Vaccine最新文献

{"title":"“It's a risk-benefit analysis”: Qualitative perspectives on barriers and enablers to post-treatment vaccination from adults affected by a haematological malignancy in Australia","authors":"Holly Chung ,&nbsp;Meinir Krishnasamy ,&nbsp;Trish Joyce ,&nbsp;Tracey Dryden ,&nbsp;Ashley Whitechurch ,&nbsp;Paul Baden ,&nbsp;Simon Harrison ,&nbsp;Benjamin W. Teh","doi":"10.1016/j.vaccine.2025.126826","DOIUrl":"10.1016/j.vaccine.2025.126826","url":null,"abstract":"<div><h3>Background</h3><div>People affected by haematological malignancies are at high risk of morbidity and mortality caused by vaccine-preventable infections. However, vaccination commencement and completion following anti-cancer treatment is sub-optimal for this population. Innovation relating to vaccination delivery and schedules, informed by the needs and preferences of the target population, may improve uptake of vaccinations. This study explored barriers and enablers to vaccinations, novel vaccines and vaccination schedules, from the perspectives of this cohort.</div></div><div><h3>Methods</h3><div>A qualitative exploratory study at an Australian specialist cancer hospital. Semi-structured interviews were conducted with patients via telephone or videoconferencing, exploring experiences of, and views regarding, vaccination after anti-cancer treatment, and barriers and enablers to vaccination. Demographic and clinical characteristics were collected prior to interviews and analysed descriptively. Qualitative data were analysed inductively using template analysis, then mapped to the COM-B model of behaviour change, and barriers and enablers identified.</div></div><div><h3>Results</h3><div>Twenty blood cancer patients participated. Participants described barriers including poor care coordination, travel, time, and financial costs, concerns regarding potential side effects and injury, intervention and appointment fatigue, and concerns regarding vaccine development processes. Enablers included: consultative conversations, information available in various formats, automated appointments and reminders, hybrid and shared models of care, being linked-in with trusted health professionals, confidence in public health advice and vaccine development processes, and seeing vaccinations as central to their recovery.</div></div><div><h3>Conclusion</h3><div>Barriers and enablers to vaccination identified suggest ways in which vaccination services for this population can be improved. While patients receiving vaccinations at their treating centre reported coordinated care that made access straightforward, other participants described being hampered by lack of coordinated care and continuity. A lack of condition-specific information coupled with common vaccine misconceptions resulted in concerns regarding vaccinations. These findings offer opportunities to address barriers to vaccination uptake through targeted service innovation and education and information interventions.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"50 ","pages":"Article 126826"},"PeriodicalIF":4.5,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143082823","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":"Attitudes and beliefs about vaccination among adults in the United States: A real-world, cross-sectional, web-based survey study","authors":"Amanda L. Eiden ,&nbsp;deMauri S. Mackie ,&nbsp;Kushal Modi ,&nbsp;Sheila Drakeley ,&nbsp;Amanda R. Mercadante ,&nbsp;Alexandra Bhatti ,&nbsp;Anthony DiFranzo","doi":"10.1016/j.vaccine.2025.126807","DOIUrl":"10.1016/j.vaccine.2025.126807","url":null,"abstract":"<div><h3>Background</h3><div>Approaches best suited for encouraging adults to vaccinate themselves may differ from those for encouraging parents to vaccinate their children.</div></div><div><h3>Objectives</h3><div>To describe vaccine hesitancy and literacy among the US adult population.</div></div><div><h3>Methods</h3><div>This cross-sectional survey assessed vaccine hesitancy and literacy among the US adult population (aged 18–60), grouped by their role as decision makers (parents for their children aged &lt;18 vs. adults for themselves). Results were also examined among adults without children aged &lt;18 by race and by household income. Data were collected using multiple-choice questions, which are reported as numbers and percentages, or a 5-point Likert scale.