Human Vaccines & Immunotherapeutics最新文献

{"title":"A phase 3, single-arm, open-label study to evaluate the safety, tolerability, and immunogenicity of a 15-valent pneumococcal conjugate vaccine, V114, in a 3+1 regimen in healthy infants in South Korea (PNEU-PED-KOR).","authors":"Alvino Maestri, Su Eun Park, Fiona Fernandes, Zhongyi Lucy Li, Yae-Jean Kim, Yun-Kyung Kim, Jin Lee, Ji Young Park, Dong Hyun Kim, GyongSeon Yang, Hyunjung Lim, Jin Oh Kim, Robert Lupinacci, Tina M Sterling, Marissa Wilck, Alejandra Esteves-Jaramillo, Natalie Banniettis","doi":"10.1080/21645515.2024.2321035","DOIUrl":"10.1080/21645515.2024.2321035","url":null,"abstract":"<p><p>There is an ongoing burden of pneumococcal disease in children despite the use of pneumococcal conjugate vaccines (PCVs). This phase 3, open-label, single-arm, multisite, descriptive study was designed to evaluate the safety and immunogenicity of a 3 + 1 regimen of V114 (VAXNEUVANCE™), a 15-valent PCV, in South Korean infants and toddlers. Adverse events (AEs) were reported for 14 d following any vaccination, and throughout the study period for serious AEs. Serotype-specific immunoglobulin G (IgG) response rates (proportion of participants meeting an IgG threshold value of ≥0.35 μg/mL) and geometric mean concentrations (GMCs) for the 15 serotypes at 30 d postdose 3 (PD3) and at 30 d postdose 4 (PD4) were evaluated as endpoints. Healthy infants enrolled at 42-90 d after birth were vaccinated with V114 (<i>N</i> = 57). The most commonly reported AEs were those solicited in the trial. The majority of reported AEs were transient and of mild or moderate intensity. Few serious AEs were reported; none were vaccine related. No participants died nor discontinued the study vaccine because of an AE. V114 was immunogenic for all 15 serotypes contained in the vaccine, as assessed by IgG response rates at 30 d PD3 and IgG GMCs at 30 d PD3 and at 30 d PD4. V114 was well tolerated and immunogenic when administered as a 3 + 1 regimen in healthy South Korean infants and toddlers.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10950266/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140144437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulation development of a stable influenza recombinant neuraminidase vaccine candidate.","authors":"Bing Li, Irina V Ustyugova, Lisa Szymkowicz, Shaolong Zhu, Marin Ming, Karen Y Y Fung, Guadalupe Cortés, D Andrew James, Michael Hrynyk, Nausheen Rahman, Roger H Brookes, Salvador F Ausar","doi":"10.1080/21645515.2024.2304393","DOIUrl":"10.1080/21645515.2024.2304393","url":null,"abstract":"<p><p>Current influenza vaccines could be augmented by including recombinant neuraminidase (rNA) protein antigen to broaden protective immunity and improve efficacy. Toward this goal, we investigated formulation conditions to optimize rNA physicochemical stability. When rNA in sodium phosphate saline buffer (NaPBS) was frozen and thawed (F/T), the tetrameric structure transitioned from a \"closed\" to an \"open\" conformation, negatively impacting functional activity. Hydrogen deuterium exchange experiments identified differences in anchorage binding sites at the base of the open tetramer, offering a structural mechanistic explanation for the change in conformation and decreased functional activity. Change to the open configuration was triggered by the combined stresses of acidic pH and F/T. The desired closed conformation was preserved in a potassium phosphate buffer (KP), minimizing pH drop upon freezing and including 10% sucrose to control F/T stress. Stability was further evaluated in thermal stress studies where changes in conformation were readily detected by ELISA and size exclusion chromatography (SEC). Both tests were suitable indicators of stability and antigenicity and considered potential critical quality attributes (pCQAs). To understand longer-term stability, the pCQA profiles from thermally stressed rNA at 6 months were modeled to predict stability of at least 24-months at 5°C storage. In summary, a desired rNA closed tetramer was maintained by formulation selection and monitoring of pCQAs to produce a stable rNA vaccine candidate. The study highlights the importance of understanding and controlling vaccine protein structural and functional integrity.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10950269/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140144439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of COVID-19 vaccination status on hospitalization and disease severity: A descriptive study in Nagasaki Prefecture, Japan.","authors":"Guoxi Cai, Shiwen Liu, Yixiao Lu, Yumika Takaki, Fumiaki Matsumoto, Akira Yoshikawa, Toshitsugu Taguri, Jianfen Xie, Kazuhiko Arima, Satoshi Mizukami, Jiwen Wu, Taro Yamamoto, Maiko Hasegawa, Nguyen Tien Huy, Masaya Saito, Shouhei Takeuchi, Kouichi Morita, Kiyoshi Aoyagi, Fei He","doi":"10.1080/21645515.2024.2322795","DOIUrl":"10.1080/21645515.2024.2322795","url":null,"abstract":"<p><p>Coronavirus disease 2019 (COVID-19) was extraordinarily harmful, with high rates of