VaccinePub Date : 2025-05-27DOI: 10.1016/j.vaccine.2025.127309
Bahaa Abu-Raya , Michelle L. Giles , Tobias Kollmann
{"title":"Co-administration of vaccines in pregnancy: unique challenges and knowledge gaps","authors":"Bahaa Abu-Raya , Michelle L. Giles , Tobias Kollmann","doi":"10.1016/j.vaccine.2025.127309","DOIUrl":"10.1016/j.vaccine.2025.127309","url":null,"abstract":"<div><div>Vaccination in pregnancy directly protects the mother and can prevent serious infections in early life. There are an increasing number of vaccines that are recommended during pregnancy and deployed in a growing number of countries. However, most recommendations for administration of these vaccines in pregnancy are based on studies that investigate one vaccine at a time. Largely lacking are data on the impact of co-administration including spacing and timing of the multiple vaccines during pregnancy on safety, efficacy and immunogenicity. We here place what is known into the context co-administration of vaccines with focus on the mother as well as the infant.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127309"},"PeriodicalIF":4.5,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147256","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}
{"title":"A phase I, randomized, placebo-controlled, double-blind, ascending-dose and single-center study to evaluate immunogenicity and safety of a live attenuated tetravalent dengue vaccine (KD-382) in Flavivirus antibody-naïve healthy adults","authors":"Motoharu Abe, Yasuhiko Shinmura, Yoshiyuki Tokieda, Yukiko Mitsuhiro, Kengo Sonoda","doi":"10.1016/j.vaccine.2025.127313","DOIUrl":"10.1016/j.vaccine.2025.127313","url":null,"abstract":"<div><h3>Background</h3><div>Dengue viruses (DENV1–4) cause dengue fever and dengue hemorrhagic fever. Developing a live attenuated tetravalent dengue vaccine (LATDV) faces challenges in overcoming viral interference to induce a balanced immune response. KD-382 is an LATDV candidate being developed by KM Biologics Co., Ltd. for dengue prevention.</div></div><div><h3>Methods</h3><div>This first-in-human Phase I study of KD-382 is a randomized, placebo-controlled, double-blind, ascending-dose study in 60 flavivirus antibody-naïve healthy subjects aged 18–65 years. The study was conducted in two parts evaluating low dose (Part 1) and standard dose (Part 2). In each part, subjects were randomized in a 3:2:1 ratio to receive either KD-382 as a single dose, two doses, or placebo. Subjects received subcutaneous injections on Days 1 and 29 and were followed up for 1 year.</div></div><div><h3>Results</h3><div>Eight (Part 1: 3; Part 2: 5) of 60 vaccinated subjects were withdrawn from the study. Both low and standard doses of KD-382, regardless of the dosing regimen, showed a 100 % seroconversion rate for all four serotypes (DENV1–4) at Day 57 and retained 100 % seropositivity for DENV1, 2, and 4 through the 12-month follow-up. For DENV3, a single dose in the low dose group of KD-382 retained a 100 % seroconversion rate at Months 3 and 12, while in the standard dose group, it was 91.7 % at Month 12. The most frequently reported solicited local treatment-emergent adverse events (TEAEs) were erythema, followed by pain and injection site pruritus; solicited systemic TEAEs were fatigue, followed by headache and myalgia. No serious or severe solicited TEAEs, or TEAEs leading to study vaccine withdrawal or death were reported.</div></div><div><h3>Conclusions</h3><div>KD-382 was safe and well-tolerated in flavivirus antibody-naïve healthy subjects. It elicited a long-lasting neutralizing antibody response for all four DENV serotypes during the 1-year follow-up, even with single-dose administration.</div><div>Australia New Zealand Clinical Trial Registry: ACTRN12618001027202.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127313"},"PeriodicalIF":4.5,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147201","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}
