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Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study 无硫柳汞重组戊型肝炎疫苗的安全性和免疫原性:一项随机、双盲、主动对照研究
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-20 DOI: 10.1016/j.vaccine.2025.127510
Junrong Li , Xiujuan Wang , Dengxiang Zhang , Fangqin Xie , Sumei Zhong , Xiaoshan Yu , Shasha Chen , Qinbiao Huang , Rui Wang , Qiufen Zhang , Dongjuan Zhang
{"title":"Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study","authors":"Junrong Li ,&nbsp;Xiujuan Wang ,&nbsp;Dengxiang Zhang ,&nbsp;Fangqin Xie ,&nbsp;Sumei Zhong ,&nbsp;Xiaoshan Yu ,&nbsp;Shasha Chen ,&nbsp;Qinbiao Huang ,&nbsp;Rui Wang ,&nbsp;Qiufen Zhang ,&nbsp;Dongjuan Zhang","doi":"10.1016/j.vaccine.2025.127510","DOIUrl":"10.1016/j.vaccine.2025.127510","url":null,"abstract":"<div><h3>Introduction</h3><div>The first recombinant hepatitis E vaccine (<em>Escherichia Coli</em>), Hecolin® (Xiamen Innovax, China), was approved for people aged ≥16 years. Innovax has developed a thiomersal-free formulation process change according to the requirement of <em>2020 Chinese Pharmacopoeia</em>. This study aimed to evaluate the safety and immunogenicity of the thiomersal-free hepatitis E vaccine compared with the licensed hepatitis E vaccine in people aged ≥16 years. Clinical Trial Registration: <span><span>NCT06564116</span><svg><path></path></svg></span>.</div></div><div><h3>Methods</h3><div>This was a single-center, randomized, double-blind, active-controlled study conducted in China. Eligible participants were randomly assigned in a 1:1 ratio to the thiomersal-free hepatitis E vaccine group (HEV-TF group) or the hepatitis E vaccine group (HEV group) stratified by sex and age. Each participant received three doses of the vaccine intramuscularly at 0, 1 and 6 months. Safety was evaluated based on adverse events (AEs) occurred within 30 days following each dose, serious adverse events (SAEs) and pregnancy events occurred during the study period. Immunogenicity was evaluated through quantification of anti-HEV IgG in serum samples collected at 0 and 7 months.</div></div><div><h3>Results</h3><div>A total of 612 eligible participants were enrolled and received at least 1 dose of vaccine. 558 participants were included in the per protocol set for immunogenicity. All participants seroconverted in both groups by month 7. The seroconversion rate difference was 0.00 % (95 % confidence interval [CI] -1.38 to 1.34). The geometric mean concentrations (GMCs) in HEV-TF group and HEV group were 16.57 U/mL and 18.47 U/mL, respectively. The GMC ratio was 0.90 (95 % CI 0.79 to 1.01). The overall AEs rates were similar between the groups (16.88 % vs. 12.50 %). Most of AEs were grade 1 or 2. No vaccine-related SAE occurred during the study period.</div></div><div><h3>Conclusions</h3><div>The thiomersal-free hepatitis E vaccine demonstrated non-inferior immunogenicity compared with the licensed hepatitis E vaccine Hecolin® and showed an acceptable safety profile.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127510"},"PeriodicalIF":4.5,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144665845","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
Racial and ethnic differences among Mpox vaccination recipients by vaccination facility type in New York City—August–December 2022 2022年8月至12月,纽约市按疫苗接种机构类型划分的麻疹疫苗接种者的种族和民族差异
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-20 DOI: 10.1016/j.vaccine.2025.127520
Melanie S. Askari , Michelle Macaraig, Alexandra Ternier, Bindy Crouch
