Vaccine: X最新文献

{"title":"Vaccine optimization for highly pathogenic avian influenza: Assessment of antibody responses and protection for virus-like particle vaccines in chickens","authors":"Chia-Chi Ku ,&nbsp;Cheng-Yu Lin ,&nbsp;Chin-Rur Yang ,&nbsp;Yu-Chih Yang ,&nbsp;Po-Ling Chen ,&nbsp;Yi-Te Lin ,&nbsp;Pei-Ru Wang ,&nbsp;Min-Shi Lee ,&nbsp;Shu-Mei Liang ,&nbsp;Pei-Wen Hsiao","doi":"10.1016/j.jvacx.2024.100552","DOIUrl":"10.1016/j.jvacx.2024.100552","url":null,"abstract":"<div><h3>Background</h3><p>Recent outbreaks of clade 2.3.4.4b highly pathogenic avian influenza (HPAI) H5N1 viruses in regions previously less affected since 2020 have raised global concerns. Implementing mass immunization or ring vaccination in poultry should be a countermeasure ready to contain disease outbreaks. This study focuses on developing a recombinant H5N2 vaccine based on virus-like particles (VLPs) against clade 2.3.4.4c, the predominant HPAI subclade in Taiwan since its emergence, leading to a large outbreak in 2015.</p></div><div><h3>Methods</h3><p>The study aimed to confirm the effectiveness of clade 2.3.4.4c H5N2 VLPs in protecting chickens and identify the best adjuvants for the VLP vaccine. We used Montanide 71VG-adjuvanted inactivated RG6 to establish the immunization protocol, followed by prime-boost H5N2-VLP immunizations. We compared adjuvants: 71VG, 71VG with VP3, and Alum with VP3. Serum samples were tested for antibodies against homologous vaccine antigens and cross-clade antigens by hemagglutination inhibition (HI) assays. Finally, we evaluated the protective efficacy by lethally challenging immunized chickens with H5 viruses from clade 1 or 2.3.4.4c.</p></div><div><h3>Results</h3><p>Poultry adjuvant 71VG significantly enhanced antibody responses in chickens with inactivated RG6 compared to unadjuvanted inactivated virus. While increasing antigen dosage enhanced 71VG adjuvanted RG6-induced antibody titers, the vaccine displayed minimal cross-reactivity against locally circulating HPAI H5N2. In contrast, H5N2-VLP containing the HA protein of clade 2.3.4.4c, adjuvanted with (FMDV) VP3 in 71VG, significantly promoted HI antibody responses. All H5N2-VLP immunized chickens survived lethal challenges with the local clade 2.3.4.4c H5 strain.</p></div><div><h3>Conclusion</h3><p>The study demonstrated the immunogenic potential of the VLP vaccine in chickens. Our findings offer insights for optimizing VLP vaccines, allowing the incorporation of the HA of currently circulating H5 viruses to effectively mitigate the impact of the rapidly evolving clade 2.3.4.4 H5 outbreaks.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100552"},"PeriodicalIF":2.7,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001256/pdfft?md5=862567a96a8d3dc9674175a63e9a691c&pid=1-s2.0-S2590136224001256-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142167200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clearance of anal and penile HPV 6, 11, 16, and 18 DNA and antibodies among adolescent men who have sex with men (HYPER): An observational cohort study","authors":"Tian Tian ,&nbsp;Leiwen Fu ,&nbsp;Bingyi Wang ,&nbsp;Xinyi Zhou ,&nbsp;Yi-Fan Lin ,&nbsp;Yanxiao Gao ,&nbsp;Yuwei Li ,&nbsp;Yinghui Sun ,&nbsp;Jianghong Dai ,&nbsp;Huachun Zou","doi":"10.1016/j.jvacx.2024.100551","DOIUrl":"10.1016/j.jvacx.2024.100551","url":null,"abstract":"<div><h3>Background</h3><p>Clearance of human papillomavirus (HPV) among adolescent men who have sex with men (MSM) is not well studied. This study aimed to evaluate the clearance of HPV DNA and antibodies among adolescent MSM.</p></div><div><h3>Methods</h3><p>In our cohort study, we enrolled adolescent MSM in Melbourne between October 2010 and September 2013. At baseline, 3, 6, and 12 months, anal and penile swabs for HPV DNA and serum for HPV antibodies against genotypes 6, 11, 16, and 18, were collected. Definite clearance was defined as HPV DNA (same site) /antibodies for the same genotype undetected following a positive HPV DNA /antibodies test at baseline or month 3. Possible clearance was defined as HPV DNA (same site) /antibodies for the same genotype undetected at month 12 following a positive HPV DNA/antibodies test at month 6. Overall clearance was defined as either definite or possible clearance. The agreement between HPV DNA clearance and antibodies clearance was calculated.