</div></div><div><h3>Results</h3><div>Respondents included 1875 adults: 1183 adults without children aged &lt;18 (63.1 %) and 692 parents of children aged &lt;18 (36.9 %). Respondents generally agreed that vaccines are safe, effective, and a good way to protect themselves or their families. Respondents generally disagreed that vaccines are dangerous and overused and were neutral to claiming religious exemptions from vaccination. Most respondents trusted vaccines that had been available for two years or less (59.7 %). Respondents received most vaccine information from doctors' offices, public health sources, or pharmacies. Comparing parents with other adults, parents followed advice from friends, family, and colleagues more than other adults (<em>p</em> &lt; 0.001) and parents felt they understood vaccine information better than other adults (p &lt; 0.001). Parents were also more comfortable researching vaccine information than were other adults (<em>p</em> = 0.005). Adults reported pharmacies were most convenient of all points of care, and parents reported them second most convenient.</div></div><div><h3>Conclusions</h3><div>Education about vaccine safety and the importance of childhood vaccinations among social networks may increase acceptance among vaccine-hesitant parents. Strategies focusing on increasing vaccine promotion at pharmacies may be effective for reducing vaccine hesitancy for all adults.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"50 ","pages":"Article 126807"},"PeriodicalIF":4.5,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143082829","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":"Antitumoral effectiveness and safety of intravenous versus subcutaneous administration of immunomodulatory peptide GK-1 in a murine breast cancer model","authors":"Juan A. Hernández-Aceves ,&nbsp;Jacquelynne Cervantes-Torres ,&nbsp;Alfredo Cruz-Gregorio ,&nbsp;Ana Karina Aranda-Rivera ,&nbsp;Diego Moctezuma ,&nbsp;Jorge A. Peña-Agudelo ,&nbsp;Osiris J. Patiño-Chávez ,&nbsp;Marisela Hernández ,&nbsp;Sergio Sifontes-Rodríguez ,&nbsp;Tonathiu Rodriguez ,&nbsp;José Pedraza-Chaverri ,&nbsp;Edda Sciutto ,&nbsp;Gladis Fragoso","doi":"10.1016/j.vaccine.2025.126814","DOIUrl":"10.1016/j.vaccine.2025.126814","url":null,"abstract":"<div><h3>Introduction</h3><div>GK-1 is a safe and effective molecule with high antimetastatic activity against murine breast and skin cancer. GK-1 treatment enhances cytotoxic response of CD8⁺ lymphocytes against the tumor and modifies the oxidative stress in the tumor. This study was designed to compare the antitumor efficacy of GK-1 by subcutaneous (SC) versus intravenous (IV) route of administration in the 4T1 mouse mammary carcinoma model and to extend its innocuity in heart and kidney, key tissues for observing damage induced by anticancer drugs and immunotherapy.</div></div><div><h3>Material and methods</h3><div>BALB/c female mice were injected orthotopically with 1000 4T1 cells. When palpable primary tumors of about 1 mm³ were detected, GK-1 (5 mg/kg) was administered IV or SC weekly for 21 days. Tumor growth and mouse weight were monitored weekly. The primary tumor weight and volume, the number of lung metastases, and programmed cell death protein 1 (PD-1) expression were recorded after 28 days of starting treatment. Kidney, heart, spleen, serum, and blood samples from naïve mice were obtained to evaluate the safety of GK-1 administration by measuring the degree of damage to these tissues with specific cytotoxic markers.</div></div><div><h3>Results</h3><div>Subcutaneous or intravenous administration of GK-1 significantly increased the lifespan of mice and significantly reduced the primary tumor weight and volume and the number of lungs macrometastases. GK-1 reduced the expression of PD-1 in tumor-infiltrating lymphocytes in mice regardless of the route of immunization used, which is especially encouraging. No evidence of damage to kidney or heart tissues was detected in the tumor-free mice.</div></div><div><h3>Conclusions</h3><div>This study supports that subcutaneous GK-1 administered, has an efficacy non-inferior to intravenous administration, well-tolerated with a similar safety profile and therefore offers a less invasive valid treatment alternative.