{"title":"Racial and ethnic differences among Mpox vaccination recipients by vaccination facility type in New York City—August–December 2022","authors":"Melanie S. Askari ,&nbsp;Michelle Macaraig,&nbsp;Alexandra Ternier,&nbsp;Bindy Crouch","doi":"10.1016/j.vaccine.2025.127520","DOIUrl":"10.1016/j.vaccine.2025.127520","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate if race and ethnicity were associated with mpox vaccination at routine care sites (i.e., existing healthcare facilities), compared with temporary sites (i.e., government-operated sites).</div></div><div><h3>Methods</h3><div>We analyzed data from New York City's (NYC's) Immunization Information System during August 8–December 14, 2022, the period when routine and temporary mpox vaccination sites were operational. We used generalized estimating equations to assess whether race and ethnicity were associated with vaccination facility type, adjusting for demographics and accounting for doses received.</div></div><div><h3>Results</h3><div>In NYC, 102,583 mpox vaccine doses were administered during August 8–December 14, 2022 (22.1 % at routine care sites and 77.9 % at temporary sites). Black non-Latino and Latino New Yorkers were 61 % and 34 % more likely, respectively, than White non-Latino New Yorkers to get vaccinated at routine care vs temporary sites (adjusted odds ratio [aOR] = 1.61; 95 % CI = 1.54–1.68; aOR = 1.34, 95 % CI = 1.29–1.39).</div></div><div><h3>Conclusions</h3><div>Although fewer persons were vaccinated at routine care sites, compared with temporary sites, routine care enhanced vaccine access for historically marginalized populations during NYC's 2022 mpox outbreak.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127520"},"PeriodicalIF":4.5,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144665558","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
COVID-19 vaccine hesitancy and perceived post-vaccination adverse event: Findings from a cross-sectional survey COVID-19疫苗犹豫和疫苗接种后感知的不良事件:来自横断面调查的结果
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-20 DOI: 10.1016/j.vaccine.2025.127529
Maude Dionne , Chantal Sauvageau , Jeremy K. Ward , Jérémie Sylvain-Morneau , Fátima Gauna , Radhouene Doggui , Ève Dubé
{"title":"COVID-19 vaccine hesitancy and perceived post-vaccination adverse event: Findings from a cross-sectional survey","authors":"Maude Dionne ,&nbsp;Chantal Sauvageau ,&nbsp;Jeremy K. Ward ,&nbsp;Jérémie Sylvain-Morneau ,&nbsp;Fátima Gauna ,&nbsp;Radhouene Doggui ,&nbsp;Ève Dubé","doi":"10.1016/j.vaccine.2025.127529","DOIUrl":"10.1016/j.vaccine.2025.127529","url":null,"abstract":"<div><h3>Introduction</h3><div>In Quebec, COVID-19 vaccine uptake among adults was high for the first two doses but decreased for the subsequent booster doses. This study assesses the relationships between attitudes towards vaccination and self-reported experience and severity of adverse events following immunization (AEFIs).</div></div><div><h3>Methods</h3><div>A web survey of Quebec adults who received at least one dose of the COVID-19 vaccine was conducted in September 2023. Participants share their level of vaccine hesitancy before vaccination and their experience with AEFIs after receiving a dose. Participants were asked to note the severity of the symptoms they believed were due to vaccination. Intention to receive other vaccines in the future was questioned. Two coders performed a qualitative content analysis on reported AEFIs (<em>N</em> = 3808). Descriptive and multivariate logistic regression analyses were performed.</div></div><div><h3>Results</h3><div>Among the 8419 vaccinated respondents, 46.7 % reported having experienced AEFIs. Fatigue or malaise (20.7 %), injection site disorder (17.3 %), musculoskeletal pain (11.2 %), headache (11.0 %), and fever (10.6 %) were the most commonly reported, respectively. Respondents who were very hesitant before the COVID-19 vaccine reported more frequently having a severe AEFI compared to those who were not hesitant (25.0 % vs 3.4 % =, <em>p</em> &lt; 0.001). This affirmation stays true when all severity of adverse events are considered (68.7 % vs 36.9 %) (<em>p</em> &lt; 0.001). Younger age (aOR = 0.98), being a female (aOR = 1.31), a higher education level (University degree aOR = 1.56 vs high school or less), being vaccine-hesitant in general (aOR = 1.69 vs non or less hesitant) were significantly associated (<em>p</em> &lt; 0.001) with self-reported AEFIs in multivariate analysis. Self-reported AEFIs that prevented doing activities (aOR = 4.87) and being vaccine-hesitant in general (aOR = 4.94) were significantly associated with reduced intention to receive other vaccines in the future.