</p></div><div><h3>Results</h3><p>A total of 183 MSM were included (median age: 19 years, interquartile [IQR]: 18 to 20). At the anus, overall clearance rate was 21.6 (95 % confidence interval[CI]: 7.9 to 47.0), 44.8 (19.3 to 88.3), 51.9 (20.9 to 106.9) and 33.7 (7.0 to 98.5) per 1000 person months (PM) for HPV 6, 11, 16 and 18. At the penis, overall clearance rate was 64.5 (13.3 to 188.5), 71.3 (14.7 to 208.2), 96.5 (31.3 to 225.3) and 333.3 (8.4 to 1857.2) per 1000 PM for HPV 6, 11, 16 and 18. For antibodies, overall clearance rate was 22.2 (9.6 to 43.7), 18.8 (3.9 to 55.0), 10.8 (0.3 to 60.1) and 19.0 (2.3 to 68.8) per 1000 PM. Agreement between anal/penile HPV DNA clearance and antibodies clearance was low: <em>kappa</em> = -0.18 (95 % CI: −0.28 to 0.08)/-0.13 (−0.24 to −0.02), 0.04 (−0.29 to 0.36)/0.22 (−0.32 to 0.76), −0.10 (−0.27 to 0.08)/-0.14 (−0.37 to 0.10) and −0.14 (−0.28 to 0.01)/-0.14 (−0.33 to 0.06) for HPV 6, 11, 16 and 18, respectively.</p></div><div><h3>Conclusion</h3><p>Clearance rates of HPV DNA were low and varied by genotypes and anatomical sites among adolescent MSM. Antibodies against HPV were stable during the study period.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100551"},"PeriodicalIF":2.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001244/pdfft?md5=456806e08a34c17c107d9285d1ce16af&pid=1-s2.0-S2590136224001244-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142136524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Queuing analysis for improving performance in bacterial vaccine quality control process","authors":"Sallyta Ayu Martha ,&nbsp;Akhmad Yunani ,&nbsp;Wega Setiabudi ,&nbsp;Budi Harsanto","doi":"10.1016/j.jvacx.2024.100550","DOIUrl":"10.1016/j.jvacx.2024.100550","url":null,"abstract":"<div><p>The aim of the research is to analyze and improve the performance of the vaccine quality control queuing system to reduce delays and achieve the firm’s long-term goal on vaccine production capacity. The research focuses on the Bacterial Vaccine Quality Control (BVQC) at the largest vaccine manufacturers in Indonesia and Southeast Asia. The vaccines handled by BVQC include TT, DTP, BCG, BioTT, BioTd, DT, Td, and DTP-Hb-Hib. The BVQC operates a queuing system with eight servers, each assigned a fixed task. The existing system experienced delays ranging from 13 % to 61 % from January to June 2022. After identifying the queuing characteristics of the existing system, improvement proposals were suggested by modifying the assignment of the servers. This proposal was then simulated in November 2022, resulting in improved performance with no delays, a reduction in the length of the queue in the system (Lq) from 2.88 to 2.59, and a reduction in the average time spent in the system (Ws) from 0.0099 to 0.0044. The research suggests that modifying server assignments can be an effective method for improving the performance of a queuing system in vaccine quality control. This can lead to reduced delays, optimized queue lengths, and improved overall efficiency, potentially enhancing the firm’s ability to meet vaccine demand in the future.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100550"},"PeriodicalIF":2.7,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001232/pdfft?md5=f4a6faefedab08ee4b05b5ca3a76da11&pid=1-s2.0-S2590136224001232-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142047898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Human papilloma virus vaccination in the resource-limited settings of sub-Saharan Africa: Challenges and recommendations","authors":"Grant Murewanhema ,&nbsp;Enos Moyo ,&nbsp;Mathias Dzobo ,&nbsp;Rachel S. Mandishora-Dube ,&nbsp;Tafadzwa Dzinamarira","doi":"10.1016/j.jvacx.2024.100549","DOIUrl":"10.1016/j.jvacx.2024.100549","url":null,"abstract":"<div><p>Human papillomaviruses (HPV) cause 99% of all cervical cancer cases globally, with the high-risk genotypes 16 and 18 causing at least 70% of these cases. An estimated 90% of the global cervical cancer burden occurs in low-to-middle-income countries (LMICs), particularly