Vaccine: X最新文献

{"title":"Enhanced safety surveillance of the adjuvanted respiratory syncytial virus vaccine among Italian older adults","authors":"Alexander Domnich ,&nbsp;Andrea Orsi ,&nbsp;Piero Luigi Lai ,&nbsp;Elvira Massaro ,&nbsp;Carlo-Simone Trombetta ,&nbsp;Julieta Pastorino ,&nbsp;Charlott Roihl ,&nbsp;Sara Tardito ,&nbsp;Marianna Pianta ,&nbsp;Giancarlo Icardi ,&nbsp;Donatella Panatto","doi":"10.1016/j.jvacx.2025.100647","DOIUrl":"10.1016/j.jvacx.2025.100647","url":null,"abstract":"<div><div>An adjuvanted vaccine to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in older adults has recently become available. Post-authorization safety studies (PASSs) conducted under real-world conditions complement data obtained from clinical trials characterized by stringent eligibility criteria. The aim of this PASS study was to evaluate reactogenicity and safety of the novel RSVPreF3 OA, which is currently not included in the Italian immunization schedule. In 2024, adult individuals aged ≥60 years were invited to get vaccinated with a single dose of RSVPreF3 OA. Following vaccination, they were instructed to fill in a diary on the occurrence, grade and duration of local and systemic adverse events (AEs) during the first week post-vaccination. They were also encouraged to notify any other events occurring at any time post-vaccination. The exposure set included 453 adults. Of these, 398 individuals returned valid diaries. At least one solicited AE (generally lasted 1–3 days) was reported by 70.6 % (95 % CI: 65.9–75.0 %) of vaccinees. Injection-site pain was the far most prevalent (60.1 %; 95 % CI: 55.1–64.9 %) solicited AE. Among systemic AEs, malaise/fatigue, headache, arthralgia and myalgia occurred in &gt;10 % of vaccinees, while fever was rare (0.3 %; 95 % CI: 0–1.4 %). Grade 3 severe AEs were registered in 3.5 % (95 % CI: 1.9–5.8 %) of vaccinees. Older age was associated with a lower likelihood of reporting AEs. During a median follow-up of 211 days, no unsolicited serious AEs were registered. This PASS study confirmed an acceptable safety and reactogenicity profiles of RSVPreF3 OA.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100647"},"PeriodicalIF":2.7,"publicationDate":"2025-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143887241","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":"Behavioural and Social Drivers of Seasonal Influenza Vaccination (BeSD IN) in Jordan","authors":"Ayman Bani Mousa ,&nbsp;Nizar Maswadi ,&nbsp;Zaid Al-Hamdan ,&nbsp;Mohammad Alhawarat ,&nbsp;Lora Al Sawalha ,&nbsp;Raid Anwar Al-Shboul ,&nbsp;Feras Ibrahim Hawari","doi":"10.1016/j.jvacx.2025.100643","DOIUrl":"10.1016/j.jvacx.2025.100643","url":null,"abstract":"<div><h3>Background</h3><div>Cultural norms and social beliefs play a significant role in shaping attitudes toward vaccination. The Jordanian Ministry of Health, with the support of international health organizations, has launched several initiatives to improve influenza vaccination coverage. However, challenges persist, particularly among certain demographic groups, making it essential to understand the underlying knowledge, behaviors, and attitudes influencing vaccination decisions. This study aims to explore these factors through a large-scale survey conducted among healthcare workers, pregnant women, and elderly people in Jordan.</div></div><div><h3>Method</h3><div>A cross-sectional survey was designed to identify social and behavioral drivers (BeSD) of influenza vaccination among three key target groups in Jordan: healthcare workers, pregnant women, and the elderly. A convenience sample comprising 1,500 participants was recruited from the three target groups. The sample randomly selected from the three regions in Jordan, Data were collected through interviews conducted by trained and qualified research assistants.</div></div><div><h3>Result</h3><div>The study revealed that 82.9 % of participants were aware of the influenza vaccine, with healthcare workers showing the highest awareness at 95 %, followed by pregnant women at 76 %, and the elderly at 70 %. Despite high awareness, only 45.6 % of respondents had been vaccinated in the past two years. Healthcare workers had the highest vaccination rates (65 %), while pregnant women (30 %) and the elderly (25 %) exhibited lower rates, primarily due to concerns about vaccine safety and accessibility challenges. Misconceptions were common, with 30 % of participants believing the flu vaccine causes influenza, and 25 % doubting its efficacy. These misconceptions were more prevalent among the elderly and rural populations. Access and affordability were significant barriers, particularly for the elderly, with many reporting difficulties in traveling to vaccination centres and lacking insurance coverage.