Expert Review of Vaccines最新文献_第9页

Waning intra-season vaccine effectiveness against influenza A(H3N2) underlines the need for more durable protection. 甲型 H3N2 流感疫苗的季节内效力正在减弱，这凸显了提供更持久保护的必要性。

IF 6.2 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-03-18 DOI: 10.1080/14760584.2024.2331073

Alexander Domnich, Andrea Orsi, Alessio Signori, Maria Chironna, Ilaria Manini, Christian Napoli, Caterina Rizzo, Donatella Panatto, Giancarlo Icardi

{"title":"Waning intra-season vaccine effectiveness against influenza A(H3N2) underlines the need for more durable protection.","authors":"Alexander Domnich, Andrea Orsi, Alessio Signori, Maria Chironna, Ilaria Manini, Christian Napoli, Caterina Rizzo, Donatella Panatto, Giancarlo Icardi","doi":"10.1080/14760584.2024.2331073","DOIUrl":"10.1080/14760584.2024.2331073","url":null,"abstract":"Background: The question of whether influenza vaccine effectiveness (VE) wanes over the winter season is still open and some contradictory findings have been reported. This study investigated the possible decline in protection provided by the available influenza vaccines.Research design and methods: An individual-level pooled analysis of six test-negative case-control studies conducted in Italy between the 2018/2019 and 2022/2023 seasons was performed. Multivariable logistic regression analyses were performed to estimate weekly change in the odds of testing positive for influenza 14 days after vaccination.Results: Of 6490 patients included, 1633 tested positive for influenza. Each week that had elapsed since vaccination was associated with an increase in the odds of testing positive for any influenza (4.9%; 95% CI: 2.0-8.0%) and for A(H3N2) (6.5%; 95% CI: 2.9-10.3%). This decline in VE was, however, significant only in children and older adults. A similar increase in the odds of testing positive was seen when the dataset was restricted to vaccinees only. Conversely, VE waning was less evident for A(H1N1)pdm09 or B strains.Conclusions: Significant waning of VE, especially against influenza A(H3N2), may be one of the factors associated with suboptimal end-of-season VE. Next-generation vaccines should provide more durable protection against A(H3N2).","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":"23 1","pages":"380-388"},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143121","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}

引用次数: 0

Comparing reactogenicity of COVID-19 vaccine boosters: a systematic review and meta-analysis. 比较 COVID-19 疫苗增强剂的致反应性：系统回顾和荟萃分析。

IF 6.2 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-02-26 DOI: 10.1080/14760584.2024.2315089

Alberto San Francisco Ramos, Carolina Liu Sanchez, Tatiana Bovill Rose, David Smith, Natasha Thorn, Eva Galiza, Thahmena Miah, Jennifer Pearce, Cecilia Hultin, Catherine Cosgrove, Yingfen Hsia, Paul T Heath

{"title":"Comparing reactogenicity of COVID-19 vaccine boosters: a systematic review and meta-analysis.","authors":"Alberto San Francisco Ramos, Carolina Liu Sanchez, Tatiana Bovill Rose, David Smith, Natasha Thorn, Eva Galiza, Thahmena Miah, Jennifer Pearce, Cecilia Hultin, Catherine Cosgrove, Yingfen Hsia, Paul T Heath","doi":"10.1080/14760584.2024.2315089","DOIUrl":"10.1080/14760584.2024.2315089","url":null,"abstract":"Introduction: Different COVID-19 vaccines are being utilized as boosters. This systematic review and meta-analysis aims to evaluate the reactogenicity of COVID-19 vaccines given as booster doses, according to vaccine type, dose, timing, participant characteristics and primary immunization regimen received.Methods: Four databases (MEDLINE, Embase, Web of Science and CENTRAL) were searched for randomized controlled trials between 1 January 2020 and 1 January 2023 according to predetermined criteria.Results: Twenty-eight studies describing 19 vaccines of four different types (viral vector, inactivated, mRNA and protein sub-unit) were identified. BNT162b2 vaccine (Pfizer-BioNTech) was selected as the control as it was most often compared with other vaccines. Fever, fatigue, headache, injection-site pain, redness, and swelling were the most frequently reported solicited events. mRNA vaccines were the most reactogenic, followed by viral vector vaccines and protein sub-unit vaccines, while inactivated vaccines were the least reactogenic. Full-dose vaccines were more reactogenic than half-dose vaccines. Heterologous BNT162b2 boosters were more reactogenic than boosters with the same vaccine used for primary immunization.Conclusions: COVID-19 vaccine booster schedules have distinct reactogenicity profiles, dependent on dose and vaccine type, which may allow targeted recommendations and provide choice for specific populations. Greater standardization of adverse event reporting will aid future studies.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"266-282"},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139905485","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}