in sub-Saharan Africa (SSA). Primary prevention through the administration of efficacious HPV vaccines is key to the World Health Organization’s global strategy for accelerating the elimination of cervical cancer as a disease of public health concern. The rollout of HPV vaccination in SSA is faced with several challenges, such as the high cost of vaccine procurement, a lack of funding and political will from the central governments of countries, and inadequate infrastructure for vaccine cold chain storage and transport. Stigma, misinformation, lack of education and awareness, and vaccine hesitancy constitute the social factors that affect the successful rollout or implementation of vaccination programs in SSA. Based on the challenges SSA faces in rolling out HPV vaccination, we recommend using strategies that address both the demand-side and supply-side obstacles to HPV vaccination uptake. These include costs and availability, fighting vaccine hesitancy, and increasing vaccine confidence.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100549"},"PeriodicalIF":2.7,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001220/pdfft?md5=0c617d253b401e682b1150fd6a0b9b9e&pid=1-s2.0-S2590136224001220-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142047897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of measles plaque reduction neutralization test (PRNT) and measles virus-specific IgG ELISA for assessment of immunogenicity of measles-mumps-rubella vaccination at 5–7 months of age and maternal measles antibodies","authors":"Dorthe Maria Vittrup ,&nbsp;Andreas Jensen ,&nbsp;Michelle Malon ,&nbsp;Anne Cathrine Zimakoff ,&nbsp;Jesper Kiehn Sørensen ,&nbsp;Brickley Littell ,&nbsp;Eric A.F. Simões ,&nbsp;Jannet Svensson ,&nbsp;Lone Graff Stensballe","doi":"10.1016/j.jvacx.2024.100548","DOIUrl":"10.1016/j.jvacx.2024.100548","url":null,"abstract":"<div><h3>Background</h3><p>Assessing the risk of measles outbreaks and identifying the susceptible parts of the population is essential to timely intervention. Infants between 6–12 months are increasingly susceptible to measles but evaluating the performance of high throughput enzyme immunoassays (ELISAs) in infants &lt; 9 months of age is lacking.</p></div><div><h3>Methods</h3><p>A commercially available ELISA kit (Creative Diagnostics, DEIA359) for estimating measles seroprotection was evaluated in infants 5–7 months of age. In an immunogenicity substudy in the Danish MMR trial conducted between 2019–2021, infants (and mothers at baseline) were sampled before and one month after measles-mumps-rubella vaccination (MMR) or placebo as well as one month after routine MMR at 15 months. Measles IgG ELISA was compared to the gold standard but labor-intensive measles plaque reduction neutralization test (PRNT) by Pearson and Spearman correlations and by estimating sensitivity, specificity, and positive and negative predictive values (PPV and NPV).</p></div><div><h3>Findings</h3><p>Measles IgG levels compared to PRNT antibodies had a Pearson’s correlation coefficient between 0.10–0.24. Seroprotection rates measured by ELISA in young infants were 10–14% lower than measured by PRNT. The sensitivity of the ELISA to detect serological protection compared to PRNT in the infant population differed markedly across sampling time points and was 14%, 40%, and 92% at baseline, post-intervention, and post-routine MMR, whereas the specificity was 99%, 93%, and 43%, respectively. The PPV and NPV were 68% and 87% in infants at baseline.</p></div><div><h3>Interpretation</h3><p>The correlation between measles IgG and PRNT antibodies was low. Seroprotection was underestimated using ELISA. High-accuracy tests are needed to avoid misclassifications and practices that lead to primary or secondary vaccine failure or retention of vaccination in outbreak settings. Baseline PPV and NPV suggested some applicability of ELISA in predicting serological protection in this age group. However, PRNT may be the only accurate estimator of serological protection in young infants.