{"title":"Real-world effectiveness of MBA-VN vaccine against mpox, a test-negative case-control study","authors":"Pía Escobar-Ziede , Blanca Borras-Bermejo , Laia Pinós-Tella , Martí Vivet-Escalé , Arnau Peñalver-Piñol , Judith Martinez , Jose-Ángel Rodrigo-Pendás , Jorge García-Pérez , Patricia Álvarez-López , Patricia Nadal-Baron , Andrés Antón , Oleguer Parés-Badell","doi":"10.1016/j.vaccine.2025.127295","DOIUrl":"10.1016/j.vaccine.2025.127295","url":null,"abstract":"<div><h3>Introduction</h3><div>Mpox is a viral illness for which the MVA-BN vaccine was authorized during the 2022 global outbreak. Although initial studies reported high immunogenicity, real-world evidence on vaccine effectiveness (VE) remains scarce. This study aimed to estimate the real-world VE of at least one dose of the MVA-BN vaccine against symptomatic mpox in adults tested at a tertiary hospital in Barcelona, Spain.</div></div><div><h3>Methods</h3><div>We conducted a test-negative case-control study between July 2022 and December 2023. Adults tested for mpox by PCR were included. Cases were PCR-positive; controls were PCR-negative. Vaccine effectiveness of at least one dose was calculated as (1 − adjusted odds ratio) × 100 %, using multivariable logistic regression.</div></div><div><h3>Results</h3><div>Among 301 participants, 126 were cases and 175 controls. Crude VE of ≥1 dose ≥14 days before testing was 47 % (95 % CI: −17 % to 77 %). After adjusting for sex, age, testing center, sexually transmitted infection (STI) testing in the last year and risk criteria for mpox VE increased to 74 % (95 % CI: 38 % to 90 %) but decreased to 44 % (95 % CI: −52 % to 79 %) when additionally adjusting for epidemiological weeks. Similar patterns were observed in a subgroup of men with at least one risk criteria for mpox.</div></div><div><h3>Conclusions</h3><div>Our study provides context-specific evidence on the effectiveness of a single MVA-BN vaccine dose against symptomatic mpox in a real-world setting. Vaccine effectiveness estimates varied depending on adjustment strategy, highlighting the importance of accounting for epidemiological weeks to avoid overestimation.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"59 ","pages":"Article 127295"},"PeriodicalIF":4.5,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144139157","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}
VaccinePub Date : 2025-05-27DOI: 10.1016/j.vaccine.2025.127277
Deepit Bhatia , Natasha Crowcroft , Sébastien Antoni , M. Carolina Danovaro-Holliday , Anindya Sekhar Bose , Anna Minta , Balcha Masresha , Matthew J. Ferrari
{"title":"Prediction of subnational-level vaccination coverage estimates using routine surveillance data and survey data","authors":"Deepit Bhatia , Natasha Crowcroft , Sébastien Antoni , M. Carolina Danovaro-Holliday , Anindya Sekhar Bose , Anna Minta , Balcha Masresha , Matthew J. Ferrari","doi":"10.1016/j.vaccine.2025.127277","DOIUrl":"10.1016/j.vaccine.2025.127277","url":null,"abstract":"<div><h3>Background</h3><div>Measles vaccination has significantly reduced the global burden of the disease, but disparities in vaccination coverage persist. Accurate and timely estimates of subnational vaccination coverage are crucial for identifying high-risk areas and guiding targeted interventions. However, existing methods face limitations related to accuracy, timeliness, and spatial resolution. We explored the use of routinely collected case-based surveillance data to predict measles vaccination coverage at the subnational level.</div></div><div><h3>Methods</h3><div>The study used aggregated case data from 18 countries in the WHO African region, obtained from the WHO measles surveillance database. Three surveillance-based indicators were derived: mean age of suspected measles cases, proportion of vaccinated suspected cases, and proportion of IgM-negative suspected cases. These indicators were used to build a beta regression model with measles vaccination coverage from the Demographic and Health Surveys (DHS) as the gold standard. We compared out-of-sample predictions created using this model to withheld DHS estimates using Pearson's rho.</div></div><div><h3>Findings</h3><div>We found that each of the three surveillance-based indicators were more strongly correlated with DHS-based survey coverage than administrative estimates. Out-of-sample predictions achieved high correlation with DHS-based coverage, with a rho of 0.74.</div></div><div><h3>Interpretation</h3><div>The findings suggest that routinely collected measles surveillance data can effectively predict subnational measles vaccination coverage. The approach addresses limitations of existing methods by providing yearly estimates that are more accurate than administrative data and more readily available than surveys. This enables timely identification of low-coverage areas and facilitates targeted interventions.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127277"},"PeriodicalIF":4.5,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147204","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}
