Expert Review of VaccinesPub Date : 2024-01-01Epub Date: 2024-03-01DOI: 10.1080/14760584.2024.2323128
Daisuke Kurai, Akiko Mizukami, Victor Preckler, Frederik Verelst, Daniel Molnar, Taizo Matsuki, Yufan Ho, Ataru Igarashi
{"title":"The potential public health impact of the respiratory syncytial virus prefusion F protein vaccine in people aged ≥60 years in Japan: results of a Markov model analysis.","authors":"Daisuke Kurai, Akiko Mizukami, Victor Preckler, Frederik Verelst, Daniel Molnar, Taizo Matsuki, Yufan Ho, Ataru Igarashi","doi":"10.1080/14760584.2024.2323128","DOIUrl":"10.1080/14760584.2024.2323128","url":null,"abstract":"<p><strong>Background: </strong>Respiratory syncytial virus (RSV), a common respiratory pathogen, can lead to severe symptoms, especially in older adults (OA). A recently developed RSV prefusion F protein (RSVPreF3 OA) vaccine confers high protection against RSV lower respiratory tract disease (LRTD) over two full RSV seasons. The aim of this study was to assess the potential public health impact of RSVPreF3 OA vaccination in the Japanese OA population.</p><p><strong>Research design and methods: </strong>A static Markov model was used to estimate the number of symptomatic RSV cases, hospitalizations and deaths in the Japanese population aged ≥ 60 years over a 3-year time horizon. Japan-specific RSV epidemiology and healthcare resource use parameters were used; vaccine efficacy was derived from a phase 3 randomized study (AReSVi-006, NCT04886596). Vaccination coverage was set to 50%.</p><p><strong>Results: </strong>Without vaccination, >5 million RSV acute respiratory illness (ARI) would occur (2.5 million LRTD and 2.8 million upper respiratory tract infections) leading to ~ 3.5 million outpatient visits, >534,000 hospitalizations and ~ 25,500 RSV-related deaths over 3 years. Vaccination could prevent > 1 million RSV-ARI cases, 728,000 outpatient visits, 143,000 hospitalizations and 6,840 RSV-related deaths.</p><p><strong>Conclusions: </strong>RSVPreF3 OA vaccination is projected to have a substantial public health impact by reducing RSV-related morbidity and mortality in the OA population.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"23 1","pages":"303-311"},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139996057","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":"Safety and immunogenicity of the SARS-CoV-2 LYB001 RBD-based VLP vaccine (CHO cell) phase 1 in Chinese adults: a randomized, double-blind, positive-parallel-controlled study.","authors":"Rong Tang, Ying Zeng, Yu Zhou, Qi Liang, Wei Kang, Zhonghua Yang, Xiaoxiang Zheng, Xia Zang, Hongxing Pan, Jing Jin, Fengcai Zhu","doi":"10.1080/14760584.2024.2337051","DOIUrl":"https://doi.org/10.1080/14760584.2024.2337051","url":null,"abstract":"<p><strong>Background: </strong>Vaccination remains the cornerstone of defense against COVID-19 globally. This study aims to assess the safety and immunogenicity profile of innovative vaccines LYB001.</p><p><strong>Research design and methods: </strong>This was a randomized, double-blind, parallel-controlled trial, in 100 healthy Chinese adults (21 to 72 years old). Three doses of 30 or 60 µg of SARS-CoV-2 RBD-based VLP vaccine (LYB001), or the SARS-CoV-2 RBD-based protein subunit vaccine (ZF2001, control group) were administered with a 28-day interval. Differences in the incidence of adverse events (AEs) and indicators of humoral and cellular immunity among the different groups were measured.</p><p><strong>Results: </strong>No severe adverse events were confirmed to be vaccine-related, and there was no significant difference in the rate of adverse events between the LYB001 and control group or the age subgroups (<i>p</i> > 0.05). The LYB001 groups had significantly higher or comparable levels of seroconversion rates, neutralization antibody, S protein-binding antibody, and cellular immunity after whole vaccination than the control group.</p><p><strong>Conclusions: </strong>Our findings support that LYB001 developed on the VLP platform is safe and well tolerated with favorable immunogenicity for fundamental vaccination in healthy adults. Therefore, further larger-scale clinical studies are warranted.</p><p><strong>Trial registration: </strong>This trial was registered with ClinicalTrials.gov (NCT05552573).</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"23 1","pages":"498-509"},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140863449","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":"Research progress on the quality control of mRNA vaccines.","authors":"Chaoying Hu, Yu Bai, Jianyang Liu, Yiping Wang, Qian He, Xuanxuan Zhang, Feiran Cheng, Miao Xu, Qunying Mao, Zhenglun Liang","doi":"10.1080/14760584.2024.2354251","DOIUrl":"10.1080/14760584.2024.2354251","url":null,"abstract":"<p><strong>Introduction: </strong>The mRNA vaccine technologies have progressed rapidly in recent years. The COVID-19 pandemic has accelerated the application of mRNA vaccines, with research and development and clinical trials underway for many vaccines. Application of the quality by design (QbD) framework to mRNA vaccine development and establishing standardized quality control protocols for mRNA vaccines are essential for the continued development of high-quality mRNA vaccines.