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A study on the willingness and influencing factors of non-EPI vaccines recommendations among Chinese vaccination staff under major infectious disease outbreaks.
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-26 DOI: 10.1080/21645515.2025.2469987
Xie Qixin, Yan Liu, Xinren Che, Jian Du, Yuyang Xu, Jiayin Han, Zhaojun Lu, Yingying Yang, Wenwen Gu

WHO had warned of the impending "X disease," emphasizing the need to quickly establish an immune barrier. The willingness of vaccination staff to recommend vaccines was crucial in such scenarios. This study aimed to investigate willingness and influencing factors of Non-EPI Vaccines recommendations among Chinese vaccination staff in Hangzhou, China. We selected vaccination staff in 191 vaccination clinics from Hangzhou for a questionnaire-based survey using a cross-sectional survey. Descriptive statistics were made on the characteristics of participants. Univariate and multivariable analyses were used to determine the influencing factors of Non-EPI Vaccines recommendations. The overall recommendation rate was 76.2%. Compared to Supplementary and Individual Non-EPI Vaccines, vaccination staff were more willing to recommend Alternative (x2 = 215.655, P < 0.05) and Combined Non-EPI Vaccines (x2 = 214.998, P < 0.05). Multivariate logistic regression analysis showed that vaccination staff who did not participate in COVID-19 vaccination work (OR = 2.942, 95%CI:1.121 ~ 9.302), believe they had an obligation to recommend Non-EPI Vaccines (OR disagree = 7.957, 95%CI:1.238 ~ 87.69; OR neutrality = 4.187, 95%CI:1.66 ~ 10.563), and think that the effects of non-routine immunization vaccines were very good (OR disagree = 3.133, 95%CI:1.677 ~ 14.495; OR neutrality = 2.512, 95%CI:1.164 ~ 5.418) were more willing to recommend Non-EPI Vaccines. On the contrary, vaccination staff who believe that recommending Non-EPI vaccines increased their workload (OR disagree = 0.307, 95%CI:0.11 ~ 0.856; OR neutrality = 0.642, 95%CI:0.258 ~ 0.986) would decrease willingness to recommend them. The most of vaccination staff were willing to recommend non-EPI vaccines under major infectious disease outbreaks. To further control the pandemic of major infectious diseases, the health management departments should enhance the knowledge of vaccines among vaccination staff and alleviate their workload.

{"title":"A study on the willingness and influencing factors of non-EPI vaccines recommendations among Chinese vaccination staff under major infectious disease outbreaks.","authors":"Xie Qixin, Yan Liu, Xinren Che, Jian Du, Yuyang Xu, Jiayin Han, Zhaojun Lu, Yingying Yang, Wenwen Gu","doi":"10.1080/21645515.2025.2469987","DOIUrl":"10.1080/21645515.2025.2469987","url":null,"abstract":"<p><p>WHO had warned of the impending \"X disease,\" emphasizing the need to quickly establish an immune barrier. The willingness of vaccination staff to recommend vaccines was crucial in such scenarios. This study aimed to investigate willingness and influencing factors of Non-EPI Vaccines recommendations among Chinese vaccination staff in Hangzhou, China. We selected vaccination staff in 191 vaccination clinics from Hangzhou for a questionnaire-based survey using a cross-sectional survey. Descriptive statistics were made on the characteristics of participants. Univariate and multivariable analyses were used to determine the influencing factors of Non-EPI Vaccines recommendations. The overall recommendation rate was 76.2%. Compared to Supplementary and Individual Non-EPI Vaccines, vaccination staff were more willing to recommend Alternative (<math><mrow><msup><mi>x</mi><mn>2</mn></msup></mrow></math> = 215.655, <i>P</i> < 0.05) and Combined Non-EPI Vaccines (<math><mrow><msup><mi>x</mi><mn>2</mn></msup></mrow></math> = 214.998, <i>P</i> < 0.05). Multivariate logistic regression analysis showed that vaccination staff who did not participate in COVID-19 vaccination work (OR = 2.942, 95%CI:1.121 ~ 9.302), believe they had an obligation to recommend Non-EPI Vaccines (OR <sub>disagree</sub> = 7.957, 95%CI:1.238 ~ 87.69; OR <sub>neutrality</sub> = 4.187, 95%CI:1.66 ~ 10.563), and think that the effects of non-routine immunization vaccines were very good (OR <sub>disagree</sub> = 3.133, 95%CI:1.677 ~ 14.495; OR <sub>neutrality</sub> = 2.512, 95%CI:1.164 ~ 5.418) were more willing to recommend Non-EPI Vaccines. On the contrary, vaccination staff who believe that recommending Non-EPI vaccines increased their workload (OR <sub>disagree</sub> = 0.307, 95%CI:0.11 ~ 0.856; OR <sub>neutrality</sub> = 0.642, 95%CI:0.258 ~ 0.986) would decrease willingness to recommend them. The most of vaccination staff were willing to recommend non-EPI vaccines under major infectious disease outbreaks. To further control the pandemic of major infectious diseases, the health management departments should enhance the knowledge of vaccines among vaccination staff and alleviate their workload.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2469987"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505380","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}
引用次数: 0
Outbreak report of rotavirus gastroenteritis among remotely vaccinated travelers: A potential implication of booster vaccine for travelers to endemic countries.
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-26 DOI: 10.1080/21645515.2025.2467475
Masayuki Onaka, Taito Kitano, Sayaka Yoshida

