Vaccine最新文献

{"title":"Impact of electronic immunization registries and electronic logistics management information systems in four low-and middle-income countries: Guinea, Honduras, Rwanda, and Tanzania","authors":"C. Mantel ,&nbsp;C. Hugo ,&nbsp;C. Federici ,&nbsp;N. Sano ,&nbsp;S. Camara ,&nbsp;E. Rodriguez ,&nbsp;L. Castillo ,&nbsp;J. Condo ,&nbsp;P. Irakiza ,&nbsp;I. Sabi ,&nbsp;E. Nyanda ,&nbsp;W. Olomi ,&nbsp;M. Cavazza ,&nbsp;V. Mangiaterra ,&nbsp;M. Verykiou ,&nbsp;E. Ferenchick ,&nbsp;A. Torbica ,&nbsp;T. Cherian ,&nbsp;S. Malvolti","doi":"10.1016/j.vaccine.2025.127066","DOIUrl":"10.1016/j.vaccine.2025.127066","url":null,"abstract":"<div><h3>Background</h3><div>There is increasing interest in low-and middle-income countries (LMICs) to introduce and scale-up digital health tools like electronic immunization registries (eIR), and electronic logistics management information systems (eLMIS) to support immunization services. An evaluation of the use of these tools was conducted in four LMICs to inform decisions about their further expansion and investments.</div></div><div><h3>Methods</h3><div>Purposive sampling of regions, districts, and health facilities was done in each country based on predefined criteria. Primary data were collected between October 2021 and September 2022 in 50 health facilities in Guinea, 88 in Honduras, 36 in Rwanda, and 101 in Tanzania using semi-structured questionnaires, standardized competency assessments and data accuracy checks. Data focused on electronic tool usage, user experience, infrastructure, workforce needs, and decision-making, as well as immunization data quality and perceptions of health workers and vaccine recipients. Data analysis combined both quantitative and qualitative methods.</div></div><div><h3>Findings</h3><div>The implementation of eIR and eLMIS was associated with improvements in National Immunization Programme (NIP) processes and outcomes. Users were satisfied with the tools (87 % satisfaction rate), and 95 % of users in the African countries valued the accessibility of information, with 91 % finding it accurate and complete. Some caregivers reported better organization and shorter waiting times in health facilities using the tools. Most eIR users noted improvements in process efficiencies (81 %) and immunization service delivery (89 %). In Rwanda and Tanzania data accuracy was higher in exclusively paper or electronic settings (60 %) compared to dual paper-electronic systems (45 %). eLMIS use was associated with improvements in vaccine stock data quality and reduced stock-outs. While 77 % of health workers were digitally literate, inadequate digital infrastructure was a key barrier to tool use. Interoperability with the Civil Registration and Vital Statistics system (CRVS) was limited, hindering the tracking of unimmunized children.</div></div><div><h3>Conclusions</h3><div>To fully realize the potential of electronic tools in LMICs, full government ownership, targeted infrastructure investments, migration to fully electronic systems, and the integration of eIR with the CRVS will be essential.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"54 ","pages":"Article 127066"},"PeriodicalIF":4.5,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143748268","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}

{"title":"Corrigendum to, “Attitudes and beliefs of healthcare providers toward vaccination in the United States: A cross-sectional online survey” [Vaccine (2024) Dec 2 42(26) 126437]","authors":"Amanda L. Eiden ,&nbsp;Sheila Drakeley ,&nbsp;Kushal Modi ,&nbsp;deMauri S. Mackie ,&nbsp;Alexandra Bhatti ,&nbsp;Anthony DiFranzo","doi":"10.1016/j.vaccine.2025.127054","DOIUrl":"10.1016/j.vaccine.2025.127054","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127054"},"PeriodicalIF":4.5,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143758961","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":"Respiratory syncytial virus vaccine uptake among adults aged ≥60 years in a large, integrated healthcare system in Southern California 2023–2024","authors":"Rudy Patrick ,&nbsp;Parag Mahale ,&nbsp;Bradley K. Ackerson ,&nbsp;Vennis Hong ,&nbsp;Sally Shaw ,&nbsp;Banshri Kapadia ,&nbsp;Brigitte Spence ,&nbsp;Matt Feaster ,&nbsp;Jeff Slezak ,&nbsp;Julie A. Stern ,&nbsp;Gregg S. Davis ,&nbsp;Gabriella Goodwin ,&nbsp;Bruno Lewin ,&nbsp;Joseph A. Lewnard ,&nbsp;Hung Fu Tseng ,&nbsp;Sara