</div></div><div><h3>Conclusion</h3><div>To improve influenza vaccination rates, targeted public health campaigns should be conducted to correct misconceptions, especially among the elderly and pregnant women. Possible plans of action for improving uptake rates are improving accessibility by organizing mobile clinics, offering subsidized vaccines, and giving healthcare providers the necessary training to combat hesitancy among the general population. Further research needs to be undertaken to develop strategies for reassuring the public that vaccinations are safe and effective.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100643"},"PeriodicalIF":2.7,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143807725","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":"Antibody response after SARS-CoV-2 infection or vaccination in China: A cross-sectional study","authors":"Peng Zhu ,&nbsp;Yan Chen ,&nbsp;Xia Xu ,&nbsp;Deyong Tan ,&nbsp;Ledong Xiao ,&nbsp;Chengling Liao ,&nbsp;Huan Xia ,&nbsp;Ting Zhang ,&nbsp;Jing Zou ,&nbsp;Xuan Chen ,&nbsp;Man Li ,&nbsp;Yang Yang ,&nbsp;Jian Zhou ,&nbsp;Jia Liu ,&nbsp;Wei Zhang ,&nbsp;Honghao Zhou ,&nbsp;Qing Li","doi":"10.1016/j.jvacx.2025.100644","DOIUrl":"10.1016/j.jvacx.2025.100644","url":null,"abstract":"<div><h3>Background</h3><div>It is crucial to understand how antibodies are generated after the individual has been infected or vaccinated to control the COVID-19 pandemic and develop future vaccination strategies.</div></div><div><h3>Methods</h3><div>The level of SARS-CoV-2 IgG/IgM was assessed in 348 plasma samples in the current study.</div></div><div><h3>Results</h3><div>Results showed that the SARS-CoV-2 IgG level of mild/moderate infections was higher than that of asymptomatic infections. Strong correlations were found between the SARS-CoV-2 IgG and the geometric mean neutralizing titers (GMTs), detected using pseudotyped neutralization assay, against BA.4/5 (<em>r</em> = 0.776, <em>p</em> &lt; 0.001) or XBB.1.5 (<em>r</em> = 0.329, <em>p</em> = 0.004), while SARS-CoV-2 IgM showed a weaker correlation with BA.4/5 (<em>r</em> = 0.247, <em>p</em> = 0.030). The GMTs against BA.4/5 were higher in mild/moderate infections than in asymptomatic infections. Moreover, we found that the convalescent patients with vaccination had higher antibody responses than the convalescent patients without vaccination. The XBB.1.5 variant, however, was able to escape the immune response induced by BA.5 breakthrough infection and vaccination. To ensure the population maintains a sufficient level of protective antibodies, it might be required to periodically enhance immune responses by administering antigens obtained from the circulating variants.</div></div><div><h3>Conclusions</h3><div>It is highly essential to optimize vaccination protocols in practice settings and develop future vaccines that offer a broader spectrum of protection.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100644"},"PeriodicalIF":2.7,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143820845","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":"Strengthening national immunization program governance: Recent reforms and achievements of the Korean Expert Committee on Immunization Practices (KECIP)","authors":"So-Yeon Kim ,&nbsp;Hang Jin Jeong ,&nbsp;Hanseul Ko ,&nbsp;Seunghyun Lewis Kwon ,&nbsp;Dongwoo Lee","doi":"10.1016/j.jvacx.2025.100642","DOIUrl":"10.1016/j.jvacx.2025.100642","url":null,"abstract":"","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100642"},"PeriodicalIF":2.7,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143859139","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":"COVID-19 vaccination as a rare potential etiology for cause of death after medicolegal autopsy. A Finnish nationwide study.","authors":"Lasse Pakanen ,&nbsp;Tuomo Nieminen ,&nbsp;Paula Kuvaja ,&nbsp;Hanna Nohynek ,&nbsp;Sirkka Goebeler ,&nbsp;Miia Artama ,&nbsp;Petteri Hovi","doi":"10.1016/j.jvacx.2025.100645","DOIUrl":"10.1016/j.jvacx.2025.100645","url":null,"abstract":"<div><div>COVID-19 vaccinations