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"50 ","pages":"Article 126814"},"PeriodicalIF":4.5,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143082825","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":"Optimising the M72/AS01E tuberculosis vaccine candidate phase 3 trial based on the phase 2b trial results","authors":"Katie D. Dale ,&nbsp;Justin T. Denholm","doi":"10.1016/j.vaccine.2025.126816","DOIUrl":"10.1016/j.vaccine.2025.126816","url":null,"abstract":"","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126816"},"PeriodicalIF":4.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076821","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":"Implementing behavioural science-informed letter interventions to increase COVID-19 vaccination uptake in London residents. A difference-in-difference study in London, United Kingdom","authors":"Kate Grailey ,&nbsp;Roberto Fernandez Crespo ,&nbsp;Lena Woldmann ,&nbsp;Matthew Chisambi ,&nbsp;Kirstie Black ,&nbsp;Bahram Hassanpourfard ,&nbsp;Joe Nguyen ,&nbsp;Bob Klaber ,&nbsp;Ara Darzi ,&nbsp;Sarah Huf","doi":"10.1016/j.vaccine.2025.126781","DOIUrl":"10.1016/j.vaccine.2025.126781","url":null,"abstract":"<div><div>The accelerated development of vaccines to mitigate COVID-19 was crucial in the response to the 2020 pandemic. The success of vaccination strategies relies upon adequate uptake across the population. In the United Kingdom, COVID-19 vaccination began in December 2020, with population groups invited in priority groups according to age and clinical vulnerability. By February 2021, uptake rates were lower in North West London than the national average. This study aimed to explore whether behaviourally-informed (BI) letters could increase the rate of first vaccine uptake in previously uncontactable residents.</div><div>BI letters were designed to invoke a sense of ownership, and highlight the ease of accessing a vaccine. Letters were sent to unvaccinated uncontactable residents in a Central London Borough over a 3-week period. Three neighbouring boroughs in London with similar non-responder data acted as controls. A linear difference in difference (DID) analysis assessed the change in the rate of vaccine uptake across all four boroughs, with percentage point change adjusted for covariates including ethnicity, age, gender and socioeconomic status.</div><div>In total, 10,161 residents in Central London were eligible to receive our BI letter. All four boroughs demonstrated an increase in vaccination, with an absolute increase of 4.3 % in the intervention borough. Our linear DID analysis showed a 14.7 % increase in vaccination likelihood in the intervention borough following the intervention on average across all weeks included in the study. Residents with a mixed or multiple ethnic background were less likely to receive a COVID-19 vaccination. Those from a more deprived socioeconomic background demonstrated the largest rate of change.</div><div>Our study highlights the effectiveness of traditional communication strategies such as letters in those who are uncontactable by other means. Incorporating behavioural science principles into healthcare communication, such as those designed to evoke a sense of ownership can enhance their effectiveness.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126781"},"PeriodicalIF":4.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076817","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":"Efficacy, immunogenicity, and safety of the Novavax COVID-19 vaccine in immunocompromised patients: A targeted literature review","authors":"Manuela H. Gschwend ,&nbsp;Anthony M. Marchese ,&nbsp;Dirk Poelaert ,&nbsp;Brandy Warren ,&nbsp;Matthew D. Rousculp ,&nbsp;Freddy Caldera","doi":"10.1016/j.vaccine.2025.126777","DOIUrl":"10.1016/j.vaccine.2025.126777","url":null,"abstract":"<div><div>Individuals who are immunocompromised (IIC) may have impaired infection prevention/resolution, potentially causing increased disease severity, complications, and healthcare-system strain. Exclusion of IIC from COVID-19 vaccine trials and limited real-world Novavax COVID-19 vaccine assessments have resulted in a data gap. This article provides a review of literature on IIC who received the Novavax COVID-19 vaccine. A targeted literature search of BIOSIS Previews®, Embase®, Embase Preprints, MEDLINE®, and publicly available content was performed to identify published clinical data assessing