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The Costs and Cost-Effectiveness of a Two-Dose Oral Cholera Vaccination Campaign: A Case Study in a Refugee Camp Setting in Thailand. 两剂口服霍乱疫苗接种活动的成本和成本效益:泰国难民营案例研究》。
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-30 DOI: 10.3390/vaccines12111235
Aaron S Wallace, Kashmira Date, Sarah W Pallas, Nuttapong Wongjindanon, Christina R Phares, Taiwo Abimbola
{"title":"The Costs and Cost-Effectiveness of a Two-Dose Oral Cholera Vaccination Campaign: A Case Study in a Refugee Camp Setting in Thailand.","authors":"Aaron S Wallace, Kashmira Date, Sarah W Pallas, Nuttapong Wongjindanon, Christina R Phares, Taiwo Abimbola","doi":"10.3390/vaccines12111235","DOIUrl":"10.3390/vaccines12111235","url":null,"abstract":"<p><p>Oral cholera vaccination (OCV) campaigns are increasingly used to prevent cholera outbreaks; however, little is known about their cost-effectiveness in refugee camps. We conducted a cost-effectiveness analysis of a pre-emptive OCV campaign in the Maela refugee camp in Thailand, where outbreaks occurred with an annual incidence rate (IR) of up to 10.7 cases per 1000. Data were collected via health sector records and interviews and household interviews. In the base-case scenario comparing the OCV campaign with no campaign, we estimated the campaign effect on the cholera IR and case fatality rate (CFR: 0.09%) from a static cohort model and calculated incremental cost-effectiveness ratios for the outcomes of death, disability-adjusted life-years (DALYs), and cases averted. In sensitivity analyses, we varied the CFR and IR. The household economic cost of illness was USD 21, and the health sector economic cost of illness was USD 51 per case. The OCV campaign economic cost was USD 289,561, 42% attributable to vaccine costs and 58% to service delivery costs. In our base case, the incremental cost was USD 1.9 million per death averted, USD 1745 per case averted, and USD 69,892 per DALY averted. Sensitivity analyses that increased the CFR to 0.35% or the IR to 10.4 cases per 1000 resulted in a cost per DALY of USD 15,666. The low multi-year average CFR and incidence of the cholera outbreaks in the Maela camp were key factors associated with the high cost per DALY averted. However, the sensitivity analyses indicated higher cost-effectiveness in a setting with a higher CFR or cholera incidence, indicating when to consider campaign use to reduce the outbreak risk.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11598253/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142732960","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}
引用次数: 0
Protective Impact of Influenza Vaccination on Healthcare Workers. 流感疫苗对医护人员的保护作用。
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-30 DOI: 10.3390/vaccines12111237
Yimei Tian, Yue Ma, Jianchao Ran, Lifang Yuan, Xianhu Zeng, Lu Tan, Li Chen, Yifan Xu, Shaxi Li, Ting Huang, Hongzhou Lu
{"title":"Protective Impact of Influenza Vaccination on Healthcare Workers.","authors":"Yimei Tian, Yue Ma, Jianchao Ran, Lifang Yuan, Xianhu Zeng, Lu Tan, Li Chen, Yifan Xu, Shaxi Li, Ting Huang, Hongzhou Lu","doi":"10.3390/vaccines12111237","DOIUrl":"10.3390/vaccines12111237","url":null,"abstract":"<p><strong>Background: </strong>Influenza vaccine uptake among healthcare workers is crucial for preventing influenza infections, yet its effectiveness needs further investigation.</p><p><strong>Objectives: </strong>This prospective observational study aimed to assess the protective effect of influenza vaccination among healthcare workers in Shenzhen.</p><p><strong>Methods: </strong>We enrolled 100 participants, with 50 receiving the 2023-2024 quadrivalent influenza vaccine (QIV) and 50 serving as unvaccinated controls. Epidemiological data were collected when the participants presented influenza-like illness. Serum samples were collected at three time points (pre-vaccination and 28 and 180 days after vaccination). Hemagglutination inhibition (HI) assay was performed against the strains included in the 2023-2024 QIV (H1N1, H3N2, BV and BY strains) to assess antibody protection levels. Demographics comparisons revealed no significant differences between the vaccinated and control groups (<i>p</i> > 0.05), ensuring group comparability.