Pub Date : 2025-11-07DOI: 10.1016/j.jvacx.2025.100747
Bente Smagge , Susan Hahné , Hester de Melker , Ferishta Bakhshi-Raiez , Susan van den Hof , Brechje de Gier
In the Netherlands, medical risk data and SARS-CoV-2 test results were not available for stratifying vaccine effectiveness (VE) against COVID-19 hospitalisation during the COVID-19 pandemic. Such data became available afterwards, allowing for re-estimating VE and the number needed to vaccinate (NNV) by medical risk group for severe COVID-19. We conducted a nationwide register-based cohort study, estimating VE against first-time COVID-19 hospitalisation from 06 to 01-2021 to 31-12-2021 in persons aged ≥12 years without registered prior SARS-CoV-2 infection. VE of one and two vaccinations, versus unvaccinated, were estimated by age, medical risk, vaccine type and time since vaccination using Cox models with vaccination status as time-varying exposure. Additionally, we computed the NNV to prevent one hospitalisation. Among 14.3 million individuals in this study, 43,405 COVID-19 first-time hospitalisations were recorded. VE of two doses was >80 % in the first quarter post-vaccination across all strata. VE decreased over time, but vaccination remained protective three quarters post-vaccination. Among persons aged ≥60 years without medical risk conditions, VE was 96.1 %, 91.0 % and 84.9 % in the first, second and third quarter since vaccination. VE was lower and waned faster among persons with medical risk conditions: 91.1 %, 80.0 %, 70.8 % and 85.4 %, 73.4 %, 60.6 %, in the first three quarters post-vaccination in the moderate and high medical risk groups, respectively. Nonetheless, the NNV was lower among medical risk groups. These findings suggest that prioritising medical risk populations for booster vaccination was warranted. To adequately respond to future epidemics and optimise vaccination programmes, the data infrastructure should allow near-real-time stratified VE analyses.
{"title":"COVID-19 vaccine effectiveness against hospitalisation in the Netherlands, 2021: Improved stratified estimates","authors":"Bente Smagge , Susan Hahné , Hester de Melker , Ferishta Bakhshi-Raiez , Susan van den Hof , Brechje de Gier","doi":"10.1016/j.jvacx.2025.100747","DOIUrl":"10.1016/j.jvacx.2025.100747","url":null,"abstract":"<div><div>In the Netherlands, medical risk data and SARS-CoV-2 test results were not available for stratifying vaccine effectiveness (VE) against COVID-19 hospitalisation during the COVID-19 pandemic. Such data became available afterwards, allowing for re-estimating VE and the number needed to vaccinate (NNV) by medical risk group for severe COVID-19. We conducted a nationwide register-based cohort study, estimating VE against first-time COVID-19 hospitalisation from 06 to 01-2021 to 31-12-2021 in persons aged ≥12 years without registered prior SARS-CoV-2 infection. VE of one and two vaccinations, versus unvaccinated, were estimated by age, medical risk, vaccine type and time since vaccination using Cox models with vaccination status as time-varying exposure. Additionally, we computed the NNV to prevent one hospitalisation. Among 14.3 million individuals in this study, 43,405 COVID-19 first-time hospitalisations were recorded. VE of two doses was >80 % in the first quarter post-vaccination across all strata. VE decreased over time, but vaccination remained protective three quarters post-vaccination. Among persons aged ≥60 years without medical risk conditions, VE was 96.1 %, 91.0 % and 84.9 % in the first, second and third quarter since vaccination. VE was lower and waned faster among persons with medical risk conditions: 91.1 %, 80.0 %, 70.8 % and 85.4 %, 73.4 %, 60.6 %, in the first three quarters post-vaccination in the moderate and high medical risk groups, respectively. Nonetheless, the NNV was lower among medical risk groups. These findings suggest that prioritising medical risk populations for booster vaccination was warranted. To adequately respond to future epidemics and optimise vaccination programmes, the data infrastructure should allow near-real-time stratified VE analyses.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100747"},"PeriodicalIF":2.2,"publicationDate":"2025-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145525339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Seasonal influenza vaccination is a recognized means for promoting healthy ageing. In regions like Liguria (Italy), which has the oldest population in Europe, influenza vaccination becomes even more critical. This study aimed to assess influenza vaccine effectiveness (IVE) for the prevention of hospitalization for laboratory-confirmed influenza among Ligurian adults. We conducted a retrospective test-negative case-control study in an inpatient setting, using routinely collected data. Adults (≥18 years) presenting to emergency department from November 4, 2024 through April 27, 2025, who were prescribed a molecular test for the detection of influenza virus and were subsequently hospitalized, were eligible. IVE was estimated via conditional logistic regression. In all, 173 cases and 1166 influenza-negative inpatient controls were included. Most cases were due to influenza A(H1N1)pdm09 (34 %) and A(H3N2) (59 %). In the overall population ̥≥18 years, IVE against hospitalization for any influenza virus was 47 % [95 % confidence interval (CI): 22 %, 63 %]. IVE in older adults ≥65 years was lower (43 %; 95 % CI: 14 %, 62 %) than in younger adults (76 %; 95 % CI: 5 %, 94 %). In an analysis on the effect of prior vaccination, repeat vaccinees were immunized earlier than non-repeat vaccinees. Compared to adults who were not vaccinated in either the previous or current season, those vaccinated in both seasons and current season only, were protected at 48 % (95 % CI: 19 %, 66 %) and 45 % (95 % CI, −17 %; 75 %), respectively. Influenza vaccines available for Italian adults during the 2024/2025 season provided a moderate protection against influenza-related hospitalization.
