Vaccines最新文献

{"title":"A Phase II Study of Denileukin Diftitox in Patients with Advanced Treatment Refractory Breast Cancer.","authors":"William R Gwin, Lupe G Salazar, James Y Dai, Doreen Higgins, Andrew L Coveler, Jennifer S Childs, Rosie Blancas, Yushe Dang, Jessica Reichow, Meredith Slota, Hailing Lu, Mary L Disis","doi":"10.3390/vaccines13020117","DOIUrl":"10.3390/vaccines13020117","url":null,"abstract":"<p><p><b>Background/Objectives</b>: Regulatory T cells (Treg) suppress immunity in the tumor microenvironment, are linked to poor prognosis across breast cancer subtypes, and suppress the cytolytic function of cytotoxic CD8+ T cells. Denileukin diftitox, a diphtheria toxin (DT)/IL-2 fusion protein, targets and depletes Tregs. This Phase II study aimed to assess the safety of denileukin diftitox and its effect on Tregs and tumor growth in patients with advanced breast cancer. <b>Methods</b>: This single-arm Phase II study of denileukin diftitox enrolled patients with refractory stage IV breast cancer. Patients received denileukin diftitox 18 mcg/kg/day IV for Days 1-5 every 21 days for up to six cycles. Toxicity was assessed using CTCAE v3.0 and tumor response was evaluated per RECIST criteria. Blood samples were collected to analyze Tregs by flow cytometry and anti-DT antibodies by ELISA. <b>Results</b>: Fifteen patients with stage IV breast cancer were enrolled. Four patients completed all planned denileukin diftitox infusions and achieved stable disease (27%, 95% CI [0.08, 0.55]). Two patients (13%) discontinued due to toxicity, and nine patients (60%) discontinued due to progressive disease. Eleven patients experienced at least one grade 3 or 4 adverse event. Although there was a general reduction in peripheral blood Tregs, the difference in CD4+CD25+FOXP3+ Tregs levels post-treatment was not statistically significant (<i>p</i> = 0.10). Six patients (40%) achieved ≥25% reductions in Tregs. A significant increase in anti-DT IgG antibodies was observed post-treatment (<i>p</i> < 0.005). <b>Conclusions</b>: Denileukin diftitox demonstrated moderate toxicity in this advanced breast cancer cohort. Denileukin diftitox modulated regulatory T cells. However, the majority of patients experienced disease progression in the study.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Zero-Dose Vaccination of Self-Paid Vaccines Among Migrant and Left-Behind Children in China: Evidence from Zhejiang and Henan Provinces.","authors":"Yaguan Zhou, Heng Anna Du, Shu Chen, Shenglan Tang, Xiaolin Xu","doi":"10.3390/vaccines13020118","DOIUrl":"10.3390/vaccines13020118","url":null,"abstract":"<p><strong>Background/objectives: </strong>As zero-dose vaccination has become a global health concern, understanding the practice of self-paid immunizations in migrant and left-behind children in China is crucial to the prevention and control of infectious diseases.</p><p><strong>Methods: </strong>A cross-sectional study was conducted in 1648 children and their caregivers in urban areas in Zhejiang Province and rural areas in Henan Province. The participants were then classified into four groups: urban local, migrant, non-left-behind, and left-behind.</p><p><strong>Results: </strong>Compared to urban local children, migrant (prevalence ratios: 1.29, 95% confidence intervals: 0.69-2.41), non-left-behind (4.72, 3.02-7.37), and left-behind (4.79, 3.03-7.56) children were more likely to be zero-dose vaccinated. Children aged 1-2 years (odds ratio: 1.60, 95% confidence intervals: 1.14-2.23) and born later (1.55, 1.12-2.14), with caregivers aged >35 years (1.49, 1.03-2.15) and less educated (elementary school or lower: 4.22, 2.39-7.45) were less likely to receive self-paid vaccinations, while caregivers other than parents (0.62, 0.41-0.94) and lower household income (0.67, 0.49-0.90) lowered the likelihood of zero-dose vaccination of self-paid vaccines. For migrant and rural zero-dose children, the majority of caregivers reported they \"didn't know where to get a vaccination\", with responses ranging from 82.3% to 93.8%.</p><p><strong>Conclusions: </strong>Migrant and rural children should be prioritized in the promotion of self-paid immunization in order to accomplish the WHO Immunization Agenda 2030's goal of \"leaving no one behind\".