Human Vaccines & Immunotherapeutics最新文献

{"title":"Pembrolizumab- induced subacute cutaneous lupus erythematosus in a patient with oropharyngeal squamous cell carcinoma: A case report and literature review.","authors":"Beata Mayer, Pavel Babál, Lucia Krivošíková","doi":"10.1080/21645515.2025.2454073","DOIUrl":"10.1080/21645515.2025.2454073","url":null,"abstract":"<p><p>Considering the increasing use of immune checkpoint inhibitors in cancer treatment, our aim is to report a rare cutaneous immune-related adverse event induced by PD-1 inhibitor pembrolizumab and provide a brief overview of pembrolizumab-induced subacute cutaneous lupus erythematosus (SCLE) cases in the literature. We report a 67-year-old woman with oropharyngeal squamous cell carcinoma who developed SCLE during treatment with pembrolizumab. After 18 weeks (sixth cycle) of pembrolizumab immunotherapy, a widespread pruritic erythematous rash evaluated as grade 3 immune-related adverse event appeared primarily on the patient's limbs. Histopathological examination and direct immunofluorescence showed characteristic features of SCLE. The patient was treated with oral prednisone 40 mg daily and topical corticosteroids. In 2 weeks, her rash had cleared up significantly and her pruritus had disappeared. SCLE is an infrequent but recognized immune-related adverse event linked to pembrolizumab treatment.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2454073"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143014664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neoantigen mRNA vaccines and A₂A receptor antagonism: A strategy to enhance T cell immunity.","authors":"Saber Imani, Parham Jabbarzadeh Kaboli, Ali Babaeizad, Mazaher Maghsoudloo","doi":"10.1080/21645515.2025.2458936","DOIUrl":"10.1080/21645515.2025.2458936","url":null,"abstract":"<p><p>Although neo-antigen mRNA vaccines are promising for personalized cancer therapy, their effectiveness is often limited by the immunosuppressive tumor microenvironment (TME). The adenosine A₂A receptor (A₂AR) inhibits dendritic cell (DC) function and weakens antitumor T cell responses through hypoxia-driven mechanisms within the TME. This review explores a novel strategy combining neo-antigen mRNA vaccines with A₂AR antagonists (A₂ARi). By targeting A₂AR, this approach reduces TME-induced immunosuppression, enhances DC activation, and improves neo-antigen presentation. The review also discusses lipid nanoparticles (LNPs) to co-deliver A₂ARi and mRNA vaccines, optimizing their effectiveness. The integration of neo-antigen mRNA-LNPs with A₂ARi modulation offers a promising strategy to overcome immunosuppression, stimulate DC activation, and achieve precise anti-tumor responses with minimal off-target effects. This synergy represents significant progress in cancer immunotherapy, advancing the potential for personalized neoantigen therapies.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2458936"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784654/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068990","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":"Limitations of neutralizing antibody titers in COVID-19 vaccine efficacy trials and a call for additional correlates of protection.","authors":"Young Hoon Hwang, Dal-Hee Min, Wan Beom Park","doi":"10.1080/21645515.2025.2473795","DOIUrl":"10.1080/21645515.2025.2473795","url":null,"abstract":"<p><p>The coronavirus disease (COVID-19) pandemic accelerated development of various vaccine platforms. Among them, mRNA vaccines played a crucial role in controlling the pandemic due to their swift development and efficacy against virus variants. Despite the success of these vaccines, recent studies highlight challenges in evaluating vaccine efficacy, especially in individuals with prior COVID-19 infection. Weakened neutralizing antibody responses after additional doses are observed in these populations, raising concerns about using neutralizing antibody titers as the sole immune correlate of protection. While neutralizing antibodies remain the primary endpoint in immunogenicity trials, they may not fully capture the immune response in populations with widespread prior infection or vaccination. This review explores reduced neutralizing antibody responses in previously infected individuals, and their impact on vaccine efficacy evaluation. It also offers recommendations for improving efficacy assessment, stressing incorporation of additional immune markers such as cell-mediated immunity to enable more comprehensive understanding of vaccine-induced immunity.