VaccinePub Date : 2025-05-26DOI: 10.1016/j.vaccine.2025.127306
Adiya S. Katseff , Christina Toumanios , Eman Barahim , Alison A. McCormick , Paul M. Arnaboldi
{"title":"PcrV in an intranasal adjuvanted tobacco mosaic virus conjugate vaccine mediates protection from Pseudomonas aeruginosa via an early Th1/Th17 skewed localized and systemic immune response.","authors":"Adiya S. Katseff , Christina Toumanios , Eman Barahim , Alison A. McCormick , Paul M. Arnaboldi","doi":"10.1016/j.vaccine.2025.127306","DOIUrl":"10.1016/j.vaccine.2025.127306","url":null,"abstract":"<div><div>Multi-drug-resistant <em>Pseudomonas aeruginosa</em> (PA) infections are a growing problem for at-risk populations, causing thousands of deaths per year, and novel therapies to treat or prevent severe PA infection are desperately needed. We developed a novel intranasal (IN) protein subunit vaccine using tobacco mosaic virus (TMV) as a vaccine delivery platform. Recombinant PcrV (rPcrV) was covalently linked to TMV and delivered IN with the adjuvant curdlan (TMV-PcrV+c). IN delivery of TMV-PcrV+c elicited significantly higher anti-PcrV antibody titers than unadjuvanted TMV-PcrV and rPcrV with or without adjuvant, and it provided significantly greater protection from lethal pneumonic infection with PA compared to all other groups. The protective vaccine formulation elicited anti-PcrV IgA in the lungs, while anti-PcrV IgG1 in the serum was associated with survival after infection. Following infection, TMV-PcrV+c immunization was associated with early IL-17 and IFN-γ secretion in the lungs and later IL-17 secretion in the spleen. This corresponded with a rapid, but transient recruitment of neutrophils to the lungs of vaccinated mice compared to unvaccinated controls, which was followed by an increase in the number of lung macrophages. This is indicative of a Th1/Th17 response mediating localized and systemic inflammation to clear the PA infection while limiting host-derived tissue damage, ultimately enhancing protection. As a vaccine antigen, PcrV did not confer complete protection, so we evaluated OprF and OprI as part of a multivalent vaccine. However, these additional antigens did not enhance protective efficacy despite generating high antibody titers. Overall, TMV-PcrV+c is a promising vaccine candidate that elicits specific antibodies, localized IFN-γ secretion and IL-17 secretion both locally and systemically after PA challenge, phagocyte recruitment to the infection site, and protection against a lethal dose of PA in a pneumonic disease model.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127306"},"PeriodicalIF":4.5,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147202","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}
VaccinePub Date : 2025-05-26DOI: 10.1016/j.vaccine.2025.127314
Kota Senpuku , Yuta Kunishima , Kotaro Taniguchi , Taiki Ito , Toshiro Hirai , Teruya Nakamura , Chikako Kataoka-Nakamura , Yasuo Yoshioka
{"title":"Development and characterization of MRC-5 and Vero cell-adapted enterovirus D68 strains for vaccine production","authors":"Kota Senpuku , Yuta Kunishima , Kotaro Taniguchi , Taiki Ito , Toshiro Hirai , Teruya Nakamura , Chikako Kataoka-Nakamura , Yasuo Yoshioka","doi":"10.1016/j.vaccine.2025.127314","DOIUrl":"10.1016/j.vaccine.2025.127314","url":null,"abstract":"<div><div>Enterovirus D68 (EV-D68) is a pathogen that causes respiratory and neurological diseases. Currently, there are no licensed vaccines for EV-D68. Here, we adapted EV-D68 to MRC-5 and Vero cells, which are widely used in vaccine manufacturing, to develop EV-D68 strains applicable for vaccine production. We successfully isolated