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Evaluation of vaccine uptake and opportunity of in-hospital vaccination against pneumococcus in vulnerable hospitalized patients 易感住院病人肺炎球菌疫苗摄取和住院疫苗接种机会的评估
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-05 DOI: 10.1016/j.vaccine.2025.127364
Elvira Marín-Caba , Alberto Benavente-Fernández , Gonzalo Morales-Jiménez , Sandra Comino-Fernández , María Isabel Cueto-Martín , Laura Lirola-Andreu , Inmaculada Guerrero-Fernández de Alba , María del Carmen Valero-Ubierna , José Juan Jiménez-Moleón , Mario Rivera-Izquierdo
{"title":"Evaluation of vaccine uptake and opportunity of in-hospital vaccination against pneumococcus in vulnerable hospitalized patients","authors":"Elvira Marín-Caba ,&nbsp;Alberto Benavente-Fernández ,&nbsp;Gonzalo Morales-Jiménez ,&nbsp;Sandra Comino-Fernández ,&nbsp;María Isabel Cueto-Martín ,&nbsp;Laura Lirola-Andreu ,&nbsp;Inmaculada Guerrero-Fernández de Alba ,&nbsp;María del Carmen Valero-Ubierna ,&nbsp;José Juan Jiménez-Moleón ,&nbsp;Mario Rivera-Izquierdo","doi":"10.1016/j.vaccine.2025.127364","DOIUrl":"10.1016/j.vaccine.2025.127364","url":null,"abstract":"<div><h3>Background</h3><div>Pneumococcal infections are an increased cause of morbimortality worldwide. The most effective preventive strategy is adequate vaccination. The aim of this work was to evaluate the vaccination coverage and associated factors for vulnerable hospitalized patients, and the opportunity of vaccination within hospitalization.</div></div><div><h3>Methods</h3><div>Observational study conducted on a secondary care public hospital. The sample was composed of patients admitted to an Internal Medicine service, excluding participants with terminal conditions. Descriptive and bivariate analyses using chi-square and <em>t</em>-tests were applied. To detect profiles of non-vaccinated patients, a dendrogram was fitted using cluster analysis techniques. Multivariable logistic regression models were designed to analyse associated factors with vaccination uptake. Vaccination was finally applied if indicated.</div></div><div><h3>Findings</h3><div>A total of 388 patients were included. Of them, 330 (85.7 %) had indication of pneumococcal vaccination, but only 180 (54.4 %) had received any previous vaccination, and 276 with indication (83.6 %) were not correctly vaccinated. During hospitalization, 192 (49.7 %) of the admitted patients were vaccinated<em>.</em> Vaccination coverage was higher in patients with chronic heart failure (59.4 %) or diabetes mellitus (57.5 %) than in patients with neoplasia (50.9 %) or chronic hepatopathy (26.7 %). The main factors associated with lower vaccination coverage were sex female (OR = 1.74, 95 %CI: 1.13–2.68) and COVID-19 infection (OR = 3.50, 95 %CI: 1.36–9.01).</div></div><div><h3>Interpretation</h3><div>Our results suggest that hospitalized patients, mostly elderly patients with high frequency of comorbidities and indication of antipneumococcal vaccine (e.g., Internal Medicine or Geriatric services), have low vaccination uptake. Therefore, hospitalization admission could be a great opportunity to increase pneumococcal vaccination coverage in patients at risk. Further studies should confirm the associations with lower coverage to optimize future vaccination strategies.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127364"},"PeriodicalIF":4.5,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144222184","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
Long-term immunogenicity of a live attenuated herpes zoster vaccine in patients with systemic lupus erythematosus 减毒带状疱疹活疫苗对系统性红斑狼疮患者的长期免疫原性
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-05 DOI: 10.1016/j.vaccine.2025.127365
Chi Chiu Mok, Kar Li Chan, Sau Mei Tse