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2473795"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11901426/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143574000","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":"An mRNA-based seasonal influenza vaccine in adults: Results of two phase 3 randomized clinical trials and correlate of protection analysis of hemagglutination inhibition titers.","authors":"Boris Kandinov, Mieke Soens, Wenmei Huang, Conrado Llapur, David Ensz, Brandon Essink, Carlos Fierro, Jignesh Vakil, Alicia Pucci, Jia Guo, Sinead Rudden, Kristi Hall, Bryony Hicks, Kristin Schaefers, Honghong Zhou, Chong Ma, Lingyi Zheng, Andrei Avanesov, Yoonyoung Park, Evelyn Du, Jacqueline Miller, Jintanat Ananworanich, Raffael Nachbagauer","doi":"10.1080/21645515.2025.2484088","DOIUrl":"10.1080/21645515.2025.2484088","url":null,"abstract":"<p><p>The safety, immunogenicity, and efficacy of the original formulation of the investigational mRNA-1010 vaccine for seasonal influenza were investigated in two randomized, active-controlled, phase 3 trials in adults (NCT05415462 and NCT05566639), and the results were used to evaluate hemagglutination inhibition (HAI) titers as correlates of risk and protection against influenza-like illness. mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials. The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains and lower responses against influenza B strains relative to an active comparator (licensed inactivated influenza vaccine). An analysis of HAI titers as a correlate of protection against influenza infection provided support for its use as a surrogate endpoint for mRNA-1010, similar to licensed influenza vaccines. These findings support further optimization and development of mRNA-1010 against seasonal influenza.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2484088"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11970786/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774496","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":"Health economic evaluation of implementing a universal immunization program with nirsevimab compared to standard of care for the prevention of respiratory syncytial virus disease in Canadian infants.","authors":"Thomas Shin, Jason Kh Lee, Alexia Kieffer, Michael Greenberg, Jianhong Wu","doi":"10.1080/21645515.2025.2480875","DOIUrl":"10.1080/21645515.2025.2480875","url":null,"abstract":"<p><p>Respiratory syncytial virus (RSV) is a highly contagious pathogen and a leading cause of severe lower respiratory tract illness (LRTI) in infants and young children, irrespective of risk factors. Nirsevimab, an extended half-life monoclonal antibody, was approved in Canada in 2023 as a passive immunizing agent for the prevention of RSV LRTI. This study evaluated the optimal price per dose (PPD) at commonly accepted willingness-to-pay (WTP) thresholds among Canadian infants compared to the current standard of care (i.e. palivizumab for preterm infants and those with specific medical conditions). A static decision tree model was developed to assess the impact of nirsevimab on RSV-related health and economic outcomes among Canadian infants - including outpatient physician and emergency department visits, inpatient hospitalizations including intensive care unit (ICU) admissions and mechanical ventilation, and the associated healthcare costs of these outcomes. The model utilized Canadian epidemiological and cost inputs where possible, adopting a societal perspective. Compared to the standard of care, nirsevimab was expected to prevent 47,609 RSV-related health events, including 2,296 hospitalizations and a reduction of approximately $45 million in direct healthcare costs. At a WTP threshold of $50,000 per quality-adjusted life-year (QALY), the estimated base case PPD was $536, based on average cost assumptions across several costing scenarios. These findings suggest that universal immunization with nirsevimab could significantly reduce the health and economic burden of RSV among Canadian Infants.