引用次数: 0

The broader benefits of vaccines: methodologies for inclusion in economic evaluation. 疫苗更广泛的益处：纳入经济评估的方法。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-09-04 DOI: 10.1080/14760584.2024.2387599

Steven Simoens, Sandy Tubeuf, Nicolas Dauby, Olivier Ethgen, Sophie Marbaix, Marjan Willaert, Jeroen Luyten

{"title":"The broader benefits of vaccines: methodologies for inclusion in economic evaluation.","authors":"Steven Simoens, Sandy Tubeuf, Nicolas Dauby, Olivier Ethgen, Sophie Marbaix, Marjan Willaert, Jeroen Luyten","doi":"10.1080/14760584.2024.2387599","DOIUrl":"10.1080/14760584.2024.2387599","url":null,"abstract":"Background: As the societal value of vaccines is increasingly recognized, there is a need to examine methodological approaches that could be used to integrate these various benefits in the economic evaluation of a vaccine.Research design and methods: A literature review and two expert panel meetings explored methodologies to value herd immunity, health spillover effects (beyond herd immunity), impact on antimicrobial resistance, productivity, and equity implications of vaccines.Results: The consideration of broader benefits of vaccines in economic evaluation is complicated and necessitates technical expertise. Whereas methodologies to account for herd immunity and work productivity are relatively well established, approaches to investigate equity implications are developing and less frequently applied. Modeling the potential impact on antimicrobial resistance not only depends on the multi-faceted causal relationship between vaccination and resistance but also on data availability.Conclusions: Different methods are available to value the broad impact of vaccines, and it is important that analysts are aware of their strengths and limitations and justify their choice of method. In the future, we expect that an increasing number of economic evaluations will consider the broader benefits of vaccines as part of their base-case analysis or in sensitivity analyses.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"779-788"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141970935","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}

引用次数: 0

A review of the immunogenicity and safety of booster doses of omicron variant-containing mRNA-1273 COVID-19 vaccines in adults and children. 成人和儿童接种含 mRNA-1273 COVID-19 的奥米克变体疫苗的免疫原性和安全性综述。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-09-09 DOI: 10.1080/14760584.2024.2397026

Frances Priddy, Spyros Chalkias, Brandon Essink, Jordan Whatley, Adam Brosz, Ivan T Lee, Jing Feng, LaRee Tracy, Weiping Deng, Wen Zhou, Honghong Zhou, Avika Dixit, Sabine Schnyder-Ghamloush, Bethany Girard, Elizabeth de Windt, Anne Yeakey, Jacqueline Miller, Rituparna Das, Barbara J Kuter