began globally at the end of 2020. By the end of 2021, 9.8 million doses were given in Finland. Regarding safety, most vaccine-related adverse reactions have been mild, but severe and lethal ones have also occurred. Autopsies in post vaccination deaths may give insight to the extent of fatal health conditions with potential COVID-19 vaccine etiology and provide new hypotheses of possible causalities between vaccination and severe health conditions. We searched the complete documentation on all medicolegal autopsies in Finland between December 2020 and December 2021 to assess how often the indication for autopsy was a suspected fatal adverse reaction to COVID-19 vaccination, and whether vaccination remained a potential etiology for any health condition determined as a cause of death after the autopsy. We linked register-based data on individual COVID-19 vaccination course and pre-existing health conditions. We found 428 autopsy cases with a mention of COVID-19 vaccination, and prior to autopsy, vaccination was suspected to play a part in 76 deaths. Post autopsy, a forensic pathologist considered vaccination to be potentially related to underlying cause of death in five and contributory cause of death in seven autopsy cases. These included seven thromboembolisms, two diabetic ketoacidoses, one myocarditis, one acute pancreatitis, and one eosinophilic granulomatosis with polyangiitis. In relation to the number of vaccinations within Finland, medicolegal autopsies were rarely performed because of a possible vaccine-related severe adverse reaction. Among the autopsies performed for such reasons, only a few considered a vaccine-related severe adverse reaction as a cause of death, although considerable doubt remains in the accuracy of individual considerations, and autopsy cannot definitively confirm causality between vaccination and death. Regarding vaccination safety, continuing evaluation of suspected vaccine-related deaths is essential, and autopsy should be considered in cases of death where vaccine etiology is possible.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100645"},"PeriodicalIF":2.7,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143820846","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":"Targeting age-appropriate adults' vaccine hesitancy to the herpes zoster vaccine in Ningbo, China: A latent profile analysis","authors":"Jianmei Wang ,&nbsp;Qiuhong Mei ,&nbsp;Shaoying Zhou ,&nbsp;Tianchi Yang ,&nbsp;Mengqian Lyu ,&nbsp;Yueyi Feng ,&nbsp;Zhaya Wang ,&nbsp;Lili Hu ,&nbsp;Bingqian Huang ,&nbsp;Rui Ma","doi":"10.1016/j.jvacx.2025.100641","DOIUrl":"10.1016/j.jvacx.2025.100641","url":null,"abstract":"<div><div>Abstract</div><div>This study aims to clarify the profiles of the psychological antecedents to the herpes zoster vaccine (HZV) among age-appropriate adults in Ningbo. A multistage stratified sampling method was employed to take samples We performed a face-to-face questionnaire survey among adults aged 40 years and older in late 2023. Participants were asked to report demographics, knowledge of HZV, the modified 5C vaccine hesitancy scale, and HZV uptake intention. Confirmatory factor analysis (CFA) was utilized to evaluate the modified 5C scale's validation, and latent profile analysis was used to identify distinct profiles. A total of 2100 participants were investigated, and 2025 valid cases were kept for further analysis. The CFA showed good reliability and validity for the modified 5C scale. The findings indicated three profiles: “skeptics” (24.15 %; high complacency, constraint), “believers” (38.67 %; high confidence, calculation, collective responsibility), and “free riders” (37.19 %; median confidence, calculation, collective responsibility, high complacency, constraint). Compared to believers, skeptics and free riders were older, more likely to reside in urban and suburban areas, lacked Urban Employee Basic Medical Insurance, and knew less about vaccine-related knowledge. From the highest to the lowest on vaccination intention were believers, then free riders, and finally skeptics under four distinct scenarios (recommendations from HCWs, from friends and family, from the media and internet, and HZV is free of charge). Based on 5C psychological antecedents, we identified two other profiles in addition to believers. This research may help build tailored immunization strategies to lessen vaccine hesitancy and increase willingness to receive HZV.