{"title":"Influenza vaccine effectiveness among Italian adult inpatients, 2024/2025 season","authors":"Alexander Domnich , Andrea Orsi , Vincenzo Paolozzi , Davide Bonassi , Giada Garzillo , Elvira Massaro , Valentina Ricucci , Matilde Ogliastro , Giancarlo Icardi","doi":"10.1016/j.jvacx.2025.100748","DOIUrl":"10.1016/j.jvacx.2025.100748","url":null,"abstract":"<div><div>Seasonal influenza vaccination is a recognized means for promoting healthy ageing. In regions like Liguria (Italy), which has the oldest population in Europe, influenza vaccination becomes even more critical. This study aimed to assess influenza vaccine effectiveness (IVE) for the prevention of hospitalization for laboratory-confirmed influenza among Ligurian adults. We conducted a retrospective test-negative case-control study in an inpatient setting, using routinely collected data. Adults (≥18 years) presenting to emergency department from November 4, 2024 through April 27, 2025, who were prescribed a molecular test for the detection of influenza virus and were subsequently hospitalized, were eligible. IVE was estimated via conditional logistic regression. In all, 173 cases and 1166 influenza-negative inpatient controls were included. Most cases were due to influenza A(H1N1)pdm09 (34 %) and A(H3N2) (59 %). In the overall population ̥≥18 years, IVE against hospitalization for any influenza virus was 47 % [95 % confidence interval (CI): 22 %, 63 %]. IVE in older adults ≥65 years was lower (43 %; 95 % CI: 14 %, 62 %) than in younger adults (76 %; 95 % CI: 5 %, 94 %). In an analysis on the effect of prior vaccination, repeat vaccinees were immunized earlier than non-repeat vaccinees. Compared to adults who were not vaccinated in either the previous or current season, those vaccinated in both seasons and current season only, were protected at 48 % (95 % CI: 19 %, 66 %) and 45 % (95 % CI, −17 %; 75 %), respectively. Influenza vaccines available for Italian adults during the 2024/2025 season provided a moderate protection against influenza-related hospitalization.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100748"},"PeriodicalIF":2.2,"publicationDate":"2025-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145525338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-02DOI: 10.1016/j.jvacx.2025.100744
Antonio Musolino , Marco Roversi , Mariateresa Romaniello , Vittorio Scoppola , Chiara Di Camillo , Laura Celestini , Alberto Villani , Diletta Valentini
Introduction
Pneumococcal vaccination has significantly decreased the burden of invasive pneumococcal disease in the general population, however studies on effectiveness in Down syndrome (DS) are heterogeneous. In this cross-sectional study we evaluated the prevalence of adequate immune response in children with DS after pneumococcal vaccination and we searched for possible clinical predictors associated with it, in order to provide data to optimize vaccination strategies in this high-risk group.
Methods
Data of children with DS referred to the DS outpatient Clinic of Bambino Gesù Children's Hospital, Rome, Italy, between September 2021 and March 2022 were reviewed. Clinical and laboratory predictors of immunological response to PCV vaccine, defined as an anti-pneumococcal IgG titer threshold above 0.35 μg/mL were compared and evaluated with bivariate analyses and logistic regression.
Results
In this cohort of 406 patients the mean age was 8.4 years and 56.2 % of individuals were male. Most of them had congenital cardiopathy (57.8 %) and recurrent respiratory infections (57.4 %). An anti-pneumococcal Ig titer ≥0.35 μg/mL was found in 50.5 % of patients. Those with Ig < 0.35 μg/mL were significantly younger (p < 0.001) and less likely to have autoimmune disorders or hypothyroidism. Logistic regression showed that a positive history of previous surgery increased the likelihood of Ig ≥ 0.35 μg/mL (OR 2.25, p = 0.001), as well as hypothyroidism (OR 3.14, p = 0.016) and celiac disease (OR 3.70, p = 0.030). Additionally, older age at last PCV13 dose positively correlated with higher Ig levels (p = 0.018).
Conclusion
Our findings confirm a lower prevalence of adequate immune response after anti-pneumococcal vaccination in individuals with DS. Older age at last PCV13 dose was found to be correlated to higher specific IgG titers; we suggest a tailored vaccination schedule or a booster dose in individuals with DS that could improve their immune protection.