</p><p><strong>Results: </strong>The incidence of influenza-like illness was significantly lower in the vaccinated (18%) compared to the control group (36%; <i>p</i> = 0.046; OR = 0.39; 95% CI: 0.15 to 0.98). The vaccinated group also exhibited a higher rate of consecutive two-year vaccinations (48% vs. 24% in the control group, <i>p</i> < 0.05). Additionally, the vaccinated healthcare workers were more inclined to recommend vaccination to their families (80% vs. 48%, <i>p</i> < 0.05). HI titers against H1N1 (<i>p</i> < 0.01), H3N2 (<i>p</i> < 0.01), BV (<i>p</i> < 0.001) and BY (<i>p</i> < 0.01) significantly increased in the vaccinated group at 28 days post-vaccination. Moreover, a marked and sustained increase in HI titers against the H3N2 strain (<i>p</i> < 0.001) was observed at 180 days post-vaccination, highlighting the vaccine's enduring impact on the immune response. The fold change in the HI titers, indicative of the magnitude of the immune response, was significantly higher for H1N1 (<i>p</i> < 0.01), H3N2 (<i>p</i> < 0.001), BV (<i>p</i> < 0.01) and BY (<i>p</i> < 0.05) among the vaccinated individuals compared to the control group, underscoring the vaccine's efficacy in eliciting a robust and sustained antibody response.</p><p><strong>Conclusion: </strong>Influenza vaccination significantly reduces the incidence of influenza-like illness among healthcare workers and promotes a sustained immune response. The study supports the importance of annual vaccination for this group to enhance personal and public health.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11599008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142732391","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}
引用次数: 0
Enhanced Broad-Spectrum Efficacy of an L2-Based mRNA Vaccine Targeting HPV Types 6, 11, 16, 18, with Cross-Protection Against Multiple Additional High-Risk Types. 针对 6、11、16、18 型人类乳头瘤病毒的 L2 型 mRNA 疫苗具有更强的广谱效力,并对其他多种高危类型具有交叉保护作用。
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-30 DOI: 10.3390/vaccines12111239
Kosuke Tsukamoto, Akio Yamashita, Masatoshi Maeki, Manabu Tokeshi, Hirotatsu Imai, Akira Fukao, Toshinobu Fujiwara, Koji Okudera, Nobuhisa Mizuki, Kenji Okuda, Masaru Shimada
{"title":"Enhanced Broad-Spectrum Efficacy of an L2-Based mRNA Vaccine Targeting HPV Types 6, 11, 16, 18, with Cross-Protection Against Multiple Additional High-Risk Types.","authors":"Kosuke Tsukamoto, Akio Yamashita, Masatoshi Maeki, Manabu Tokeshi, Hirotatsu Imai, Akira Fukao, Toshinobu Fujiwara, Koji Okudera, Nobuhisa Mizuki, Kenji Okuda, Masaru Shimada","doi":"10.3390/vaccines12111239","DOIUrl":"10.3390/vaccines12111239","url":null,"abstract":"<p><strong>Background: </strong>Current L1-based human papillomavirus (HPV) vaccines provide type-specific protection but offer limited cross-protection against non-vaccine HPV types. Therefore, developing a broad-spectrum HPV vaccine is highly desirable.</p><p><strong>Methods: </strong>In this study, we optimized mRNA constructs and developed a multivalent L2-based mRNA vaccine encoding L2 aa 2-130, which includes all known neutralizing epitopes from four prevalent HPV types (HPV-6, -11, -16, and -18). We evaluated its immunogenicity in a mouse model and compared the efficacy of a commercially available mRNA delivery reagent with a custom-synthesized lipid nanoparticle (LNP) formulation.</p><p><strong>Results: </strong>We identified that a construct containing E01 (a 5'-untranslated region) and SL2.7 (a poly(A) polymerase recruitment sequence) significantly increased protein expression. The L2-based mRNA vaccine induced robust and long-lasting humoral immune responses, with significant titers of cross-reactive serum IgG antibodies against L2 epitopes. Notably, the vaccine elicited cross-neutralizing antibodies and conferred cross-protective immunity not only against vaccine-targeted HPV types but also against non-vaccine HPV types, following intravaginal challenge in mice. We also found that LNP delivered mRNA more effectively in vivo.</p><p><strong>Conclusions: </strong>The L2-based mRNA vaccine developed in this study shows significant potential for broad-spectrum protection against multiple HPV types. This approach offers a promising strategy for reducing the global burden of HPV-associated cancers.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11598371/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142733039","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}
引用次数: 0
Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity. 评估 COVID-19 疫苗中和抗体免疫原性研究的质量。
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-30 DOI: 10.3390/vaccines12111238