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100548"},"PeriodicalIF":2.7,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001219/pdfft?md5=86c68ece9fe4677f8fc2c33d51c94a1e&pid=1-s2.0-S2590136224001219-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142012235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Science-based exit from stringent countermeasures against COVID-19: Mortality prediction using immune landscape between 2021 and 2022 in Japan","authors":"Taishi Kayano ,&nbsp;Misaki Sasanami ,&nbsp;Hiroshi Nishiura","doi":"10.1016/j.jvacx.2024.100547","DOIUrl":"10.1016/j.jvacx.2024.100547","url":null,"abstract":"<div><h3>Background</h3><p>Stringent public health and social measures against COVID-19 infection were implemented to avoid an overwhelming hospital caseload and excessive number of deaths, especially among elderly people. We analyzed population-level immunity and predicted mortality, calculated as the potential number of deaths on a given calendar date in Japan, to develop a science-based exit strategy from stringent control measures.</p></div><div><h3>Methods</h3><p>Immune proportions were inferred by age group using vaccination coverage data and the estimated number of naturally infected individuals. Immunity against symptomatic illness and death were estimated separately, allowing for inference of the immune fraction that was protected against either COVID-19-related symptomatic infection or death. By multiplying the infection fatality risk by age group for the immune fraction, the potential number of deaths was obtained.</p></div><div><h3>Results</h3><p>Accounting for a second and third dose of messenger RNA vaccine in the present-day population, approximately 155,000 potential deaths would be expected among people aged ≥ 60 years if all individuals were infected at the very end of 2022. A fourth dose (i.e., second booster) with a coverage identical to that of the third dose could reduce mortality by 60%. In all examined settings, the largest number of deaths occurred among people aged 80 years and older.</p></div><div><h3>Conclusions</h3><p>Our estimates can help policymakers understand the mortality impact of the COVID-19 epidemic in a quantitative manner and the critical importance of timely immunization so as to assist in decision making.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100547"},"PeriodicalIF":2.7,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001207/pdfft?md5=488d409c0db01b224917f3cbcbe045b6&pid=1-s2.0-S2590136224001207-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141990709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVID-19 vaccines are effective at preventing symptomatic and severe infection among healthcare workers: A clinical review","authors":"Oliver Galgut ,&nbsp;Fiona Ashford ,&nbsp;Alexandra Deeks ,&nbsp;Andeep Ghataure ,&nbsp;Mimia Islam ,&nbsp;Tanvir Sambhi ,&nbsp;Yiu Wayn Ker ,&nbsp;Christopher J.A. Duncan ,&nbsp;Thushan I. de Silva ,&nbsp;Susan Hopkins ,&nbsp;Victoria Hall ,&nbsp;Paul Klenerman ,&nbsp;Susanna Dunachie ,&nbsp;Alex Richter","doi":"10.1016/j.jvacx.2024.100546","DOIUrl":"10.1016/j.jvacx.2024.100546","url":null,"abstract":"<div><h3>Introduction</h3><p>Health care workers (HCWs) have been at increased risk of infection during the SARS-CoV-2 pandemic and as essential workers have been prioritised for vaccination. Due to increased exposure HCW are considered a predictor of what might happen in the general population, particularly working age adults. This study aims to summarise effect of vaccination in this ‘at risk’ cohort.</p></div><div><h3>Methods</h3><p>Ovid MEDLINE and Embase were searched, and 358 individual articles were identified. Of these 49 met the inclusion criteria for review and 14 were included in a meta-analysis.</p></div><div><h3>Results</h3><p>Participants included were predominantly female and working age. Median time to infection was 51 days. Reported vaccine effectiveness against infection, symptomatic infection, and infection requiring hospitalisation were between 5 and 100 %, 34 and 100 %, and 65 and 100 % (respectively). No vaccinated HCW deaths were recorded in any study. Pooled estimates of protection against infection, symptomatic infection, and hospitalisation were, respectively, 84.7 % (95 % CI 72.6–91.5 %, <em>p</em> &lt; 0.0001), 86.0 % (95 % CI 67.2 %-94.0 %; p &lt; 0.0001), and 96.1 % (95 % CI 90.4 %-98.4 %). Waning protection against infection was reported by four studies, although protection against hospitalisation for severe infection persists for at least 6 months post vaccination.