{"title":"A review of the immunogenicity and safety of booster doses of omicron variant-containing mRNA-1273 COVID-19 vaccines in adults and children.","authors":"Frances Priddy, Spyros Chalkias, Brandon Essink, Jordan Whatley, Adam Brosz, Ivan T Lee, Jing Feng, LaRee Tracy, Weiping Deng, Wen Zhou, Honghong Zhou, Avika Dixit, Sabine Schnyder-Ghamloush, Bethany Girard, Elizabeth de Windt, Anne Yeakey, Jacqueline Miller, Rituparna Das, Barbara J Kuter","doi":"10.1080/14760584.2024.2397026","DOIUrl":"10.1080/14760584.2024.2397026","url":null,"abstract":"Introduction: Vaccination against SARS-CoV-2 is an integral pillar of the public health approach to COVID-19. With the emergence of variants of concern that increase transmissibility and escape from vaccine- or infection-induced protection, vaccines have been developed to more closely match the newly circulating SARS-CoV-2 strains to improve protection. The safety and immunogenicity of multiple authorized messenger RNA (mRNA)-based COVID-19 vaccines targeting the omicron sublineage (BA.1, BA.4/BA.5, and XBB.1.5) have been demonstrated in several clinical trials among adults and children.Areas covered: This review will comprehensively detail the available evidence (published through July 2024) from ongoing clinical trials on omicron variant-containing mRNA-1273 vaccines administered as additional doses in previously vaccinated target demographics.Expert opinion: Across three clinical trials, omicron variant-containing mRNA-1273 vaccines induced immune responses to vaccine-matched omicron strains as well as ancestral SARS-CoV-2, with a safety and reactogenicity profile comparable to the original mRNA-1273 vaccine. Combined with pivotal data demonstrating the safety, efficacy, and effectiveness of the original mRNA-1273 vaccine, these findings support the use of variant-containing mRNA-1273 vaccines and provide confidence that expeditious development of updated vaccines using this established mRNA platform can maintain protection against COVID-19.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"862-878"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132281","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}

引用次数: 0

Indirect protection in adults ≥18 years of age from pediatric pneumococcal vaccination: a review. 小儿肺炎球菌疫苗接种对≥18 岁成人的间接保护：综述。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-10-28 DOI: 10.1080/14760584.2024.2416229

Elmira Flem, Celine Mouawad, Arto A Palmu, Heather Platt, Kelly D Johnson, E David McIntosh, Jacobo Abadi, Ulrike K Buchwald, Kristen Feemster

{"title":"Indirect protection in adults ≥18 years of age from pediatric pneumococcal vaccination: a review.","authors":"Elmira Flem, Celine Mouawad, Arto A Palmu, Heather Platt, Kelly D Johnson, E David McIntosh, Jacobo Abadi, Ulrike K Buchwald, Kristen Feemster","doi":"10.1080/14760584.2024.2416229","DOIUrl":"10.1080/14760584.2024.2416229","url":null,"abstract":"Introduction: Infant immunization programs using pneumococcal conjugate vaccines (PCVs) have reduced the rates of pneumococcal disease through direct vaccine-induced protection in vaccinated children and through indirect protection in non-vaccinated children and adults.Areas covered: This review summarizes current evidence on the indirect protection of adults conferred by pediatric pneumococcal vaccination, including the impact on invasive pneumococcal disease (IPD) incidence and mortality, pneumonia admissions, and nasopharyngeal carriage prevalence. Factors affecting indirect protection against IPD are also discussed.Expert opinion: Pediatric immunization with PCVs has substantially decreased vaccine-serotype IPD and pneumonia through indirect protection in both older (≥65 years of age) and younger adults, including those with underlying medical conditions. However, serotype replacement by non-vaccine serotypes, the persistence of some vaccine serotypes, and divergence of serotypes between children and adults have limited the impact of pediatric PCV programs on adult populations. Designing complementary vaccines that leverage indirect protection from pediatric immunization and target the most prevalent adult serotypes may be a preferred strategy to maximize the public health impact of pneumococcal vaccination.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"997-1010"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461606","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}

引用次数: 0

Global pandemic preparedness: learning from the COVID-19 vaccine development and distribution. 全球大流行病防备：从 COVID-19 疫苗的开发和分发中学习。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-08-30 DOI: 10.1080/14760584.2024.2395546