</div></div><div><h3>Conclusion</h3><div>Vaccine hesitancy could influence self-reported AEFIs and their perceived severity. Transparent and tailored communication explaining AEFIs while emphasizing strategies to mitigate these effects could helpful. Our findings also have implications for pharmacovigilance.</div><div>301 mots.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127529"},"PeriodicalIF":4.5,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144665835","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
Non-typhoidal Salmonella combination vaccines: clinical development plan and regulatory considerations 非伤寒沙门氏菌联合疫苗:临床开发计划和监管考虑
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-19 DOI: 10.1016/j.vaccine.2025.127515
Jean-Louis Excler , Tarun Saluja , Annelies Wilder-Smith , Robert W. Kaminski , Calman A. MacLennan , Marco Cavaleri , Jerome H. Kim
{"title":"Non-typhoidal Salmonella combination vaccines: clinical development plan and regulatory considerations","authors":"Jean-Louis Excler ,&nbsp;Tarun Saluja ,&nbsp;Annelies Wilder-Smith ,&nbsp;Robert W. Kaminski ,&nbsp;Calman A. MacLennan ,&nbsp;Marco Cavaleri ,&nbsp;Jerome H. Kim","doi":"10.1016/j.vaccine.2025.127515","DOIUrl":"10.1016/j.vaccine.2025.127515","url":null,"abstract":"<div><div>Invasive non-typhoidal serovars of <em>Salmonella enterica,</em> <em>S.</em> Typhimurium and <em>S.</em> Enteritidis, (iNTS<em>)</em> are estimated to cause over 500,000 cases of disease leading to more than 79,000 deaths with a high case fatality ratio of 14.5 %. Most infections occur in infants and young children in LMICs in sub–Saharan Africa where host risk factors for iNTS disease such as malaria, malnutrition, HIV infection, and anemia are common. iNTS disease is observed from birth, with a peak incidence early in the second year of life, declining before the age of 3 years. The prevalence of multiple drug resistance of iNTS has increased markedly by decade, emphasizing the need for effective vaccines.</div><div>A clinical development plan and regulatory pathway for licensure of iNTS vaccines has been shaped following the development of Preferred Product Characteristics and R&amp;D Roadmap through a series of expert consultations. Several iNTS alone or combined with Typhoid Conjugate Vaccine platforms are in early clinical development. Encouraging safety and immunogenicity data have prompted developers and manufacturers to plan efficacy trials, aligned with regulatory expectations. It is critical to clearly communicate iNTS disease burden in endemic countries and to discuss complexities related to iNTS single component or combination vaccine clinical development with regulators. An essential component is the disease burden in infants less than 6 months of age, which will inform the optimal age of first vaccination (less than or from 6 months), compatibility across national expanded programme on immunization schedules, and whether a booster dose would be needed. Early regulatory guidance is essential to make informed regulatory decisions and to guide the clinical development plan and licensure pathway. Continued communication with public health stakeholders and end-user representatives will effectively contribute to better awareness and education about iNTS disease and protection afforded by vaccination.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127515"},"PeriodicalIF":4.5,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144662409","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
Real-world effectiveness of NVX-CoV2373 and BNT162b2 mRNA COVID-19 vaccination in South Korea NVX-CoV2373和BNT162b2 mRNA COVID-19疫苗在韩国的实际有效性