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2480875"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11980512/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143788875","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":"Safety and immunogenicity of PHH-1V booster against SARS-CoV-2 variants, including omicron subvariants: Results from a phase IIb open-label extension study.","authors":"María Jesús López, Maria Del Mar Vazquez, Melchor Alvarez-Mon, José Ramón Arribas, Eunate Arana-Arri, Patricia Muñoz, Jorge Navarro-Pérez, Rafael Ramos, José Molto, Susana Otero-Romero, Elena Aurrecoechea, Roc Pomarol, Laia Bernad, Ignasi Esteban, Raúl Pérez-Caballero, Montserrat Plana, Júlia G Prado, Álex Soriano","doi":"10.1080/21645515.2025.2474775","DOIUrl":"10.1080/21645515.2025.2474775","url":null,"abstract":"<p><p>SARS-CoV-2 vaccination campaigns on current endemic situation would benefit from vaccine alternatives with easy logistics and accessibility, sustained response and cross-reactivity against emerging variants. Herein, safety and immunogenicity of PHH-1V, adjuvanted recombinant RBD-based vaccine, as fourth dose for the most prevalent SARS-CoV-2 variants in Spain in subjects ≥18 years was investigated for 6 months in HIPRA-HH-2 open-label extension study. Subjects received a fourth dose of PHH-1V after either two BNT162b2 doses plus one PHH-1V dose (cohort 1) or three BNT162b2 doses (cohort 2). As regulatory endpoint, neutralization titers were investigated for PHH-1 V as fourth dose vs BNT162b2 as third dose in subjects receiving previous BNT162b2-based regimens. PHH-1 V immunogenicity (GMT) was investigated against Beta, Delta, and Omicron BA.1, BA.4/5 and XBB.1.5 on Days 14, 98 and 182 post-immunization. Two hundred and eighty-eight subjects received PHH-1V. Neutralizing antibodies against Omicron BA.1 at Day 14 significantly increased after the PHH-1V as fourth booster vs the third BNT162b2 booster (GMT ratio 0.43 (95% CI: 0.28; 0.65; p-value < .0001)). PHH-1V fourth booster induced a significant increase in neutralizing titers vs baseline (GMFR on Day 14 [95% CI]: Beta 6.96 [5.23, 9.25]; Delta 6.27 [4.79, 8.22]; Omicron BA.1 9.21 [5.57, 15.21]; Omicron BA.4/5 11.80 [8.29, 16.80]; Omicron XBB.1.5 5.22 [3.97, 6.87]), remaining significantly higher up to 6 months. The most frequent adverse events were injection site pain and fatigue. As conclusion, PHH-1V booster induced sustained humoral and cellular immune response against Beta, Delta variants and cross reactivity against distant Omicron subvariants and could be an appropriate strategy for implementing heterologous vaccination campaigns.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2474775"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12045571/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144027436","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":"Pneumococcal vaccine hyporesponsiveness in people living with HIV: A narrative review of immunological mechanisms and insights from minimally invasive lymph node sampling.","authors":"Giovanni E Loe-Sack-Sioe, Danny W de Vos, Leo G Visser, Simon P Jochems, Anna H E Roukens","doi":"10.1080/21645515.2025.2503602","DOIUrl":"10.1080/21645515.2025.2503602","url":null,"abstract":"<p><p>Despite highly effective antiretroviral therapy, people living with HIV (PLWH) remain at elevated risk for invasive pneumococcal disease. Clinical studies show that, even with high CD4⁺ counts, PLWH exhibit diminished serological responses and rapid antibody decline following pneumococcal vaccination, plausibly due to underlying immune dysfunction. Germinal centers (GCs), located within lymph nodes, are essential for generating high-affinity antibodies, but are structurally and functionally disrupted in PLWH. These local impairments, combined with systemic immune dysregulation, contribute to vaccine hyporesponsiveness in PLWH. This narrative review links immunological findings from experimental and in vivo studies to clinical pneumococcal vaccine trials, to investigate mechanisms that may be leveraged to strengthen vaccine-induced immunity in PLWH. We also highlight the application of fine needle aspiration (FNA) of the lymph node as a way to study pneumococcal vaccine hyporesponsiveness in the GC and provide potential direction to improve responses for next-generation pneumococcal conjugate vaccines in PLWH.