{"title":"Long-term immunogenicity of a live attenuated herpes zoster vaccine in patients with systemic lupus erythematosus","authors":"Chi Chiu Mok,&nbsp;Kar Li Chan,&nbsp;Sau Mei Tse","doi":"10.1016/j.vaccine.2025.127365","DOIUrl":"10.1016/j.vaccine.2025.127365","url":null,"abstract":"<div><h3>Objectives</h3><div>To study the 5-year immunogenicity of a live attenuated herpes zoster (HZ) vaccine in systemic lupus erythematosus (SLE).</div></div><div><h3>Method</h3><div>This is an extended observational study of the immunogenicity of a live HZ vaccine (Zostavax) in adult patients with stable SLE (SLEDAI &lt;6 and immunosuppressive treatment for ≥6 months) who participated in a placebo (PBO)-controlled randomized controlled trial (RCT). Humoral (anti-VZV IgG reactivity) and cell-mediated (VZV-stimulated IFN-γ enzyme-linked ELISPOT assay) responses to HZ at 5 years were reassessed.</div></div><div><h3>Results</h3><div>Of the 90 patients in the original RCT, 70 patients consented for this study (32 treated with vaccine; 38 treated with PBO; age 51.9 ± 15.5 vs 50.0 ± 13.2 years; <em>p</em> = 0.59; 91 % vs 97 % women; <em>p</em> = 0.33). The change in anti-VZV IgG reactivity from week 6 to year 5 was −14.5 % (<em>p</em> = 0.06) in the vaccine and − 10.1 % (<em>p</em> = 0.02) in the PBO group, respectively. The anti-VZV IgG reactivity at year 5 was significantly higher in vaccinated than PBO-treated patients, after adjustment for baseline values (3.61 ± 1.56 vs 2.94 ± 1.03; <em>p</em> = 0.01). The number of IFN-γ secreting T-cell spots (per 5 × 10<sup>5</sup> cells) increased in vaccinated patients (+65.5 %; <em>p</em> = 0.23) from week 6 to year 5 but decreased in PBO-treated patients (−5.3 %; <em>p</em> = 0.83). The T-cell spots number at year 5 was higher in vaccine than PBO treated patients after adjustment for baseline values (58.1 ± 71.5 vs 24.9 ± 23.2; <em>p</em> = 0.06). The proportion of patients who had a reduction in T-cell spots number by ≥20 % was significantly lower in the vaccine (30.8 %) than PBO (61.1 %) groups (<em>p</em> = 0.046). Among vaccinated patients, a trend of higher cumulative prednisolone, more new addition or dosage increase of non-glucocorticoid immunosuppressive drugs was observed in those who had reduction in T-cell or humoral HZ responses by ≥20 %. One vaccinated patient (3.1 %) and three PBO-treated patients (7.9 %) experienced HZ reactivation, but the difference was not significant (<em>p</em> = 0.62).</div></div><div><h3>Conclusions</h3><div>Immunogenicity of Zostavax in stable SLE patients is largely retained at 5 years.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127365"},"PeriodicalIF":4.5,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144222256","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 efficacy and safety of SYN023 (Zamerovimab and Mazorelvimab injection), the recombinant humanized anti-rabies virus monoclonal antibody mixture, combined with rabies vaccine in a WHO category III rabies post-exposure population: A randomized, double-blind, positive control, phase III clinical trial. 重组人源抗狂犬病毒单克隆抗体混合物SYN023 (Zamerovimab and Mazorelvimab注射液)联合狂犬病疫苗在WHO III类狂犬病暴露后人群中的有效性和安全性:一项随机、双盲、阳性对照的III期临床试验。
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-05 DOI: 10.1016/j.vaccine.2025.127289
Xiaoqiang Liu , Jingyu Li , Yongxian Zha , Zhengxiong Wang , Ya Jiang , Xiangyu Zhang , Jiangshu Guo , Jiajie Yu , Xiangjun Li , Qingchao Zhang , Caroline Reid , J. Bruce McClain , Eric Tsao
{"title":"The efficacy and safety of SYN023 (Zamerovimab and Mazorelvimab injection), the recombinant humanized anti-rabies virus monoclonal antibody mixture, combined with rabies vaccine in a WHO category III rabies post-exposure population: A randomized, double-blind, positive control, phase III clinical trial.","authors":"Xiaoqiang Liu ,&nbsp;Jingyu Li ,&nbsp;Yongxian Zha ,&nbsp;Zhengxiong Wang ,&nbsp;Ya Jiang ,&nbsp;Xiangyu Zhang ,&nbsp;Jiangshu Guo ,&nbsp;Jiajie Yu ,&nbsp;Xiangjun Li ,&nbsp;Qingchao Zhang ,&nbsp;Caroline Reid ,&nbsp;J. Bruce McClain ,&nbsp;Eric Tsao","doi":"10.1016/j.vaccine.2025.127289","DOIUrl":"10.1016/j.vaccine.2025.127289","url":null,"abstract":"<div><h3>Background</h3><div>The SYN023–006 study was conducted in WHO Category III rabies-exposed patient populations to assess the safety and efficacy of post-exposure prophylaxis that included either the monoclonal antibody mixture SYN023 or human rabies immunoglobulin (HRIG).