Vaccines最新文献

{"title":"Evaluating Families' Opinions of Routine Influenza Vaccination in Children Under 5 Years of Age in Spain.","authors":"Sílvia Burgaya-Subirana, Anna Ruiz-Comellas, Queralt Miró Catalina, Mònica Balaguer","doi":"10.3390/vaccines13010054","DOIUrl":"10.3390/vaccines13010054","url":null,"abstract":"<p><strong>Background/objectives: </strong>Influenza vaccination is the main method for preventing influenza. The objectives of this study are to evaluate the opinions of families on influenza vaccination and to determine the acceptance of influenza vaccination as a routine vaccine in children under 5 years of age.</p><p><strong>Methods: </strong>The method used was a descriptive cross-sectional study based on an ad-hoc survey. Between October 2023 and January 2024, an online survey was conducted among families with children between 6 months and 14 years of age attending paediatric consultations at a health centre.</p><p><strong>Results: </strong>A total of 388 families were surveyed. Out of these, 22.68% reported having ever vaccinated their children against influenza. The main reason for having them vaccinated was having received the recommendation from the paediatrician (68.18%). While 53.61% agreed with routine influenza vaccination, 53.09% did not intend to vaccinate their children against influenza in the 2023/24 period. The reasons for not vaccinating in 2023/24 were unawareness of the disease (29.41%), fear of unwanted effects of vaccination (27.94%) and lack of information about vaccination (19.61%). The reasons for vaccination in 2023/24 were protection of the child (81.87%), recommendation by the paediatrician (43.41%) and protection of the general population and susceptible persons (20.33%).</p><p><strong>Conclusions: </strong>Routine influenza vaccination is accepted by half of the parents. A lack of risk perception of the disease, concern about vaccine safety and lack of information are the main reasons for not vaccinating. It is essential to follow the health professionals' recommendation to vaccinate.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11768964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143033933","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":"Genetically Engineered Bacterial Ghosts as Vaccine Candidates Against <i>Klebsiella pneumoniae</i> Infection.","authors":"Svetlana V Dentovskaya, Anastasia S Vagaiskaya, Alexandra S Trunyakova, Alena S Kartseva, Tatiana A Ivashchenko, Vladimir N Gerasimov, Mikhail E Platonov, Victoria V Firstova, Andrey P Anisimov","doi":"10.3390/vaccines13010059","DOIUrl":"10.3390/vaccines13010059","url":null,"abstract":"<p><p><b>Background/Objectives</b> Bacterial ghosts (BGs), non-living empty envelopes of bacteria, are produced either through genetic engineering or chemical treatment of bacteria, retaining the shape of their parent cells. BGs are considered vaccine candidates, promising delivery systems, and vaccine adjuvants. The practical use of BGs in vaccine development for humans is limited because of concerns about the preservation of viable bacteria in BGs. <b>Methods:</b> To increase the efficiency of <i>Klebsiella pneumoniae</i> BG formation and, accordingly, to ensure maximum killing of bacteria, we exploited previously designed plasmids with the lysis gene <i>E</i> from bacteriophage φX174 or with holin-endolysin systems of λ or L-413C phages. Previously, this kit made it possible to generate bacterial cells of <i>Yersinia pestis</i> with varying degrees of hydrolysis and variable protective activity. <b>Results:</b> In the current study, we showed that co-expression of the holin and endolysin genes from the L-413C phage elicited more rapid and efficient <i>K. pneumoniae</i> lysis than lysis mediated by only single gene <i>E</i> or the low functioning holin-endolysin system of λ phage. The introduction of alternative lysing factors into <i>K. pneumoniae cells</i> instead of the E protein leads to the loss of the murein skeleton. The resulting frameless cell envelops are more reminiscent of bacterial sacs or bacterial skins than BGs. Although such structures are less naive than classical bacterial ghosts, they provide effective protection against infection by a hypervirulent strain of <i>K. pneumoniae</i> and can be recommended as candidate vaccines. For our vaccine candidate generated using the O1:K2 hypervirulent <i>K. pneumoniae</i> strain, both safety and immunogenicity aspects were evaluated. Humoral and cellular immune responses were significantly increased in mice that were intraperitoneally immunized compared with subcutaneously vaccinated animals (<i>p</i> < 0.05). <b>Conclusions:</b> Therefore, this study presents novel perspectives for future research on <i>K. pneumoniae</i> ghost vaccines.