</p></div><div><h3>Conclusions</h3><p>Vaccination against SARS-CoV2 in HCWs is protective against infection, symptomatic infection, and hospitalisation. Waning protection is reported but this awaits more mature studies to understand durability more clearly. This study is limited by varying non-pharmacological responses to COVID-19 between included studies, a predominantly female and working age population, and limited information on asymptomatic transmission or long COVID protection.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100546"},"PeriodicalIF":2.7,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001190/pdfft?md5=1f7b30485082d7dbf6452ef88042fb7f&pid=1-s2.0-S2590136224001190-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141963408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Logistic and organizational barriers to herpes zoster vaccination in europe: A systematic review","authors":"Michele Sorrentino ,&nbsp;Alessandro Belpiede ,&nbsp;Claudio Fiorilla ,&nbsp;Michelangelo Mercogliano ,&nbsp;Maria Triassi ,&nbsp;Raffale Palladino","doi":"10.1016/j.jvacx.2024.100544","DOIUrl":"10.1016/j.jvacx.2024.100544","url":null,"abstract":"<div><h3>Background</h3><p>The Herpes Zoster (HZ) poses a significant public health threat, leading to morbidity and occasional mortality in unvaccinated adults aged 50 and older. With over 95 % of individuals in this age group globally having prior exposure to Varicella-Zoster Virus, a substantial portion of the world’s population is susceptible to developing HZ. Without vaccination, individuals reaching 85 years face a 50 % lifetime risk of HZ. Organizational and logistical barriers further hinder vaccination efforts, involving complexities in cost management, demanding vaccine storage requirements, supply limitations, distribution challenges, absence of a streamlined status collection system, and healthcare system deficiencies.</p></div><div><h3>Methods</h3><p>A systematic review was conducted on the studies that examined the logistical and organizational barriers to HZ vaccination among frail and older adults, aligning with the PRISMA guidelines. Eligibility criteria focus on English studies in Europe, excluding pediatric or irrelevant populations. Rayyan AI was used for data extraction, and bias was assessed using the AXIS tool.</p></div><div><h3>Results</h3><p>After excluding 841 based on titles and abstracts, 22 publications were selected. A thorough analysis identified 4 studies meeting inclusion criteria, conducted between 2009 and 2022, unveiling several barriers on HZ vaccination: challenges with healthcare professionals, obstacles related to patients’ perceptions and knowledge, difficulties in accessibility, structural issues, social dynamics.</p></div><div><h3>Conclusions</h3><p>The study represents a comprehensive examination, emphasizing the need for targeted interventions to overcome these barriers. The findings underscore the urgency of addressing these challenges to enhance vaccination rates and mitigate the public health burden associated with HZ.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100544"},"PeriodicalIF":2.7,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001177/pdfft?md5=f4ee87863946d561157a0701ed2ab1b1&pid=1-s2.0-S2590136224001177-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141962760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influenza virus strains expressing SARS-CoV-2 receptor binding domain protein confer immunity in K18-hACE2 mice","authors":"Nathaniel A. Rader ,&nbsp;Katherine S. Lee ,&nbsp;Andrea N. Loes ,&nbsp;Olivia A. Miller-Stump ,&nbsp;Melissa Cooper ,&nbsp;Ting Y. Wong ,&nbsp;Dylan T. Boehm ,&nbsp;Mariette Barbier ,&nbsp;Justin R. Bevere ,&nbsp;F. Heath Damron","doi":"10.1016/j.jvacx.2024.100543","DOIUrl":"10.1016/j.jvacx.2024.100543","url":null,"abstract":"<div><p>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), rapidly spread across the globe in 2019. With the emergence of the Omicron variant, COVID-19 