Vaccine最新文献

{"title":"A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study.","authors":"Elke Jordan, Victoria Jenkins, Günter Silbernagl, Maria Paulina Velasco Chávez, Darja Schmidt, Frauke Schnorfeil, Stephanie Schultz, Liddy Chen, Fernanda Salgado, Jeanne-Marie Jacquet, Tobias Welte, Laurence De Moerlooze","doi":"10.1016/j.vaccine.2024.126427","DOIUrl":"10.1016/j.vaccine.2024.126427","url":null,"abstract":"<p><p>Respiratory syncytial virus (RSV) causes a significant disease burden in older adults. The live recombinant vaccine based on a nonreplicating modified vaccinia Ankara (MVA-BN) poxvirus, MVA-BN-RSV, encoding for multiple proteins of RSV subtypes A and B, was assessed for efficacy against respiratory disease caused by RSV. Adults aged ≥60 years, with or without underlying chronic conditions, were enrolled and randomized in a 1:1 ratio to receive a single dose of vaccine or placebo and were followed for disease caused by RSV infection during the 2022-2023 season. The 2 primary endpoints were RSV-associated lower respiratory tract disease (LRTD) with ≥3 and ≥ 2 symptoms; acute respiratory disease (ARD) was a key secondary endpoint. The humoral RSV-specific immune response was assessed at baseline and 14 days post-vaccination. Safety was evaluated by collection of solicited adverse events (AEs) and unsolicited AEs for 7 and 28 days post-vaccination respectively, and SAEs for the entire study period. In total, 18,348 participants were included in the final efficacy and safety analyses. Vaccine efficacy was 42.9 % (95 % CI: -16.1; 71.9) against RSV-associated LRTD with ≥3 symptoms, 59.0 % (95 % CI: 34.7; 74.3) against LRTD with ≥2 symptoms, and 48.8 % (95 % CI: 25.8; 64.7) against ARD. The primary objective was not met for LRTD with ≥3 symptoms since the lower bound of the 95 % CI was below 20 %, the prespecified success criterion. The vaccine-elicited immune response showed mean fold-increases of 1.7 for RSV A and B neutralizing antibodies and 2.9 and 4.3 for RSV-specific IgG and IgA, respectively. The vaccine displayed mild to moderate reactogenicity, and no safety concerns were identified. MVA-BN-RSV induced suboptimal protection against RSV-associated LRTD, likely due to suboptimal neutralizing antibody response. The vaccine had an acceptable safety profile and confirmed immunogenicity, overall showing promise for MVA-BN-vectored constructs targeting other diseases. Trial Registration:Clinicaltrials.gov Identifier NCT05238025 (Registered February 14, 2022).</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126427"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515709","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}

{"title":"Comparable and sustained levels of S1-RBD-IgG and S1-RBD-IgA in BNT162b2 homologous and CoronaVac-BNT162b2 heterologous booster vaccination: A 22-month prospective study in Malaysia.","authors":"Anis Atifah Mohd Hisham, Aini Syahida Mat Yassim, Rapeah Suppian, Maryam Azlan, Amiratul Aifa Mohamad Asri, Nur Suhaila Idris, Rosediani Muhamad, Mohd Nor Norazmi","doi":"10.1016/j.vaccine.2024.126471","DOIUrl":"10.1016/j.vaccine.2024.126471","url":null,"abstract":"<p><p>This prospective cohort study examines the long-term humoral immune responses post-COVID-19 vaccination in 146 individuals who received either a homologous three-dose BNT162b2 vaccine regimen (PPP) or two primary doses of CoronaVac followed by BNT162b2 booster (SSP) in Malaysia. The study focuses on serum anti-S1-RBD-IgG, -IgA, and -IgM, using the ELISA method. The results show that BNT162b2 outperformed CoronaVac in the two dose primary vaccination series. BNT162b2 booster dose significantly raised serum anti-S1-RBD-IgG and -IgA levels, sustaining this increase from 26 to 52 weeks after administration, regardless of the vaccine regimen. This leads to equivalent levels of anti-S1-RBD-IgG and -IgA after boosting with BNT162b2 in both groups. Breakthrough infections, particularly with the emergence of the Omicron variant, did not result in increased anti-S1-RBD-IgG and -IgA levels. No significant induction of anti-S1-RBD-IgM was observed following multiple vaccine doses. The long-term investigation revealed that PPP and SSP groups had comparable humoral immune responses to SARS-CoV-2, highlighting the advantage of mRNA booster dose in our cohort.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126471"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142570850","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}