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11768506/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034219","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":"Surveillance of Adverse Events Following Varicella Vaccine Immunization in Zhejiang Province, China, from 2020 to 2022.","authors":"Hui Liang, Xiaohua Qi, Yaping Chen, Xuejiao Pan","doi":"10.3390/vaccines13010057","DOIUrl":"10.3390/vaccines13010057","url":null,"abstract":"<p><p><b>Background</b>: China has a high incidence rate of varicella yet a low coverage rate of the varicella vaccine (VarV), with safety concerns being a leading cause of the lack of vaccination willingness. This study aimed to describe VarV-related adverse events following immunization (AEFIs) and analyze their characteristics in Zhejiang, China, 2020-2022. <b>Methods</b>: VarV-related AEFIs in Zhejiang Province from 1 January 2020 to 31 December 2022 were collected through the Chinese National AEFI Information System (CNAEFIS) for a descriptive epidemiological analysis. <b>Results</b>: From 2020 to 2022, a total of 1477 VarV-related AEFI cases were reported (incidence rate: 34.79/100,000). The three most frequently reported clinical symptoms of common adverse reactions were fever, redness, and induration at the vaccination site. The distribution of VarV-related AEFIs varied significantly by age, dose, severity, and season. VarV-related AEFIs were more likely to be non-severe adverse events that occurred in the summer and winter seasons following the first dose of vaccine and among those under 3 years old. The top three regions with the highest incidence rates were Lishui City (59.53/100,000), Quzhou City (41.05/100,000), and Jinhua City (40.43/100,000). Most of the cases achieved full recovery without treatment (96.21%), and the rest were successfully treated without any sequelae. <b>Conclusions</b>: VarV demonstrates a safe profile in Zhejiang Province. Most VarV-related AEFIs are common reactions without requiring treatment, and the rates of rare and severe AEFIs remain low. Consistent monitoring, investigation, and diagnosis are needed to guide future VarV research and vaccination strategy adjustment. Our findings call for more policy changes, such as integrating VarV into China's National Immunization Program and conducting more trials to evaluate the safety and effectiveness of VarV.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11769265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034423","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":"Evaluating the Efficacy and Safety of Hepatitis E Vaccination in Reproductive-Age Women: A Systematic Review and Meta-Analysis.","authors":"Vaidas Jotautis, Antigoni Sarantaki","doi":"10.3390/vaccines13010053","DOIUrl":"10.3390/vaccines13010053","url":null,"abstract":"<p><strong>Background: </strong>Hepatitis E virus (HEV) infection presents a significant health risk in endemic regions, especially for pregnant women, who face higher risks of severe complications, including maternal and fetal mortality. The recombinant HEV vaccine, HEV239, has demonstrated high efficacy in the general population, yet data on its safety and efficacy in women of a childbearing age remain limited. This systematic review and meta-analysis aim to evaluate the safety and effectiveness of HEV239 in this specific population, with a focus on pregnancy-related outcomes.</p><p><strong>Methods: </strong>A comprehensive search was conducted in PubMed, Embase, Cochrane Library, and Scopus, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies were included if they reported outcomes on HEV239's safety or efficacy in women of childbearing age, with data being extracted and analyzed for immunogenicity, HEV incidence, and maternal adverse events. The risk of bias was assessed using the Cochrane and Newcastle Ottawa Scales, and a random-effects meta-analysis was performed.</p><p><strong>Results: </strong>Three studies, enrolling over 23,000 participants, were included in the current systematic review, with two meeting the criteria for meta-analysis. HEV239 demonstrated high efficacy in preventing hepatitis E infection, with no significant increase in adverse pregnancy outcomes such as stillbirth or elective termination. However, there was an elevated risk of miscarriage (odds ratio [OR], 1.60; 95% confidence interval [CI], 0.99-2.57). The analysis revealed high heterogeneity for miscarriage outcomes (I² = 67%), reflecting variability in study designs and populations.</p><p><strong>Conclusions: </strong>HEV239 is effective in preventing HEV infection among women of childbearing age, although caution is advised when administering the vaccine near conception due to potential miscarriage risks. Future studies should focus on understanding the biological mechanisms and timing-specific safety to guide vaccination recommendations.