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100641"},"PeriodicalIF":2.7,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143816418","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":"Household transmission of the SARS-CoV-2 omicron variant in New Zealand, 2022","authors":"Nayyereh Aminisani ,&nbsp;Q. Sue Huang ,&nbsp;Lauren Jelley ,&nbsp;Timothy Wood ,&nbsp;Tineke Jennings ,&nbsp;Danielle Currin ,&nbsp;Ruth Seeds ,&nbsp;Maritza Marull ,&nbsp;Amanda Kvalsvig ,&nbsp;Michael G. Baker ,&nbsp;Nhung Nghiem ,&nbsp;Paul G. Thomas ,&nbsp;Richard J. Webby ,&nbsp;The SHIVERS investigation team","doi":"10.1016/j.jvacx.2025.100638","DOIUrl":"10.1016/j.jvacx.2025.100638","url":null,"abstract":"<div><h3>Background</h3><div>Studying the transmissibility of the SARS-CoV-2 and its driving factors is valuable due to the ongoing emergence of new variants. We examined the household transmission characteristics of the Omicron-dominant variant.</div></div><div><h3>Methods</h3><div>The study took place in Wellington, New Zealand, from 7-February to 2-October 2022. When an individual had a confirmed case of SARS-CoV-2, all household members were instructed to take a swab every 3rd day until two consecutive negative swabs were obtained from the last person with SARS-CoV-2. Participants were monitored daily for acute respiratory symptoms until no further symptoms.</div></div><div><h3>Results</h3><div>We enrolled 75 households with confirmed cases of SARS-CoV-2 (total enrolled individuals = 306). The median serial interval was 4 days, and the secondary attack rate (SAR) was 60.6 % (95 % confidence interval (CI) 54.1–66.7). The SAR was higher for older household contacts and lower for contacts of fully vaccinated index cases. The SAR was highest when both the index case and the contacts were unvaccinated or received only one vaccine dose (88 %).</div></div><div><h3>Conclusions</h3><div>In this household cohort, the SARS-CoV-2 Omicron variant showed a high SAR which was modifiable by vaccination; the vaccination status of the index case and household members significantly reduced this.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100638"},"PeriodicalIF":2.7,"publicationDate":"2025-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143843779","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":"Sex and gender differences in response to vaccines: Unveiling the biological and societal factors shaping immunity","authors":"Anna Ruggieri,&nbsp;Simona Anticoli","doi":"10.1016/j.jvacx.2025.100637","DOIUrl":"10.1016/j.jvacx.2025.100637","url":null,"abstract":"","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100637"},"PeriodicalIF":2.7,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143776682","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":"University Students' understanding of masking policies and their mask use in relation to COVID-19 vaccination history, both in and out of the classroom, during the pandemic, 2022–2023","authors":"Linda S. Gutierrez ,&nbsp;Kate S. Brien ,&nbsp;Walter Faig ,&nbsp;Carmelita Whitfield ,&nbsp;Susannah Anderson ,&nbsp;Sarah Bauerle Bass ,&nbsp;Stella Winters ,&nbsp;Charlotte A. Moser ,&nbsp;Barbara J. Kuter","doi":"10.1016/j.jvacx.2025.100636","DOIUrl":"10.1016/j.jvacx.2025.100636","url":null,"abstract":"<div><h3>Background</h3><div>This study aimed to identify masking behaviors in and out of the classroom and knowledge of masking policies in relationship to COVID-19-vaccination among university students during the COVID-19 pandemic in 2022–2023.</div></div><div><h3>Methods</h3><div>A total of 2223 students at four universities in Pennsylvania completed a survey in the spring of 2023 on masking requirements at their schools, when they wore a mask (in and outside of the classroom), their COVID-19 vaccination history, and their likelihood of continuing to mask during their in-person classes in the future.