</div></div><div><h3>Methods</h3><div>This phase 3, double-blind, randomized, controlled trial was conducted at multiple clinical disease control sites in China. Patients were randomized 3:1 (stratified by study site) to wound infiltration with 0.3 mg/kg SYN023 or 20 IU/kg HRIG. All patients received thorough wound washing and 5 doses intramuscular Vero cell rabies vaccine. The composite primary study objective was to demonstrate: 1) superiority of Day 8 geometric mean (GM) concentration of serum rabies virus neutralizing antibodies (RVNA) with SYN023 versus HRIG (protocol-defined superiority margin: GM RVNA ratio 95 % confidence interval [CI] lower limit &gt;1.2) and 2) no rabies in SYN023 recipients. Efficacy was evaluated in the Per-Protocol population. Safety endpoints included solicited and unsolicited adverse events (AEs) analyzed in all patients receiving any study treatment. Trial registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT04644484</span><svg><path></path></svg></span>.</div></div><div><h3>Results</h3><div>From 23 September 2020 to 26 June 2021, 537 male and 463 female patients were randomized (<em>n</em> = 750 SYN023, <em>n</em> = 250 HRIG). Day 8 GM RVNA was 4.339 IU/mL (standard error [SE]: 1.035) with SYN023 and 0.232 IU/mL (SE: 1.060) with HRIG. The SYN023:HRIG GM RVNA ratio was 18.695 (95 % CI: 16.440, 21.260) indicating superior RVNA with SYN023. No suspected rabies cases or deaths occurred. AEs were generally similar between treatment groups except greater local solicited AEs frequencies with HRIG (SYN023: 165/750 patients [22.0 %]; HRIG: 97/250 [38.8 %]).</div></div><div><h3>Conclusion</h3><div>This study indicates that SYN023, a monoclonal antibody product, may be used as part of rabies post-exposure prophylaxis and provides superior protection sooner after exposure than HRIG.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127289"},"PeriodicalIF":4.5,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144222257","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 effect of school-based interventions on HPV vaccine-related knowledge, attitudes, and practices among adolescents in France: Secondary results from the PrevHPV trial 学校干预对法国青少年HPV疫苗相关知识、态度和实践的影响:PrevHPV试验的次要结果
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-05 DOI: 10.1016/j.vaccine.2025.127344
Josée M. Dussault , Alexia F. Rivera Torres , Damien Oudin Doglioni , Amandine Gagneux-Brunon , Anne-Sophie Le Duc-Banaszuk , Sébastien Bruel , Morgane Michel , Aurélie Gauchet , Anne-Sophie Barret , Jonathan Sicsic , Jocelyn Raude , Nathalie Thilly , Judith E. Mueller , On behalf of the PrevHPV Consortium
{"title":"The effect of school-based interventions on HPV vaccine-related knowledge, attitudes, and practices among adolescents in France: Secondary results from the PrevHPV trial","authors":"Josée M. Dussault ,&nbsp;Alexia F. Rivera Torres ,&nbsp;Damien Oudin Doglioni ,&nbsp;Amandine Gagneux-Brunon ,&nbsp;Anne-Sophie Le Duc-Banaszuk ,&nbsp;Sébastien Bruel ,&nbsp;Morgane Michel ,&nbsp;Aurélie Gauchet ,&nbsp;Anne-Sophie Barret ,&nbsp;Jonathan Sicsic ,&nbsp;Jocelyn Raude ,&nbsp;Nathalie Thilly ,&nbsp;Judith E. Mueller ,&nbsp;On behalf of the PrevHPV Consortium","doi":"10.1016/j.vaccine.2025.127344","DOIUrl":"10.1016/j.vaccine.2025.127344","url":null,"abstract":"<div><h3>Background</h3><div>In France, HPV vaccine uptake among adolescents remains a public health concern. Therefore, we examined changes in French adolescents' knowledge, attitudes, and practices (KAP) following exposure to HPV-vaccination-related interventions.</div></div><div><h3>Methods</h3><div>Our cluster-randomized trial applied an incomplete factorial design to allocate three intervention components (in-school education, free in-school vaccination, and general practitioner [GP] trainings) into six arms, randomly assigned to 91 French municipalities. Adolescents' (<em>N</em> = 2758; typically aged 13–14) self-reported HPV-vaccine-related KAP was assessed via online questionnaires at baseline and follow-up. Using logistic regression, we estimated the decomposed effects of each intervention component on favorable responses to individual KAP items. Each model adjusted for the baseline level of the outcome. We conducted subgroup analyses of the effect of the education component.