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11768898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143033999","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":"An mRNA-Based Respiratory Syncytial Virus Vaccine Elicits Strong Neutralizing Antibody Responses and Protects Rodents Without Vaccine-Associated Enhanced Respiratory Disease.","authors":"Jianglong Li, Haiyan Long, Shaoyi Chen, Zhendong Zhang, Shuang Li, Qi Liu, Jun Liu, Jiaru Cai, Liping Luo, Yucai Peng","doi":"10.3390/vaccines13010052","DOIUrl":"10.3390/vaccines13010052","url":null,"abstract":"<p><strong>Background: </strong>Respiratory syncytial virus (RSV) causes the most common type of severe lower respiratory tract infection worldwide, and the fusion (F) protein is a target for neutralizing antibodies and vaccine development. This study aimed to investigate the immunogenicity and efficacy of an mRNA-based RSV vaccine with an F protein sequence.</p><p><strong>Methods: </strong>We designed an mRNA construct encoding a modified RSV F protein, which was further developed into an LNP-encapsulated mRNA vaccine (LVRNA007). LVRNA007 was administered to mice and cotton rats, followed by immunogenicity analysis and viral challenge studies. Protection of rodents from the viral infection was evaluated based on the presence of the virus in the lung and pathological examination of respiratory tissues.</p><p><strong>Results: </strong>LVRNA007 induced robust humoral and cellular immune responses in both mice and cotton rats, with neutralization antibody levels in the immunized animals maintained at high levels for over one year. Vaccination of LVRNA007 also protected the rodents from RSV challenge, judged by the much decreased virus titer and the pathological score in the lung tissue. In addition, no vaccine-enhanced disease (VED) phenomenon was observed with LVRNA007 vaccination.</p><p><strong>Conclusions: </strong>Based on the preclinical immunogenicity and efficacy data, LVRNA007 could be a potential promising vaccine for prophylaxis of RSV infection.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11768429/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034396","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":"Developing an Effective Therapeutic HPV Vaccine to Eradicate Large Tumors by Genetically Fusing Xcl1 and Incorporating IL-9 as Molecular Adjuvants.","authors":"Zhongjie Sun, Zhongyan Wu, Xuncheng Su","doi":"10.3390/vaccines13010049","DOIUrl":"10.3390/vaccines13010049","url":null,"abstract":"<p><strong>Background: </strong>Human papillomavirus (HPV) is a prevalent infection affecting both men and women, leading to various cytological lesions. Therapeutic vaccines mount a HPV-specific CD8+ cytotoxic T lymphocyte response, thus clearing HPV-infected cells. However, no therapeutic vaccines targeting HPV are currently approved for clinical treatment due to limited efficacy. Our goal is to develop a vaccine that can effectively eliminate tumors caused by HPV.</p><p><strong>Methods: </strong>We genetically fused the chemokine XCL1 with the E6 and E7 proteins of HPV16 to target cDC1 and enhance the vaccine-induced cytotoxic T cell response, ultimately developing a DNA vaccine. Additionally, we screened various interleukins and identified IL-9 as an effective molecular adjuvant for our DNA vaccine.</p><p><strong>Results: </strong>The fusion of Xcl1 significantly improved the quantity and quality of the specific CD8+ T cells. The fusion of Xcl1 also increased immune cell infiltration into the tumor microenvironment. The inclusion of IL-9 significantly elevated the vaccine-induced specific T cell response and enhanced anti-tumor efficacy. IL-9 promotes the formation of central memory T cells.</p><p><strong>Conclusions: </strong>the fusion of Xcl1 and the use of IL-9 as a molecular adjuvant represent promising strategies for vaccine development.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11768903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034359","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":"Rotavirus Vaccination Protects Against Diabetes Mellitus Type 1 in Children in Developed Countries: A Systematic Review and Meta-Analysis.","authors":"Chrysoula Kosmeri, Achilleas Klapas, Nikolas Evripidou, Evanthia Kantza, Anastasios Serbis, Ekaterini Siomou, Fani Ladomenou","doi":"10.3390/vaccines13010050","DOIUrl":"10.3390/vaccines13010050","url":null,"abstract":"<p><p><b>Background</b>: The etiology of type 1 diabetes (T1D) remains an area of active research, with genetic and environmental factors being investigated. This meta-analysis aimed to determine if rotavirus vaccination influences the onset of T1D in children. <b>Methods</b>: Following PRISMA 2020 guidelines, two researchers independently searched multiple databases, including PubMed and Google Scholar, for studies published in English from 