肺炎球菌疫苗接种显著降低了普通人群侵袭性肺炎球菌疾病的负担，然而，对唐氏综合征（DS）有效性的研究存在差异。在这项横断面研究中，我们评估了肺炎球菌疫苗接种后DS患儿充分免疫应答的患病率，并寻找与之相关的可能的临床预测因素，以便为优化这一高危人群的疫苗接种策略提供数据。方法回顾2021年9月至2022年3月意大利罗马Bambino Gesù儿童医院DS门诊转介的DS患儿数据。采用双变量分析和logistic回归对PCV疫苗免疫应答的临床和实验室预测因子进行了比较和评估，其定义为抗肺炎球菌IgG滴度阈值高于0.35 μg/mL。结果406例患者的平均年龄为8.4岁，56.2%为男性。以先天性心脏病（57.8%）和反复呼吸道感染（57.4%）居多。50.5%的患者抗肺炎球菌Ig滴度≥0.35 μg/mL。Ig <； 0.35 μg/mL的患者明显更年轻（p < 0.001），发生自身免疫性疾病或甲状腺功能减退的可能性更小。Logistic回归分析显示，既往手术史阳性患者Ig≥0.35 μg/mL （OR 2.25, p = 0.001）、甲状腺功能减退（OR 3.14, p = 0.016）和乳糜泻（OR 3.70, p = 0.030）的可能性增加。最后一次PCV13剂量的年龄与较高的Ig水平呈正相关（p = 0.018）。结论：我们的研究结果证实，DS患者接种抗肺炎球菌疫苗后免疫反应不足的发生率较低。PCV13最后剂量年龄越大，特异性IgG滴度越高；我们建议为退行性椎体滑移患者量身定制疫苗接种计划或加强剂量，以提高他们的免疫保护。
{"title":"Antibody response after pneumococcal vaccination in a large cohort of Italian children and adolescents with Down syndrome","authors":"Antonio Musolino , Marco Roversi , Mariateresa Romaniello , Vittorio Scoppola , Chiara Di Camillo , Laura Celestini , Alberto Villani , Diletta Valentini","doi":"10.1016/j.jvacx.2025.100744","DOIUrl":"10.1016/j.jvacx.2025.100744","url":null,"abstract":"<div><h3>Introduction</h3><div>Pneumococcal vaccination has significantly decreased the burden of invasive pneumococcal disease in the general population, however studies on effectiveness in Down syndrome (DS) are heterogeneous. In this cross-sectional study we evaluated the prevalence of adequate immune response in children with DS after pneumococcal vaccination and we searched for possible clinical predictors associated with it, in order to provide data to optimize vaccination strategies in this high-risk group.</div></div><div><h3>Methods</h3><div>Data of children with DS referred to the DS outpatient Clinic of Bambino Gesù Children's Hospital, Rome, Italy, between September 2021 and March 2022 were reviewed. Clinical and laboratory predictors of immunological response to PCV vaccine, defined as an anti-pneumococcal IgG titer threshold above 0.35 μg/mL were compared and evaluated with bivariate analyses and logistic regression.</div></div><div><h3>Results</h3><div>In this cohort of 406 patients the mean age was 8.4 years and 56.2 % of individuals were male. Most of them had congenital cardiopathy (57.8 %) and recurrent respiratory infections (57.4 %). An anti-pneumococcal Ig titer ≥0.35 μg/mL was found in 50.5 % of patients. Those with Ig < 0.35 μg/mL were significantly younger (<em>p</em> < 0.001) and less likely to have autoimmune disorders or hypothyroidism. Logistic regression showed that a positive history of previous surgery increased the likelihood of Ig ≥ 0.35 μg/mL (OR 2.25, <em>p</em> = 0.001), as well as hypothyroidism (OR 3.14, <em>p</em> = 0.016) and celiac disease (OR 3.70, <em>p</em> = 0.030). Additionally, older age at last PCV13 dose positively correlated with higher Ig levels (<em>p</em> = 0.018).</div></div><div><h3>Conclusion</h3><div>Our findings confirm a lower prevalence of adequate immune response after anti-pneumococcal vaccination in individuals with DS. Older age at last PCV13 dose was found to be correlated to higher specific IgG titers; we suggest a tailored vaccination schedule or a booster dose in individuals with DS that could improve their immune protection.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100744"},"PeriodicalIF":2.2,"publicationDate":"2025-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145474093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-28DOI: 10.1016/j.jvacx.2025.100742
Maria Lahuerta , Angel Gil , Cristina Méndez , Francisco Javier Esteban Fernández , Teresa Álvarez de Espejo , Victor Julián Moreno , Pablo del Valle , Juan E. Losa , José Yuste , Julie Catusse , Mohammad Ali , Jo Southern , Elizabeth Begier , Michael Pride , Christian Theilacker , Luis Jodar , Bradford D. Gessner , Mariana Haeberer , on behalf of the CIBELES study team
Background
Few data exist on vaccine effectiveness (VE) of the 13-valent pneumococcal conjugate vaccine (PCV13) against vaccine-type community acquired pneumonia (CAP) among adults, particularly for multiple years post-vaccination. We evaluated PCV13 VE among older adults in Spain right after the emergence of SARS-CoV2.
Methods
Adults aged ≥60 years hospitalized with CAP were enrolled at five hospitals between March 2021–September 2023. VE was assessed using a test-negative design. Cases were participants from whom PCV13 serotypes were identified from culture or urinary antigen detection assays. All others served as controls. Due to changes in healthcare-seeking behavior, hospital admission, vaccination policies, and CAP etiology during the COVID pandemic period, participants enrolled from March 2021–August 2022 were excluded from analyses.