Maeva Katzmarzyk, Robert Naughton, Ioannis Sitaras, Henning Jacobsen, Melissa M Higdon, Maria Deloria Knoll
{"title":"Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity.","authors":"Maeva Katzmarzyk, Robert Naughton, Ioannis Sitaras, Henning Jacobsen, Melissa M Higdon, Maria Deloria Knoll","doi":"10.3390/vaccines12111238","DOIUrl":"10.3390/vaccines12111238","url":null,"abstract":"<p><p><b>Objective:</b> COVID-19 vaccine-neutralizing antibodies provide early data on potential vaccine effectiveness, but their usefulness depends on study reliability and reporting quality. <b>Methods:</b> We systematically evaluated 50 published post-vaccination neutralizing antibody studies for key parameters that determine study and data quality regarding sample size, SARS-CoV-2 infection, vaccination regimen, sample collection period, demographic characterization, clinical characterization, experimental protocol, live virus and pseudo-virus details, assay standardization, and data reporting. Each category was scored from very high to low or unclear quality, with the lowest score determining the overall study quality score. <b>Results:</b> None of the studies attained an overall high or very high score, 8% (<i>n</i> = 4) attained moderate, 42% (<i>n</i> = 21) low, and 50% (<i>n</i> = 25) unclear. The categories with the fewest studies assessed as ≥ high quality were SARS-CoV-2 infection (42%), sample size (30%), and assay standardization (14%). Overall quality was similar over time. No association between journal impact factor and quality score was found. <b>Conclusions:</b> We found that reporting in neutralization studies is widely incomplete, limiting their usefulness for downstream analyses.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11598362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142733041","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}
引用次数: 0
Scientific and Regulatory Lessons Learnt on Building a Chemistry, Manufacturing, and Controls (CMC) Package for COVID-19 Variant Vaccine Updates in the EU-A Regulator's Perspective. 为欧盟 COVID-19 变异疫苗更新建立化学、制造和控制 (CMC) 一揽子方案的科学和监管经验教训--监管机构的视角。
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-29 DOI: 10.3390/vaccines12111234
Ragini Shivji, Elena Grabski, Veronika Jekerle
{"title":"Scientific and Regulatory Lessons Learnt on Building a Chemistry, Manufacturing, and Controls (CMC) Package for COVID-19 Variant Vaccine Updates in the EU-A Regulator's Perspective.","authors":"Ragini Shivji, Elena Grabski, Veronika Jekerle","doi":"10.3390/vaccines12111234","DOIUrl":"10.3390/vaccines12111234","url":null,"abstract":"<p><p>During the COVID-19 pandemic, eight COVID-19 vaccines were authorised in the European Union (EU); as a result of emerging SARS-CoV-2 variants and waning immunity, some of these have been adapted to broaden the immunity against circulating variants. The pace at which variants emerge challenges the technical feasibility to make adapted vaccines available in a suitable timeframe and in sufficient quantities. Despite the current absence of a clear-cut seasonal spread for COVID-19, the EU regulatory approach thus far is a pragmatic approach following a pathway similar to that of seasonal influenza. This approach currently requires chemistry, manufacturing, and controls (CMC-the design, development and consistent manufacture of a specified medicinal product of good quality) and non-clinical data (from product laboratory and animal studies), as well as demonstrating that updated vaccines induce an immune response that can predict clinical efficacy and safety in humans. For CMC data, COVID-19 mRNA vaccine adaptations generally made use of the same formulation, control strategy, manufacturing process, and inclusion of registered manufacturing sites for the drug product; therefore assessment was generally streamlined. The experience gained from the vaccine adaptations, combined with a continuous early regulator-developer scientific discussion, permits increasingly greater predictability for timing and positive regulatory outcomes. Here, we review key aspects of the quality control and manufacture of updating COVID-19 vaccines to protect against new variants. Although most experience has been gained with mRNA vaccines, we note that investment in the streamlining of manufacturing processes for recombinant protein vaccines would facilitate future strain updates/adaptations thereby safeguarding availability of different COVID-19 vaccine types, which is considered of value for public health. We also reflect on the challenges and opportunities in establishing more predictable regulatory mechanisms for future COVID-19 vaccine adaptions and more widely for future vaccines containing rapidly evolving pathogens with the potential to cause health threats.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11598271/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142732663","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}