infection and hospitalization. This study aimed to evaluate the impact of COVID-19 vaccination status and other factors on hospitalization and disease severity, using data from Nagasaki Prefecture, Japan. Confirmed cases of COVID-19 infection with vaccination status were included and the differences in characteristics between different vaccination statuses, hospitalization or not, and patients with varying levels of disease severity were analyzed. Furthermore, logistic regression was used to calculate odds ratio (ORs) and 95% confidence intervals (CI) to evaluate the association of various factors with hospitalization and disease severity. From March 14, 2020 to August 31, 2022, 23,139 patients were unvaccinated 13,668 vaccinated the primary program with one or two doses, and 4,575 completed the booster. Vaccination reduced the risk of hospitalization with an odd ratio of 0.759 (95% CI: 0.654-0.881) and the protective effect of completed booster vaccination was more pronounced (OR: 0.261, 95% CI: 0.207-0.328). Similarly, vaccination significantly reduced the risk of disease severity (vaccinated primary program: OR: 0.191, 95% CI: 0.160-0.228; completed booster vaccination: OR: 0.129, 95% CI: 0.099-0.169). Overall, unvaccinated, male, elderly, immunocompromised, obese, and patients with other severe illness factors were all risk factors for COVID-19-related hospitalization and disease severity. Vaccination was associated with a decreased risk of hospitalization and disease severity, and highlighted the benefits of completing booster.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962621/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Opportunities for HPV vaccine education in school-based immunization programs in British Columbia, Canada: A qualitative study.","authors":"Isabella Brohman, Gabriel Blank, Hana Mitchell, Eve Dubé, Julie A Bettinger","doi":"10.1080/21645515.2024.2326779","DOIUrl":"10.1080/21645515.2024.2326779","url":null,"abstract":"<p><p>Despite the availability of school-based immunization programs (SBIPs) in Canada, human papillomavirus (HPV) vaccine uptake remains suboptimal. Vaccine education may improve vaccine uptake among adolescents. The objective of this qualitative study was to identify opportunities for HPV vaccine education in British Columbia, Canada, by exploring the perspectives of students, parents, school staff, and public health nurses on the current SBIP. Individual semi-structured interviews were conducted with adult participants and focus groups were conducted with grade 6 students between November 2019 and May 2020. The interviews and focus groups were transcribed and then analyzed using reflexive thematic analysis. Opportunities for HPV vaccine education were identified in three themes: 1) making SBIPs student-centered; 2) adopting a collaborative and interdisciplinary approach to vaccine education; and 3) actualizing parent education opportunities. Broad support existed for a formal, collaborative HPV grade 6 vaccine curriculum delivered by teachers and public health nurses to provide evidence-based health information. Participants voiced that the curriculum should integrate students' perspectives on topics of interest and address needle associated pain and anxiety. Parents were identified as the primary vaccine decisionmakers, therefore, participants stated it was crucial to also provide parent-directed vaccine education as part of SBIP. Our findings support the development of a collaborative HPV vaccine curriculum directed to and informed by students and parents to buttress current SBIPs in British Columbia.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVID-19 vaccination perspectives among patients with Long COVID: A qualitative study.","authors":"Sarah R MacEwan, Saurabh Rahurkar, Willi L Tarver, Alice A Gaughan, Laura J Rush, Andrew Schamess, Ann Scheck McAlearney","doi":"10.1080/21645515.2024.2327663","DOIUrl":"10.1080/21645515.2024.2327663","url":null,"abstract":"<p><p>Individuals who have Long COVID may have unique perspectives about COVID-19 vaccination due to the significant impact that COVID-19 has had on their lives. However, little is known about the specific vaccination perspectives among this patient population. The goal of our study was to improve our understanding of perspectives about COVID-19 vaccines among individuals with Long COVID. Interviews were conducted with patients receiving care at a post-COVID recovery clinic. Deductive thematic analysis was used to characterize participant perspectives according to the vaccine acceptance continuum framework, which recognizes a spectrum from vaccine acceptance to refusal. From interviews with 21 patients, we identified perspectives across the continuum of vaccine acceptance. These perspectives included acceptance of vaccines to prevent future illness, concerns about vaccine side effects on Long COVID symptoms, and refusal of vaccines due to perceived natural immunity. A limitation of our study is that these perspectives are specific to individuals receiving care at one post-COVID recovery clinic. In conclusion, our study demonstrates that some patients with Long COVID are uncertain about COVID-19 vaccines and boosters but may also be amenable to conversations that impact future vaccination acceptance. Patient perspectives should be considered when communicating recommendations for COVID-19 vaccinations to this population.