Suneth Agampodi, Ondari D Mogeni, Rebecca Chandler, Megha Pansuriya, Jerome H Kim, Jean-Louis Excler

{"title":"Global pandemic preparedness: learning from the COVID-19 vaccine development and distribution.","authors":"Suneth Agampodi, Ondari D Mogeni, Rebecca Chandler, Megha Pansuriya, Jerome H Kim, Jean-Louis Excler","doi":"10.1080/14760584.2024.2395546","DOIUrl":"10.1080/14760584.2024.2395546","url":null,"abstract":"Introduction: The COVID-19 pandemic catalyzed unprecedented vaccine innovation, revealing critical shortcomings in achieving equitable vaccine access and underscoring the need for a focused review of the lessons learned to inform future pandemic preparedness, with emphasis on vaccine delivery, equity, and challenges in LMICs.Areas covered: We critically analyzed the pandemic vaccine development and distribution journey and the operational mechanisms that facilitated these achievements. For this purpose, we primarily searched pandemic vaccine stakeholder websites, reports, and publications. The analysis extends beyond the scientific narrative to address the 'how' of the process while anchoring the discussion on equity and global health security as fundamental to preparing for future pandemics.Expert opinion: Drawing on the insights gained from the COVID-19 pandemic, we identify several key challenges requiring immediate attention to fortify preparedness for future pandemics. These are cultivating leadership in the field of vaccinology, guaranteeing equitable global access to diagnostics, therapeutic agents, and vaccines, securing adequate funding for ongoing research and development, ensuring the fair distribution of vaccines, and strategically allocating biomedical manufacturing facilities to ensure a balanced global production capacity. Addressing these challenges is imperative to establish a robust pandemic response framework and mitigate the impact of future global health crises.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"761-772"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016882","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}

引用次数: 0

Vaccines against mpox: MVA-BN and LC16m8. Mpox 疫苗：MVA-BN 和 LC16m8。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-09-01 DOI: 10.1080/14760584.2024.2397006

John D Grabenstein, Adam Hacker

{"title":"Vaccines against mpox: MVA-BN and LC16m8.","authors":"John D Grabenstein, Adam Hacker","doi":"10.1080/14760584.2024.2397006","DOIUrl":"10.1080/14760584.2024.2397006","url":null,"abstract":"Introduction: Global outbreaks involving mpox clade IIb began in mid-2022. Today, clade IIb and clade I outbreaks continue. Reliable mpox vaccines can prevent serious mpox disease and death.Areas covered: Globally, two vaccines hold mpox indications, regardless of mpox viral clade: MVA-BN (Bavarian Nordic) and LC16m8 (KM Biologics). This review summarizes the human and pivotal animal data establishing safety and efficacy for MVA-BN and LC16m8, including real-world evidence gathered during mpox outbreaks from 2022 through 2024.Expert opinion: Some regulatory decisions for MVA-BN and LC16m8 followed pathways based on surrogate outcomes, including lethal-challenge studies in nonhuman primates, among other atypical aspects. Nonetheless, MVA-BN and LC16m8 hold unencumbered registration in multiple countries. Effectiveness of MVA-BN as primary preventive vaccination (PPV) in humans against clade IIb mpox is clear from real-world studies; effectiveness of LC16m8 against clade IIb is likely from surrogate endpoints. Effectiveness of MVA-BN and LC16m8 as PPV against more-lethal clade I is likely, based on animal-challenge studies with multiple orthopoxvirus species and other studies. Both vaccines have solid safety records. MVA-BN's replication incompetence favors adoption, whereas LC16m8 has more pediatric data. Additional real-world evidence, in additional geographic settings and special populations (e.g. pregnancy, immune suppression, atopic dermatitis), is needed.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"796-811"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142072357","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}

引用次数: 0

Adult indication 13-valent pneumococcal conjugate vaccine clinical development overview: formulation, safety, immunogenicity (dosing and sequence), coadministration, and efficacy. 成人适应症 13 价肺炎球菌结合疫苗临床开发概述：配方、安全性、免疫原性（剂量和顺序）、联合用药和疗效。