</div></div><div><h3>Results</h3><div>Adolescents who received in-school education, compared to those who did not, provided improved responses on all knowledge items at follow-up. They also reported more favorable attitudes, which included the perceived benefit-risk balance (OR = 1.6 [95 %-CI, 1.2–2.0]) and judging reduced onward transmission as important (1.5 [1.1–2.1]). In-school education increased the likelihood of having HPV-vaccine-related discussions with friends (1.8 [1.2–2.6]). In-school vaccination increased adolescents' likelihood of knowing that friends are vaccinated (3.1 [2.2–4.2]), and perceived accessibility (2.2 [1.5–3.2]). Perceived difficulties in accessing clear vaccine information increased specifically among multilingual adolescents (0.5 [0.2–0.9]).</div></div><div><h3>Conclusion</h3><div>Free in-school HPV vaccination significantly increases perceived ease of access to HPV vaccination for students who are already motivated to get vaccinated, and in-school education and motivation improves students' HPV vaccine-related knowledge and attitudes and can encourage them to get vaccinated. Thus, when offered together over the course of multiple academic years, we would expect to see increased vaccine uptake as adolescents become both more amenable toward vaccination and perceive easier access. Educational material needs tailoring for families from different linguistic and cultural backgrounds.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127344"},"PeriodicalIF":4.5,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144213229","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
Effective strategies in human papillomavirus (HPV) vaccination interventions to increase uptake in rural, low socioeconomic, indigenous and migrant populations: A scoping review 人乳头瘤病毒(HPV)疫苗接种干预措施的有效策略,以增加农村,低社会经济,土著和移民人口的吸收:范围审查
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-04 DOI: 10.1016/j.vaccine.2025.127359
Kate Roux , Felicity Roux , Sharyn Burns , Rebecca Guy
{"title":"Effective strategies in human papillomavirus (HPV) vaccination interventions to increase uptake in rural, low socioeconomic, indigenous and migrant populations: A scoping review","authors":"Kate Roux ,&nbsp;Felicity Roux ,&nbsp;Sharyn Burns ,&nbsp;Rebecca Guy","doi":"10.1016/j.vaccine.2025.127359","DOIUrl":"10.1016/j.vaccine.2025.127359","url":null,"abstract":"<div><h3>Background</h3><div>Human Papillomavirus (HPV) vaccination is a key strategy to reduce HPV-related cancers such as cervical cancer. Rural, low socioeconomic status, ethnic minority, Indigenous and migrant populations often experience inequity when accessing HPV vaccination.</div></div><div><h3>Methods</h3><div>This scoping review searched six databases for intervention studies which measured the uptake of HPV vaccination of rural, low SES, ethnic minority, Indigenous or migrant adolescent-young adult population. Strategies were categorised according to their setting: clinical, school-based, community, or a combination of one or more of these settings.</div></div><div><h3>Results</h3><div>Effective strategies from 46 studies which increased equity in HPV vaccination uptake included: (1) Information disseminated through handouts, multilingual material, and health care conversations using presumptive language; (2) ‘Prompting’ using a practice-wide coordination to flag patient records, remind patients, and alert them of their appointment for HPV vaccination; (3) Health Care Professional (HCP) training to communicate information effectively about HPV vaccination, and include HCP champions as HPV vaccination advocates; (4) School-based programs, using strategies such as on-site vaccination, student-engagement fetes and partnership with clinics to increase HPV vaccination ‘catch-up’; (5) Family-centred care to motivate HPV vaccination for cancer prevention.