shifted into an endemic phase. Given the anticipated rise in cases during the fall and winter seasons, the strategy of implementing seasonal booster vaccines for COVID-19 is becoming increasingly valuable to protect public health. This practice already exists for seasonal influenza vaccines to combat annual influenza seasons. Our goal was to investigate an easily modifiable vaccine platform for seasonal use against SARS-CoV-2. In this study, we evaluated the genetically modified influenza virus ΔNA(RBD) as an intranasal vaccine candidate for COVID-19. This modified virus was engineered to replace the coding sequence for the neuraminidase (NA) protein with a membrane-anchored form of the receptor binding domain (RBD) protein of SARS-CoV-2. We designed experiments to assess the protection of ΔNA(RBD) in K18-hACE2 mice using lethal (Delta) and non-lethal (Omicron) challenge models. Controls of COVID-19 mRNA vaccine and our lab’s previously described intranasal virus like particle vaccine were used as comparisons. Immunization with ΔNA(RBD) expressing ancestral RBD elicited high anti-RBD IgG levels in the serum of mice, high anti-RBD IgA in lung tissue, and improved survival after Delta variant challenge. Modifying ΔNA(RBD) to express Omicron variant RBD shifted variant-specific antibody responses and limited viral burden in the lungs of mice after Omicron variant challenge. Overall, this data suggests that ΔNA(RBD) could be an effective intranasal vaccine platform that generates mucosal and systemic immunity towards SARS-CoV-2.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100543"},"PeriodicalIF":2.7,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001165/pdfft?md5=3b5fb587e718d82fcf1fa3214035e3db&pid=1-s2.0-S2590136224001165-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141963409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety pharmacology of human endogenous retrovirus-enveloped baculoviral DNA vaccines against SARS-CoV-2 in Sprague-Dawley rats and beagle dogs","authors":"Sang-Jin Park ,&nbsp;Joung‐Wook Seo ,&nbsp;Kang-Hyun Han ,&nbsp;Byoung-Seok Lee ,&nbsp;Chanyeong Lee ,&nbsp;Young Bong Kim ,&nbsp;Kyong-Cheol Ko ,&nbsp;Yong-Bum Kim","doi":"10.1016/j.jvacx.2024.100545","DOIUrl":"10.1016/j.jvacx.2024.100545","url":null,"abstract":"<div><p>The coronavirus disease 2019 (COVID-19) emerged as a major global health crisis, posing significant health, economic, and social challenges. Vaccine development has been a crucial response to the severe-acute-respiratory-syndrome-related coronavirus-2 pandemic owing to the critical role of immunization in controlling infectious diseases, leading to the expedited development of several effective vaccines. Although mRNA platform-based COVID-19 vaccines authorized under emergency-use authorization have been administered globally, concerns regarding the vaccines have increased owing to the occurrence of various side effects. The present study aimed to evaluate the safety of a non-replicating recombinant baculovirus expressing the human endogenous retrovirus envelope gene (AcHERV) vaccine encoding SARS-CoV-2 antigens. Owing to the limited number of existing safety pharmacology studies on AcHERV as a viral vector vaccine, we conducted neurobehavior (Modified Irwin’s Test), body temperature, and respiratory function studies in rats and cardiovascular system studies in male beagle dogs, which were administered the AcHERV-COVID-19 vaccine using telemetry. The safety assessment revealed no significant toxicological alterations. However, in rats, both sexes administered with the AcHERV-COVID-19 vaccine exhibited a temporary increase in body temperature, which normalized or showed signs of recovery. In conclusion, AcHERV-COVID-19 demonstrates a sufficient safety profile that supports its potential evaluation in future clinical trials.</p></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"20 ","pages":"Article 100545"},"PeriodicalIF":2.7,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2590136224001189/pdfft?md5=f8a5cad510f471864968f8b33d6d2177&pid=1-s2.0-S2590136224001189-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141953151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}