Vaccines最新文献

{"title":"Generation of Vaccine Candidate Strains That Antigenically Match Classical Swine Fever Virus Field Strains.","authors":"Maya Kobayashi, Loc Tan Huynh, Saho Ogino, Lim Yik Hew, Miki Koyasu, Hikaru Kamata, Takahiro Hiono, Norikazu Isoda, Yoshihiro Sakoda","doi":"10.3390/vaccines13020188","DOIUrl":"10.3390/vaccines13020188","url":null,"abstract":"<p><strong>Background: </strong>Classical swine fever virus (CSFV) is genetically categorized into three genotypes. A live-attenuated vaccine strain GPE^-, currently used in Japan, belongs to genotype 1 and is genetically distinct from the field strains circulating in Japan, which belong to genotype 2. This study aimed to understand the antigenicity of recent field isolates in Japan and develop new vaccine candidates that antigenically match field strains.</p><p><strong>Methods: </strong>The serum samples of 20 pigs vaccinated with GPE^- were subjected to a serum neutralizing test (SNT) using one of the field strains, CSFV/wb/Jpn-Mie/P96/2019 (Mie/2019). For the antigenic matching, vGPE^-/HiBiT/Mie E2 was generated by replacing the viral glycoprotein E2, the main target of the neutralizing antibody, with that of Mie/2019. Additionally, vGPE^-/HiBiT/Mie E2/PAPeV E^rns was generated by further substituting glycoprotein E^rns with that of pronghorn antelope pestivirus (PAPeV) since E^rns is not important as a vaccine immunogen and can be replaced by that of other pestiviruses to provide an immunological marker. The efficacy of vGPE^-/HiBiT/Mie E2/PAPeV E^rns was further evaluated by the challenge experiments in pigs.</p><p><strong>Results: </strong>The SNT titers of serum sample against Mie/2019 were 6.1-fold lower than that against vGPE^-. The generated recombinant viruses showed closer antigenicity to Mie/2019 than vGPE^-. The challenge study confirmed that vGPE^-/HiBiT/Mie E2/PAPeV E^rns provided clinical and virological protection against a field CSFV equivalent to vGPE^-.</p><p><strong>Conclusions: </strong>This study demonstrated that swapping the E2 encoding region with the prevalent field CSFVs is a promising strategy to achieve antigenic matching between the vaccine and field strains.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860266/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immunosuppressive Treatments and Risk Factors Associated with Non-Response to Hepatitis B Vaccination: A Cohort Study.","authors":"Raquel Padilla-Matas, Victoria Salguero-Cano, Eva Soler-Iborte, Javier Baca-Hidalgo, Marta Pérez-Dionisio, Soledad Gutiérrez-Linares, Inmaculada Guerrero-Fernández de Alba, María Del Carmen Valero-Ubierna, María Fernández-Prada, Mario Rivera-Izquierdo","doi":"10.3390/vaccines13020184","DOIUrl":"10.3390/vaccines13020184","url":null,"abstract":"<p><p><b>Background</b>: The aim of this study was to evaluate the serological response after the complete hepatitis B vaccination of patients according to the immunosuppressive treatment they underwent, and to identify potential factors associated with non-responders. <b>Methods</b>: A prospective cohort study was conducted, and patients under immunosuppressive therapies were considered exposed. The main outcome was non-response to hepatitis B vaccination. Bivariate analysis was conducted to detect differences between exposed and non-exposed patients. A multivariable log-binomial regression model was designed to analyze potential factors independently associated with non-responders. <b>Results</b>: A total of 289 patients were included. Immunosuppressive treatment was associated with non-response to hepatitis B vaccination (RR = 2.49, 95% CI: 1.26-4.96). Concretely, the use of cytotoxic therapies showed increased risk, although anti-CD20 and anti-JAK also showed a tendency to be associated with non-responders. Other variables associated with non-responders were older age (6-7% higher risk per year), smoking (RR = 3.08, 95% CI: 1.41-6.74) and certain vaccine regimens. These findings were similar for persistent non-responders despite an additional booster dose. <b>Conclusions</b>: Patients receiving immunosuppressive treatments, who are older in age or who are smokers have a higher risk of non-response to conventional hepatitis B vaccination. These data might serve to optimize hepatitis B vaccination in high-risk patients.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11861145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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 Efficacy of Influenza Vaccination in Kidney Graft Recipients in Late Period After Kidney Transplantation.","authors":"Anna Zawiasa-Bryszewska, Maja Nowicka, Monika Górska, Piotr Edyko, Krzysztof Edyko, Damian Tworek, Adam Antczak, Jacek Burzyński, Ilona Kurnatowska","doi":"10.3390/vaccines13020189","DOIUrl":"10.3390/vaccines13020189","url":null,"abstract":"<p><strong>Background/objectives: </strong>Influenza is a viral infection affecting up to 20% of the general population annually. Solid organ transplant recipients have a higher morbidity and mortality risk, as well as a greater likelihood of severe disease complications. Vaccination against the influenza virus is a safe and recommended prophylaxis; however, immunosuppression and high comorbidity burdens impair the immune response. We assessed the efficacy, safety, and humoral response to influenza vaccine in a population of kidney transplant recipients (KTx).