</div></div><div><h3>Conclusion</h3><div>Although interventions demand preparation and coordination to initiate, they can positively influence the uptake of HPV vaccination. There are a wide range of effective strategies to increase equity in HPV vaccination in the rural, low SES, ethnic minority, Indigenous and migrant adolescent-young adult populations. Future evaluation of effective strategies could explore their sustainability and long-term implementation in interventions.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127359"},"PeriodicalIF":4.5,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144213228","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
Hesitancy and confidence in pediatric COVID-19 vaccination among diverse caregivers of unvaccinated children 未接种疫苗儿童的不同照料者对儿童COVID-19疫苗接种的犹豫和信心
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-04 DOI: 10.1016/j.vaccine.2025.127245
Lisa M. Costello , Ellen K. Kerns , Russell J. McCulloh , James R. Roberts , Daniel B. Blatt , Susanne E. Tanski , Timothy Ryan Smith , Walter Dehority , Margaret P. Huntwork , Zain Alamarat , Melinda D. Delaney , Christine W. Hockett , Ryan S. McKee , Jonathan M. Miller , Di Chang , Songthip Ounpraseuth , Sophia R. Newcomer
{"title":"Hesitancy and confidence in pediatric COVID-19 vaccination among diverse caregivers of unvaccinated children","authors":"Lisa M. Costello ,&nbsp;Ellen K. Kerns ,&nbsp;Russell J. McCulloh ,&nbsp;James R. Roberts ,&nbsp;Daniel B. Blatt ,&nbsp;Susanne E. Tanski ,&nbsp;Timothy Ryan Smith ,&nbsp;Walter Dehority ,&nbsp;Margaret P. Huntwork ,&nbsp;Zain Alamarat ,&nbsp;Melinda D. Delaney ,&nbsp;Christine W. Hockett ,&nbsp;Ryan S. McKee ,&nbsp;Jonathan M. Miller ,&nbsp;Di Chang ,&nbsp;Songthip Ounpraseuth ,&nbsp;Sophia R. Newcomer","doi":"10.1016/j.vaccine.2025.127245","DOIUrl":"10.1016/j.vaccine.2025.127245","url":null,"abstract":"<div><h3>Introduction</h3><div>Understanding factors associated with hesitancy about pediatric COVID-19 vaccination is important for identifying strategies to improve vaccination rates. Our objective was to describe beliefs about COVID-19 vaccination among caregivers who had not yet vaccinated their children against COVID-19.</div></div><div><h3>Methods</h3><div>From July 2022 to February 2023, caregivers of children unvaccinated for COVID-19 across 15 states within the IDeA States Pediatrics Clinical Trial Network were recruited into a randomized, controlled trial of a COVID-19 vaccine communication phone app. Recruitment sites served high numbers of children from rural areas or of backgrounds other than non-Hispanic White. At baseline, caregivers answered questions from the SAGE Vaccine Hesitancy Scale (VHS), and questions about trusted sources of information about COVID-19. We compared responses by rurality, race, and ethnicity using chi-square tests, and used multivariable modeling of a composite outcome of summed VHS scores to identify factors associated with vaccine hesitancy.</div></div><div><h3>Results</h3><div>A total of 725 caregivers were randomized; 512 completed the baseline survey. Many caregivers lived in a rural area (34.9 %) and nearly half were of non-White race (47.3 %). Over 80 % somewhat or strongly agreed that vaccines are important, that childhood vaccines are effective, and that vaccination is a good way to protect children from disease. Rural caregivers were more likely than non-rural caregivers to state that they generally do what their doctor recommends with regard to childhood vaccines (46.93 % vs. 37.00 %, <em>p</em> &lt; .0021). In the multivariable model, the combined group of Asian, Native Hawaiian, Other Pacific Islander or multiracial caregivers, and Black or African American caregivers, had a higher vaccine hesitancy compared to White caregivers (25.25, 25.91, 22.50 respectively) (<em>p</em> &lt; .0001).</div></div><div><h3>Conclusions</h3><div>As we navigate work to build vaccine confidence, this study provides support for additional directions of study to better understand particular populations and could be further reproduced to look at intentions with other vaccines.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127245"},"PeriodicalIF":4.5,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144205053","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 safety studies among special populations: A systematic review and meta-analysis of 120 observational studies and randomized clinical trials 特殊人群中COVID-19疫苗安全性研究:120项观察性研究和随机临床试验的系统回顾和荟萃分析