引用次数: 0
Proceedings of the Conference "CMV Vaccine Development-How Close Are We?" (27-28 September 2023). CMV 疫苗开发--我们还有多远?"会议记录(2023 年 9 月 27-28 日)。
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-29 DOI: 10.3390/vaccines12111231
Mark R Schleiss, Chelsea M Crooks, Krithika P Karthigeyan, Rebecca M Kruc, Claire E Otero, Hsuan-Yuan Sherry Wang, Sallie R Permar, Stanley A Plotkin, Rajeev Gautam
{"title":"Proceedings of the Conference \"CMV Vaccine Development-How Close Are We?\" (27-28 September 2023).","authors":"Mark R Schleiss, Chelsea M Crooks, Krithika P Karthigeyan, Rebecca M Kruc, Claire E Otero, Hsuan-Yuan Sherry Wang, Sallie R Permar, Stanley A Plotkin, Rajeev Gautam","doi":"10.3390/vaccines12111231","DOIUrl":"10.3390/vaccines12111231","url":null,"abstract":"<p><p>Congenital cytomegalovirus (cCMV) is the most common infectious cause of disability in children, including sensorineural hearing loss. There is interest in developing a pre-conception vaccine that could confer protective immunity on a woman of child-bearing age, hence resulting in a reduced cCMV disease burden. Other populations, including solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) patients, could also benefit from CMV vaccination. To review and discuss vaccines that are in clinical development, a workshop, sponsored by the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID), was empaneled. At this workshop, correlates of protective immunity against CMV, epidemiologic features of CMV transmission, and vaccine platforms in development were reviewed. Representatives from academia, pharma, and the NIH engaged in discussion on the current state-of-the-art in CMV vaccinology. A summary of the presentations from this is provided in this report.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11598149/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142732343","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}
引用次数: 0
Cost-Effectiveness of Bivalent Respiratory Syncytial Virus Prefusion F Vaccine for Prevention of Respiratory Syncytial Virus Among Older Adults in Greece. 希腊老年人接种二价呼吸道合胞病毒预混 F 疫苗预防呼吸道合胞病毒的成本效益。
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-29 DOI: 10.3390/vaccines12111232
George Gourzoulidis, Charalampos Tzanetakos, Argyro Solakidi, Eleftherios Markatis, Marios Detsis, Diana Mendes, Myrto Barmpouni
{"title":"Cost-Effectiveness of Bivalent Respiratory Syncytial Virus Prefusion F Vaccine for Prevention of Respiratory Syncytial Virus Among Older Adults in Greece.","authors":"George Gourzoulidis, Charalampos Tzanetakos, Argyro Solakidi, Eleftherios Markatis, Marios Detsis, Diana Mendes, Myrto Barmpouni","doi":"10.3390/vaccines12111232","DOIUrl":"10.3390/vaccines12111232","url":null,"abstract":"<p><strong>Background/objectives: </strong>To evaluate the health benefits, costs, and cost-effectiveness of vaccination with bivalent respiratory syncytial virus stabilized prefusion F vaccine (RSVpreF) for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in Greek adults 60 years of age and older.</p><p><strong>Methods: </strong>A Markov model was adapted to simulate lifetime risk of health and economic outcomes from the public payer's perspective over a lifetime horizon. Epidemiology, vaccine effectiveness, utilities, and direct medical costs (EUR, 2024) were obtained from published studies, official sources, and local experts. Model outcomes included the number of medically attended RSV cases, stratified by care setting (i.e., hospital, emergency department [ED], outpatient visits [OV]), and attributable RSV-related deaths, costs, life years (LY), quality-adjusted life-years (QALY), and incremental cost-effectiveness ratios (ICERs) of RSVpreF vaccination compared with no vaccination.