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10978020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140294996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhanced immunity against SARS-CoV-2 in returning Chinese individuals.","authors":"Runyu Yuan, Huimin Chen, Lina Yi, Xinxin Li, Ximing Hu, Xing Li, Huan Zhang, Pingping Zhou, Chumin Liang, Huifang Lin, Lilian Zeng, Xue Zhuang, QianQian Ruan, Yueling Chen, Yingyin Deng, Zhe Liu, Jing Lu, Jianpeng Xiao, Liang Chen, Xincai Xiao, Jing Li, Baisheng Li, Yan Li, Jianfeng He, Jiufeng Sun","doi":"10.1080/21645515.2023.2300208","DOIUrl":"10.1080/21645515.2023.2300208","url":null,"abstract":"<p><p>Global COVID-19 vaccination programs effectively contained the fast spread of SARS-CoV-2. Characterizing the immunity status of returned populations will favor understanding the achievement of herd immunity and long-term management of COVID-19 in China. Individuals were recruited from 7 quarantine stations in Guangzhou, China. Blood and throat swab specimens were collected from participants, and their immunity status was determined through competitive ELISA, microneutralization assay and enzyme-linked FluoroSpot assay. A total of 272 subjects were involved in the questionnaire survey, of whom 235 (86.4%) were returning Chinese individuals and 37 (13.6%) were foreigners. Blood and throat swab specimens were collected from 108 returning Chinese individuals. Neutralizing antibodies against SARS-CoV-2 were detected in ~90% of returning Chinese individuals, either in the primary or the homologous and heterologous booster vaccination group. The serum NAb titers were significantly decreased against SARS-CoV-2 Omicron BA.5, BF.7, BQ.1 and XBB.1 compared with the prototype virus. However, memory T-cell responses, including specific IFN-γ and IL-2 responses, were not different in either group. Smoking, alcohol consumption, SARS-CoV-2 infection, COVID-19 vaccination, and the time interval between last vaccination and sampling were independent influencing factors for NAb titers against prototype SARS-CoV-2 and variants of concern. The vaccine dose was the unique common influencing factor for Omicron subvariants. Enhanced immunity against SARS-CoV-2 was established in returning Chinese individuals who were exposed to reinfection and vaccination. Domestic residents will benefit from booster homologous or heterologous COVID-19 vaccination after reopening of China, which is also useful against breakthrough infection.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10793704/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139404861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative immunogenicity and neutralizing antibody responses post heterologous vaccination with CoronaVac (Sinovac) and Vaxzevria (AstraZeneca) in HIV-infected patients with varying CD4+ T lymphocyte counts.","authors":"Sorawit Chittrakarn, Pisud Siripaitoon, Sarunyou Chusri, Siripen Kanchanasuwan, Boonsri Charoenmak, Thanaporn Hortiwakul, Phaiwon Kantikit, Narongdet Kositpantawong","doi":"10.1080/21645515.2024.2309734","DOIUrl":"10.1080/21645515.2024.2309734","url":null,"abstract":"<p><p>The immune response to heterologous coronavirus disease (COVID-19) vaccination in people living with HIV (PLWH) is still unclear. Herein, our prospective cohort study aimed to compare the immune response of heterologous vaccination with CoronaVac (Sinovac) and Vaxzevria (AstraZeneca) between PLWH having CD4 counts ≤ 200 cells/µL (low CD4+) and > 200 cells/µL (high CD4+). Anti-receptor-binding domain (RBD) immunoglobulin G (IgG) levels and the percentage inhibition of neutralizing antibodies (nAbs) were analyzed at 2 and 12 weeks after immunization. Participants in the low and high CD4+ groups had mean CD4+ counts of 139 and 575 cell/µL, respectively. Two and 12 weeks after immunization, in the low CD4 group, the median anti-RBD-IgG levels were 159 IU/mL and 143 IU/mL, respectively, whereas the nAb level was 71% and decreased to 47.2%, respectively. Contrarily, the median anti-RBD-IgG levels in the high CD4+ group were 273 IU/mL and 294 IU/mL, respectively, whereas the nAb levels were 89.3% and relatively stable at 81.6%. However, although immune responses between the two study groups were not significantly different, a decline in nAb levels was observed at 12 weeks in the low CD4+ group. Therefore, a COVID-19 booster vaccine dose is suggested for immunoprotection.