efficacy, immunogenicity, and safety of the Novavax COVID-19 vaccine in IIC, with predefined terms for immune-modifying diseases/conditions and medications. Identified publications were screened to ensure they described study data from IIC who received the Novavax COVID-19 vaccine. The search (through October 2024) identified 137 reports indicating use of the Novavax COVID-19 vaccine in IIC. Screening resulted in 10 publications for review; exclusionary reasons included a lack of vaccine-specific data (i.e., limited [&lt;0.2% or <em>n</em> &lt; 3] vaccine recipients, pooled/aggregated cohorts) and/or IIC population. Conditions described include HIV, multiple sclerosis, inflammatory rheumatic diseases, transplant recipients, and hematologic malignancies. Overall, the Novavax COVID-19 vaccine was immunogenic and had a tolerable safety profile across diverse populations of IIC; some outcomes varied based on condition, disease, and/or concomitant medication(s). Limited efficacy data indicates that the Novavax COVID-19 vaccine may help protect IIC against symptomatic/severe COVID-19; however, additional studies with larger sample sizes are needed. Future research should include disease-specific populations to assess how individual characteristics (e.g., disease state, concomitant medications, prior COVID-19 vaccination) impact vaccine response.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126777"},"PeriodicalIF":4.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076805","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":"What will introducing and delivering new maternal vaccines cost in Ghana and Mozambique? A prospective analysis","authors":"Ranju Baral ,&nbsp;Kwame Amponsa-Achiano ,&nbsp;Iracema Barros ,&nbsp;Patience Cofie ,&nbsp;Patience Dapaah ,&nbsp;Jessica A. Fleming ,&nbsp;Chris Opoku Fofie ,&nbsp;Sadaf Khan ,&nbsp;Braiton Maculuve ,&nbsp;Lauren Newhouse ,&nbsp;Leonildo Nhampossa ,&nbsp;Rosemond Owusu ,&nbsp;Melanie Picolo ,&nbsp;Diana Quelhas ,&nbsp;Yara Voss De Lima ,&nbsp;Clint Pecenka","doi":"10.1016/j.vaccine.2025.126769","DOIUrl":"10.1016/j.vaccine.2025.126769","url":null,"abstract":"<div><h3>Introduction</h3><div>The maternal vaccine landscape is expanding, including the anticipated global rollout of the now approved respiratory syncytial virus maternal vaccine. Integrating maternal immunization (MI) into health systems in low-and middle-income countries (LMICs) will require adaptation to existing immunization delivery platforms and have cost implications. In this study, we project the cost of maternal vaccine introduction and delivery in Ghana and Mozambique to help inform introduction decisions and ensure financial sustainability of future MI interventions.</div></div><div><h3>Methods</h3><div>We used an activity-based prospective cost projection approach to estimate MI introduction and delivery costs for a five-year period from a health system perspective. Country stakeholders informed the strategies for MI delivery. Interviews with key immunization and maternal health program representatives informed on the anticipated health system adaptation requirements, activities, and resource needs taken into account in the cost projections. Supplementary data from a sample of sub-national health administrative units, vaccine stores, and health facilities also informed the costing analysis. Financial and economic costs are estimated and presented in 2023 USD units.</div></div><div><h3>Results</h3><div>New maternal vaccines in both countries are anticipated to be delivered leveraging the existing maternal tetanus vaccine delivery practices. The non-vaccine cost of delivering one dose of maternal vaccine was estimated at $3.42 (financial) and $4.12 (economic) in Ghana, and $1.84 (financial) and $2.21 (economic) in Mozambique. Health worker training, communication and social mobilization, and program planning and coordination constitute the main cost drivers. Cost differences between countries are partly driven by the anticipated baseline coverage and baseline health system capacity gaps.</div></div><div><h3>Discussion</h3><div>Very few studies exist on the costs of delivering maternal vaccine in LMICs. This study begins to fill this gap. These MI cost projections are comparable to other new vaccine introduction costs in similar settings, providing insights for local and global stakeholders seeking to understand costs of MI delivery.