MRC-5 cell-adapted strains by serial passaging in MRC-5 cells. Although efforts to isolate Vero cell-adapted strains through serial passaging of EV-D68 in Vero cells were unsuccessful, we isolated Vero cell-adapted strains by serial passaging of MRC-5 cell-adapted strains in Vero cells. Inactivated whole-virion vaccines were prepared from vaccine-manufacturing cell-adapted strains and mice were immunized with these vaccines. We found that in some cases, the parental and cell-adapted strains induced similar levels of protective immunity against EV-D68, whereas in other cases, the cell-adapted strains were significantly less effective than the parental strains. These data provide valuable information for EV-D68 vaccine production.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127314"},"PeriodicalIF":4.5,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147254","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}
VaccinePub Date : 2025-05-26DOI: 10.1016/j.vaccine.2025.127307
Hui Li , Jingnan Zhang , Ruhai Guo , JunDa Li , Xiao Zhang , Likang Han , Honglin Xie , Xinglong Wang
{"title":"Immunogenicity evaluation of a recombinant pseudorabies virus co-expressing PCV2 and PCV3 capsid proteins in mice and piglets","authors":"Hui Li , Jingnan Zhang , Ruhai Guo , JunDa Li , Xiao Zhang , Likang Han , Honglin Xie , Xinglong Wang","doi":"10.1016/j.vaccine.2025.127307","DOIUrl":"10.1016/j.vaccine.2025.127307","url":null,"abstract":"<div><div>Porcine circovirus type 2 (PCV2), porcine circovirus type 3 (PCV3), and pseudorabies virus (PRV) are major pathogens posing significant threats to the swine industry. Viral evolution and mutations have limited the efficacy of current commercial vaccines, necessitating the development of more effective prophylactic strategies. In this study, a novel recombinant virus strain, designated as rPRV-ΔTK-PCV3(Cap)/ΔgIgE-PCV2(Cap), was generated using PRV SX-10 variant as the backbone. CRISPR/Cas9-mediated deletion of TK and gE/gI genes was performed, followed by insertion of PCV3 and PCV2 capsid protein genes into the respective loci. The engineered recombinant strain demonstrated stable proliferation in BHK-21 cells, efficiently expressed heterologous PCV3 and PCV2 capsid proteins, while maintaining biological properties comparable to its parental strain. The rPRV-ΔTK-PCV3(Cap)/ΔgIgE-PCV2(Cap) demonstrated favorable safety and immunogenicity profiles in mice and piglets, eliciting robust immune responses characterized by high titers of specific antibodies against PRV, PCV3, and PCV2, along with significantly elevated levels of cytokines (IFN-γ, IL-2, and IL-4). Histopathological analysis and viral load quantification demonstrated that rPRV-ΔTK-PCV3(Cap)/ΔgIgE-PCV2(Cap) immunization significantly attenuated tissue lesions and decreased viral copies of PRV and PCV in mice and piglets. Collectively, these findings suggest that rPRV-ΔTK-PCV3(Cap)/ΔgIgE-PCV2(Cap) serves as a promising candidate vaccine against PRV and PCV infections.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127307"},"PeriodicalIF":4.5,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147253","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}
VaccinePub Date : 2025-05-26DOI: 10.1016/j.vaccine.2025.127303
Molly Kroeger , Eduardo Fano , Amanda Sponheim , Kent J. Schwartz , Fernando L. Leite , Oliver Gomez-Duran , Luiz Lecznieski , Pablo E. Piñeyro
{"title":"Assessment of homologous and heterologous PCV2 vaccine efficacy in a PCV2d/PRRSV co-challenge model","authors":"Molly Kroeger , Eduardo Fano , Amanda Sponheim , Kent J. Schwartz , Fernando L. Leite , Oliver Gomez-Duran , Luiz Lecznieski , Pablo E. Piñeyro","doi":"10.1016/j.vaccine.2025.127303","DOIUrl":"10.1016/j.vaccine.2025.127303","url":null,"abstract":"<div><div>Porcine circovirus 2 (PCV2) is an economically significant, ubiquitous pathogen affecting the global swine industry. While vaccines have been highly efficacious in controlling clinical disease, questions have arisen in recent years regarding gaps in clinical protection observed in the field due to heterologous PCV2 infection and coinfections with virulent, contemporary porcine reproductive and respiratory syndrome virus (PRRSV) isolates. Therefore, this