Y. Tartof","doi":"10.1016/j.vaccine.2025.127033","DOIUrl":"10.1016/j.vaccine.2025.127033","url":null,"abstract":"<div><div>During the 2023–2024 respiratory syncytial virus (RSV) season, vaccination was recommended for adults ≥60 years based on shared clinical decision-making with their healthcare providers. We examined RSV vaccine uptake and characteristics associated with uptake among age-eligible Kaiser Permanente Southern California (KPSC) patients. Our study cohort included all patients ≥60 years from September 23, 2023 (i.e., date RSV vaccination first became available at KPSC; <em>N</em> = 1,003,132) to April 9, 2024 (i.e., end of local RSV season). To identify sociodemographic and clinical characteristics associated with RSV vaccination, we used multivariable robust Poisson regression to estimate the adjusted relative risk (aRR) and 95 % CI. Overall, 7.6 % of patients were vaccinated for RSV. In multivariable regression analyses, those aged 70–79.9 years (aRR: 1.36; 95 % CI: 1.34–1.39) and aged ≥80 years (aRR: 1.35; 95 % CI: 1.32–1.38) were more likely to be vaccinated, compared with those aged 60–69.9 years. Compared with Non-Hispanic White patients, Asian (aRR: 0.95; 95 % CI: 0.93–0.97), Hispanic (aRR: 0.52; 95 % CI: 0.51–0.54), Non-Hispanic Black (aRR: 0.69; 95 % CI: 0.67–0.71), Pacific Islander (aRR: 0.91; 95 % CI: 0.84–0.98), and Native American or Alaska Native (aRR: 0.80; 95 % CI: 0.70–0.92) patients were less likely to be vaccinated. Those in higher neighborhood deprivation quartiles were less likely to be vaccinated (Q2: aRR: 0.86; 95 % CI: 0.85–0.88; Q3: aRR: 0.77; 95 % CI: 0.76–0.79; and Q4: aRR: 0.67; 95 % CI: 0.65–0.68), compared with those in the lowest deprivation quartile. We found low vaccination uptake and identified disparities in vaccination that might exacerbate existing disparities in RSV infection and severe RSV disease among certain populations. CDC's ACIP recently updated their recommendations for all adults 75+ years, and this might begin to address these disparities.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127033"},"PeriodicalIF":4.5,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143758959","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}

{"title":"Pertussis seroepidemiology in mother-newborn pairs during an epidemic period in China, 2024","authors":"Xiaoli Chen ,&nbsp;Weilun Zuo ,&nbsp;Qunshan Xu ,&nbsp;Ling Chen ,&nbsp;Ye Wang ,&nbsp;Jumei Liu ,&nbsp;Xiaochun Fu ,&nbsp;Min Zhu ,&nbsp;Xiaoqing Yang ,&nbsp;Huiming Ye","doi":"10.1016/j.vaccine.2025.127081","DOIUrl":"10.1016/j.vaccine.2025.127081","url":null,"abstract":"<div><h3>Background</h3><div>In 2024, the reported incidence of pertussis in China has increased sharply. As a vulnerable group, neonates continue to be at highest risk of severe outcomes from pertussis infection. However, there have been no serological assessment of population immunity since the 2024 pertussis outbreak in China. This study aimed to ascertain the PT-antibody status of pregnant women and their newborns during the epidemic period and offer insights to maternal immunization in China.</div></div><div><h3>Methods</h3><div>From April to June 2024, 227 newborn-mother pairs in Xiamen City were recruited to test serum anti-PT IgG levels by ELISA. The geometric mean, undetectable rate (&lt; 5 IU/mL), seropositivity rate (≥ 40 IU/mL), recent infection rate (≥ 100 IU/mL), and newborn-to-maternal ratio of anti-PT IgG were calculated. Statistical analysis was made based on maternal age, gravidity, parity, delivery mode, gestational age and newborn sex.</div></div><div><h3>Results</h3><div>The anti-PT IgG levels were positively correlated (R² = 0.761) between pregnant women and their newborns. We found that 97.8 % of participants were seronegative, and 75.3 % of pregnant woman and 64.3 % of newborn had anti-PT IgG levels below 5 IU/mL. The seropositive prevalence of them were both only 2.2 % (95 % CI 0.9–5.1). The newborn-to-maternal ratio was stable in the range of 1.1 to 1.3 across all groups. There was no significant difference in the anti-PT IgG level of all participants across maternal and neonatal demographic characteristics. There was also no significant difference in the prevalence of seropositivity across demographic characteristics, except for delivery mode among newborns.</div></div><div><h3>Conclusions</h3><div>Almost all of the pregnant women and their newborns in this study had anti-PT IgG levels low enough to suggest susceptibility to pertussis infection, especially during an epidemic period. Infants are unprotected until the onset of primary immunization series, which would support the rationale for maternal immunization.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127081"},"PeriodicalIF":4.5,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143758954","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}