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-04 DOI: 10.1016/j.vaccine.2025.127342
Sima Mohammadi , Malede Mequanent Sisay , Putri Widi Saraswati , Alhadi Khogali Osman , Nicolaas P.A. Zuithoff , Daniel Weibel , Miriam Sturkenboom , Fariba Ahmadizar
{"title":"COVID-19 vaccine safety studies among special populations: A systematic review and meta-analysis of 120 observational studies and randomized clinical trials","authors":"Sima Mohammadi ,&nbsp;Malede Mequanent Sisay ,&nbsp;Putri Widi Saraswati ,&nbsp;Alhadi Khogali Osman ,&nbsp;Nicolaas P.A. Zuithoff ,&nbsp;Daniel Weibel ,&nbsp;Miriam Sturkenboom ,&nbsp;Fariba Ahmadizar","doi":"10.1016/j.vaccine.2025.127342","DOIUrl":"10.1016/j.vaccine.2025.127342","url":null,"abstract":"<div><h3>Background</h3><div>The COVID-19 vaccines were rapidly developed and tested, but concerns about vaccine-related adverse events remain, especially in special groups like pregnant women, children, and those with certain health conditions. This review aims to summarize rates of such adverse events in individuals often not included in randomized clinical trials (RCT).</div></div><div><h3>Method</h3><div>From December 2019 to February 2022, we searched Embase and Medline for observational studies and RCTs on adverse events post-COVID-19 vaccination in special populations. We examined severe and non-severe events in individuals with specific medical conditions, infants, children, pregnant individuals, and socioeconomically disadvantaged individuals. Cumulative risks for all events were calculated. The Incidence rate (IR) and 95% confidence intervals were reported for those studies that met the follow-up period criteria based on the referenced literature. For events with data on exposed and unexposed groups, we calculated the odds ratio (OR). Pooled incidence rates were calculated per 1000,000 person-days using a random-effects model. Sub-group analyses were conducted based on vaccine types and doses, with heterogeneity assessed using I<sup>2</sup>.</div></div><div><h3>Results</h3><div>Of the 4,254 papers, 235 met eligibility criteria, including 120 studies with 171,073 participants (113 observational, eight RCTs). We examined 17 severe and seven non-severe adverse event categories. Lymphadenopathy (IR: 1950[1200,3190]), autoimmune disease and multiple sclerosis flare-up (1130 [470,2680]), and cardiac symptoms (0.26[0.00,10.58]) were the most prevalent severe adverse events. Autoimmune disease flare-ups and cardiac symptoms were more common following the second dose compared to the first dose. The overall incidence of serious adverse events was low in children and adolescents, pregnant, autoimmune, and cancer patients.</div></div><div><h3>Discussion</h3><div>This review highlights COVID-19 vaccine safety in special populations, enhancing vaccination strategies. Further real-world research is needed to validate and extend our findings, especially in addressing safety gaps among special groups.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127342"},"PeriodicalIF":4.5,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144205052","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
Low-dose intradermal mRNA-1273 boosting vaccine following BBiBP-CorV vaccination during the omicron pandemics 在大流行期间接种BBiBP-CorV疫苗后,低剂量皮内mRNA-1273增强疫苗
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-04 DOI: 10.1016/j.vaccine.2025.127330