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-18 DOI: 10.1016/j.vaccine.2025.127496
Eunseon Gwak , Seung-Ah Choe , Kyuwon Kim , Erdenetuya Bolormaa , Jonathan Fix , Muruga Vadivale , Matthew D. Rousculp , Young June Choe
{"title":"Real-world effectiveness of NVX-CoV2373 and BNT162b2 mRNA COVID-19 vaccination in South Korea","authors":"Eunseon Gwak ,&nbsp;Seung-Ah Choe ,&nbsp;Kyuwon Kim ,&nbsp;Erdenetuya Bolormaa ,&nbsp;Jonathan Fix ,&nbsp;Muruga Vadivale ,&nbsp;Matthew D. Rousculp ,&nbsp;Young June Choe","doi":"10.1016/j.vaccine.2025.127496","DOIUrl":"10.1016/j.vaccine.2025.127496","url":null,"abstract":"<div><h3>Objectives</h3><div>In February 2022, NVX-CoV2373 became available in South Korea; real-world effectiveness of multiple doses compared with mRNA-based vaccines has not been thoroughly evaluated.</div></div><div><h3>Methods</h3><div>This retrospective study identified NVX-CoV2373 and BNT162b2 recipients aged ≥12 years from the K-COV-N database. Vaccine groups were propensity score–matched based on demographic characteristics, Seoul capital area residence, income level, comorbidity/disability, prior SARS-CoV-2 infection, and prior vaccination dose/timing. Outcomes were any and severe (intensive-care-unit admission or death within 8 weeks of infection) laboratory-confirmed SARS-CoV-2 infection assessed from 7 days after the third and fourth dose. Adjusted hazard ratios (aHRs) from matched groups measured vaccine effectiveness up to a 180-day risk window.</div></div><div><h3>Results</h3><div>From February to December 2022, 923,833 NVX-CoV2373 and 1,286,604 BNT162b2 doses were administered. The 180-day risk-window aHRs (95% CI) for NVX-CoV2373 compared with BNT162b2 for any SARS-CoV-2 infection were 0.78 (0.76–0.79) post third dose and 0.86 (0.86–0.87) post fourth dose. The 180-day aHRs (95% CI) for severe infection were 0.73 (0.53–1.00) after the third dose and 1.21 (1.03–1.42) after the fourth dose.</div></div><div><h3>Conclusions</h3><div>NVX-CoV2373 demonstrated favorable and similar effectiveness against any and severe SARS-CoV-2 infection, respectively, compared with BNT162b2, with evidence of enhanced NVX-CoV2373 durability.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127496"},"PeriodicalIF":4.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657242","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
Understanding the decline in HPV vaccination in Colombia: A population-based analysis of girls and parents in early rollout cohorts 了解哥伦比亚HPV疫苗接种率下降的原因:对早期接种队列中的女孩和父母进行的基于人群的分析
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-18 DOI: 10.1016/j.vaccine.2025.127507
Karen Cárdenas-Garzon , María Cecilia Agudelo , Olga Lucia Tovar-Aguirre , Caroline Reuter , Nelson Enrique Arias-Ortiz , Sandra Milena Franco , Kelly Paola Valverde , Samuel Agudelo , Isabel C. Garcés-Palacio , María Patricia Arbelaez , Nilton Edu Montoya , Difariney Gonzalez-Gómez , Karly S Louie , Simon Beddows , Gloria I. Sanchez
{"title":"Understanding the decline in HPV vaccination in Colombia: A population-based analysis of girls and parents in early rollout cohorts","authors":"Karen Cárdenas-Garzon ,&nbsp;María Cecilia Agudelo ,&nbsp;Olga Lucia Tovar-Aguirre ,&nbsp;Caroline Reuter ,&nbsp;Nelson Enrique Arias-Ortiz ,&nbsp;Sandra Milena Franco ,&nbsp;Kelly Paola Valverde ,&nbsp;Samuel Agudelo ,&nbsp;Isabel C. Garcés-Palacio ,&nbsp;María Patricia Arbelaez ,&nbsp;Nilton Edu Montoya ,&nbsp;Difariney Gonzalez-Gómez ,&nbsp;Karly S Louie ,&nbsp;Simon Beddows ,&nbsp;Gloria I. Sanchez","doi":"10.1016/j.vaccine.2025.127507","DOIUrl":"10.1016/j.vaccine.2025.127507","url":null,"abstract":"<div><div>Many countries in the world are facing challenges to reach the WHO proposed target of HPV vaccination of 90 % of girls by the age of 15. A population-based cross-sectional survey was conducted in Manizales, Colombia to identify sociodemographic factors and components of the health belief model related to HPV vaccination in the 2003, 2004, and 2005 birth cohorts of