2006 to September 2024. They used the search terms \"rotavirus vaccination\" and \"type 1 diabetes\", and assessed study quality using the ROBINS-E tool. The analysis pooled hazard ratios (HRs) from selected studies using a fixed-effects model, with statistical significance set at <i>p</i> < 0.05 and heterogeneity evaluated using the I² statistic. <b>Results</b>: A systematic search identified 90 records, of which 5 studies met the inclusion criteria. These studies, encompassing a total population of 4,427,291 children from developed countries, suggest a protective effect of rotavirus vaccination against T1D. The pooled HR was 0.87 (95% CI: 0.78-0.98), indicating a 13% lower risk of T1D in vaccinated children compared to unvaccinated ones (<i>p</i> = 0.03). Moderate heterogeneity was noted (χ² = 10.02, df = 4, <i>p</i> = 0.04, I² = 60%). <b>Conclusions</b>: This analysis suggests that rotavirus vaccination may reduce the risk of T1D in children from high-income Western countries. While these findings are promising, they may not be generalizable to settings outside similar advanced healthcare systems. Further research is needed to confirm the protective effects of rotavirus vaccination against T1D across diverse populations.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11769441/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034410","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":"Peptide Antigen Modifications Influence the On-Target and Off-Target Antibody Response for an Influenza Subunit Vaccine.","authors":"Megan C Schulte, Adam C Boll, Agustin T Barcellona, Elida A Lopez, Adam G Schrum, Bret D Ulery","doi":"10.3390/vaccines13010051","DOIUrl":"10.3390/vaccines13010051","url":null,"abstract":"<p><strong>Background/objectives: </strong>Peptide amphiphile micelles (PAMs) are an exciting nanotechnology currently being studied for a variety of biomedical applications, especially for drug delivery. Specifically, PAMs can enhance in vivo trafficking, cell-targeting, and cell interactions/internalization. However, modifying peptides, as is commonly performed to induce micellization, can influence their bioactivity. In our previous work, murine antibody responses to PAMs containing the influenza antigen M2_2-16 were slightly incongruous with prior PAM vaccine studies using other antigens. In this current work, the effect of native protein linkages and non-native micellizing moieties on M2 immunogenicity was studied.</p><p><strong>Methods: </strong>PAMs were synthesized using an elongated M2 antigen (i.e., Palm₂K-M2_1-24-(KE)₄). The PAMs were characterized, then their immunogenicity was evaluated with bone marrow-derived dendritic cells and in mice.</p><p><strong>Results: </strong>Although the modification scheme yielded immunogenic PAMs, these PAMs induced a substantial amount of off-target antibody production compared to unmodified peptidyl micelles (PMs, M2_1-24 peptide).</p><p><strong>Conclusions: </strong>While the impact PAM-induced off-target antibodies had on vaccine efficacy remains to be elucidated, on-target antibodies from both PAM- and PM-vaccinated mice were excitingly able to recognize the M2 antigen within the context of the full M2 protein. This provides preliminary evidence that the PAM-induced on-target antibodies will at minimum be able to recognize the influenza virus upon exposure.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11768957/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034372","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":"Safety, Tolerability, and Immunogenicity of the Invaplex_AR-Detox<i>Shigella</i> Vaccine Co-Administered with the dmLT Adjuvant in Dutch and Zambian Adults: Study Protocol for a Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase Ia/b Clinical Trial.","authors":"Geert V T Roozen, Nsofwa Sukwa, Masuzyo Chirwa, Jessica A White, Marcus Estrada, Nicole Maier, Kevin R Turbyfill, Renee M Laird, Akamol E Suvarnapunya, Aicha Sayeh, Flavia D'Alessio, Candice Marion, Laura Pattacini, Marie-Astrid Hoogerwerf, Rajagopal Murugan, Manuela Terrinoni, Jan R Holmgren, Sodiomon B Sirima, Sophie Houard, Michelo Simuyandi, Meta Roestenberg","doi":"10.3390/vaccines13010048","DOIUrl":"10.3390/vaccines13010048","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Shigella infections remain endemic in places with poor sanitation and are a leading cause of diarrheal mortality globally, as well as a major contributor to gut enteropathy and stunting. There are currently no licensed vaccines for shigellosis but it has been estimated that an effective vaccine could avert 590,000 deaths over a 20-year period. A challenge to effective Shigella vaccine development has been the low immunogenicity and protective efficacy of candidate Shigella vaccines in infants and young children. Additionally, a new vaccine