小鼠产生了显著的抗H1 IgG1反应和对H1的IFNγ脾T细胞反应,并与H5和H3交叉反应。总的来说,我们的研究结果表明,2G272 + 1V270可能是一种通用的疫苗共佐剂系统,可促进更大范围的交叉反应性Th1/Th2免疫应答和强大的GC B细胞形成,包括在老年人中。
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引用次数: 0
Mind the gap: A qualitative assessment of limitations in school-age immunisation programme delivery for Orthodox Jewish children in northeast London 注意差距:对伦敦东北部正统犹太儿童学龄免疫接种项目实施限制的定性评估
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-02-27 Epub Date: 2026-01-09 DOI: 10.1016/j.vaccine.2025.128193
Ben Kasstan-Dabush , Tehseen Khan , Vanessa Saliba , Tracey Chantler

Introduction

School-based vaccine programme delivery offers convenience to parents, and reduces the burden on primary care capacity. Vaccine coverage among school-age children is lower in Hackney (northeast London), and post-pandemic coverage recovery has been limited in Hackney compared to London and England. Hackney is home to the largest Orthodox Jewish (OJ) population in Europe where most children attend independent faith schools. This study aimed to assess (i): vaccine programme delivery gaps via independent OJ schools in Hackney; and (ii) the primary care catch-up and commissioning strategies undertaken to help close gaps.

Methods

Qualitative evaluations of national incident responses for poliovirus and measles tailored to underserved communities in northeast London (2022–24). Data consisted of in-depth semi-structured interviews (n = 53) with public health professionals, healthcare practitioners, community partners, and OJ parents. Vaccine clinic visits (n = 11) were conducted in northeast London, affording additional (n = 43) focused and opportunistic interviews with OJ parents attending for catch-up.

Results

Evaluating the delivery of routine and outbreak vaccination campaigns to school-age children demonstrates that independent OJ schools in Hackney are a key programme delivery gap, directly impacting access to catch-up and routine adolescent programmes. OJ parents reported that they did not receive relevant vaccine programme information and invitations for school-age children via independent faith schools. Primary care-led outreach clinics were hosted to offer school-age immunisations to OJ adolescents, but did not offer HPV vaccines. Sub-commissioning community organisations to liaise with independent schools may be a strategy to help resolve this delivery gap, but would require responsibilities within school-age immunisation partnerships to be clearly assigned.