</p><p><strong>Methods: </strong>Adult KTx recipients at least 6 months post-KTx were divided into vaccinated (vKTx) and non-vaccinated (nvKTx) groups based on consent for vaccination. The vKTx group received one dose of quadrivalent split virion inactivated vaccine (Vaxigrip Tetra Sanofi Pasteur). Subjective symptoms and side effects were recorded in paper journals. Antibody levels were assessed with ELISA prior to and 3 months following vaccination. Serum creatinine and proteinuria were assessed prior to vaccination as well as 3 and 6 months after.</p><p><strong>Results: </strong>Of 450 recruited KTx recipients, 91 in the vKTx group and 36 in the nvKTx group of comparable age, KTx vintage, and graft function were included in the study. Graft function and proteinuria remained stable in both groups. The vKTx group experienced no severe adverse events. The most common complaints were general malaise (20.5%) and injection site pain (10.3%). Overall infection rates were comparable, yet the vKTx group experienced significantly fewer serious infections (11.4% vs. 32.3%, <i>p</i> = 0.01); the vKTx group showed a greater increase of Influenza A IgM (<i>p</i> = 0.05) and Influenza B IgG (<i>p</i> = 0.01) compared with the nvKTx group.</p><p><strong>Conclusions: </strong>Influenza vaccination prevents severe infections in KTx recipients, with good serological response and no impact on graft function or severe adverse events.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11861709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143503816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Current Development of Therapeutic Vaccines in Lung Cancer.","authors":"Jesus Salvador Flores Banda, Sanjana Gangane, Fatima Raza, Erminia Massarelli","doi":"10.3390/vaccines13020185","DOIUrl":"10.3390/vaccines13020185","url":null,"abstract":"<p><p>Cancer vaccines have a potential to change the current landscape of immunotherapy research and development. They target and neutralize specific tumor cells by utilizing the body's own immune system which offers a promising modality in treating various cancers including lung cancer. Historically, prior vaccination approaches specifically towards lung cancer have posed several challenges but also potential with early phase I/II trials showing improved overall survival. With better understanding of the body's immune system as well as advancements in vaccine development, the use of vaccines to target lung cancer cells in both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) has shown promise but also challenges in the setting of advanced stage cancers, tumor resistance mechanisms, immune evasion, and tumor heterogeneity. The proposed solution is to enroll patients in the early stages of the disease, rather than waiting until progression occurs. Additionally, future efforts will focus on the targeted identification of specific and novel tumor neo-antigens. This review offers discussion and analysis of both completed and ongoing trials utilizing different strategies for vaccine development in relation to treating lung cancer as well as current challenges faced.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860707/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In Situ Tumor Vaccination Using Lipid Nanoparticles to Deliver Interferon-β mRNA Cargo.","authors":"Kenji Kimura, Aidan Aicher, Emma Niemeyer, Phurin Areesawangkit, Caitlin Tilsed, Karen P Fong, Tyler E Papp, Steven M Albelda, Hamideh Parhiz, Jarrod D Predina","doi":"10.3390/vaccines13020178","DOIUrl":"10.3390/vaccines13020178","url":null,"abstract":"<p><p><i>Background:</i> In situ cancer vaccination is a therapeutic approach that involves stimulating the immune system in order to generate a polyclonal, anti-tumor response against an array of tumor neoantigens. Traditionally, in situ vaccination approaches have utilized adenoviral vectors to deliver immune-stimulating genes directly to the tumor microenvironment. Lipid nanoparticle (LNP)-mediated delivery methods offer several advantages over adenoviral delivery approaches, including increased safety, repeated administration potential, and enhanced tumor microenvironment activation. <i>Methods:</i> To explore in situ vaccination using LNPs, we evaluated LNP-mediated delivery of a reporter gene, mCherry, and an immune-stimulating gene, IFNβ, in several in vitro and in vivo models of lung cancer. <i>Results:</i> In vitro experiments demonstrated successful transfection of murine cancer cell lines with LNPs carrying both mCherry and IFN-β mRNA, resulting in high expression levels and IFNβ production. In vivo studies using LLC.ova flank tumors showed that intratumoral injection of IFNβ-mRNA LNPs led to significant IFNβ production within the tumor microenvironment, with minimal systemic exposure. Therapeutic efficacy was evaluated by injecting established LLC.ova flank tumors with IFNβ-mRNA LNPs bi-weekly for two weeks. Treated tumors showed significant growth inhibition compared to controls. Flow cytometric analysis of tumor-infiltrating leukocytes revealed that tumors injected with IFNβ-mRNA LNPs were associated with an increased CD8:CD4 T-cell ratio among lymphocytes, more CD69-expressing CD8 T-cells, and an increased presence of M1 macrophages. Efficacy and an abscopal effect were confirmed in a squamous cell carcinoma model, MOC1. No toxicity was observed. <i>Conclusions:</i> These findings show that intratumoral LNP delivery of immune-stimulating mRNA transcripts, such as IFNβ, can effectively stimulate local anti-tumor immune responses and warrants further investigation as a potential immunotherapeutic approach for cancer.