</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pediatric Vaccine Hesitancy in the United States-The Growing Problem and Strategies for Management Including Motivational Interviewing.","authors":"Ashlesha Kaushik, Julia Fomicheva, Nathan Boonstra, Elizabeth Faber, Sandeep Gupta, Helen Kest","doi":"10.3390/vaccines13020115","DOIUrl":"10.3390/vaccines13020115","url":null,"abstract":"<p><p>Vaccine hesitancy is a significant global issue and is recognized by the World Health Organization (WHO) as one of the most pressing threats to public health. Defined as the delay in acceptance or refusal of vaccines despite their availability, vaccine hesitancy undermines decades of progress in preventing vaccine-preventable diseases. The issue is complex, influenced by misinformation, distrust in healthcare systems, cultural beliefs, and access barriers. These challenges require innovative and empathetic solutions to increase vaccine acceptance. Addressing this growing epidemic requires a multifaceted approach, which involves broader strategies and policymaking and in addition, effective communication tools for clinicians. Motivational Interviewing (MI), a patient-centered communication technique, offers an effective strategy to address pediatric vaccine hesitancy by fostering trust, understanding, and informed decision-making. This review aims to explore the problem of pediatric vaccine hesitancy in the United States, examine its underlying factors, and highlight evidence-based strategies, including Motivational Interviewing, to address this growing concern in clinical and public health settings. It offers practical guidance for healthcare providers and pediatricians to tackle this growing problem effectively and emphasizes the need for a combined effort of communication, community outreach, education, and systemic policy to overcome vaccine hesitancy.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860934/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investment Opportunities for mRNA Technology in Low- and Middle-Income Countries: Key Findings and Future Perspectives.","authors":"Ariane de Jesus Lopes de Abreu, Cheleka A M Mpande, Matthias Helble, Martin W Nicholson, María de Los Ángeles Cortés, María Eugenia Pérez Ponsa, Ivan Redini Blumenthal, Francisco Caccavo, Tomas Pippo, Judit Rius Sanjuan, Claudia Nannei","doi":"10.3390/vaccines13020112","DOIUrl":"10.3390/vaccines13020112","url":null,"abstract":"<p><p>In April 2024, a hybrid meeting organized by the WHO, PAHO, and MPP during the World Bank Spring Meetings focused on financing mRNA-based technologies in Low- and Middle-Income Countries (LMICs). This meeting sought to engage multilateral development banks (MDBs) and stakeholders in financing the expansion of vaccine production and enhancing pandemic preparedness. The COVID-19 pandemic underscored the disparities in vaccine production and distribution, highlighting the need for localized production to improve global health equity. The WHO's mRNA Technology Transfer Programme, initiated in 2021, aims to build local capacity for mRNA vaccine development and manufacturing. Key sessions covered during the meeting include innovative investment models, with MDBs discussing funding instruments and the necessity of an integrated ecosystem for sustainable vaccine manufacturing. Challenges such as technological risks and the need for higher risk appetite were addressed, along with innovative financing mechanisms like blended financing. An analysis of capital and operational expenditures for mRNA vaccine facilities was presented, projecting significant production capacity in LMICs within a decade. Panelists emphasized the need for sustainable R&D investment and shared experiences in securing funding for mRNA technology. The meeting underscored the importance of collaboration, innovative financing, ecosystem development, and public-private partnerships, marking a pivotal step towards advancing mRNA technology in LMICs to tackle global health challenges.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11861337/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Phenotypes of Headaches After COVID-19 Vaccinations Differentiated According to the Vaccine Used.","authors":"Carl Hartmut Göbel, Axel Heinze, Katja Heinze-Kuhn, Sarah Karstedt, Mascha Morscheck, Lilian Tashiro, Anna Cirkel, Qutyaba Hamid, Rabih Halwani, Mohamad-Hani Temsah, Malte Ziemann, Siegfried Görg, Thomas Münte, Hartmut Göbel","doi":"10.3390/vaccines13020113","DOIUrl":"10.3390/vaccines13020113","url":null,"abstract":"<p><p><b>Background/Objectives</b>: In this ongoing, multicenter, global cohort observational study, phenotypes of headaches after COVID-19 vaccination were directly compared between different vaccines. <b>Methods</b>: Phenotypes of postvaccinal headache were recorded in 18,544 participants. The study was launched immediately after the start of the global COVID-19 vaccination campaign on 12 January 2021 and continued until 1 August 2023. Specific aspects of headaches and related variables were collected via an online questionnaire. The