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10841008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139651994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>Ex vivo</i> observation of <i>Pythium insidiosum</i>-antigen treated neutrophils on three <i>Pythium insidiosum</i> strains isolated from vascular pythiosis patients.","authors":"Sadeep Medhasi, Apichaya Sriwarom, Nitipong Permpalung, Pattama Torvorapanit, Rongpong Plongla, Ariya Chindamporn, Navaporn Worasilchai","doi":"10.1080/21645515.2024.2304372","DOIUrl":"10.1080/21645515.2024.2304372","url":null,"abstract":"<p><p>The mechanisms of <i>Pythium insidiosum</i>-antigen (PIA) immunotherapy activating a patient's immune system are unknown. We evaluated the interleukin-8 (IL-8) serum levels during <i>P. insidiosum</i> infection and after vaccination with PIA in vascular pythiosis cases. Furthermore, we studied the anti-<i>P. insidiosum</i> activity of neutrophils stimulated with various concentrations of PIA <i>ex vivo</i> in 3 strains of <i>P. insidiosum</i> isolated from vascular pythiosis patients. IL-8 serum levels were evaluated using the ELISA technique. We assessed the effect of PIA-stimulated neutrophils on the viability of zoospores using MTT assay, visualized neutrophil extracellular trap (NET) formation via microscopy, and measured the levels of double-stranded DNA (dsDNA) using PicoGreen dsDNA quantitation assay in 3 strains of <i>P. insidiosum</i> isolated from vascular pythiosis patients. Serum levels of IL-8 gradually lowered from the early to the end phases of vaccination with PIA among the surviving group of vascular pythiosis cases. Neutrophils stimulated with 0.01 µg/ml PIA reduced zoospore viability significantly compared to PIA-unstimulated neutrophils for strain 1 and strain 3 (<i>p</i> < .05). Neutrophils stimulated with 0.01, 0.1, 1, and 10 µg/ml PIA exhibited significantly lower zoospore viability than PIA-unstimulated neutrophils for strain 2 (<i>p</i> < .05). IL-8 can be used as a biomarker for monitoring vascular pythiosis cases treated with the PIA vaccine. Also, anti-<i>P. insidiosum</i> activity of PIA-stimulated neutrophils was probably due to the disruption of cellular activity in zoospores rather than the mechanisms based on the formation of NETs.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10854268/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139693331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reconsidering the inclusion of Ladapo's work in the meta-analysis: Validity concerns and implications.","authors":"Borja Somovilla Del Saz","doi":"10.1080/21645515.2024.2315711","DOIUrl":"10.1080/21645515.2024.2315711","url":null,"abstract":"<p><p>This is a response to Marchand & Masoud's response letter regarding my criticism \"Response to Dr. Somovilla del Saz's letter to the editor regarding \"Risk of all-cause and cardiac-related mortality after vaccination against COVID-19: A meta-analysis of self-controlled case series studies.\"\" The response is a defense of the initial criticism to the paper regarding the validity of the inclusion of Ladapo´s paper.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10880802/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139742445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season.","authors":"Marina Amaral de Avila Machado, Sonja Gandhi-Banga, Sophie Gallo, Tathyana Giannotti Cousseau, Reddappa Maniganahally Byrareddy, Markku Nissilä, Jörg Schelling, Celine Monfredo","doi":"10.1080/21645515.2024.2322196","DOIUrl":"10.1080/21645515.2024.2322196","url":null,"abstract":"<p><p>Enhanced Passive Safety Surveillance (EPSS) was conducted for quadrivalent inactivated split-virion influenza vaccines (IIV4) in Germany (high dose [HD]) and Finland (standard dose [SD]) for the northern hemisphere (NH) 2022/23 influenza season. The primary objective was to assess adverse events following immunization (AEFI) occurring ≤7 days post-vaccination. In each country, the EPSS was conducted at the beginning of the NH influenza season. Exposure information was documented using vaccination cards (VC), and AEFI were reported via an electronic data collection system or telephone. AEFI were assessed by seriousness and age group (Finland only). The vaccinee reporting rate (RR) was calculated as the number of vaccinees reporting ≥ 1 AEFI divided by the total vaccinees. In Germany, among 1041 vaccinees, there were 31 AEFI (ten vaccinees) during follow-up, including one serious AEFI. Of 16 AEFI (six vaccinees) with reported time of onset, 15 occurred ≤7 days post-vaccination (RR 0.58%, 95% confidence interval [CI] 0.21, 1.25), which was lower than the 2021/22 season (RR 1.88%, 95% CI: 1.10, 3.00). In Finland, among 1001 vaccinees, there were 142 AEFI (51 vaccinees) during follow-up, none of which were serious. Of 133 AEFI (48 vaccinees) with time of onset reported, all occurred ≤7 days post-vaccination (RR 4.80%, 95% CI: 3.56, 6.31), which was similar to the 2021/22 season (RR 4.90%, 95% CI: 3.65, 6.43). The EPSS for HD-IIV4 and for SD-IIV4 in the 2022/23 influenza season did not suggest any clinically relevant changes in safety beyond what is known/expected for IIV4s.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10936612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140050775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}