</p><p><strong>Areas covered: </strong>mRNA vaccines include linear mRNA, self-amplifying mRNA, and circular RNA vaccines. This article summarizes the progress of research on quality control of these three types of vaccines and presents associated challenges and considerations.</p><p><strong>Expert opinion: </strong>Although there has been rapid progress in research on linear mRNA vaccines, their degradation patterns remain unclear. In addition, standardized assays for key impurities, such as residual dsRNA and T7 RNA polymerase, are still lacking. For self-amplifying mRNA vaccines, a key focus should be control of stability in vivo and in vitro. For circular RNA vaccines, standardized assays, and reference standards for determining degree of circularization should be established and optimized.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"570-583"},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140908200","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}
Expert Review of VaccinesPub Date : 2024-01-01Epub Date: 2024-07-10DOI: 10.1080/14760584.2024.2375329
Amelia K Gerste, Arman Majidulla, Anurima Baidya, Onimitein Georgewill, Andrea N DeLuca, Puck T Pelzer, Michelle M Gill, Degu Jerene, Joeri S Buis, Andrew D Kerkhoff, Rupali J Limaye
{"title":"Lessons from a decade of adult vaccine rollout in low- and middle-income countries: a scoping review.","authors":"Amelia K Gerste, Arman Majidulla, Anurima Baidya, Onimitein Georgewill, Andrea N DeLuca, Puck T Pelzer, Michelle M Gill, Degu Jerene, Joeri S Buis, Andrew D Kerkhoff, Rupali J Limaye","doi":"10.1080/14760584.2024.2375329","DOIUrl":"10.1080/14760584.2024.2375329","url":null,"abstract":"<p><strong>Introduction: </strong>The historical focus of vaccines on child health coupled with the advent of novel vaccines targeting adult populations necessitates exploring strategies for adult vaccine implementation.</p><p><strong>Areas covered: </strong>This scoping review extracts insights from the past decade's experiences introducing adult vaccines in low- and middle-income countries. Among 25 papers reviewed, 19 focused on oral cholera vaccine, 2 on Meningococcal A vaccines, 2 on tetanus toxoid vaccine, 1 on typhoid vaccine, and 1 on Ebola vaccine. Aligned with WHO's Global Framework for New TB Vaccines for Adults and Adolescents, our findings center on vaccine availability, accessibility, and acceptance.</p><p><strong>Expert opinion: </strong>Availability findings underscore the importance of understanding disease burden for prioritization, multi-sectoral collaboration during planning, and strategic resource allocation and coordination. Accessibility results highlight the benefits of leveraging existing health infrastructure and adequately training healthcare workers, and contextually tailoring vaccine delivery approaches to reach challenging sub-groups like working male adults. Central to fostering acceptance, resonant sensitization, and communication campaigns engaging the communities and utilizing trusted local leaders countered rumors and increased awareness and uptake. As we approach the introduction of a new adult TB vaccine, insights from this review equips decision-makers with key evidence-based recommendations to support successful and equitable vaccinations targeting adults.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"688-704"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534110","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}
Expert Review of VaccinesPub Date : 2024-01-01Epub Date: 2024-04-02DOI: 10.1080/14760584.2024.2333952
Gabiria Pastore, Jacopo Polvere, Fabio Fiorino, Simone Lucchesi, Giorgio Montesi, Ilaria Rancan, Sara Zirpoli, Arianna Lippi, Miriam Durante, Massimiliano Fabbiani, Mario Tumbarello, Francesca Montagnani, Donata Medaglini, Annalisa Ciabattini
{"title":"Homologous or heterologous administration of mRNA or adenovirus-vectored vaccines show comparable immunogenicity and effectiveness against the SARS-CoV-2 Omicron variant.","authors":"Gabiria Pastore, Jacopo Polvere, Fabio Fiorino, Simone Lucchesi, Giorgio Montesi, Ilaria Rancan, Sara Zirpoli, Arianna Lippi, Miriam Durante, Massimiliano Fabbiani, Mario Tumbarello, Francesca Montagnani, Donata Medaglini, Annalisa Ciabattini","doi":"10.1080/14760584.2024.2333952","DOIUrl":"10.1080/14760584.2024.2333952","url":null,"abstract":"<p><strong>Background: </strong>Heterologous prime-boost schedules have been employed in SARS-CoV-2 vaccination, yet additional data on immunogenicity and effectiveness are still needed.</p><p><strong>Research design and methods: </strong>Here, we measured the immunogenicity and effectiveness in the real-world setting of the mRNA booster dose in 181 subjects who had completed primary vaccination with ChAdOx1, BNT162b2, or mRNA1273 vaccines (IMMUNO_COV study; protocol code 18,869). The spike-specific antibody and B cell responses were analyzed up to 6 months after boosting.