</div></div><div><h3>Results</h3><div>Masking in class was not required at the universities during the 2022–2023 academic year; two schools allowed instructors to determine masking policies for their classes. At schools with no masking requirement, 46.2 % of students in fall 2022 and 62.1 % of students in spring 2023 correctly reported there was no requirement. In fall 2022, 50 % of students reported they did not wear a mask during class; the rate rose to 76 % during spring 2023. Outside of class, 52 % indicated they wore a mask in healthcare facilities, 44 % wore a mask when they thought they might be sick, 30 % reported masking when required outside of class or when in large crowds, and 18 % indicated they never wore a mask outside of class. Students who masked reported receiving more doses of COVID-19 vaccine compared with students who never masked. Students who planned to continue to mask, regardless of university requirements, tended to be non-White, non-male, and up-to-date on COVID-19 vaccinations.</div></div><div><h3>Conclusions</h3><div>Masking behavior among university students varied by semester, location (in or out of the classroom), perceptions of their university's masking policy and COVID-19 vaccination status. These findings provide perspective on student behaviors around masking as an important public health measure and may inform students' likelihood of adhering to masking recommendations in future outbreaks or pandemics.</div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100636"},"PeriodicalIF":2.7,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143776684","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":"A mixed methods study protocol for CONFIVAC, an intervention to enhance paediatric nurses' and paediatricians' skills to promote vaccination and vaccine confidence","authors":"Elisabet Henderson ,&nbsp;Sara Valmayor ,&nbsp;Victoria Porthé ,&nbsp;Alba Asensio ,&nbsp;Xavier Bruna ,&nbsp;Usue Elizondo-Alzola ,&nbsp;Anna Ramirez-Morros ,&nbsp;Gemma Ricós ,&nbsp;Josep Vidal-Alaball ,&nbsp;M. Isabel Pasarín ,&nbsp;Cristina Rius ,&nbsp;Elena Roel ,&nbsp;Elia Díez ,&nbsp;CONFIVAC Research Group","doi":"10.1016/j.jvacx.2025.100635","DOIUrl":"10.1016/j.jvacx.2025.100635","url":null,"abstract":"<div><h3>Background</h3><div>Vaccine hesitancy (VH), defined as the delay in acceptance or refusal of vaccination despite its availability, is a global health threat. Paediatric healthcare workers (PHCWs) are key in promoting vaccination but often feel unprepared to manage VH effectively. We developed CONFIVAC, an intervention designed to strengthen the knowledge, self-efficacy, and skills of PHCWs in improving childhood vaccination, addressing VH, and fostering a culture of immunization within primary care. This study protocol outlines the design, contents, planned implementation, and mixed-methods effectiveness evaluation of CONFIVAC.</div></div><div><h3>Methods</h3><div>We will conduct a two-arm parallel cluster randomised controlled trial including PHCWs from 74 paediatric primary healthcare teams from Catalonia, Spain. Paediatric teams will be randomly assigned to the intervention or control arm (standard care). PHCWs in the intervention arm will participate in the training program CONFIVAC, which includes 10 h of online learning and 2 h of in-person training featuring role-playing exercises. Grounded in health behaviour theories, the curriculum includes evidence-based strategies to improve vaccination uptake. It addresses key topics such as vaccine knowledge, communication strategies, and organizational tools to promote vaccination. Process evaluation will assess overall satisfaction, likelihood of recommending CONFIVAC, and applicability. Main effectiveness outcomes will include vaccine-promoting behaviours (presumptive communication, anticipation of upcoming vaccines, and explicitly recommending vaccination in VH cases) and self-perception of having sufficient training to handle VH. We will perform adjusted ordinal regression models using an intention-to-treat approach. Quantitative results will be triangulated with qualitative insights from focus groups of PHCWs in the intervention arm employing a phenomenological approach.</div></div><div><h3>Discussion</h3><div>CONFIVAC is expected to provide PHCWs with evidence-based knowledge, communication techniques, and organizational skills to address VH and promote vaccination. By enhancing their skills and confidence, we aim to improve vaccination uptake and streamline vaccine-related tasks in primary care settings.</div><div><strong>Trial registration:</strong> ClinicalTrials ID: <span><span>NCT06489236</span><svg><path></path></svg></span></div></div>","PeriodicalId":43021,"journal":{"name":"Vaccine: X","volume":"24 ","pages":"Article 100635"},"PeriodicalIF":2.7,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143724239","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}