{"title":"Anti-RBD IgG dynamics following infection or vaccination.","authors":"Amira Harrache, Kahina Saker, Bouchra Mokdad, Laurence Generenaz, Carla Saade, Sylvie Pons, Jean-Baptiste Fassier, Antonin Bal, Mary-Anne Trabaud, Muriel Rabilloud, Amna Abichou-Klich, Sophie Trouillet-Assant","doi":"10.1016/j.vaccine.2024.126464","DOIUrl":"10.1016/j.vaccine.2024.126464","url":null,"abstract":"<p><p>Identifying parameters influencing SARS-CoV-2 antibody dynamics post infection or vaccination is crucial for refining vaccination strategies. In a longitudinal analysis of 1340 samples from 375 healthcare workers, we characterized peak serological response and IgG half-life. Peak antibody titers post 2 vaccine doses were ∼ 20 times higher than natural infection; conversely, infected individuals had extended antibody half-life. Clinical and demographical factors such as BMI, age and smoking shaped peak response without affecting anti-RBD IgG half-life. A third mRNA vaccine dose increased peak antibody titers and prolonged half-life compared to the second dose. These findings underscore the diverse kinetics of SARS-CoV-2 antibody responses, which is influenced by immunization type/number and clinical factors.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126464"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484726","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}

{"title":"Documenting human papillomavirus vaccine refusal among adolescents in electronic health records: A mixed methods study.","authors":"Nadja A Vielot, Christine A P Ballard, Denise T St Jean, Sophie Page, Kelli Hammond, Peyton Thompson, Anne M Butler, Leah M Ranney","doi":"10.1016/j.vaccine.2024.126467","DOIUrl":"10.1016/j.vaccine.2024.126467","url":null,"abstract":"<p><strong>Background: </strong>Human papillomavirus (HPV) vaccination is often refused by patients or caregivers. We conducted a mixed-methods study to understand how health care providers document HPV vaccination refusal and use this information in subsequent encounters.</p><p><strong>Methods: </strong>Using electronic health records (EHR) in a public academic health system, we identified patients aged 9-17 years with documentation of refusal of a recommended vaccination in billing codes or clinic notes from October 15, 2015 and December 31, 2021. We summarized the number of encounters in which vaccination was refused; the incidence of HPV vaccination following an initial refusal; and the content of clinic notes describing HPV vaccination refusal. Next, we held focus groups with clinic personnel to understand strategies for documenting HPV vaccination refusal and holding future conversations about HPV vaccination.</p><p><strong>Results: </strong>Of 523 patients with a documented vaccination refusal, 351 (67 %) refused HPV. Of these, 88 (27 %) eventually received HPV vaccination; incidence of vaccination was not associated with the method used to document refusal in the EHR (ICD-10 code versus clinic note). From focus group discussions, we learned that providers usually make brief notes describing when HPV vaccination was offered and refused, and generally plan to recommend vaccination again at a subsequent encounter. Documenting specific reasons for refusal (e.g., patient age, a conflicting priority) was considered helpful to guide future conversations.</p><p><strong>Conclusions: </strong>Patients who refuse HPV vaccination might accept vaccination in the future if providers continue to recommend it. Documenting the refusal in EHR can provide meaningful context to guide subsequent recommendations.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126467"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142524051","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}