Warawut Chaiwong , Nuchjira Takheaw , Witida Laopajon , Chote Nisoong , Supansa Pata , Pilaiporn Duangjit , Juthamas Inchai , Chaicharn Pothirat , Chaiwat Bumroongkit , Athavudh Deesomchok , Theerakorn Theerakittikul , Atikun Limsukon , Pattraporn Tajarernmuang , Nutchanok Niyatiwatchanchai , Konlawij Trongtrakul , Watchara Kasinrerk , Chalerm Liwsrisakun
{"title":"Low-dose intradermal mRNA-1273 boosting vaccine following BBiBP-CorV vaccination during the omicron pandemics","authors":"Warawut Chaiwong ,&nbsp;Nuchjira Takheaw ,&nbsp;Witida Laopajon ,&nbsp;Chote Nisoong ,&nbsp;Supansa Pata ,&nbsp;Pilaiporn Duangjit ,&nbsp;Juthamas Inchai ,&nbsp;Chaicharn Pothirat ,&nbsp;Chaiwat Bumroongkit ,&nbsp;Athavudh Deesomchok ,&nbsp;Theerakorn Theerakittikul ,&nbsp;Atikun Limsukon ,&nbsp;Pattraporn Tajarernmuang ,&nbsp;Nutchanok Niyatiwatchanchai ,&nbsp;Konlawij Trongtrakul ,&nbsp;Watchara Kasinrerk ,&nbsp;Chalerm Liwsrisakun","doi":"10.1016/j.vaccine.2025.127330","DOIUrl":"10.1016/j.vaccine.2025.127330","url":null,"abstract":"<div><h3>Background</h3><div>Long-term kinetics of the neutralizing antibody (NAb) response against Omicron using 1/10 intradermal (ID) mRNA vaccination as a booster following a complete series of inactivated vaccines, as well as its safety are still limited. Therefore, the objective of this study was to compare local and systemic reactions, NAb levels against Omicron BA.2 and BA.4/5 after four weeks of boosting, and durability of NAb against BA.2 and BA.4/5 after 12 and 24 weeks of mRNA-1273 vaccine boosting among the 1/10 ID, 1/5 ID, and full-dose IM groups in subjects who received a standard primary series of the BBIBP-CorV vaccine.</div></div><div><h3>Methods</h3><div>Two-week side effects and baseline, 4-week, 12-week and 24-week NAb levels against wild type, BA.2 and BA.4/5 Omicron among 3 groups were compared.</div></div><div><h3>Results</h3><div>There were 140 participants with 46, 47, and 47 subjects in 1/10 ID, 1/5 ID, and IM groups, respectively. The 1/10 ID-induced localized pain is less common than IM and 1/5 ID. Systemic reactions were lower than IM and comparable to 1/5 ID. BA.2 NAb was indifferent from the other 2 groups, except 2.5-fold lower than IM at 12 weeks. BA.2 NAb in 1/10 ID was higher than the cut-off level throughout the 24-week study period whereas BA.4/5 NAb at 24 weeks was below the NAb detection threshold and significantly lower than IM group.</div></div><div><h3>Conclusion</h3><div>The 1/10 ID mRNA-1273 boosting after BBIBP-CorV priming was safe and induced above-threshold NAb against BA.2 and BA.4/5 for at least 12 weeks.</div></div><div><h3>Clinical trials registry</h3><div>This study was registered to the Thai Clinical Trials Registry with study ID: TCTR20210822002.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127330"},"PeriodicalIF":4.5,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144205056","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 serological survey utilizing antenatal serum samples in British Columbia 利用产前血清样本在不列颠哥伦比亚省进行COVID-19血清学调查
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-04 DOI: 10.1016/j.vaccine.2025.127310
Ana Citlali Márquez , Saina Beitari , Tahereh Valadbeigy , Hind Sbihi , James Zlosnik , Lucia Forward , Sarah Mansour , Zoey Nesbitt , Guadalein Tanunliong , Mel Krajden , Agatha Jassem , Inna Sekirov , Deborah Money
{"title":"COVID-19 serological survey utilizing antenatal serum samples in British Columbia","authors":"Ana Citlali Márquez ,&nbsp;Saina Beitari ,&nbsp;Tahereh Valadbeigy ,&nbsp;Hind Sbihi ,&nbsp;James Zlosnik ,&nbsp;Lucia Forward ,&nbsp;Sarah Mansour ,&nbsp;Zoey Nesbitt ,&nbsp;Guadalein Tanunliong ,&nbsp;Mel Krajden ,&nbsp;Agatha Jassem ,&nbsp;Inna Sekirov ,&nbsp;Deborah Money","doi":"10.1016/j.vaccine.2025.127310","DOIUrl":"10.1016/j.vaccine.2025.127310","url":null,"abstract":"<div><div>The COVID-19 pandemic, caused by SARS-CoV-2, highlighted the need for accurate and timely data on virus spread and immune responses at a population level. Serological surveys offer a comprehensive view of population-level immune response to SARS-CoV-2 post- infection and/or vaccination. Here, we performed a serial cross-sectional study from residual serum samples collected from pregnant individuals