Conclusion

Limitations in vaccine programme delivery via independent faith schools in northeast London may play a role in suboptimal vaccination coverage. Programme gaps must be addressed to help ensure that every eligible child is invited for, and can access, routine vaccination via accessible pathways.
以学校为基础的疫苗规划的实施为家长提供了便利,并减轻了初级保健能力的负担。哈克尼(伦敦东北部)学龄儿童的疫苗覆盖率较低,与伦敦和英格兰相比,大流行后哈克尼的疫苗覆盖率恢复有限。哈克尼是欧洲最大的正统犹太人(OJ)人口的家园,大多数孩子都在独立的宗教学校上学。本研究旨在评估(i):通过哈克尼的独立OJ学校提供疫苗规划的差距;(ii)为帮助缩小差距而采取的初级保健追赶和委托战略。方法针对伦敦东北部服务不足社区定制的国家脊髓灰质炎病毒和麻疹事件应对(2022-24)进行定性评估。数据包括与公共卫生专业人员、医疗从业人员、社区合作伙伴和OJ父母的深度半结构化访谈(n = 53)。在伦敦东北部进行了疫苗诊所访问(n = 11),提供了额外的(n = 43)重点和机会性访谈,与参加的OJ父母进行了跟进。结果对向学龄儿童提供常规和暴发疫苗接种运动的评估表明,哈克尼的独立OJ学校是一个关键的方案提供差距,直接影响到获得追赶和常规青少年方案。OJ父母报告说,他们没有通过独立的宗教学校收到有关疫苗方案的信息和学龄儿童的邀请。以初级保健为主导的外展诊所为OJ青少年提供学龄免疫接种,但不提供HPV疫苗。委托社区组织与私立学校联系可能是帮助解决这一交付差距的一种策略,但这需要明确分配学龄免疫伙伴关系中的责任。结论伦敦东北部独立宗教学校疫苗接种计划的局限性可能是疫苗接种覆盖率不理想的原因之一。必须填补规划空白,以帮助确保每一个符合条件的儿童都被邀请并能够通过无障碍途径获得常规疫苗接种。
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引用次数: 0
Hepatitis B core antigen-based trivalent VLP vaccine against porcine viral diarrhea 猪病毒性腹泻乙型肝炎核心抗原三价VLP疫苗。
IF 4.5 3区 医学 Q2 IMMUNOLOGY Pub Date : 2026-02-27 Epub Date: 2026-01-10 DOI: 10.1016/j.vaccine.2026.128210
Shouzhi Sheng , Yixue Sun , Jiayi Qin , Jinghui Zhao , Ao He , Siqi Li , Chao Gao , Yanlong Cong
Porcine viral diarrhea imposes substantial economic burdens on the swine industry. The commercial triplex-attenuated vaccine against TGEV, PEDV, and PoRV infections has limitations in preparation and efficacy. The Hepatitis B virus core antigen (HBcAg), known for its ability to self-assemble into virus-like particles (VLPs) in vitro and stably present exogenous antigens, serves as a critical technical foundation for the development of innovative nano-vaccines. In this study, we strategically concatenated truncated and full-length monomers of HBcAg, with the conserved linear neutralizing epitopes from TGEV, PEDV, and PoRV being respectively integrated exclusively into the truncated variants to develop a trivalent-VLP (triVLP) vaccine candidate for porcine viral diarrhea. The immunogenicity of triVLPs at two distinct dosages (25 μg and 50 μg) was then evaluated in BALB/c mice following their administration. Notably, the higher dosage of 50 μg triVLP was found to significantly enhance cellular immunity compared to the 25 μg triVLP group, as evidenced by the substantial increase in serum levels of IFN-γ and IL-4 observed at 35 days post-immunization (dpi). Furthermore, at 35 dpi, the IgG and virus neutralizing (VN) antibody titers against TGEV, PEDV, and PoRV in the 50 μg triVLP group were significantly higher than those observed in the group receiving the commercial triplex-attenuated vaccine, indicating a pronounced humoral immune response. Collectively, our data indicate that HBcAg-based trivalent VLPs elicit potent cellular and humoral immunity, positioning them as a prospective vaccine candidate for porcine viral diarrhea.
猪病毒性腹泻给养猪业带来了巨大的经济负担。针对TGEV、PEDV和PoRV感染的商用三联减毒疫苗在制备和效力方面存在局限性。乙型肝炎病毒核心抗原(HBcAg)以其在体外自组装成病毒样颗粒(vlp)并稳定呈递外源抗原的能力而闻名,是开发创新型纳米疫苗的关键技术基础。在这项研究中,我们战略性地连接HBcAg的截断和全长单分子,将TGEV、PEDV和PoRV的保守线性中和表位分别整合到截断的变体中,以开发猪病毒性腹泻的三价vlp (triVLP)候选疫苗。然后在给药后对两种不同剂量(25 μg和50 μg)的BALB/c小鼠进行免疫原性评价。值得注意的是,与25 μg triVLP组相比,高剂量50 μg triVLP组显著增强了细胞免疫,免疫后35天血清中IFN-γ和IL-4水平显著升高。此外,在35 dpi时,50 μg三联减毒疫苗组抗TGEV、PEDV和PoRV的IgG和病毒中和(VN)抗体滴度显著高于商用三联减毒疫苗组,表明有明显的体液免疫应答。总的来说,我们的数据表明,基于hbsag的三价VLPs可引发有效的细胞和体液免疫,使其成为猪病毒性腹泻的潜在候选疫苗。
{"title":"Hepatitis B core antigen-based trivalent VLP vaccine against porcine viral diarrhea","authors":"Shouzhi Sheng ,&nbsp;Yixue Sun ,&nbsp;Jiayi Qin ,&nbsp;Jinghui Zhao ,&nbsp;Ao He ,&nbsp;Siqi Li ,&nbsp;Chao Gao ,&nbsp;Yanlong Cong","doi":"10.1016/j.vaccine.2026.128210","DOIUrl":"10.1016/j.vaccine.2026.128210","url":null,"abstract":"<div><div>Porcine viral diarrhea imposes substantial economic burdens on the swine industry. The commercial triplex-attenuated vaccine against TGEV, PEDV, and PoRV infections has limitations in preparation and efficacy. The Hepatitis B virus core antigen (HBcAg), known for its ability to self-assemble into virus-like particles (VLPs) in vitro and stably present exogenous antigens, serves as a critical technical foundation for the development of innovative nano-vaccines. In this study, we strategically concatenated truncated and full-length monomers of HBcAg, with the conserved linear neutralizing epitopes from TGEV, PEDV, and PoRV being respectively integrated exclusively into the truncated variants to develop a trivalent-VLP (triVLP) vaccine candidate for porcine viral diarrhea. The immunogenicity of triVLPs at two distinct dosages (25 μg and 50 μg) was then evaluated in BALB/c mice following their administration. Notably, the higher dosage of 50 μg triVLP was found to significantly enhance cellular immunity compared to the 25 μg triVLP group, as evidenced by the substantial increase in serum levels of IFN-γ and IL-4 observed at 35 days post-immunization (dpi). Furthermore, at 35 dpi, the IgG and virus neutralizing (VN) antibody titers against TGEV, PEDV, and PoRV in the 50 μg triVLP group were significantly higher than those observed in the group receiving the commercial triplex-attenuated vaccine, indicating a pronounced humoral immune response. Collectively, our data indicate that HBcAg-based trivalent VLPs elicit potent cellular and humoral immunity, positioning them as a prospective vaccine candidate for porcine viral diarrhea.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"74 ","pages":"Article 128210"},"PeriodicalIF":4.5,"publicationDate":"2026-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145954620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Vaccine
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