Results
Among 1512 eligible participants, 1241 (82.1 %) were included in the analysis. Median age was 78 years (interquartile range [IQR] 72–85), 34.3 % were immunocompromised and 99.4 % had radiologically-confirmed CAP. Almost half (49.2 %) had received PCV13 of which 33.1 % were vaccinated in 2020 during the COVID-19 pandemic (median time since vaccination: 2.0 years [IQR:2.0–4.2]). Most participants (72.7 %) had previously received the pneumococcal polysaccharide vaccine (PPV23). PCV13 serotypes were identified in 89 (7.2 %) participants, most commonly serotype 3 (56 cases, 62.9 % of PCV13-type CAP). The PCV13 VE against PCV13-type CAP was 26.0 % (−15.21, 52.4 %) overall, 40.9 % (−23.1, 71.6 %) excluding serotype 3 and 51.9 % (−26.0, 81.6 %) among PPV23-naive. Among patients vaccinated <2 years before CAP hospitalization, VE against PCV13-type was 68.9 % (11.9, 89.0 %).
Conclusions
In a setting with high serotype 3 prevalence, PCV13 was highly effective in preventing PCV13-type CAP in older adults for two years after vaccination, with lower effectiveness at later time points. Given challenges associated with the pandemic and low statistical power, additional studies are indicated to evaluate serotype-specific duration of protection to inform the need for adult booster vaccinations.
{"title":"Effectiveness of the 13-valent pneumococcal vaccine against hospitalized community-acquired pneumonia among adults ≥60 years in Madrid-Spain after the COVID-19 pandemic","authors":"Maria Lahuerta , Angel Gil , Cristina Méndez , Francisco Javier Esteban Fernández , Teresa Álvarez de Espejo , Victor Julián Moreno , Pablo del Valle , Juan E. Losa , José Yuste , Julie Catusse , Mohammad Ali , Jo Southern , Elizabeth Begier , Michael Pride , Christian Theilacker , Luis Jodar , Bradford D. Gessner , Mariana Haeberer , on behalf of the CIBELES study team","doi":"10.1016/j.jvacx.2025.100742","DOIUrl":"10.1016/j.jvacx.2025.100742","url":null,"abstract":"<div><h3>Background</h3><div>Few data exist on vaccine effectiveness (VE) of the 13-valent pneumococcal conjugate vaccine (PCV13) against vaccine-type community acquired pneumonia (CAP) among adults, particularly for multiple years post-vaccination. We evaluated PCV13 VE among older adults in Spain right after the emergence of SARS-CoV2.</div></div><div><h3>Methods</h3><div>Adults aged ≥60 years hospitalized with CAP were enrolled at five hospitals between March 2021–September 2023. VE was assessed using a test-negative design. Cases were participants from whom PCV13 serotypes were identified from culture or urinary antigen detection assays. All others served as controls. Due to changes in healthcare-seeking behavior, hospital admission, vaccination policies, and CAP etiology during the COVID pandemic period, participants enrolled from March 2021–August 2022 were excluded from analyses.</div></div><div><h3>Results</h3><div>Among 1512 eligible participants, 1241 (82.1 %) were included in the analysis. Median age was 78 years (interquartile range [IQR] 72–85), 34.3 % were immunocompromised and 99.4 % had radiologically-confirmed CAP. Almost half (49.2 %) had received PCV13 of which 33.1 % were vaccinated in 2020 during the COVID-19 pandemic (median time since vaccination: 2.0 years [IQR:2.0–4.2]). Most participants (72.7 %) had previously received the pneumococcal polysaccharide vaccine (PPV23). PCV13 serotypes were identified in 89 (7.2 %) participants, most commonly serotype 3 (56 cases, 62.9 % of PCV13-type CAP). The PCV13 VE against PCV13-type CAP was 26.0 % (−15.21, 52.4 %) overall, 40.9 % (−23.1, 71.6 %) excluding serotype 3 and 51.9 % (−26.0, 81.6 %) among PPV23-naive. Among patients vaccinated <2 years before CAP hospitalization, VE against PCV13-type was 68.9 % (11.9, 89.0 %).</div></div><div><h3>Conclusions</h3><div>In a setting with high serotype 3 prevalence, PCV13 was highly effective in preventing PCV13-type CAP in older adults for two years after vaccination, with lower effectiveness at later time points. Given challenges associated with the pandemic and low statistical power, additional studies are indicated to evaluate serotype-specific duration of protection to inform the need for adult booster vaccinations.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100742"},"PeriodicalIF":2.2,"publicationDate":"2025-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145417289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-28DOI: 10.1016/j.jvacx.2025.100743
Danushka K. Wijesundara , Alexandra Playford , Kimberley Bruce , Andrea Corner , David A. Muller
The Vaccine Innovation Priority Strategy has identified microarray patch (MAP) devices as a top global priority for advancing equitable vaccine distribution. However, understanding the intrinsic immune-enhancing mechanisms of MAPs remains critical to guiding their optimisation. In this study, we focus on the immunological impact of MAP application, demonstrating that MAPs more effectively recruit antigen-presenting cells, particularly key dendritic cell (DC) subsets, including migratory DCs and lymphatic sinus DCs, to the draining lymph nodes compared to intradermal and intramuscular needle-and-syringe delivery. To facilitate this analysis, we developed a fluosphere-based method that allowed precise tracking of antigen-engaged DCs. This approach highlights that MAPs do not merely serve as an alternative delivery platform, but actively enhance early innate immune engagement by targeting multiple DC subsets known to drive robust and rapid adaptive responses. Together, these findings establish a practical framework to dissect MAP-specific immune mechanisms and support their refinement.