{"title":"Risk of major adverse cerebro-cardiovascular events following BNT162b2, CoronaVac, and ChAdOx1 vaccination and SARS-CoV-2 infection: A self-controlled case-series study.","authors":"Norazida Ab Rahman, Teck Long King, Kalaiarasu M Peariasamy, Sheamini Sivasampu","doi":"10.1016/j.vaccine.2024.126465","DOIUrl":"10.1016/j.vaccine.2024.126465","url":null,"abstract":"<p><strong>Objective: </strong>To assess the potential risk of major adverse cerebro-cardiovascular events (MACCE) associated with COVID-19 vaccination and SARS-CoV-2 infection.</p><p><strong>Methods: </strong>This self-controlled case series study used nationwide health database from Malaysia. The study included individuals aged ≥18 years who were hospitalised between 24 February 2021 and 30 June 2022. Outcomes were composite of MACCE: stroke, acute ischaemic heart disease, and cardiovascular death. Exposures were COVID-19 vaccination and SARS-CoV-2 infection. The risk period was day 1 to day 21 following exposure. Conditional Poisson regression model was used to estimate the incidence rate ratios (IRRs) and 95 % confidence interval (CI) comparing the outcomes in the risk and control periods.</p><p><strong>Results: </strong>The risk of MACCE within 21 days after vaccination per 100,000 doses administered were 12.0 (95% CI 11.9-12.1) (BNT162b2), 9.2 (95% CI 9.1-9.3) (CoronaVac), and 6.8 (95% CI 6.6-7.0) (ChAdOx1). The incidence rate ratios showed no increased risk of MACCE associated with the first, second, or third doses of BNT162b2, CoronaVac, and ChAdOx1 vaccines for individuals without prior cardiovascular disease (CVD). This finding was consistent for individuals with CVD. Vaccine booster dose, whether in a homologous or heterologous schedule, did not show increased risk of MACCE. Analysis by ethnic groups detected a slightly elevated risk of MACCE in Indian after the first dose of ChAdOx1 (IRR 1.64; 95% CI 1.08-2.48) in those without CVD. No significant association were observed in other subgroup analyses. SARS-CoV-2 infection was associated with significantly increased risk of MACCE in individuals without CVD (IRR 3.54; 95% CI 3.32-3.76) and with CVD (IRR 1.98; 95% CI 1.61-2.34).</p><p><strong>Conclusions: </strong>Our findings support the favourable safety profile of these COVID-19 vaccines and indicate that the overall benefit-risk ratio of the COVID-19 vaccines remains positive.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126465"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515712","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}

{"title":"Intravenous BCG vaccination in non-human primates induces superior serum antibody titers with enhanced avidity and opsonizing capacity compared to the intradermal route.","authors":"Marco Polo Peralta Alvarez, Keya Downward, Andrew White, Stephanie A Harris, Iman Satti, Shuailin Li, Alexandra Morrison, Laura Sibley, Charlotte Sarfas, Mike Dennis, Hugo Redondo Azema, Sally Sharpe, Helen McShane, Rachel Tanner","doi":"10.1016/j.vaccine.2024.126444","DOIUrl":"10.1016/j.vaccine.2024.126444","url":null,"abstract":"<p><p>A new and more effective tuberculosis (TB) vaccine is urgently needed, but development is hampered by the lack of validated immune correlates of protection. Bacillus Calmette Guérin (BCG) vaccination by the aerosol (AE) and intravenous (IV) routes has been shown to confer superior levels of protection from challenge with Mycobacterium tuberculosis (M.tb) in non-human primates (NHP) compared with standard intradermal (ID) administration. This finding offers a valuable opportunity to investigate which aspects of immunity are associated with improved control of M.tb and may represent biomarkers or correlates of protection. As TB vaccine research to date has focused largely on cellular immunity, we aimed to better characterize the poorly-understood serum antibody response to BCG administered by different routes of vaccination in NHP. We demonstrate superior M.tb-specific IgG, IgA, and IgM titers in serum following IV BCG vaccination compared to the ID or AE routes. We also observe improved capacity of IgG induced by IV BCG to opsonize the surface of mycobacteria, and report for the first time that M.tb-specific IgG from IV BCG vaccinated animals is of higher avidity compared with IgG from ID or AE BCG vaccinated animals. Notably, we identified a significant correlation between IgG avidity and measures of protection from aerosol M.tb challenge. Our findings highlight a potential role for antibodies as markers and/or mediators of the superior vaccine-induced protection IV BCG confers against TB and suggest that quality, as well as quantity, of antibodies should be considered when developing and evaluating TB vaccine candidates.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126444"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11906387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142635664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparing COVID-19 booster vaccine acceptance in the United Kingdom, Germany, Austria, and Jordan: The role of protection motivation theory, conspiracy beliefs, social media use and religiosity.","authors":"Judith Eberhardt, Walid Al-Qerem, Jonathan Ling","doi":"10.1016/j.vaccine.2024.126474","DOIUrl":"10.1016/j.vaccine.2024.126474","url":null,"abstract":"<p><strong>Background: </strong>Coronavirus Disease 2019 (COVID-19) booster vaccine uptake has been lower than that of the initial vaccine doses in many countries. Approaches to vaccination vary, with some countries implementing mandatory vaccination and others not. This study aimed to predict COVID-19 booster vaccination intention using Protection Motivation Theory (PMT), coronavirus conspiracy beliefs, social media use, and sociodemographic factors, comparing the United Kingdom (UK), Jordan, Germany, and Austria.</p><p><strong>Methods: </strong>A cross-sectional online survey was conducted in the UK, Germany, Austria, and Jordan. Convenience sampling was used to recruit 287 fully vaccinated participants. The survey included items measuring PMT constructs, conspiracy beliefs, social media use, and sociodemographic variables. Data were analysed using bivariate analysis and binary logistic regression.</p><p><strong>Results: </strong>Participants with high booster dose intention showed lower religiosity, conspiracy beliefs, perceived rewards of not getting vaccinated, and perceived costs of getting vaccinated. They had higher Twitter use, perceived susceptibility, severity of COVID-19, self-efficacy, and vaccine efficacy. Four PMT constructs (severity, self-efficacy, maladaptive response rewards, and response efficacy) significantly predicted booster dose intention.</p><p><strong>Conclusions: </strong>While PMT constructs predict booster vaccination intention, additional factors such as conspiracy beliefs, social media use, and religiosity need to be taken into account in public health campaigns to increase COVID-19 booster dose uptake.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126474"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142549925","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}