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126769"},"PeriodicalIF":4.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143075710","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":"Willingness to take Mpox vaccine and associated factors among health professionals in Ethiopia: A cross-sectional study","authors":"Getahun Fetensa ,&nbsp;Tadesse Tolossa ,&nbsp;Marga Besho ,&nbsp;Girma Yadesa ,&nbsp;Jilcha Gugsa ,&nbsp;Derara Girma Tufa ,&nbsp;Feyiso Bati ,&nbsp;Kitesa Biresa Duftu ,&nbsp;Bizuneh Wakuma","doi":"10.1016/j.vaccine.2025.126822","DOIUrl":"10.1016/j.vaccine.2025.126822","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Monkeypox (Mpox) is vaccine preventable a viral infection declared as a public health emergency of international concern by the World Health Organization in 2022. As a response to the epidemic, vaccines against the virus are being implemented in different countries, complementing other public health interventions. However, little is known about the willingness to accept the Mpox vaccine among health professionals in Africa, notably in Ethiopia. Therefore, this study aimed to identify willingness to take the Mpox vaccine and associated factors among health professionals in Ethiopia.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;A national online cross-sectional study design was employed between August 31, 2024, and September 6, 2024, among health professionals in Ethiopia. The data were collected from purposively selected healthcare professionals utilizing snowball sampling to achieve a high response rate using a semi-structured online survey tool. The tool was pretested, every survey item was drafted as a must-fill, and only data with correct characters were included after removing responses with miss response for the intended questionnaire. Variables with a &lt;em&gt;p&lt;/em&gt;-value&lt;0.25 in the bivariable logistic regression analysis were taken as candidates for multivariable analysis. An adjusted odds ratios (AORs) with 95 % confidence interval (CI) were computed and p-value &lt;0.05 were used to set statistically significant variables within final model. Finally, text, tables, and figures were used to present the data.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The study involved 749 health professionals. Of the participants, 637 (85 %) were males, 674 (90 %) were currently employed in urban areas, and 543 (72.5 %) had received the COVID-19 vaccine. Among all participants, 423 (56.5 %) demonstrated a good knowledge of Mpox, whereas 211 (28.2 %) expressed a willingness to get vaccinated against Mpox. Besides, recent travel to countries experiencing the Mpox outbreak (AOR = 3.21, 95 %CI:1.65–6.29), positive attitude towards the Mpox vaccine uptake (AOR = 3.08, 95 %CI:2.11–4.49), lack of access to Mpox infection information (AOR = 1.93, 95 %CI:1.05–3.55), the belief that avoiding treatment of Mpox cases would prevent self-contamination (AOR = 4.05, 95 %CI: 2.83–5.80), and prior contact with individuals diagnosed with COVID-19 (AOR = 1.57 95 %CI (1.07–2.32)were factors significantly associated with willingness to get vaccinated against Mpox.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;Despite the ongoing outbreak within the continent, only a low proportion of surveyed health professionals expressed willingness to receive the Mpox vaccine. In addressing the outbreak, it is crucial to consider various factors such as recent travel to Mpox-affected countries, attitude towards Mpox, knowledge about the disease, and prior exposure to confirmed COVID-19 cases when developing and distributing information about Mpox vaccine. Consequently, substantial","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126822"},"PeriodicalIF":4.