study evaluated clinical, pathological, and immunological differences in homologous and heterologous PCV2 vaccinated pigs co-challenged with PCV2d and PRRSV. The study closely mimicked field conditions where 21-day-old commercial pigs were vaccinated with a commercial PRRSV vaccine and either a commercial PCV2a or PCV2d vaccine or left as PCV2 unvaccinated controls. Pigs were <em>co</em>-challenged with PCV2d and PRRSV restriction fragment polymorphism (RFLP) 1–7-4 28 days post-vaccination. In addition to significantly higher mortality, the unvaccinated group had significantly higher tissue viral load and viremia in addition to moderate to severe lymphoid depletion with significantly greater PCV2 antigen detected in the lymph nodes, tonsil, and lung compared to both vaccinated groups. While PCV2 vaccination regardless of subtype prevented the development of severe clinical PCVAD in the majority of vaccinates, the PCV2d vaccinates had reduced tissue viral load, significantly lower viremia, and reduced lymphoid depletion with less PCV2 antigen detected in tissues compared to the PCV2a vaccinates. Additionally, approximately 20 % of the PCV2a vaccinates had moderate to severe lymphoid depletion with moderate to severe antigen detection, which is associated with clinical PCVAD. While total levels of PCV2-specific antibodies measured by ELISA were similar between the PCV2a and PCV2d vaccinates, PCV1–2 chimeric virus neutralization assays revealed differential subtype-specific neutralizing antibody (NA) titers among the PCV2a and PCV2d vaccinates. Prior to challenge on day 28 (28 days post-vaccination), PCV2d vaccinates had significantly higher NA titers against the PCV1–2d vaccine and challenge chimeric viruses, while the PCV2a vaccinates had significantly higher NA titers against the PCV1–2a vaccine chimeric virus. Collectively, homologous vaccination may provide greater protection in virulent co-infection scenarios in the field. This study provides further insight into differences in protection elicited by homologous and heterologous vaccination, resulting in valuable insights to enhance PCV2 control strategies in the current PCV2d/PRRSV co-infection paradigm.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127303"},"PeriodicalIF":4.5,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147181","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}
VaccinePub Date : 2025-05-26DOI: 10.1016/j.vaccine.2025.127300
Nelson Lee , Lena Nguyen , Sharifa Nasreen , Peter C. Austin , Kevin A. Brown , Sarah A. Buchan , Ramandip Grewal , Kevin L. Schwartz , Mina Tadrous , Kumanan Wilson , Sarah E. Wilson , Jeffrey C. Kwong , On behalf of the Canadian Immunization Research Network (CIRN) Investigators
{"title":"Limited durability of protection conferred by XBB.1.5 vaccines against omicron-associated severe outcomes among community-dwelling adults, Ontario, Canada","authors":"Nelson Lee , Lena Nguyen , Sharifa Nasreen , Peter C. Austin , Kevin A. Brown , Sarah A. Buchan , Ramandip Grewal , Kevin L. Schwartz , Mina Tadrous , Kumanan Wilson , Sarah E. Wilson , Jeffrey C. Kwong , On behalf of the Canadian Immunization Research Network (CIRN) Investigators","doi":"10.1016/j.vaccine.2025.127300","DOIUrl":"10.1016/j.vaccine.2025.127300","url":null,"abstract":"<div><div>We estimated XBB.1.5 vaccine effectiveness (VE) against hospitalization/death among adults aged ≥50 years in Ontario, Canada, from September 2023 to June 2024. Compared with non-XBB.1.5 vaccinees, the initial protection at 0–3 months was 64 % (95 %CI, 57 %–69 %) during XBB-sublineage predominance. It was reduced to 57 % (95 %CI, 48 %–64 %) when JN/KP-sublineages became predominant, and quickly declined. No significant protection was observed >6 months post-vaccination. The VE estimates were lower when the last vaccine dose in the reference group was given more recently than 12 months, or was the omicron-containing bivalent vaccine. Short durability of protection poses unique challenges for COVID-19 vaccination.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"60 ","pages":"Article 127300"},"PeriodicalIF":4.5,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144147352","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}