girls and their parents targeted by the national HPV vaccination program in 2012, 2013, and 2014. Complementary log-log generalized linear models were used to obtain adjusted Prevalence Ratios (aPR) and 95 % confidence intervals (CI). A lower prevalence of HPV vaccination was observed in girls of the 2004 (aPR 0.82; 95 % CI 0.71–0.92) and 2005 (aPR 0.61; 95 % CI 0.52–0.71) cohorts compared to the 2003 cohort. The higher scores of perceived benefits by girls (aPR 1.06; 95 % CI 1.05–1.08) or their parents (aPR 1.05; 95 % CI 1.03–1.06) were associated to a higher prevalence of HPV vaccination of the girls. Conversely, this prevalence decreased with perceived barriers by girls (aPR 0.94; 95 % CI 0.91–0.96) and parents (aPR 0.91; 95 % CI 0.88–0.94). Parent's education lower attainment, lower socioeconomic stratum, and subsidized (public) health insurance were related to decreased likelihood of HPV vaccination. The results suggest that campaigns for HPV vaccination require effective education strategies to improve public perception of the vaccine's safety and benefits. Decision-makers and implementers must address also other social determinants such as disparities in access to education by parents, the SES, and the type of health insurance to improve HPV vaccination coverage.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127507"},"PeriodicalIF":4.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657245","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
Increase in invasive Haemophilus influenzae type b disease in young children despite high vaccination coverage, France, 2018–2024 法国,2018-2024年,尽管疫苗接种覆盖率很高,但幼儿侵袭性乙型流感嗜血杆菌疾病仍在增加
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-18 DOI: 10.1016/j.vaccine.2025.127499
Anne-Sophie Barret , Céline François , Ala-Eddine Deghmane , Rémi Lefrançois , Lilas Mercuriali , Alexandra Thabuis , Cécile Marie , Elise Carraz-Billat , Laura Zanetti , Isabelle Parent du Châtelet , Muhamed-Kheir Taha
{"title":"Increase in invasive Haemophilus influenzae type b disease in young children despite high vaccination coverage, France, 2018–2024","authors":"Anne-Sophie Barret ,&nbsp;Céline François ,&nbsp;Ala-Eddine Deghmane ,&nbsp;Rémi Lefrançois ,&nbsp;Lilas Mercuriali ,&nbsp;Alexandra Thabuis ,&nbsp;Cécile Marie ,&nbsp;Elise Carraz-Billat ,&nbsp;Laura Zanetti ,&nbsp;Isabelle Parent du Châtelet ,&nbsp;Muhamed-Kheir Taha","doi":"10.1016/j.vaccine.2025.127499","DOIUrl":"10.1016/j.vaccine.2025.127499","url":null,"abstract":"<div><h3>Background</h3><div>The introduction of <em>Haemophilus influenzae</em> type b (Hib) conjugate vaccines in France led to low invasive Hib disease incidence for two decades. In 2013, the vaccination schedule changed from 3+1 to 2+1 ((2, 4, and 11 months). Hib vaccination has been mandatory for children born since 2018. Despite vaccination coverage exceeding 95%, invasive Hib disease has increased since 2018. This study reports trends and characteristics of cases in mainland France from 2018 to 2024.</div></div><div><h3>Methods</h3><div>Cases were children under five years old with invasive Hib disease confirmed by culture or PCR by the National Reference Center for <em>Haemophilus influenzae</em>. Vaccination status was reported by biologists/clinicians or by regional investigation teams. Cases were described by age and vaccination status (unvaccinated, partially vaccinated, correctly vaccinated). Vaccine failure was defined as invasive Hib disease despite completion of the three-dose series. Vaccine effectiveness (VE) for three doses was estimated using the screening method in children aged 2-4 years.</div></div><div><h3>Results</h3><div>The incidence of invasive Hib disease among children under 5 years old increased during the 2018-2024 period, peaking in 2021 with 46 cases (1.4/100,000 children). From 2018 to 2024, 181 cases of invasive Hib disease were reported. Among those aged 6-11 months (n=60), 76.7% were correctly  vaccinated with two doses. In children ≥12 months (n=65), 67.7% were correctly  vaccinated with three doses and there were 44 vaccine failures. The estimated VE for three doses was 91.2% [95% confidence interval: 76.3-96.8%].