{"title":"Exploring risk factors for Raynaud's phenomenon post COVID-19 vaccination.","authors":"Tzu-Chuan Ho, Shih-Chang Chuang, Kuo-Chen Hung, Chin-Chuan Chang, Kuo-Pin Chuang, Cheng-Hui Yuan, Ming-Hui Yang, Yu-Chang Tyan","doi":"10.1016/j.vaccine.2024.126470","DOIUrl":"10.1016/j.vaccine.2024.126470","url":null,"abstract":"<p><strong>Background: </strong>Raynaud's phenomenon (RP) has recently been observed in recipients of the COVID-19 vaccine. It is unclear whether RP is directly caused by the COVID-19 vaccine. This study aims to investigate the potential causation between RP and COVID-19 vaccination.</p><p><strong>Methods: </strong>In this study, we searched PubMed, EMBASE, and Web of Science from January 1, 2020, to March 19, 2024. We included the articles with clinical related findings, specifically case reports and case series. Conference abstracts, editorial publications, preprint, and those not specifically related to COVID-19 vaccination are excluded. The refined selection process aimed to ensure a focused and clinically relevant analysis of the association between RP and COVID-19 vaccination.</p><p><strong>Results: </strong>A total of six articles were ultimately included in this study, comprising five case reports and one case series involving 24 patients with RP after vaccination. Baseline characteristics of the studies showed the RP post COVID-19 vaccination frequently occurred with females compared to males (70.83 vs. 29.17 %). Of the patients with RP post COVID-19 vaccination, 87.5 % (21/24) had either a history or possible predisposing factors of RP. Among the patients with detailed information of vaccination (n = 20), the number of vaccine doses was not related to RP development (45 % (1st) vs. 30 % (2nd) vs. 25 % 3rd dose). For types of vaccine, 75 % of RP were found to have received the administration of mRNA vaccine (15/20).</p><p><strong>Conclusion: </strong>The risk of bias was increased due to the uncontrolled study designs and small sample size, making it impossible to attribute causation between RP and COVID-19 vaccination. These few cases may have occurred independently of vaccination. However, physicians should still remain vigilant for RP following COVID-19 vaccination, particularly as the number of vaccinated individuals continues to rise.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126470"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142524052","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}