clinical headache characteristics of patients vaccinated with the Comirnaty (BioNTech), Jcovden (Johnson & Johnson), Sputnik V (Gamelaya), Covilo (Sinopharm), Spikevax (Moderna), Vaxzevria (AstraZeneca), and Convidecia (CanSino Biologics) vaccines were investigated. <b>Results</b>: Across all vaccines, the median and mean latency of headache onset after vaccine administration were 12 h and 23.3 h, respectively. The median and mean headache duration were 12 h and 23.3 h, respectively. When the nonreplicating viral vector vaccine Sputnik V was used, headaches occurred the fastest, with a latency of 17 h. The latencies for the Vaxzevria and Convidecia nonreplicating viral vector vaccines were 14.9 h and 19.1 h, respectively. The Covilo inactivated whole-virus vaccine had a latency of 20.5 h. The latencies of the mRNA-based Comirnaty and Spikevax vaccines were 26.0 h and 22.02 h, respectively. Analysis of variance revealed no significant differences in the mean duration of postvaccinal headache for the vaccines tested. Compared with the Comirnaty, Covilo, and Vaxzevria vaccines, the Spikevax vaccine induced significantly greater headache intensities. Vaxzevria was associated with a significantly higher frequency of concomitant symptoms than the other vaccines. <b>Conclusions</b>: The phenotype of postvaccinal headache can vary significantly between vaccines. These results have clinical implications for differentiating between postvaccinal headache and other primary and secondary headaches. This knowledge is clinically relevant in differentiating life-threatening vaccination complications, such as thrombotic syndromes, which are also associated with headaches. Based on these results, new diagnostic criteria for postvaccinal headaches can be developed.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11861871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immune Response and Breakthrough Infection Risk After SARS-CoV-2 Vaccines in Patients with Hemoglobinopathy: A Single Center Experience.","authors":"Andrea Duminuco, Anna Bulla, Rosamaria Rosso, Maria Anna Romeo, Daniela Cambria, Enrico La Spina, Benedetta Ximenes, Cesarina Giallongo, Daniele Tibullo, Alessandra Romano, Francesco Di Raimondo, Giuseppe A Palumbo","doi":"10.3390/vaccines13020111","DOIUrl":"10.3390/vaccines13020111","url":null,"abstract":"<p><strong>Background: </strong>Immune system impairment is frequently reported in patients affected by hemoglobinopathies due to various mechanisms, including iron accumulation, antigenic stimulation due to numerous transfusions, chronic hemolysis, and a general hyperinflammatory state. For these reasons, the antigenic immune response after a vaccine risks being ineffective.</p><p><strong>Methods: </strong>We evaluated the anti-spike IgG production after two doses of vaccine for SARS-CoV-2 in patients affected by hemoglobinopathies.</p><p><strong>Results: </strong>All 114 enrolled patients (100%) developed adequate antibody production, with a median value of serum IgG of 2184.4 BAU/mL (IQR 1127.4-3502.9). The amount of antibody was unrelated to any other clinical characteristics evaluated, including transfusion dependence or non-transfusion dependence, age, gender, disease type, ferritin, blood count, spleen status, and therapy with hydroxyurea or iron chelators (in all the cases <i>p</i> > 0.05). Moreover, 47 (41.2%) patients developed breakthrough SARS-CoV-2 infection during the first 2 years of follow-up after vaccination, all with a mildly symptomatic course, without requiring hospitalization or experiencing a significative drop in hemoglobin values, allowing for a slight delay in their transfusion regimen.</p><p><strong>Conclusion: </strong>Vaccination against COVID-19 is safe and effective for patients affected by hemoglobinopathies, ensuring adequate protection from severe infection.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860232/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic Vaccines for Hematological Cancers: A Scoping Review of This Immunotherapeutic Approach as Alternative to the Treatment of These Malignancies.","authors":"Fernando Augusto Siqueira Mathias, Maria Gabriela Reis Carvalho, Jeronimo Conceição Ruiz","doi":"10.3390/vaccines13020114","DOIUrl":"10.3390/vaccines13020114","url":null,"abstract":"<p><p><b>Background/Objectives</b>: The need for innovative cancer treatments has brought immunotherapies to the forefront as a promising approach, with therapeutic vaccines demonstrating the potential to mobilize immune cells to eliminate tumor cells. However, challenges such as genetic variability among patients, immune evasion mechanisms, and disease relapse contribute