{"title":"Religious group membership and conspiracy beliefs influence vaccine uptake: Insights from 20 European countries","authors":"Aoife-Marie Foran ,&nbsp;Jolanda Jetten ,&nbsp;Orla T. Muldoon","doi":"10.1016/j.vaccine.2025.127086","DOIUrl":"10.1016/j.vaccine.2025.127086","url":null,"abstract":"<div><div>Reports of lower vaccine uptake within religious communities pose a significant public health challenge. While religious group membership is often associated with health benefits, recent research has revealed a paradox: it may also be linked to vaccine hesitancy. This study investigates how religious group membership may reduce COVID-19 vaccine uptake by exploring the role of enhanced conspiracy beliefs. In doing so, we examine these dynamics across individual and national contexts. Using data from 20 European countries (<em>N</em> = 31,681) collected during the 10th round of the European Social Survey (ESS10), multilevel structural equation modelling was employed to examine whether conspiracy beliefs mediated the link between religious group membership and COVID-19 vaccine uptake. Religious group membership was found to indirectly impact COVID-19 vaccine uptake through conspiracy beliefs. At the national level, countries with higher average levels of religious group membership exhibited greater conspiracy beliefs, which were associated with lower vaccine uptake. At the individual level, people who belonged to a religion were more likely to endorse conspiracy beliefs, which negatively predicted vaccine uptake. Our findings underscore the need to address conspiracy beliefs as a critical pathway linking religious group membership to COVID-19 vaccine uptake. Public health strategies should engage with religious leaders to foster trust and dispel misinformation, while promoting transparent and inclusive health communication. Such efforts can help bridge the gap between religious communities and public health initiatives, ultimately improving vaccine uptake.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127086"},"PeriodicalIF":4.5,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143758957","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":"A double-blind, randomised phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot to lot consistency of single component oral cholera vaccine BBV131 (Hillchol®) in comparison to Shanchol™","authors":"Krishna Mohan Vadrevu ,&nbsp;Abhishek Chavan ,&nbsp;Amit Chawla ,&nbsp;B.S. Chakravarthy ,&nbsp;Chandramani Singh ,&nbsp;Sagar Redkar ,&nbsp;Savita Verma ,&nbsp;Sriharsha Yandapally ,&nbsp;M. Suma Priya ,&nbsp;Vasant Khalatkar ,&nbsp;Vishal Tripathi ,&nbsp;Brunda Ganneru ,&nbsp;Siddharth Reddy ,&nbsp;Bhargav Reddy ,&nbsp;Jan Holmgren ,&nbsp;Badri Patnaik ,&nbsp;Sai D. Prasad ,&nbsp;Raches Ella","doi":"10.1016/j.vaccine.2025.126998","DOIUrl":"10.1016/j.vaccine.2025.126998","url":null,"abstract":"<div><h3>Background</h3><div>Cholera is a vaccine-preventable disease that has faced a surge in outbreaks and a shortage of vaccines. The new generation oral cholera vaccine (OCV) BBV131, featuring a simplified single stable O1 Hikojima strain, aims to enhance production efficiency and affordability. This study evaluates BBV131's immune profile, safety, and non-inferiority compared to Shanchol™ in healthy adults and children. Adding BBV131 to the vaccine stockpile could improve supply, simplify logistics, and ease administration efforts.</div></div><div><h3>Methods</h3><div>In this randomised, modified, double-blind, multi-centre, phase III trial, 1800 participants were recruited across 10 clinical trial sites across India. Participants were stratified into three age groups (adults &gt;18 years, children ≥5 to &lt;18 years, and infants ≥1 to &lt;5 years) and were randomised in a 3:1 ratio to receive either BBV131 or Shanchol™. All participants received two doses of the vaccine orally on days 0 and 14. Immunogenicity was assessed through blood samples collected at baseline, two weeks after each dose, and follow-ups at days 28, 56, 90, and 180. The primary endpoint focused on the proportion of participants achieving &gt;4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days post two doses. While secondary endpoints included Geometric Mean Titre (GMT) measurements and safety. Safety was evaluated throughout the study, reporting solicited and unsolicited adverse events (AEs). Another cohort of 1800 was added to the above study as an addendum to expand the safety database.