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11861666/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143503732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HDAC3: A Multifaceted Modulator in Immunotherapy Sensitization.","authors":"Rui Han, Yujun Luo, Jingdong Gao, Huiling Zhou, Yuqian Wang, Jiaojiao Chen, Guoyin Zheng, Changquan Ling","doi":"10.3390/vaccines13020182","DOIUrl":"10.3390/vaccines13020182","url":null,"abstract":"<p><p>Histone deacetylase 3 (HDAC3) has emerged as a critical epigenetic regulator in tumor progression and immune modulation, positioning it as a promising target for enhancing cancer immunotherapy. This work comprehensively explores HDAC3's multifaceted roles, focusing on its regulation of key immune-modulatory pathways such as cGAS-STING, ferroptosis, and the Nrf2/HO-1 axis. These pathways are central to tumor immune evasion, antigen presentation, and immune cell activation. Additionally, the distinct effects of HDAC3 on various immune cell types-including its role in enhancing T cell activation, restoring NK cell cytotoxicity, promoting dendritic cell maturation, and modulating macrophage polarization-are thoroughly examined. These findings underscore HDAC3's capacity to reshape the tumor immune microenvironment, converting immunologically \"cold tumors\" into \"hot tumors\" and thereby increasing their responsiveness to immunotherapy. The therapeutic potential of HDAC3 inhibitors is highlighted, both as standalone agents and in combination with immune checkpoint inhibitors, to overcome resistance and improve treatment efficacy. Innovative strategies, such as the development of selective HDAC3 inhibitors, advanced nano-delivery systems, and integration with photodynamic or photothermal therapies, are proposed to enhance treatment precision and minimize toxicity. By addressing challenges such as toxicity, patient heterogeneity, and resistance mechanisms, this study provides a forward-looking perspective on the clinical application of HDAC3 inhibitors. It highlights its significant potential in personalized cancer immunotherapy, paving the way for more effective treatments and improved outcomes for cancer patients.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Leveraging Electron Beam (eBeam) Technology for Advancing the Development of Inactivated Vaccines.","authors":"Ruvindu Perera, Suresh D Pillai, Adnan Alrubaye, Palmy Jesudhasan","doi":"10.3390/vaccines13020179","DOIUrl":"10.3390/vaccines13020179","url":null,"abstract":"<p><p>This review provides an overview of electron beam (eBeam) technology and its applications across a wide variety of disciplines. More importantly, it discusses this technology's advantages and its benefits in developing inactivated vaccines. eBeam technology is currently being used all around the world for a variety of industrial applications, extending from food pasteurization to the cross-linking of polymers in the wire and cable industries. It is a successful emerging alternative for developing vaccines against bacterial, protozoan, and viral pathogens. This review includes a descriptive account of the mechanism of action of eBeam and how this technology achieves the complete inactivation of pathogens while retaining the integrity of their surface epitopes. This unique advantage is crucial for the production of efficacious vaccines. This review provides a detailed account of the usage of eBeam technology for developing vaccines to protect a multitude of hosts against a wide range of pathogens. eBeam-inactivated vaccines are advantageous over live vaccines, RNA/subunit vaccines, and chemically inactivated vaccines mainly due to the complete inactivation of pathogens, and the presence of intact, highly antigenic epitopes. To conclude, this article descriptively highlights eBeam technology's advantages over other means of vaccine development.