{"title":"Tracking antigen presenting cells to uncover the intrinsic immunostimulatory properties of microarray vaccine patches using a fluosphere-based assay","authors":"Danushka K. Wijesundara , Alexandra Playford , Kimberley Bruce , Andrea Corner , David A. Muller","doi":"10.1016/j.jvacx.2025.100743","DOIUrl":"10.1016/j.jvacx.2025.100743","url":null,"abstract":"<div><div>The Vaccine Innovation Priority Strategy has identified microarray patch (MAP) devices as a top global priority for advancing equitable vaccine distribution. However, understanding the intrinsic immune-enhancing mechanisms of MAPs remains critical to guiding their optimisation. In this study, we focus on the immunological impact of MAP application, demonstrating that MAPs more effectively recruit antigen-presenting cells, particularly key dendritic cell (DC) subsets, including migratory DCs and lymphatic sinus DCs, to the draining lymph nodes compared to intradermal and intramuscular needle-and-syringe delivery. To facilitate this analysis, we developed a fluosphere-based method that allowed precise tracking of antigen-engaged DCs. This approach highlights that MAPs do not merely serve as an alternative delivery platform, but actively enhance early innate immune engagement by targeting multiple DC subsets known to drive robust and rapid adaptive responses. Together, these findings establish a practical framework to dissect MAP-specific immune mechanisms and support their refinement.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"28 ","pages":"Article 100743"},"PeriodicalIF":2.2,"publicationDate":"2025-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145645586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-27DOI: 10.1016/j.jvacx.2025.100741
Saba Sohail , Jiayuan Wang , Ding Quan Ng, Keri Hurley-Kim
Background
Vaccine disparities in the United States contribute to downstream health inequities. Until late 2024, pneumococcal conjugate vaccine (PCV) and/or pneumococcal polysaccharide vaccine (PPSV) was only recommended for those adults under 65 with certain chronic conditions. Prior studies have shown that, unlike other vaccines, PCV/PPSV uptake is comparable or even higher among non-Hispanic (NH) Black individuals under 65 compared to NH-White individuals. One proposed explanation is a higher burden of chronic disease and multimorbidity in NH-Black populations.
Methods
We used data from the National Institutes of Health All of Us database to examine this pattern. Eligible participants (N = 87,005) were ≥ 18 years old, completed the Personal and Family Health survey, consented to electronic health record (EHR) access, and had ≥1 chronic disease indication for PCV/PPSV between ages 18–64. Vaccination was defined as ≥1 EHR-recorded PCV/PPSV dose between ages 18–64.
Results
Overall, 14,495 participants (17 %) had received PCV/PPSV. The cohort was majority female (59.8 %), NH-White (64.3 %), with a mean age of 54.5 years; most had private insurance (50.8 %). Vaccination prevalence was highest among NH-Black participants (18.8 %), followed by NH-White (17.1 %), Other (15.6 %), Hispanic (13.2 %), and Asian (12.5 %).Multivariate regression adjusting for sociodemographic and chronic disease burden found higher odds of vaccination among NH-Black individuals (AOR = 1.10, 95 % CI: 1.03–1.17) and lower odds among Hispanic individuals (AOR = 0.75, 95 % CI: 0.69–0.82, p < 0.001) compared to NH-White participants. Greater chronic disease burden partially explained but did not fully account for these disparities.
Conclusions
These findings demonstrate the importance of further research to evaluate humanistic and/or health systems factors that contribute to the racial/ethnic trends in pneumococcal vaccination in younger adults, as variations in sociodemographics, rates of comorbidities, and rates of multimorbidity do not fully explain the observed pattern.