might be less immunogenic in a highly endemic setting compared to a low endemic setting (\"vaccine hyporesponsiveness\"). The use of a potent adjuvant enhancing both mucosal and systemic immunity might overcome these problems. Invaplex&lt;sub&gt;AR-Detox&lt;/sub&gt; is an injectable Shigella vaccine that uses a novel combination of conserved invasion plasmid antigen proteins and a serotype-specific bacterial lipopolysaccharide attenuated for safe intramuscular administration. The adjuvant dmLT has been shown to enhance Shigella immune responses in mice, has safely been administered intramuscularly, and was shown to enhance immune responses in healthy volunteers when given in combination with other antigens in phase I trials. This article describes the protocol of a study that will be the first to assess the safety, tolerability, and immunogenicity of Invaplex&lt;sub&gt;AR-Detox&lt;/sub&gt; co-administered with dmLT in healthy adults in low-endemic and high-endemic settings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In a multi-center, randomized, double-blind, and placebo-controlled dose-escalation phase Ia/b trial, the safety, tolerability, and immunogenicity of three intramuscular vaccinations administered 4 weeks apart with 2.5 µg or 10 µg of Invaplex&lt;sub&gt;AR-Detox&lt;/sub&gt; vaccine, alone or in combination with 0.1 µg of the dmLT adjuvant, will first be assessed in a total of 50 healthy Dutch adults (phase Ia) and subsequently in 35 healthy Zambian adults (phase Ib) aged 18-50 years. The primary outcome is safety, and secondary outcomes are humoral and cellular immune responses to the adjuvanted or non-adjuvanted vaccine.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;This trial is part of the ShigaPlexIM project that aims to advance the early clinical development of an injectable Shigella vaccine and to make the vaccine available for late-stage clinical development. This trial addresses the issue of hyporesponsiveness in an early stage of clinical development by testing the vaccine and adjuvant in an endemic setting (Zambia) after the first-in-human administration and the dose-escalation has proven safe and tolerable in a low-endemic setting (Netherlands). Besides strengthening the vaccine pipeline against a major diarrheal disease, another goal of the ShigaPlexIM project is to stimulate capacity building and strengthen global North-South relations in clinical research.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;EU CT number: 2","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11769217/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034358","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 Strategies Used by Animal Viruses to Antagonize Host Antiviral Innate Immunity: New Clues for Developing Live Attenuated Vaccines (LAVs).","authors":"Na Chen, Baoge Zhang","doi":"10.3390/vaccines13010046","DOIUrl":"10.3390/vaccines13010046","url":null,"abstract":"<p><p>As an essential type of vaccine, live attenuated vaccines (LAVs) play a crucial role in animal disease prevention and control. Nevertheless, developing LAVs faces the challenge of balancing safety and efficacy. Understanding the mechanisms animal viruses use to antagonize host antiviral innate immunity may help to precisely regulate vaccine strains and maintain strong immunogenicity while reducing their pathogenicity. It may improve the safety and efficacy of LAVs, as well as provide a more reliable means for the prevention and control of infectious livestock diseases. Therefore, exploring viral antagonistic mechanisms is a significant clue for developing LAVs, which helps to explore more viral virulence factors (as new vaccine targets) and provides a vital theoretical basis and technical support for vaccine development. Among animal viruses, ASFV, PRRSV, PRV, CSFV, FMDV, PCV, PPV, and AIV are some typical representatives. It is crucial to conduct in-depth research and summarize the antagonistic strategies of these typical animal viruses. Studies have indicated that animal viruses may antagonize the antiviral innate immunity by directly or indirectly blocking the antiviral signaling pathways. In addition, viruses also do this by antagonizing host restriction factors targeting the viral replication cycle. Beyond that, viruses may antagonize via regulating apoptosis, metabolic pathways, and stress granule formation. A summary of viral antagonistic mechanisms might provide a new theoretical basis for understanding the pathogenic mechanism of animal viruses and developing LAVs based on antagonistic mechanisms and viral virulence factors.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 1","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11768843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143034000","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}