</p><p><strong>Results: </strong>The model projected 258,170 hospitalizations, 112,248 ED encounters, 1,201,604 OV, and 25,463 deaths related to RSV in Greek older adults resulting in direct medical costs of EUR 1.6 billion over the lifetime horizon. Assuming RSV vaccination would reach the same coverage rates as pneumococcal and influenza programmes, 18,118 hospitalizations, 7874 ED encounters, 48,079 OV, and 1706 deaths could be prevented over the modelled time horizon. The health benefits associated with RSVpreF contributed to an incremental gain of 10,976 LYs and 7230 QALYs compared with no vaccination. The incremental analysis reported that vaccination with RSVpreF was estimated to be a cost-effective strategy resulting in ICERs of EUR 12,991 per LY gained, EUR 19,723 per QALY gained, and EUR 7870 per hospitalized RSV case avoided compared with no vaccination.</p><p><strong>Conclusions: </strong>Vaccination with RSVpreF was a cost-effective strategy for the prevention of RSV disease in Greek adults over 60 years of age. The introduction of RSV vaccination can improve public health by averting RSV cases and deaths and has the potential to fulfil an unmet medical need.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11598676/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142732931","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}
引用次数: 0
Analytical Challenges in Novel Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W, X). 新型五价脑膜炎球菌结合疫苗(A、C、Y、W、X)的分析挑战。
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-29 DOI: 10.3390/vaccines12111227
Pankaj Sharma, Sameer Kale, Swapnil Phugare, Sunil Kumar Goel, Sunil Gairola
{"title":"Analytical Challenges in Novel Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W, X).","authors":"Pankaj Sharma, Sameer Kale, Swapnil Phugare, Sunil Kumar Goel, Sunil Gairola","doi":"10.3390/vaccines12111227","DOIUrl":"10.3390/vaccines12111227","url":null,"abstract":"<p><p>Multivalent meningococcal conjugate vaccines are a significant focus for the scientific community in light of the WHO's mission to defeat meningitidis by 2030. Well-known meningococcal vaccines such as MenAfriVac, Nimenrix, Menveo, and MenQuadfi are licensed in various parts of the world and have been successful. Recently, the World Health Organization (WHO) qualified MenFive (meningococcal A, C, Y, W, and X) conjugate vaccine, further enhancing the battery of vaccines against meningitis. The antigenic nature of the current and new serogroups, the selection of carrier proteins, and the optimal formulation of these biomolecules are pivotal parameters for determining whether a biological preparation qualifies as a vaccine candidate. Creating appropriate quality control analytical tools for a complex biological formulation is challenging. A scoping review aims to identify the main challenges and gaps in analyzing multivalent vaccines, especially in the case of novel serogroups, such as X, as the limited literature addresses these analytical challenges. In summary, the similarities in polysaccharide backbones between meningococcal serogroups (C, Y, W sharing a sialic acid backbone and A, X sharing a phosphorous backbone) along with various conjugation chemistries (such as CNBr activation, reductive amination, CDAP, CPIP, thioether bond formation, N-hydroxy succinimide activation, and carbodiimide-mediated coupling) resulting into a wide variety of polysaccharide -protein conjugates. The challenge in analyzing carrier proteins used in conjugation (such as diphtheria toxoid, tetanus toxoid, CRM diphtheria protein, and recombinant CRM) is assessing their purity (whether they are monomeric or polymeric in nature as well as their polydispersity). Additional analytical challenges include the impact of excipients, potential interference from serogroups, selection and establishment of standards, age-dependent behavior of biomolecules indicated by molecular size distributions, and process-driven variations. This article explains the analytical insights gained (polysaccharide content, free saccharide, free proteins, MSD) during the development of the MenFive vaccine and highlights the crucial gaps and challenges in testing.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11598276/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142732464","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}
引用次数: 0
Efficacy of a New Multivalent Vaccine for the Control of Bovine Respiratory Disease (BRD) in a Randomized Clinical Trial in Commercial Fattening Units. 在商业育肥单位进行的随机临床试验中,新型多价疫苗对控制牛呼吸道疾病 (BRD) 的功效。
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-29 DOI: 10.3390/vaccines12111233
Mariona Tapiolas, Marta Gibert, Carlos Montbrau, Ester Taberner, Marina Solé, Héctor Santo Tomás, Ainhoa Puig, Ricard March