IF 5.5 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-09-25 DOI: 10.1080/14760584.2024.2404636

Mark A Fletcher, Beate Schmoele-Thoma, Jelena Vojicic, Derek Daigle, Peter R Paradiso, Graciela Del Carmen Morales

{"title":"Adult indication 13-valent pneumococcal conjugate vaccine clinical development overview: formulation, safety, immunogenicity (dosing and sequence), coadministration, and efficacy.","authors":"Mark A Fletcher, Beate Schmoele-Thoma, Jelena Vojicic, Derek Daigle, Peter R Paradiso, Graciela Del Carmen Morales","doi":"10.1080/14760584.2024.2404636","DOIUrl":"10.1080/14760584.2024.2404636","url":null,"abstract":"Introduction: There was no 13-valent pneumococcal conjugate vaccine (PCV13) adult antibody concentration threshold regulatory criterion for licensure - unlike the pediatric indication; consequently, for the adult indication, PCV13 serotype-specific opsonophagocytic activity (OPA) geometric mean titer (GMT) values were immunobridged to the 23-valent plain polysaccharide vaccine (PPV23) to infer efficacy against invasive pneumococcal disease (IPD). Subsequently, a double-blind, randomized, controlled PCV13 efficacy trial (CAPiTA) was performed in community-living, older adults to confirm efficacy against vaccine-serotype IPD (VT-IPD) and establish efficacy against vaccine-serotype pneumococcal community-acquired pneumonia (VT-CAP).Areas covered: This article summarizes 31 publications from the PCV13 adult indication clinical development trials and other PCV13 clinical studies, organized by formulation, reactogenicity and safety, immunogenicity, coadministration, and clinical efficacy.Expert opinion: PCV13 had a favorable safety profile with an OPA response generally greater than PPV23 irrespective of age and of previous pneumococcal vaccination. PCV13 primed for enhanced immune responses with subsequent PCV13 or PPV23 dosing. Conversely, PPV23 was shown to blunt the response to subsequent PCV13. CAPiTA demonstrated PCV13 efficacy for at least five years against both VT-IPD and VT-CAP. The PCV13 clinical development program provided fundamental insights into this vaccine's adult-specific immune responses and confirmed the advantages of conjugate over plain polysaccharide technology.","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":"944-957"},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282790","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}

引用次数: 0

Research progress on the quality control of mRNA vaccines. mRNA 疫苗质量控制的研究进展。

IF 6.2 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-05-24 DOI: 10.1080/14760584.2024.2354251

Chaoying Hu, Yu Bai, Jianyang Liu, Yiping Wang, Qian He, Xuanxuan Zhang, Feiran Cheng, Miao Xu, Qunying Mao, Zhenglun Liang

{"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":"Introduction: 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.Areas covered: 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.Expert opinion: 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.","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}

引用次数: 0

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. 中国成年人接种基于 LYB001 RBD 的 SARS-CoV-2 VLP 疫苗（CHO 细胞）第一阶段的安全性和免疫原性：随机、双盲、阳性平行对照研究。

IF 6.2 3区医学

Expert Review of Vaccines Pub Date : 2024-01-01 Epub Date: 2024-05-02 DOI: 10.1080/14760584.2024.2337051

Rong Tang, Ying Zeng, Yu Zhou, Qi Liang, Wei Kang, Zhonghua Yang, Xiaoxiang Zheng, Xia Zang, Hongxing Pan, Jing Jin, Fengcai Zhu

{"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":"Background: Vaccination remains the cornerstone of defense against COVID-19 globally. This study aims to assess the safety and immunogenicity profile of innovative vaccines LYB001.Research design and methods: 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.Results: 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 (p > 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.Conclusions: 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.Trial registration: This trial was registered with ClinicalTrials.gov (NCT05552573).","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}

引用次数: 0