{"title":"Effect of chronic disease rates and diagnoses on young adult pneumococcal vaccination status in the All of Us database","authors":"Saba Sohail , Jiayuan Wang , Ding Quan Ng, Keri Hurley-Kim","doi":"10.1016/j.jvacx.2025.100741","DOIUrl":"10.1016/j.jvacx.2025.100741","url":null,"abstract":"<div><h3>Background</h3><div>Vaccine disparities in the United States contribute to downstream health inequities. Until late 2024, pneumococcal conjugate vaccine (PCV) and/or pneumococcal polysaccharide vaccine (PPSV) was only recommended for those adults under 65 with certain chronic conditions. Prior studies have shown that, unlike other vaccines, PCV/PPSV uptake is comparable or even higher among non-Hispanic (NH) Black individuals under 65 compared to NH-White individuals. One proposed explanation is a higher burden of chronic disease and multimorbidity in NH-Black populations.</div></div><div><h3>Methods</h3><div>We used data from the National Institutes of Health All of Us database to examine this pattern. Eligible participants (<em>N</em> = 87,005) were ≥ 18 years old, completed the Personal and Family Health survey, consented to electronic health record (EHR) access, and had ≥1 chronic disease indication for PCV/PPSV between ages 18–64. Vaccination was defined as ≥1 EHR-recorded PCV/PPSV dose between ages 18–64.</div></div><div><h3>Results</h3><div>Overall, 14,495 participants (17 %) had received PCV/PPSV. The cohort was majority female (59.8 %), NH-White (64.3 %), with a mean age of 54.5 years; most had private insurance (50.8 %). Vaccination prevalence was highest among NH-Black participants (18.8 %), followed by NH-White (17.1 %), Other (15.6 %), Hispanic (13.2 %), and Asian (12.5 %).Multivariate regression adjusting for sociodemographic and chronic disease burden found higher odds of vaccination among NH-Black individuals (AOR = 1.10, 95 % CI: 1.03–1.17) and lower odds among Hispanic individuals (AOR = 0.75, 95 % CI: 0.69–0.82, <em>p</em> < 0.001) compared to NH-White participants. Greater chronic disease burden partially explained but did not fully account for these disparities.</div></div><div><h3>Conclusions</h3><div>These findings demonstrate the importance of further research to evaluate humanistic and/or health systems factors that contribute to the racial/ethnic trends in pneumococcal vaccination in younger adults, as variations in sociodemographics, rates of comorbidities, and rates of multimorbidity do not fully explain the observed pattern.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100741"},"PeriodicalIF":2.2,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145417290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In this study, we used baculovirus to express hemagglutinin (HA) and neuraminidase (NA) to prepare a novel genotype of H3N2 canine influenza virus particles (VLPs). The effectiveness of the H3N2 VLP vaccine was evaluated by detecting HI antibodies, the antiviral protection rate, antibody persistence and anatomical examination of the lungs.A challenge model has been established in a previous study for the study of canine influenza virus-like particle vaccines. A/Canine/Shanghai/0103/2019, with a challenge dose of 106 EID50, infects 10-week-old healthy beagle dogs through nasal instillation and can cause severe clinical symptoms. Using a single dose of VLP vaccine for beagle dogs, the vaccine was tested at titers of 26 intranasally and 26 intramuscularly. One week after a single immunization, the HI titer promptly reached 28 among the immunized groups. The duration of antibody can persist for four months. We differentiated between CD4+ and CD8+ T cells in the peripheral blood. Four weeks after the single immunization, all beagles except those in the noninfected and nonimmunized groups were intranasally challenged with live H3N2 virus (1 × 106 EID50). All immunized beagles shed no virus at d 1–4 post-challenge. After the challenge, the placebo control beagles shed the virus on d 1 post-challenge (105.85±0.071 EID50). An anatomical examination of the lungs revealed that visible lesions were rarely detected in the lungs of the nasal immunization group, and the lungs were as healthy as those of the noninfected and nonimmunized groups were. The lung surfaces presented visible bleeding spots in the intramuscular immunization group and placebo-control group. Their effectiveness will provide a scientific basis for the promotion and use of these products.
{"title":"Robust and sustained immunity in beagles following one single nasal administration of H3N2 canine influenza virus-like particle","authors":"Fei-fei Ge , Li-ping Shen , De-quan Yang, Hai-xiao Shen, Xin Li, Jian Liu, Jian Wang, Hongjin Zhao","doi":"10.1016/j.jvacx.2025.100739","DOIUrl":"10.1016/j.jvacx.2025.100739","url":null,"abstract":"<div><div>In this study, we used baculovirus to express hemagglutinin (HA) and neuraminidase (NA) to prepare a novel genotype of H3N2 canine influenza virus particles (VLPs). The effectiveness of the H3N2 VLP vaccine was evaluated by detecting HI antibodies, the antiviral protection rate, antibody persistence and anatomical examination of the lungs.A challenge model has been established in a previous study for the study of canine influenza virus-like particle vaccines. A/Canine/Shanghai/0103/2019, with a challenge dose of 10<sup>6</sup> EID<sub>50</sub>, infects 10-week-old healthy beagle dogs through nasal instillation and can cause severe clinical symptoms. Using a single dose of VLP vaccine for beagle dogs, the vaccine was tested at titers of 2<sup>6</sup> intranasally and 2<sup>6</sup> intramuscularly. One week after a single immunization, the HI titer promptly reached 2<sup>8</sup> among the immunized groups. The duration of antibody can persist for four months. We differentiated between CD4+ and CD8+ T cells in the peripheral blood. Four weeks after the single immunization, all beagles except those in the noninfected and nonimmunized groups were intranasally challenged with live H3N2 virus (1 × 10<sup>6</sup> EID<sub>50</sub>). All immunized beagles shed no virus at d 1–4 post-challenge. After the challenge, the placebo control beagles shed the virus on d 1 post-challenge (10<sup>5.85±0.071</sup> EID<sub>50</sub>). An anatomical examination of the lungs revealed that visible lesions were rarely detected in the lungs of the nasal immunization group, and the lungs were as healthy as those of the noninfected and nonimmunized groups were. The lung surfaces presented visible bleeding spots in the intramuscular immunization group and placebo-control group. Their effectiveness will provide a scientific basis for the promotion and use of these products.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100739"},"PeriodicalIF":2.2,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145325796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-15DOI: 10.1016/j.jvacx.2025.100738
Giovanni Genovese , Elisabetta Genovese , Domenico Santoro , Flavia Pennisi , Giuseppe Trimarchi , Raffaele Squeri , Daniela Lo Giudice , Cristina Genovese
Background
Chronic kidney disease is (CKD) a highly prevalent condition worldwide, with an increasing prevalence in the general population. Effective vaccination strategies are crucial in this population to prevent hepatitis B virus (HBV)-related complications. This study aimed to evaluate the effectiveness of different HBV vaccines in patients with CKD undergoing dialysis, focusing on seroconversion rates and overall immune response.