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076162","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 phase I/II study of CpG/alum-adjuvanted mammalian-derived quadruple antigen carrying virus-like particle COVID-19 vaccine","authors":"Ismail Cem Yilmaz ,&nbsp;Emre Mert Ipekoglu ,&nbsp;Berfu Saraydar Golcuklu ,&nbsp;Tugce Bildik ,&nbsp;Aslı Gulce Bartan Aksoy ,&nbsp;Irem Evcili ,&nbsp;Nilsu Turay ,&nbsp;Naz Surucu ,&nbsp;Artun Bulbul ,&nbsp;Nese Guvencli ,&nbsp;Muzaffer Yildirim ,&nbsp;Tugce Canavar Yildirim ,&nbsp;Yagmur Aydin Atalay ,&nbsp;Irem Abras ,&nbsp;Yasemin Ceylan ,&nbsp;Yasemin Ozsurekci ,&nbsp;Elif Tukenmez Tigen ,&nbsp;Volkan Korten ,&nbsp;Mayda Gursel ,&nbsp;Ihsan Gursel","doi":"10.1016/j.vaccine.2025.126787","DOIUrl":"10.1016/j.vaccine.2025.126787","url":null,"abstract":"<div><h3>Background</h3><div>Waning Spike-elicited immunity and emerging COVID-19 variants underscore the need for vaccines leveraging multiple SARS-CoV-2 antigens, rapidly adaptable to evolving strains. Herein, we evaluated the safety and immunogenicity of a CpG ODN-adjuvanted, alum-adsorbed, virus-like particle (VLP) vaccine displaying the hexaproline stabilized Spike (S) protein and the Nucleocapsid, Membrane, and Envelope proteins of SARS-CoV-2.</div></div><div><h3>Methods</h3><div>In phase 1 randomized, double-blind, placebo-controlled, dose-escalation trial, participants (<em>N</em> = 38, aged 18–59) received two subcutaneous injections of either 10 μg or 40 μg of VLP or placebo, 21 days apart. The primary and secondary objectives of the study was to evaluate the safety, reactogenicity and immunogenicity, respectively. In the double blind, multi-center phase-2 study, participants (<em>N</em> = 349, aged 18–55) were randomized into three cohorts receiving two doses of 40 μg VLPs displaying Wuhan-Spike, Alpha-Spike, or a combination. The primary and secondary objectives were humoral, and cell mediated immunogenicity (CMI) and safety, respectively. Antibody responses were analyzed using ELISA while ELIspot and CBA assays were used to assess the CMI.</div></div><div><h3>Results</h3><div>The VLP vaccine demonstrated a good safety profile, with 255 non-serious adverse events in phase 1 and 308 in phase 2. Five serious AEs were reported in phase 2, all of which were resolved completely. The VLP vaccine, in phase 2, was well-tolerated, elicited moderate but sustained anti-S and anti-N antibody titers for 180 days and induced T-helper-1 biased cellular responses in participants.</div></div><div><h3>Conclusions</h3><div>The VLP platform is rapidly adaptable to accommodate stabilized Spike proteins from emerging variants and inclusion of other structural SARS-CoV-2 proteins could broaden the breadth of T cell-mediated immunity.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>; <span><span>NCT04818281</span><svg><path></path></svg></span> and <span><span>NCT04962893</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126787"},"PeriodicalIF":4.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076799","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":"How to accelerate the supply of vaccines to all populations worldwide? Part III: Reflections after the pandemic","authors":"Mic McGoldrick ,&nbsp;Tran Ba Quang Truong ,&nbsp;Cristiana Campa ,&nbsp;Murtuza Ali ,&nbsp;Antonio Guzzi ,&nbsp;Mark Van Ooij ,&nbsp;Cecile Feuillet ,&nbsp;Jennifer Eck","doi":"10.1016/j.vaccine.2025.126782","DOIUrl":"10.1016/j.vaccine.2025.126782","url":null,"abstract":"<div><div>When the Covid-19 pandemic was declared by WHO, a team of vaccine manufacturers worked with the COVAX (COVID-19 Vaccine Global Access) Manufacturing SWAT (Support Work to Advance) team to propose regulatory agilities for accelerating access to vaccines. The cooperation and success demonstrated during the pandemic demonstrated the benefits of simplifying requirements and reliance. Vaccine developers, manufacturers, the Coalition for Epidemic Preparedness Innovations (CEPI), and other stakeholders have engaged in discussions to highlight the lessons learned from this experience and to find solutions to address those challenges. This paper discusses efforts to accelerate pandemic preparedness and reports a comparative assessment of early and later pandemic experiences from vaccine manufacturers. The lessons learned and the risk-based approaches were invaluable in bringing vaccines to patients. However, the shift from cooperative pandemic pathways to strict non-pandemic requirements can impact supply. Flexibility and reliance are still needed to ensure timely product availability. This article emphasizes the importance of continuing pandemic preparedness and acting on lessons learned.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"49 ","pages":"Article 126782"},"PeriodicalIF":4.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076812","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}