</div></div><div><h3>Findings</h3><div>Of the 1800 enrolled participants, 1794 completed the study. Post-vaccination, the percentage of participants in the BBV131 group who exhibited a &gt; 4-fold increase in anti-<em>V. cholerae</em> antibody titres were 68.25 % for Ogawa and 69.52 % for Inaba—demonstrating non-inferiority to Shanchol™, with a lower limit of 95 % CI above the non-inferiority margin. The safety profile revealed 257 AEs among 236 participants (13.1 %), with similar incidence across age groups and between vaccines; common AEs included dry mouth and headache.</div></div><div><h3>Interpretation</h3><div>The findings indicate that BBV131 demonstrates non-inferior immunogenicity and comparable safety to Shanchol™ in healthy Indian adults and children, supporting its potential as an effective OCV. Clinical Trial Registration: CTRI/2022/01/039734.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"55 ","pages":"Article 126998"},"PeriodicalIF":4.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143746343","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":"Post-introduction evaluation (PIE) of the seasonal influenza vaccination program in Kyrgyzstan in 2023","authors":"Dinagul Otorbaeva ,&nbsp;Rakhat Akmatova ,&nbsp;Katharine M. Cooley ,&nbsp;Chelsea Iwamoto ,&nbsp;Lisa A. Jacques-Carroll ,&nbsp;Camille E. Jones ,&nbsp;Almea M. Matanock ,&nbsp;Angela K. Shen ,&nbsp;Cara Tupps","doi":"10.1016/j.vaccine.2025.127052","DOIUrl":"10.1016/j.vaccine.2025.127052","url":null,"abstract":"<div><div>Vaccination is an effective preventive strategy against influenza. Kyrgyzstan introduced a comprehensive influenza vaccination program in 2013 and has collaborated with the Task Force for Global Health since 2017 to expand vaccination coverage. In 2023, an influenza vaccine post-introduction evaluation was conducted to identify strengths and weaknesses in the influenza vaccination program and to identify measures for improvement. Site visits were conducted across six regions of the country and interviews were conducted with national, regional and district staff, health facility staff, and individuals from priority populations for influenza vaccination using standardized questionnaires. Two major challenges identified in this evaluation were the inadequate supply of influenza vaccine to cover the priority groups and the low acceptance and uptake of influenza vaccine among pregnant people. These findings are important as they can inform targeted strategies and policy updates to increase influenza vaccine implementation and uptake in Kyrgyzstan.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"55 ","pages":"Article 127052"},"PeriodicalIF":4.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143746342","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 global regulatory landscape for combined vaccines: A comparative case study of registration strategies for diphtheria-tetanus-pertussis-containing vaccines.","authors":"Xiangchuan He ,&nbsp;Yiwen Pu ,&nbsp;Zeyu Li ,&nbsp;Shitong Huan ,&nbsp;Yue Yang","doi":"10.1016/j.vaccine.2025.127017","DOIUrl":"10.1016/j.vaccine.2025.127017","url":null,"abstract":"<div><div>Diphtheria-tetanus-pertussis-containing vaccines (DTPCVs) represent the forefront of combination vaccine development globally. However, the licensing of high-valent DTPCVs varies worldwide owing to diverse regulatory requirements. Some national regulatory authorities (NRAs) have adopted flexible strategies to fast-track the approval and uptake of critical DTPCVs to address public health needs. This study examined the global regulatory status of combination vaccines, using descriptive and comparative analyses to highlight pivotal registration issues for DTPCVs. Specifically, it sheds light on the regulatory approaches of the Food and Drug Administration (FDA), European Medicines Agency (EMA), National Medical Products Administration (NMPA), and other Asian regulators through a case study of hepatitis B-containing DTPCVs. Drawing on these findings, this study advocates the initiation of regulatory convergence efforts, establishment of practical regulatory strategies, and swift approval and wider adoption of high-valent DTPCVs.