</p><p><strong>Results: </strong>After an initial slower antibody response, the heterologous ChAdOx1/mRNA prime-boost formulation elicited spike-specific IgG titers comparable to homologous approaches, while spike-specific B cells showed a higher percentage of CD21<sup>-</sup>CD27<sup>-</sup> atypical cells compared to homologous mRNA vaccination. Mixed combinations of BNT162b2 and mRNA-1273 elicited an immune response comparable with homologous strategies. Non-significant differences in the Relative Risk of infection, calculated over a period of 18 months after boosting, were reported among homologous or heterologous vaccination groups, indicating a comparable relative vaccine effectiveness.</p><p><strong>Conclusions: </strong>Our data endorse the heterologous booster vaccination with mRNA as a valuable alternative to homologous schedules. This approach can serve as a solution in instances of formulation shortages and contribute to enhancing vaccine strategies for potential epidemics or pandemics.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"432-444"},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140184056","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}
Expert Review of VaccinesPub Date : 2024-01-01Epub Date: 2024-06-25DOI: 10.1080/14760584.2024.2367457
Chiara de Waure, Elisabetta Alti, Vincenzo Baldo, Paolo Bonanni, Michele Conversano, Alberto Fedele, Giovanni Gabutti, Roberto Ieraci, Francesco Landi, Raffaele Landolfi, Andrea Orsi, Caterina Rizzo, Alessandro Rossi, Alberto Villani, Francesco Vitale, Alexander Domnich
{"title":"Mapping and ranking outcomes for the evaluation of seasonal influenza vaccine efficacy and effectiveness: a delphi study.","authors":"Chiara de Waure, Elisabetta Alti, Vincenzo Baldo, Paolo Bonanni, Michele Conversano, Alberto Fedele, Giovanni Gabutti, Roberto Ieraci, Francesco Landi, Raffaele Landolfi, Andrea Orsi, Caterina Rizzo, Alessandro Rossi, Alberto Villani, Francesco Vitale, Alexander Domnich","doi":"10.1080/14760584.2024.2367457","DOIUrl":"10.1080/14760584.2024.2367457","url":null,"abstract":"<p><strong>Background: </strong>Protection provided by seasonal influenza vaccination (SIV) may be measured against numerous outcomes, and their heterogeneity may hamper decision-making. The aim of this study was to explore outcomes used for estimation of SIV efficacy/effectiveness (VE) and obtain expert consensus on their importance.</p><p><strong>Research design and methods: </strong>An umbrella review was first conducted to collect and map outcomes considered in systematic reviews of SIV VE. A Delphi study was then performed to reach expert convergence on the importance of single outcomes, measured on a 9-point Likert scale, in principal target groups, namely children, working-age adults, older adults, subjects with co-morbidities and pregnant women.</p><p><strong>Results: </strong>The literature review identified 489 outcomes. Following data reduction, 20 outcomes were selected for the Delphi process. After two Delphi rounds and a final consensus meeting, convergence was reached. All 20 outcomes were judged to be important or critically important. More severe outcomes, such as influenza-related hospital encounters and mortality with or without laboratory confirmation, were generally top-ranked across all target groups (median scores ≥8 out of 9).</p><p><strong>Conclusions: </strong>Rather than focusing on laboratory-confirmed infection per se, experimental and observational VE studies should include more severe influenza-related outcomes because they are expected to exercise a greater impact on decision-making.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"636-644"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141310479","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}
Expert Review of VaccinesPub Date : 2024-01-01Epub Date: 2023-12-14DOI: 10.1080/14760584.2023.2290691
Thi Hoai Thu Do, Adam K Wheatley, Stephen J Kent, Marios Koutsakos
{"title":"Influenza B virus neuraminidase: a potential target for next-generation vaccines?","authors":"Thi Hoai Thu Do, Adam K Wheatley, Stephen J Kent, Marios Koutsakos","doi":"10.1080/14760584.2023.2290691","DOIUrl":"10.1080/14760584.2023.2290691","url":null,"abstract":"<p><strong>Introduction: </strong>Influenza B viruses (IBV) cause a significant health and economic burden annually. Due to lower antigenic drift rate, less extensive antigenic diversity, and lack of animal reservoirs, the development of highly effective universal vaccines against IBV might be in reach. Current seasonal influenza vaccines are formulated to induce antibodies against the Hemagglutinin (HA) protein, but their effectiveness is reduced by mismatch between vaccine and circulating strains.