Methods
A non-concurrent prospective cohort study was conducted on 160 outpatient long-term dialysis patients at the G. Martino Hospital in Messina. Patients were vaccinated with either FENDRIX (HB-AS04), HBVAXPRO 40 mg, or a combination, and their immune responses were assessed one month after the completion of the vaccination course.
Results
The study achieved 100 % vaccination coverage. The overall seroconversion rate was 62.5 %, with mean anti-HBs titers of 604.15 mIU/mL (±437.23 SD) across the cohorts. No significant differences were observed between responders and non-responders concerning demographic, clinical, and biochemical characteristics.
Conclusion
The study confirms the effectiveness of HBV vaccines in patients with CKD, though with a lower and delayed response compared to the general population. Establishing a diagnostic-therapeutic care pathway that integrates vaccination from the early stages of CKD is essential to improve outcomes in this high-risk group.
{"title":"Real-world effectiveness of hepatitis B vaccination in dialysis patients","authors":"Giovanni Genovese , Elisabetta Genovese , Domenico Santoro , Flavia Pennisi , Giuseppe Trimarchi , Raffaele Squeri , Daniela Lo Giudice , Cristina Genovese","doi":"10.1016/j.jvacx.2025.100738","DOIUrl":"10.1016/j.jvacx.2025.100738","url":null,"abstract":"<div><h3>Background</h3><div>Chronic kidney disease is (CKD) a highly prevalent condition worldwide, with an increasing prevalence in the general population. Effective vaccination strategies are crucial in this population to prevent hepatitis B virus (HBV)-related complications. This study aimed to evaluate the effectiveness of different HBV vaccines in patients with CKD undergoing dialysis, focusing on seroconversion rates and overall immune response.</div></div><div><h3>Methods</h3><div>A non-concurrent prospective cohort study was conducted on 160 outpatient long-term dialysis patients at the G. Martino Hospital in Messina. Patients were vaccinated with either FENDRIX (HB-AS04), HBVAXPRO 40 mg, or a combination, and their immune responses were assessed one month after the completion of the vaccination course.</div></div><div><h3>Results</h3><div>The study achieved 100 % vaccination coverage. The overall seroconversion rate was 62.5 %, with mean anti-HBs titers of 604.15 mIU/mL (±437.23 SD) across the cohorts. No significant differences were observed between responders and non-responders concerning demographic, clinical, and biochemical characteristics.</div></div><div><h3>Conclusion</h3><div>The study confirms the effectiveness of HBV vaccines in patients with CKD, though with a lower and delayed response compared to the general population. Establishing a diagnostic-therapeutic care pathway that integrates vaccination from the early stages of CKD is essential to improve outcomes in this high-risk group.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100738"},"PeriodicalIF":2.2,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145325792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-10-15DOI: 10.1016/j.jvacx.2025.100737
Zhe Zheng , Mitra Yousefi , Danielle MacCormac , Jennifer M. Radin , Tianyu Sun , Amanda Wilson , Rohan Shah , Michelle Skornicki , Paige Sheridan , Astra Toyip , Katherine Mues , Daina Esposito , Andre Araujo , Evan Anderson
Background
COVID-19 remains a public health concern, causing an estimated 50,000 deaths and 827,000 hospitalizations in the United States during the 2023–2024 season. As SARS-CoV-2 continues to evolve, assessing COVID-19 vaccine effectiveness (VE) remains essential. This study evaluated the effectiveness of Moderna's 2023–2024 mRNA-1273 vaccine formulation targeting the XBB.1.5 variant in preventing COVID-19 associated hospitalizations and medically attended COVID-19 in the US.
Methods
This non-interventional, matched retrospective cohort study used US administrative claims data (September 2023–February 2024). Individuals vaccinated with mRNA-1273 XBB.1.5 were matched to individuals who did not receive an updated 2023–2024 COVID-19 vaccine. COVID-19 associated hospitalizations and medically attended COVID-19 outcomes were identified 7 days after the index date. Subpopulations of interest included age group, immunocompromised individuals, and those received a BA.4/BA.5 vaccine in the prior season. VE was estimated using 1 minus hazard ratios.
Results
Among 900,194 mRNA-1273 vaccinated and matched unexposed individuals, median follow-up for COVID-19 associated hospitalizations was 111 days (vaccinated) and 99 days (unexposed). Overall, VE against COVID-19 associated hospitalizations was 56 % (95 % CI: 52 %–60 %). VE ranged from 52 % (95 % CI: 43 %–59 %) in immunocompromised individuals to 62 % (95 % CI: 35 %–78 %) in those aged 50–64 years. For medically attended COVID-19, VE was 24 % (95 % CI: 22 %–25 %).
Conclusions
mRNA-1273 XBB.1.5 demonstrates significant incremental protection against COVID-19 associated hospitalizations and medically attended COVID-19 relative to those who did not receive 2023–2024 COVID-19 vaccination. These findings reinforce the need for vaccination efforts to reduce the burden of COVID-19.