{"title":"On-time childhood vaccination before and during the COVID-19 pandemic in seven communities: Findings from the New Vaccine Surveillance Network.","authors":"Annika M Hofstetter, Eileen J Klein, Bonnie Strelitz, Rangaraj Selvarangan, Jennifer E Schuster, Julie A Boom, Leila C Sahni, Natasha B Halasa, Laura S Stewart, Mary Allen Staat, Chelsea Rohlfs, Peter G Szilagyi, Geoffrey A Weinberg, John V Williams, Marian G Michaels, Heidi Moline, Sara A Mirza, Christopher J Harrison, Janet A Englund","doi":"10.1016/j.vaccine.2024.126455","DOIUrl":"10.1016/j.vaccine.2024.126455","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic raised unprecedented challenges to vaccinating children. This multi-center study aimed to compare on-time vaccination of children before and during the COVID-19 pandemic and identify key factors associated with on-time vaccination.</p><p><strong>Methods: </strong>This study was conducted among children aged 0-6 years enrolled in the New Vaccine Surveillance Network at seven geographically diverse U.S. academic medical centers. Children with acute respiratory illness or acute gastroenteritis were enrolled from emergency department and inpatient settings; healthy control subjects were enrolled from primary care practices. Vaccination data were collected and verified from patient medical records, immunization information systems, and/or provider documentation. On-time vaccination according to Advisory Committee on Immunization Practices recommendations was compared between pre-pandemic (December 2018-February 2020) and pandemic (March 2020-August 2021) periods using bivariate and multivariable analyses, adjusting for key demographic, clinical, and study characteristics.</p><p><strong>Results: </strong>A total of 24,713 children were included in the analytic sample (non-Hispanic 73.4 %; White 51.0 %; publicly insured 69.0 %). On-time vaccination declined between the pre-pandemic (67.3 %) and pandemic (65.4 %) periods (Adjusted Odds Ratio 0.89, 95 % CI 0.84-0.95). The largest declines were observed among children who were < 12 months, male, Black, publicly insured, or whose mothers had a high school-equivalent education or less. The pandemic impact also varied by vaccine type and study site.</p><p><strong>Conclusions: </strong>This multi-center study revealed a relatively modest overall reduction in on-time vaccination, which may reflect multilevel efforts to address pandemic-associated challenges. However, some patient subgroups and sites experienced greater reductions in on-time vaccination, highlighting the importance of tailoring interventions to increase equitable vaccine delivery, access, and acceptance across populations and communities.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126455"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559930","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}

{"title":"Estimating influenza vaccine effectiveness among older adults using an integrated administrative database and the implications of potential bias: A population-based cohort study in Japan.","authors":"Ayu Kasamatsu, Yuichiro Yahata, Wakaba Fukushima, Hirofumi Sakamoto, Kaori Tanaka, Miwa Takigawa, Kaori Izu, Yuko Nishino, Motoi Suzuki, Hajime Kamiya","doi":"10.1016/j.vaccine.2024.126488","DOIUrl":"10.1016/j.vaccine.2024.126488","url":null,"abstract":"<p><strong>Background: </strong>Japan lacks an established framework for routine seasonal influenza vaccine effectiveness (SIVE) assessment at the national and municipal levels. This study aimed to estimate SIVE among older adults using an innovative population-based administrative database linking medical fee claims data with vaccination records, while also exploring its potential bias.</p><p><strong>Methods: </strong>In this retrospective population-based cohort study, we assessed SIVE against medically attended influenza during the 2017/18 season among older adults aged ≥65 years in a Japanese city. A Cox proportional hazards model was used to estimate hazard rate ratios, treating vaccination status as time-dependent. To explore potential biases, multivariate logistic regression analysis was used to investigate the association between vaccination status and acute respiratory infection (ARI) diagnosis and trauma/injury during the non-influenza season.</p><p><strong>Results: </strong>This study included 82 % (n = 110,892) of the city's older adult population, with 39.7 % vaccination coverage. The estimated SIVE was 2.9 % (95 % confidence interval: -6.2-11.2), showing no statistical significance. Similarly, subgroup analyses by age and comorbidities revealed no significant protective effect of SIVE. In the non-season analysis, adjusted odds ratios of vaccination were significantly higher for ARI [1.3 (1.3-1.4)] and trauma/injury [1.2 (1.1-1.2)]. However, no significance was observed for hospitalizations with these diagnoses, which include severe conditions less associated with healthcare-seeking behaviors [0.9 (0.8-1.1) and 0.8 (0.6-1.0), respectively].</p><p><strong>Conclusions: </strong>No significant SIVE was observed during the 2017/18 season. Our real-world observational study, based on medical fee claims data, indicates a potential underestimation of SIVE owing to bias related to healthcare-seeking behaviors.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126488"},"PeriodicalIF":0.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142565338","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}