{"title":"Efficacy of a New Multivalent Vaccine for the Control of Bovine Respiratory Disease (BRD) in a Randomized Clinical Trial in Commercial Fattening Units.","authors":"Mariona Tapiolas, Marta Gibert, Carlos Montbrau, Ester Taberner, Marina Solé, Héctor Santo Tomás, Ainhoa Puig, Ricard March","doi":"10.3390/vaccines12111233","DOIUrl":"10.3390/vaccines12111233","url":null,"abstract":"<p><p>A new multivalent vaccine (DIVENCE<sup>®</sup>), containing live gE/tk double-gene-deleted BoHV-1, live-attenuated BRSV, inactivated PI3, and BVDV-1, and BVDV-2 recombinant proteins, has been designed to protect cattle against the main viral pathogens associated with bovine respiratory disease (BRD). The aim of this study was to demonstrate the efficacy of DIVENCE<sup>®</sup> against BRD in field conditions. A total of 360 animals from three different farms were included in this study. Calves were randomly distributed to the vaccinated (<i>n</i> = 183; DIVENCE<sup>®</sup>) or control (<i>n</i> = 177; phosphate-buffered saline solution) group. All animals received two intramuscular doses (2 mL/dose) three weeks apart of the corresponding product. The entire fattening period (approximately 9 months) was monitored to assess the incidence, severity, and morbidity of BRD as well as administered treatments and growth performance. During this study, a BRSV outbreak was reported in one farm, where vaccinated animals had significantly (<i>p</i> < 0.02) lower morbidity (20.4%) and severity (score of 1.70) compared to the control group (53.70% and score of 2.11). Overall, vaccinated animals had a significantly lower number of cases (<i>p</i> < 0.001; 0.36 vs. 0.64 cases/calf), lower morbidity (<i>p</i> < 0.004; 26.78% vs. 41.24%), and lower antimicrobial treatments (<i>p</i> = 0.01; 33.3% vs. 57.4%) than control animals. Vaccinated animals presented significantly (<i>p</i> = 0.01) higher carcass weight than controls (6.58 kg). Vaccination with DIVENCE<sup>®</sup> at the beginning of the fattening period decreased the incidence and morbidity of BRD following a BRSV outbreak. Additionally, the overall incidence and morbidity of BRD throughout the entire fattening period were reduced across farms. Thus, DIVENCE<sup>®</sup> can improve economic outcomes in fattening units by reducing antibiotic treatments and enhancing performance.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11598617/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142732943","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}
引用次数: 0
Beyond Awareness: Hope for a CMV Vaccine! An Introduction to the Conference, "CMV Vaccine Development-How Close Are We?" (27-28 September 2023). 超越认知:CMV 疫苗的希望!会议简介:"CMV 疫苗开发--我们离成功还有多远?
IF 5.2 3区 医学
Vaccines Pub Date : 2024-10-29 DOI: 10.3390/vaccines12111226
Megan H Pesch, Mark R Schleiss, Stanley A Plotkin, Sallie R Permar, Rajeev Gautam
{"title":"Beyond Awareness: Hope for a CMV Vaccine! An Introduction to the Conference, \"CMV Vaccine Development-How Close Are We?\" (27-28 September 2023).","authors":"Megan H Pesch, Mark R Schleiss, Stanley A Plotkin, Sallie R Permar, Rajeev Gautam","doi":"10.3390/vaccines12111226","DOIUrl":"10.3390/vaccines12111226","url":null,"abstract":"<p><p>Congenital cytomegalovirus (cCMV) is the most common infectious cause of disability in children. The major theme of this National Institute of Allergy and Infectious Diseases (NIAID) workshop, \"CMV Vaccine Development-How Close Are We?\", was to report progress on the development of a pre-conception vaccine that could confer protective immunity for women of child-bearing age. Such a vaccine could result in a reduced cCMV disease burden, although other populations, including solid organ transplant and hematopoietic stem cell transplant patients, could benefit as well. To frame the compelling need for a cCMV vaccine, a keynote lecture by Dr. Megan Pesch, immediate past-president of the National CMV Foundation and a leading cCMV researcher from the University of Michigan, was given. This manuscript provides a summary of Dr. Pesch's presentation from this workshop, which was written as the introductory conference report for the meeting.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"12 11","pages":""},"PeriodicalIF":5.2,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11598857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142732799","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}
引用次数: 0
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