{"title":"Effectiveness of 2023–2024 mRNA-1273 XBB.1.5 vaccine against COVID-19 associated hospitalizations and medically attended COVID-19 in the United States","authors":"Zhe Zheng , Mitra Yousefi , Danielle MacCormac , Jennifer M. Radin , Tianyu Sun , Amanda Wilson , Rohan Shah , Michelle Skornicki , Paige Sheridan , Astra Toyip , Katherine Mues , Daina Esposito , Andre Araujo , Evan Anderson","doi":"10.1016/j.jvacx.2025.100737","DOIUrl":"10.1016/j.jvacx.2025.100737","url":null,"abstract":"<div><h3>Background</h3><div>COVID-19 remains a public health concern, causing an estimated 50,000 deaths and 827,000 hospitalizations in the United States during the 2023–2024 season. As SARS-CoV-2 continues to evolve, assessing COVID-19 vaccine effectiveness (VE) remains essential. This study evaluated the effectiveness of Moderna's 2023–2024 mRNA-1273 vaccine formulation targeting the XBB.1.5 variant in preventing COVID-19 associated hospitalizations and medically attended COVID-19 in the US.</div></div><div><h3>Methods</h3><div>This non-interventional, matched retrospective cohort study used US administrative claims data (September 2023–February 2024). Individuals vaccinated with mRNA-1273 XBB.1.5 were matched to individuals who did not receive an updated 2023–2024 COVID-19 vaccine. COVID-19 associated hospitalizations and medically attended COVID-19 outcomes were identified 7 days after the index date. Subpopulations of interest included age group, immunocompromised individuals, and those received a BA.4/BA.5 vaccine in the prior season. VE was estimated using 1 minus hazard ratios.</div></div><div><h3>Results</h3><div>Among 900,194 mRNA-1273 vaccinated and matched unexposed individuals, median follow-up for COVID-19 associated hospitalizations was 111 days (vaccinated) and 99 days (unexposed). Overall, VE against COVID-19 associated hospitalizations was 56 % (95 % CI: 52 %–60 %). VE ranged from 52 % (95 % CI: 43 %–59 %) in immunocompromised individuals to 62 % (95 % CI: 35 %–78 %) in those aged 50–64 years. For medically attended COVID-19, VE was 24 % (95 % CI: 22 %–25 %).</div></div><div><h3>Conclusions</h3><div>mRNA-1273 XBB.1.5 demonstrates significant incremental protection against COVID-19 associated hospitalizations and medically attended COVID-19 relative to those who did not receive 2023–2024 COVID-19 vaccination. These findings reinforce the need for vaccination efforts to reduce the burden of COVID-19.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100737"},"PeriodicalIF":2.2,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145474094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dengue virus infection continues to pose a major global health challenge, affecting approximately 3.9 billion individuals annually. Unfortunately, the efficacy and safety profiles of currently licensed dengue vaccines remain debatable. This highlights the need for a next-generation vaccine that provides protection against all DENV serotypes. In this study, the immunogenicity of five DENV proteins was evaluated, including the envelope domain III proteins of all four dengue virus serotypes and C-terminally truncated NS1 protein of DENV-2, loaded into N, N, N-trimethyl chitosan nanoparticles. We demonstrated, here, that sequential immunization with these encapsidated immunogens elicited antibody responses known to correlate with protection against all four DENV serotypes. These responses facilitated the elimination of both infected cells and virus particles through a multifaceted mechanism. Moreover, the immunization induced functional cytotoxic T cell responses to all tested immunogens. These findings indicate that immunization with the designed immunogens induces robust and protective immune responses against all four DENV serotypes. This form of immunogens offers a promising, safe and effective subunit dengue vaccine candidate.
{"title":"Immunogenicity of five Encapsidated DENV antigens supports their potential as a safe and protective subunit vaccine candidate","authors":"Mathurin Seesen , Tuksin Jearanaiwitayakul , Nattika Nantachit , Phissinee Jakaew , Jitra Limthongkul , Panya Sunintaboon , Sukathida Ubol","doi":"10.1016/j.jvacx.2025.100740","DOIUrl":"10.1016/j.jvacx.2025.100740","url":null,"abstract":"<div><div>Dengue virus infection continues to pose a major global health challenge, affecting approximately 3.9 billion individuals annually. Unfortunately, the efficacy and safety profiles of currently licensed dengue vaccines remain debatable. This highlights the need for a next-generation vaccine that provides protection against all DENV serotypes. In this study, the immunogenicity of five DENV proteins was evaluated, including the envelope domain III proteins of all four dengue virus serotypes and C-terminally truncated NS1 protein of DENV-2, loaded into <em>N, N, N</em>-trimethyl chitosan nanoparticles. We demonstrated, here, that sequential immunization with these encapsidated immunogens elicited antibody responses known to correlate with protection against all four DENV serotypes. These responses facilitated the elimination of both infected cells and virus particles through a multifaceted mechanism. Moreover, the immunization induced functional cytotoxic T cell responses to all tested immunogens. These findings indicate that immunization with the designed immunogens induces robust and protective immune responses against all four DENV serotypes. This form of immunogens offers a promising, safe and effective subunit dengue vaccine candidate.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"27 ","pages":"Article 100740"},"PeriodicalIF":2.2,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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