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2503602"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144081443","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":"Research hotspots and frontier analysis of the novel immune checkpoint Nectin-4.","authors":"Yu Qiao, Wanyu Zhao, Yusen Gou, Yuwei Li, Fang Su, Rui Wang, Jiejun Wang, Haibo Zhang, Lei Sun, Feng Qian, Zishu Wang","doi":"10.1080/21645515.2025.2504776","DOIUrl":"10.1080/21645515.2025.2504776","url":null,"abstract":"<p><p>Nectin-4 has emerged as a pivotal therapeutic target for antibody-drug conjugates (ADCs), particularly in advanced urothelial carcinoma (aUC) research. Although extensive literature has been reported on Nectin-4, it is worth noting that no studies have yet systematically investigated the hotspots, cutting-edge directions, and tissue expression of this target using a combination of bibliometric analysis and bioinformatics methods. Findings reveal growing interest in Nectin-4's role in cancer immunotherapy and ADC development. Urothelial carcinoma remains the primary focus, with breast and bladder cancers gaining traction. Key research priorities include optimizing ADC safety profiles, particularly managing cutaneous adverse events. Notably, dual targeting strategies combining Nectin-4 with TROP-2 show promise for next-generation ADC therapies. The study highlights evolving clinical needs, from target validation to treatment optimization, positioning Nectin-4 as a versatile biomarker bridging multiple cancer research domains. These insights emphasize the protein's translational potential while underscoring the importance of balancing therapeutic efficacy with toxicity management in ADC development.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2504776"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087485/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086905","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":"The role of nursing in enhancing quality of life for lung cancer patients receiving targeted and immunotherapy: Challenges, opportunities, and future directions.","authors":"Ying-Ying Sun, Li-Min Wei, Ying Qian","doi":"10.1080/21645515.2025.2506302","DOIUrl":"10.1080/21645515.2025.2506302","url":null,"abstract":"<p><p>Targeted therapy and immunotherapy are two critical contemporary strategies in the management of lung cancer. Despite their success in extending survival and mitigating symptoms, they introduce complex nursing interventions. This narrative review examines the impact of these treatment strategies on patients' quality of life, assesses the efficacy of current nursing interventions, and proposes strategies for enhancing future nursing practices. A comprehensive analysis of existing literature, covering studies published between 2014 and 2024 in the databases of WOSCC- SCIE, PubMed, CINAHL, and Embase, underscores the pivotal role of nursing in managing treatment-related adverse effects, delivering psychosocial support, and educating patients. Nevertheless, challenges remain in the areas of nursing staff training, resource allocation, and the limited scope of nursing research. Future directions should focus on the development of individualized care plans, the integration of innovative nursing technologies, and the ongoing enhancement of care quality to optimize nursing practices.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2506302"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12101592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144102647","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":"Exploring the relationship between experience of vaccine adverse events and vaccine hesitancy: A scoping review.","authors":"Fátima Gauna, Jocelyn Raude, Charles Khouri, Jean-Luc Cracowski, Jeremy K Ward","doi":"10.1080/21645515.2025.2471225","DOIUrl":"10.1080/21645515.2025.2471225","url":null,"abstract":"<p><p>Fear of side effects is the main motive for vaccine refusal. However, before the COVID-19 pandemic, little attention had been paid to the actual experience of adverse events and its relationship with vaccine hesitancy. This scoping review aimed to analyze the impact of VH on EAE and vice versa. We reviewed 55 articles. Most of the studies focused on COVID-19 vaccination and employed cross-sectional surveys with self-reported indicators. These studies identified significant correlations between EAE and VH. Social cognitive models shed some light on the influence of EAE on VH, while the converse is usually explained by the nocebo effect that predominately accounts for the converse. This emerging research field is hampered by significant inconsistencies in theoretical explanations, assessments of the relationship, and measurements of these two phenomena. A more comprehensive consideration of individual experience, both objective and subjective, would help develop more effective vaccine communication strategies and improve pharmacological surveillance.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2471225"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11901385/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587702","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}