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11861765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504274","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Plasma microRNAs to Select Optimal Patients for Antibody Production from Anti-Addiction Vaccines.","authors":"Thomas R Kosten, Amrit Koirala, David A Nielsen, Coreen B Domingo, Ynhi T Thomas, Preethi H Gunaratne, Cristian Coarfa","doi":"10.3390/vaccines13020181","DOIUrl":"10.3390/vaccines13020181","url":null,"abstract":"<p><p><b>Background</b>: Cocaine and illicit amphetamines (disguised as \"Adderall\") are being laced with fentanyl and producing accidental and intentional fatal overdoses. Vaccines can prevent these overdoses, but 33% of humans generate insufficient anti-drug antibody (AB) levels. Plasma microRNAs (miRs) can be used to predict non-responders. We have plasma stored from 152 cocaine vaccine trial participants following three vaccinations over 9 weeks and examined miRs as potential response biomarkers. <b>Methods</b>: We compared 2517 miRs before anti-cocaine vaccination in participants with the highest (n = 25) to the lowest (n = 23) antibody levels. False Discovery Rates (FDRs) were applied to identify differentially expressed (DE) miRs. We used miR target prediction pipelines to identify the miR-regulated genes. <b>Results</b>: Using a DE-FDR < 0.05 and a >3-fold difference between high- and low-AB responders yielded 12 miRs down and 3 miRs up compared to low-AB patients. Furthermore, 11 among 1673 genes were targeted by 3 or more of the 12 down DE-miRs. <b>Conclusions</b>: A significant DE-miR for identifying optimal antibody responders replicated previous vaccine study predictors (miR-150), and several more miRs appear to be strong candidates for future consideration in replications based upon significance of individual DE-miRs and upon multiple miRs converging on individual genes.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence of Mpox Vaccine Acceptance Among Students: A Systematic Review and Meta-Analysis.","authors":"Ambanna Yappalparvi, Shilpa Gaidhane, G Padmapriya, Irwanjot Kaur, Madan Lal, Suhaib Iqbal, G V Siva Prasad, Atreyi Pramanik, Promila Sharma, Praveen Malik, Teena Vishwakarma, Ankit Punia, Megha Jagga, Rachana Mehta, Sanjit Sah, Muhammed Shabil, Prakasini Satapathy, Ganesh Bushi, Ali Davod Parsa, Russell Kabir","doi":"10.3390/vaccines13020183","DOIUrl":"10.3390/vaccines13020183","url":null,"abstract":"<p><strong>Background: </strong>Mpox, formerly known as monkeypox, is a re-emerging viral disease. Vaccine acceptance is crucial for preventing its spread. This systematic review and meta-analysis assessed the acceptance of the Mpox vaccine among student populations.</p><p><strong>Methods: </strong>We searched electronic databases, including PubMed, Web of Science, and Embase, up to 14 September 2024. The studies included were observational, such as cross-sectional and cohort studies, and specifically assessed vaccine acceptance for Mpox vaccines among students. R version 4.4 was used to perform the meta-analysis, and sensitivity analyses were conducted to assess the robustness of the findings. The publication bias was evaluated using Doi plots.</p><p><strong>Results: </strong>Of the 143 studies initially identified, eight studies were included in the final analysis, comprising a total of 16,129 participants. The overall vaccine acceptance rate was 58.6%, with considerable variability across studies (I² = 100%). The sensitivity analyses indicated that acceptance rates ranged between 45% and 70%. The Doi plot demonstrated the presence of moderate publication bias.</p><p><strong>Conclusion: </strong>This systematic review and meta-analysis shows moderate acceptance of the Mpox vaccine among students. Future studies should investigate the factors influencing vaccine acceptance and design targeted strategies to improve coverage, which will be essential for controlling Mpox and ensuring successful vaccination campaigns.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860471/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel Standard Substance from Primary Hamster Kidney Cells for Quality Control of Human Rabies Vaccines in China.","authors":"Leitai Shi, Jia Li, Xiaohong Wu, Shouchun Cao, Yunpeng Wang, Danhua Zhao, Yuhua Li","doi":"10.3390/vaccines13020180","DOIUrl":"10.3390/vaccines13020180","url":null,"abstract":"<p><strong>Background: </strong>Host cell proteins (HCPs) from primary hamster kidney cells (PHKCs) used to produce rabies vaccines may cause an allergic reaction in humans, so these residual HCPs must be controlled. Establishing a national standard for PHKC HCP is very important to ensure the consistency of HCPs between batches of the vaccine and to standardize the control of HCPs.</p><p><strong>Objectives: </strong>We aimed to establish a novel national standard substance to determine the HCP residue in rabies vaccines produced with PHKCs.</p><p><strong>Methods: </strong>A two-step multi-laboratory collaborative collaboration was undertaken. In the first step, the protein concentration of the standard substance stock solution was determined using Lowry's method. In the second step, the concentration of the candidate standard substance was determined with an enzyme-linked immunosorbent assay.</p><p><strong>Results: </strong>The concentration of the PHKC protein standard was 4.0 μg/mL (95% confidence interval: 3.5-4.4 μg/mL).</p><p><strong>Conclusions: </strong>The PHKC protein standard was approved by the Chinese National Committee on Standards for the quality control of PHKC-based rabies vaccines for human use, and it plays an important role in controlling the quality of these human vaccines.</p>","PeriodicalId":23634,"journal":{"name":"Vaccines","volume":"13 2","pages":""},"PeriodicalIF":5.2,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11860641/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}