to the complexity of achieving an ideal therapy, especially for hematological cancers. This review systematically identifies and analyzes recent studies focused on the development of therapeutic immunotherapy vaccines, examining critical aspects such as development stages, key assays for therapeutic validation, treatment outcomes, and study limitations. <b>Methods</b>: A scoping review was conducted following the PRISMA extension guidelines (PRISMA-ScR). Literature searches were conducted across Scopus, PubMed, Web of Science, and Science Direct databases using keywords including \"immunotherapy\", \"vaccines\", \"immunization\", \"hematological malignancies\", \"blood cancer\", \"hematopoietic neoplasms\", and \"leukemia\". <b>Results</b>: A total of 56 articles published from 2013 to 2024 were included in the analysis. The majority of studies are in the preclinical stage, with some advancing to phase 1 and phase 2 clinical trials. Acute myeloid leukemia emerged as the most frequently studied malignancy. While first- and second-generation vaccines dominate the field, innovative approaches, such as dendritic-cell-based vaccines and mRNA vaccines, are gaining prominence. Notably, preclinical models often demonstrate superior outcomes compared to clinical trials, as results observed in animal models are not fully replicated in human studies. <b>Conclusions</b>: Despite challenges related to disease progression and patient loss, the studies reviewed highlight significant advancements in patient prognosis, emphasizing the potential of novel therapeutic vaccines as an effective alternative for the treatment of hematological cancers.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Design and Immunogenicity of an HIV-1 Clade C Pediatric Envelope Glycoprotein Stabilized by Multiple Platforms.","authors":"Sanjeev Kumar, Iván Del Moral-Sánchez, Swarandeep Singh, Maddy L Newby, Joel D Allen, Tom P L Bijl, Yog Vaghani, Liang Jing, Rakesh Lodha, Eric A Ortlund, Max Crispin, Anamika Patel, Rogier W Sanders, Kalpana Luthra","doi":"10.3390/vaccines13020110","DOIUrl":"10.3390/vaccines13020110","url":null,"abstract":"<p><strong>Background: </strong>Elite-neutralizer-derived HIV-1 envelopes (Envs), which induce broadly neutralizing antibodies (bnAbs), can inform HIV-1 vaccine design by serving as templates for bnAb-eliciting vaccines. Since single Env-based immunizations are insufficient to induce bnAb responses, sequential regimens using multivalent immunogens or Env cocktails hold greater promise. This underscores the need to develop stable Env trimers from diverse HIV-1 strains, particularly clade-C, which accounts for 50% of global infections and over 90% in India and South Africa. While various platforms exist to stabilize soluble Env trimers for use as antigenic baits and vaccines, stabilizing clade C trimers remains challenging.</p><p><strong>Methods: </strong>We stabilized an HIV-1 clade C trimer based on an Env isolated from a pediatric elite neutralizer (AIIMS_329) using multiple platforms, including SOSIP.v8.2, ferritin nanoparticles (NPs) and I53-50 two-component NPs, followed by characterization of their biophysical, antigenic, and immunogenic properties.</p><p><strong>Results: </strong>The stabilized 329 Envs showed binding to multiple HIV-1 bnAbs, with negligible binding to non-neutralizing antibodies. Negative-stain electron microscopy confirmed the native-like conformation of the Envs. Multimerization of 329 SOSIP.v8.2 on ferritin and two-component I53-50 NPs improved the affinity to HIV-1 bnAbs and showed higher immunogenicity in rabbits.</p><p><strong>Conclusions: </strong>The soluble 329 Env protein could serve as an antigenic bait, and multimeric 329 NP Envs are potential vaccine candidates.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVID-19 Breakthrough Infections in Immune-Mediated Inflammatory Diseases: Data from the SUCCEED (Safety and Immunogenicity of COVID-19 Vaccines in Systemic Autoimmune-Mediated Inflammatory Diseases) Study.","authors":"Jeremiah Tan, Sasha Bernatsky, Jennifer L F Lee, Paul R Fortin, Roya M Dayam, Anne-Claude Gingras, Ines Colmegna, Dawn M E Bowdish, Claudie Berger, Dora Chan, Maggie J Larché, Dawn P Richards, Lourdes Gonzalez Arreola, Carol A Hitchon, Nadine Lalonde, J Antonio Aviña-Zubieta","doi":"10.3390/vaccines13020104","DOIUrl":"10.3390/vaccines13020104","url":null,"abstract":"<p><p><b>Background</b>: The Safety and Immunogenicity of COVID-19 Vaccines in Systemic Autoimmune-Mediated Inflammatory Diseases (SUCCEED) study was created to better understand COVID-19 vaccination in immune-mediated inflammatory disease (IMID). Knowing the frequency of COVID-19 