in British Columbia during their first trimester antenatal screening. A total of 28,050 samples were collected between November 2021 and March 2024. We tracked changes in antibody levels over time and examined differences in antibody responses based on age and vaccination status during different phases of the pandemic. Antenatal serum samples enabled tracking of SARS-CoV-2 serostatus within the population and waves of major SARS-CoV-2 infections, such as the Omicron surge in 2021–2022 and increases in infection during the 2023–2024 respiratory season. During the 2023–2024 season, we observed a significant rise in Nucleocapsid (N) seropositivity compared to the previous year, reaching 64.3 % in the vaccinated group and 67.05 % in the unvaccinated group. This suggests a high infection rate, likely driven by the latest Omicron variants. Additionally, we differentiated between infection-induced and vaccine-induced seroprevalence. By March 2024, Spike (S) seroprevalence was 94 % in the unvaccinated group and 100 % in the vaccinated group. We assessed the longevity of vaccine-induced antibody within the population. A significant negative correlation was observed between S seropositivity (indicative of vaccination without infection, S+/N-) and time since the last vaccine dose. In contrast, anti-N levels began to rise above the cut-off value of seropositivity 15 months post-vaccination, indicating increased infection rates and N seroprevalence as time post-vaccination increased. This serosurveillance approach provide critical insights for public health strategies for the future, emphasizing the importance of ongoing serosurveillance to help understand corelates of seroprotection at a population level and to support ongoing evidence-based vaccine policy.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127310"},"PeriodicalIF":4.5,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144205055","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
Assay for rapid quantification of capped and tailed intact mRNA 带帽和带尾完整mRNA的快速定量分析
IF 4.5 3区 医学
Vaccine Pub Date : 2025-06-03 DOI: 10.1016/j.vaccine.2025.127339
Rachel Y. Gao, Tianjing Hu , Amber W. Taylor , Randy Lacey, Keely N. Thomas, Caitlin McCormick , David F. Miller, Kathy L. Rowlen, Erica D. Dawson
{"title":"Assay for rapid quantification of capped and tailed intact mRNA","authors":"Rachel Y. Gao,&nbsp;Tianjing Hu ,&nbsp;Amber W. Taylor ,&nbsp;Randy Lacey,&nbsp;Keely N. Thomas,&nbsp;Caitlin McCormick ,&nbsp;David F. Miller,&nbsp;Kathy L. Rowlen,&nbsp;Erica D. Dawson","doi":"10.1016/j.vaccine.2025.127339","DOIUrl":"10.1016/j.vaccine.2025.127339","url":null,"abstract":"<div><div>The rapid development of mRNA vaccines since the COVID-19 pandemic has highlighted the potential of mRNA technology for vaccine and therapeutic applications. However, evaluating mRNA quality, including its integrity, 5′ capping efficiency, and 3′ poly(A) tailing, remains complex and challenging. Current analytical methods provide detailed insights, but are often limited by long analysis times, complex sample preparation, and the need for specialized expertise. The 5′ Cap<strong><em>Q</em></strong> assay addresses these challenges and provides a novel, rapid, and straightforward method that offers a single, unique measurement of intact mRNA with both a 5'cap and 3'poly(A) tail. This 2-h benchtop-based assay provides quantitative or relative analysis, with high accuracy and precision without extensive sample processing. The 5′ Cap<strong><em>Q</em></strong> assay offers a significant advancement in mRNA analytics to alleviate bottlenecks in applications including <em>in vitro</em> transcription (IVT) reaction optimization, post-transcriptional capping optimization, and assessment of batch-to-batch IVT bioprocess consistency.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"61 ","pages":"Article 127339"},"PeriodicalIF":4.5,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144205057","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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