</div></div><div><h3>Discussion - Conclusion</h3><div>Invasive Hib disease increased among children under 5 years old in France during 2018-2024, and most cases were correctly vaccinated. VE estimate do not suggest waning immunity. The reasons that may explain the increase in invasive Hib cases remain uncertain. Our results call for further studies on the VE following the two primary doses and the impact of vaccination on carriage.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127499"},"PeriodicalIF":4.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657246","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 template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women 用于评估用于孕妇和哺乳期妇女的新发病原体疫苗的模板工具
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-18 DOI: 10.1016/j.vaccine.2025.127513
Flor M. Munoz , Beate Kampmann , Andy Stergachis , Manu Chaudhary , Clare L. Cutland , Asma Khalil , Angela Gentile , Christine E. Jones , Helen Marshall , Esperanca Sevene , Delese Mimi Darko , Geeta Swamy , Terri B. Hyde , Gerald Voss , Ajoke Sobanjo-Ter Muelen
{"title":"A template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women","authors":"Flor M. Munoz ,&nbsp;Beate Kampmann ,&nbsp;Andy Stergachis ,&nbsp;Manu Chaudhary ,&nbsp;Clare L. Cutland ,&nbsp;Asma Khalil ,&nbsp;Angela Gentile ,&nbsp;Christine E. Jones ,&nbsp;Helen Marshall ,&nbsp;Esperanca Sevene ,&nbsp;Delese Mimi Darko ,&nbsp;Geeta Swamy ,&nbsp;Terri B. Hyde ,&nbsp;Gerald Voss ,&nbsp;Ajoke Sobanjo-Ter Muelen","doi":"10.1016/j.vaccine.2025.127513","DOIUrl":"10.1016/j.vaccine.2025.127513","url":null,"abstract":"<div><div>Vaccination during pregnancy provides effective protection against pathogens that increase the risk of maternal and infant morbidity and mortality for mothers and their infants. The SARS-CoV-2 pandemic demonstrated the need for the inclusion of pregnant and breast-feeding women in research and development of vaccines for emerging pathogens, such as Ebola, Zika, Lassa fever, Chikungunya, and influenza virus of pandemic potential. The COVID-19 Vaccines Global Access (COVAX) Maternal Immunization Working Group (MIWG), in collaboration with the Coalition for Epidemic Preparedness Innovation and the Safety Platform for Emergency Vaccines (CEPI-SPEAC) developed a standardized template with key considerations to guide the assessment of vaccines against emerging pathogens in pregnant and breast-feeding women. The aim of this tool is to enable key stakeholders to perform an early structured assessment of the overall potential benefit and risk for maternal immunization against an emerging pathogen. It can also be used to support risk management and pharmacovigilance planning, communication strategies, policy development, and acceptance of vaccination during pregnancy in future pandemics.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127513"},"PeriodicalIF":4.5,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144655027","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
Lyme disease vaccine acceptability among healthcare providers ― United States, 2018 and 2022 莱姆病疫苗在医疗保健提供者中的可接受性——美国,2018年和2022年
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-17 DOI: 10.1016/j.vaccine.2025.127495
Taylor D. Bostic , Sarah A. Hook , Grace E. Marx