breakthrough infections is important, particularly in IMID. Our objective was to assess these events in IMID. <b>Methods</b>: We prospectively studied IMID participants who had received ≥three COVID-19 vaccine doses. Individuals provided saliva samples monthly (September 2022 to August 2023). These were evaluated by polymerase chain reaction (PCR) for SARS-CoV-2. We also assessed antibodies against SARS-CoV-2 (anti-spike, SmT1, receptor binding domain, RBD, and nucleocapsid, NP) based on dried blood spots. Multivariable general estimating equation regression produced odd ratios (OR) for PCR SARS-CoV-2 positivity, related to demographics, immunosuppressives, and antibody levels. <b>Results</b>: Diagnoses included rheumatoid arthritis RA (<i>N</i> = 161, 44% of the total), systemic lupus, psoriatic arthritis, spondylarthritis, vasculitis, systemic sclerosis, and inflammatory bowel disease. Of the 366 participants, most were taking immunosuppressive medication. Of 1266 saliva samples, 56 (5.1%) were positive for SARS-CoV-2 on PCR. Higher anti-SmT1 antibodies were inversely associated with SARS-CoV-2 detection on PCR (adjusted OR 0.66, 95% confidence interval 0.45-0.97). Antibodies to SmT1, RBD, and NP were correlated and thus could not be included in a single model, but when anti-RBD was used in place of anti-SmT1, the results were similar. No other factor (including prior COVID-19 infection) was clearly associated with SARS-CoV-2 detection. <b>Conclusions</b>: This is the first study of SARS-CoV-2 in a large prospective cohort of triple (or more) vaccinated individuals with IMIDs. Anti-SmT1 antibodies appeared to be protective against later SARS-CoV-2 positivity, although recent past infection was not clearly related. This suggests the importance of maintaining robust vaccine-induced immunity through vaccination in IMID.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860671/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143503731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New High-Throughput Method for Aluminum Content Determination in Vaccine Formulations.","authors":"Lorenzo Di Meola, Daniela Pasqui, Chiara Tigli, Stephen Luckham, Silvio Colomba, Marilena Paludi, Maxime Denis, Angelo Palmese, Daniela Stranges, Agnese Marcelli, Alessio Moriconi, Malte Meppen, Carlo Pergola","doi":"10.3390/vaccines13020105","DOIUrl":"10.3390/vaccines13020105","url":null,"abstract":"<p><strong>Objective: </strong>This manuscript describes an innovative, non-destructive, high-throughput method for the quantification of aluminum hydroxide in aluminum-adjuvanted vaccines, eliminating the need of reagents and providing real-time results. The method is based on a spectrophotometric principle, and several model proteins were studied and tested with the aim to simulate the behavior of aluminum-adjuvanted antigens.</p><p><strong>Methods: </strong>As a proof of concept, the MenB vaccine was used, and the titration of aluminum hydroxide (AH) with ethylenediaminetetraacetic acid (EDTA) was used as an orthogonal reference, as it is one of the current release methods for the content determination of aluminum-hydroxide-adjuvanted vaccine drug products (DPs). The factors influencing the spectrophotometric analysis, such as different plate 96/well containers, variation in the sedimentation of the suspension due to component addition errors during formulation, and batch-to-batch variation were studied to assess the method's robustness. Five concentration levels (ranging from 2.0 to 4.0 mg/mL AH) with two different batches of aluminum hydroxide were each measured with independent preparations performed by three different operators, for a total of four sessions/operator and 20 formulations/session. An in-depth statistical study was carried out with generated data to assess the precision (in terms of intermediate precision and repeatability), accuracy, linearity, and specificity of the method.</p><p><strong>Results: </strong>The novel spectrophotometric method and the official release one (potentiometric) yielded comparable results, demonstrating the potential of this new method as a release test for AH-adjuvanted products. A simple calibration curve enabled the measurement of samples in a 96-well plate in just a few minutes.</p><p><strong>Conclusions: </strong>We developed a novel method for Aluminum concentration determination in Aluminum-containing pharmaceutical products, like alum-adjuvanted vaccines. This method is fast, completely automatable, and as precise and accurate as already-in-place release methods.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11861868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}