</p><p><strong>Areas covered: </strong>Given antibodies against the Neuraminidase (NA) have been associated with protection during influenza infection, there is considerable interest in the development of NA-based influenza vaccines. This review summarizes insights into the role of NA-based immunity against IBV and highlights knowledge gaps that should be addressed to inform the design of next-generation influenza B vaccines. We discuss how antibodies recognize broadly cross-reactive epitopes on the NA and the lack of understanding of IBV NA antigenic evolution which would benefit vaccine development in the future.</p><p><strong>Expert opinion: </strong>Demonstrating NA antibodies as correlates of protection for IBV in humans would be paramount. Determining the extent of IBV NA antigenic evolution will be informative. Finally, it will be critical to determine optimal strategies for incorporating the appropriate NA antigens in existing clinically approved vaccine formulations.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"39-48"},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138458946","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}
Expert Review of VaccinesPub Date : 2024-01-01Epub Date: 2024-01-03DOI: 10.1080/14760584.2023.2299380
Syamala R Thimmiraju, Jason T Kimata, Jeroen Pollet
{"title":"Pseudoviruses, a safer toolbox for vaccine development against enveloped viruses.","authors":"Syamala R Thimmiraju, Jason T Kimata, Jeroen Pollet","doi":"10.1080/14760584.2023.2299380","DOIUrl":"10.1080/14760584.2023.2299380","url":null,"abstract":"<p><strong>Introduction: </strong>Pseudoviruses are recombinant, replication-incompetent, viral particles designed to mimic the surface characteristics of native enveloped viruses. They are a safer, and cost-effective research alternative to live viruses. With the potential emergence of the next major infectious disease, more vaccine scientists must become familiar with the pseudovirus platform as a vaccine development tool to mitigate future outbreaks.</p><p><strong>Areas covered: </strong>This review aims at vaccine developers to provide a basic understanding of pseudoviruses, list their production methods, and discuss their utility to assess vaccine efficacy against enveloped viral pathogens. We further illustrate their usefulness as wet-lab simulators for emerging mutant variants, and new viruses to help prepare for current and future viral outbreaks, minimizing the need for gain-of-function experiments with highly infectious or lethal enveloped viruses.</p><p><strong>Expert opinion: </strong>With this platform, researchers can better understand the role of virus-receptor interactions and entry in infections, prepare for dangerous mutations, and develop effective vaccines.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"174-185"},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139073822","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}
Expert Review of VaccinesPub Date : 2024-01-01Epub Date: 2024-12-03DOI: 10.1080/14760584.2024.2428806
Iftihar Koksal, Salah Al Awaidy, Abdullah Mufareh Assiri, Onur Ozudogru, Mansour Khalaf, Cihan Yeşiloğlu, Selim Badur
{"title":"Adult vaccination in three Eastern Mediterranean countries: current status, challenges and the way forward.","authors":"Iftihar Koksal, Salah Al Awaidy, Abdullah Mufareh Assiri, Onur Ozudogru, Mansour Khalaf, Cihan Yeşiloğlu, Selim Badur","doi":"10.1080/14760584.2024.2428806","DOIUrl":"10.1080/14760584.2024.2428806","url":null,"abstract":"<p><strong>Introduction: </strong>Changing population demographics places a premium on optimizing older adult health. Vaccine-preventable diseases represent a substantial clinical and economic burden in older adults (≥65 years).</p><p><strong>Areas covered: </strong>This narrative review summarizes the adult immunization landscape in three countries; Saudi Arabia, the United Arab Emirates and Türkiye, informed by literature searches; PubMed (23-27 September 2023) supplemented by citation tracking via Google Scholar). Existing vaccination recommendations and published data were reviewed to evaluate vaccine uptake, chiefly focusing on core adult vaccines (seasonal influenza, pneumococcal, and herpes zoster). Barriers to vaccine access and uptake were reviewed, and initiatives to improve recommended vaccine uptake in older (≥65 years) or otherwise high-risk adults are described.</p><p><strong>Expert opinion: </strong>Uptake of recommended adult vaccines is low in all three countries. Receipt of annual seasonal influenza vaccine is typically below 50% in both older and at-risk younger adults; pneumococcal vaccination rates are even lower in eligible adults (<15% and often far lower), as is herpes zoster vaccine uptake (typically <5%). Low coverage is driven chiefly by low awareness of vaccine benefits, inconsistent recommendations, and vaccine hesitancy, together with often complex adult vaccine access pathways. Initiatives and remedies aimed at augmenting adult vaccination rates are warranted.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"1068-1084"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616837","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}