{"title":"Lyme disease vaccine acceptability among healthcare providers ― United States, 2018 and 2022","authors":"Taylor D. Bostic ,&nbsp;Sarah A. Hook ,&nbsp;Grace E. Marx","doi":"10.1016/j.vaccine.2025.127495","DOIUrl":"10.1016/j.vaccine.2025.127495","url":null,"abstract":"<div><h3>Background</h3><div>A Lyme disease (LD) vaccine is expected to become available soon. We aimed to understand recent trends in healthcare provider (HCP) willingness to recommend LD vaccination.</div></div><div><h3>Methods</h3><div>Cross-sectional surveys among HCPs were conducted in 2018 and 2022. We compared willingness to recommend LD vaccination by survey year and provider characteristics.</div></div><div><h3>Results</h3><div>Among 3005 HCPs, 70.5 % reported willingness to recommend LD vaccination. This proportion was lower in 2022 than in 2018 (68 % vs 73 %; <em>p</em> &lt; 0.01) and did not differ significantly by provider medical specialty. More HCPs in states with high LD incidence were willing to recommend the vaccine compared to HCPs in neighboring or low-incidence states (<em>p</em> &lt; 0.01). Vaccine safety was the most frequently reported consideration for recommending LD vaccination (73 %).</div></div><div><h3>Conclusions</h3><div>HCP willingness to recommend LD vaccination decreased from 2018 to 2022. Vaccination education tailored to HCPs that address vaccine safety will be critical for a successful LD vaccination program.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127495"},"PeriodicalIF":4.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144655026","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
Human papillomavirus vaccination coverage and willingness among women in mainland China: A meta-analysis based on the COM-B model 中国大陆女性人乳头瘤病毒疫苗接种覆盖率和意愿:基于COM-B模型的荟萃分析
IF 4.5 3区 医学
Vaccine Pub Date : 2025-07-17 DOI: 10.1016/j.vaccine.2025.127519
Tingsu Tao , Yajuan Ni , Naiyang Shi , Xuying Yang , Hui Jin
{"title":"Human papillomavirus vaccination coverage and willingness among women in mainland China: A meta-analysis based on the COM-B model","authors":"Tingsu Tao ,&nbsp;Yajuan Ni ,&nbsp;Naiyang Shi ,&nbsp;Xuying Yang ,&nbsp;Hui Jin","doi":"10.1016/j.vaccine.2025.127519","DOIUrl":"10.1016/j.vaccine.2025.127519","url":null,"abstract":"<div><h3>Objectives</h3><div>To estimate human papillomavirus (HPV) vaccination coverage and vaccination willingness among women in mainland China and identify the influencing factors using the Capability, Opportunity, and Motivation model of Behavior (COM<img>B).</div></div><div><h3>Methods</h3><div>PubMed, Web of Science, Cochrane Library, Embase, and Chinese databases including CNKI, Wanfang Data, VIP, and CBM were searched. Pooled HPV vaccination coverage and willingness were calculated using a random-effects model with 95 % confidence intervals (CIs). Subgroup analyses and meta-regression were performed to explore heterogeneity. The COM-B model and the Theoretical Domains Framework (TDF) were employed to identify factors associated with vaccination coverage and willingness. Dichotomous outcomes were presented as odds ratios (OR) with the corresponding 95 % CIs.</div></div><div><h3>Results</h3><div>A total of 155 articles, including 10,965,863 mainland Chinese women, were included. The pooled vaccination coverage in 80 included studies was 9.5 % (95 % CI: 7.6 %–11.6 %). Subgroup analysis indicated a higher vaccination rate among women undergoing HPV or cervical cancer screening (16.9 %, 95 % CI: 10.5 %–24.4 %) and among healthcare workers (13.4 %, 95 % CI: 5.6 %–23.8 %). Vaccination willingness, based on 126 studies, was 70.6 % (95 % CI: 66.8 %–74.3 %). Furthermore, the three dimensions of the COM-B model were found to significantly influence both vaccination coverage and willingness (<em>P</em> &lt; 0.05), with capability showed the strongest correlation with HPV vaccination coverage (OR = 2.96, 95 % CI: 2.20–3.99).</div></div><div><h3>Conclusions</h3><div>There was a significant gap between vaccination willingness and actual coverage among mainland Chinese women. HPV vaccination status of family members or friends and knowledge of HPV and its vaccines were associated with higher vaccination rates.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127519"},"PeriodicalIF":4.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144657185","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
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