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"54 ","pages":"Article 127017"},"PeriodicalIF":4.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143748267","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":"Prioritization and barriers of mpox vaccination uptake among gay, bisexual and other men who have sex with men in Taiwan: 2023 HEART survey","authors":"Carol Strong ,&nbsp;Patricia Joson ,&nbsp;Isaac Yen-Hao Chu ,&nbsp;Tsan-Tse Chuang ,&nbsp;Huei-Jiuan Wu ,&nbsp;Chia-Wen Li ,&nbsp;PoYao Huang ,&nbsp;Adam Bourne ,&nbsp;Stephane Wen-Wei Ku","doi":"10.1016/j.vaccine.2025.127059","DOIUrl":"10.1016/j.vaccine.2025.127059","url":null,"abstract":"<div><div>During Taiwan's early 2023 mpox outbreak, limited vaccine availability required targeting mpox vaccine priority groups (MVPs) for effective control, including individuals with multiple sexual partners, sex workers, and those with a history of sexually transmitted infections (STIs). This study examines whether Taiwan's prioritization efforts reached MVPs. In November–December 2023, we surveyed 1656 gay, bisexual or other men who have sex with men (GBMSM) in Taiwan via social media. Of respondents, 43 % were unvaccinated, 13 % had received one dose, and 44 % completed double doses. Receiving two doses was associated with living with HIV, having multiple sexual partners, and condomless anal sex (CAS) in the last three months. Receiving two doses were also associated with other preventive behaviors, including being on pre-exposure prophylaxis (PrEP) and receiving human papillomavirus (HPV) vaccine. Despite Taiwan's free mpox vaccines efforts, uptake and completion challenges remain, highlighting the need for increased awareness and access among susceptible populations.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127059"},"PeriodicalIF":4.5,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143739972","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}

{"title":"A replicon-based COVID-19 vaccine candidate delivered by tobacco mosaic virus-like particles","authors":"Sweta Karan ,&nbsp;Patrick Opdensteinen ,&nbsp;Yifeng Ma ,&nbsp;Jessica Fernanda Affonso De Oliveira ,&nbsp;Nicole F. Steinmetz","doi":"10.1016/j.vaccine.2025.127063","DOIUrl":"10.1016/j.vaccine.2025.127063","url":null,"abstract":"<div><div>The COVID-19 pandemic highlights the opportunity for mRNA vaccines and their nanotechnology carriers to make an impact as a countermeasure to infectious disease. As alternative to the synthetic lipid nanoparticles or mammalian viruses, we developed a tobacco mosaic virus (TMV)-based mRNA vaccine delivery platform. Specifically, purified coat protein from TMV was used to package a self-amplifying Nodamura replicon expressing the receptor binding domain (RBD) from the Omicron strain of SARS-CoV-2. The replicon construct contains the origin of assembly sequence from the tobacco mosaic virus (TMV) for encapsulation and mRNA stabilization. The nanoparticle vaccine was obtained through <em>in vitro</em> assembly using purified TMV coat proteins and <em>in vitro</em> transcribed mRNA cassettes. Cell assays confirmed delivery of self-amplifying mRNA vaccine, amplification of the transgene and expression of the target protein, RBD, in mammalian cells. Immunization of mice yielded RBD-specific IgG antibodies that demonstrated neutralization of SARS-CoV-2 using an <em>in vitro</em> neutralization assay. The TMV platform nanotechnology does not require ultralow freezers for storage or distribution; and the <em>in vitro</em> assembly method provide ‘plug-and-play’ to adapt the vaccine formulation rapidly as new strains or diseases emerge. Finally, opportunity exists to produce and self-assemble the vaccine candidate in plants through molecular farming techniques, which may allow production in the region-for the region and could make a contribution to less resourced areas of the world.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"53 ","pages":"Article 127063"},"PeriodicalIF":4.5,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143739971","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}