In countries in which rotavirus vaccines have been introduced for young infants, the incidence of rotavirus infections has dramatically decreased. This report presents an outbreak of rotavirus gastroenteritis among travelers. Data regarding the long-term protective effect of rotavirus vaccines after years of vaccination are scarce. A Japanese group of 14 children and nine adults traveled to Malaysia over 4 weeks. During travel, 15 of 23 patients developed gastroenteritis symptoms (Figure 1). Stool samples were collected from two symptomatic patients that tested positive for rotavirus. None of the five members with a history of rotavirus gastroenteritis developed symptoms. Nine of the 10 vaccinated children developed symptoms of acute gastroenteritis without the need for hospitalization. The only child without a history of vaccination or infection developed acute gastroenteritis and required hospitalization for continuous intravenous hydration. While individuals with a history of infection did not develop acute gastroenteritis, the protective effects of vaccination against symptomatic infection did not sustain long. This indicates the potential need for a booster dose of the rotavirus vaccine for travelers to rotavirus-endemic countries.

{"title":"Outbreak report of rotavirus gastroenteritis among remotely vaccinated travelers: A potential implication of booster vaccine for travelers to endemic countries.","authors":"Masayuki Onaka, Taito Kitano, Sayaka Yoshida","doi":"10.1080/21645515.2025.2467475","DOIUrl":"10.1080/21645515.2025.2467475","url":null,"abstract":"<p><p>In countries in which rotavirus vaccines have been introduced for young infants, the incidence of rotavirus infections has dramatically decreased. This report presents an outbreak of rotavirus gastroenteritis among travelers. Data regarding the long-term protective effect of rotavirus vaccines after years of vaccination are scarce. A Japanese group of 14 children and nine adults traveled to Malaysia over 4 weeks. During travel, 15 of 23 patients developed gastroenteritis symptoms (Figure 1). Stool samples were collected from two symptomatic patients that tested positive for rotavirus. None of the five members with a history of rotavirus gastroenteritis developed symptoms. Nine of the 10 vaccinated children developed symptoms of acute gastroenteritis without the need for hospitalization. The only child without a history of vaccination or infection developed acute gastroenteritis and required hospitalization for continuous intravenous hydration. While individuals with a history of infection did not develop acute gastroenteritis, the protective effects of vaccination against symptomatic infection did not sustain long. This indicates the potential need for a booster dose of the rotavirus vaccine for travelers to rotavirus-endemic countries.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2467475"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143505445","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}
引用次数: 0
Pneumococcal vaccination in elderly care facilities in Japan: A cross-sectional, web-based survey.
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-07 DOI: 10.1080/21645515.2025.2461814
Youngju Kim, Hironori Taniguchi, Kotoba Okuyama, Junpei Kamimoto, Kenji Kawakami

This study evaluated pneumococcal vaccination status using evaluable data collected from 445 of 1,313 managing directors of elderly care facilities in Japan through an online survey (September 5, 2022-November 25, 2022; UMIN000048747); comparisons were made with the influenza (2021-2022 vaccination only) and coronavirus disease 2019 (COVID-19) vaccination status. Among facilities who kept pneumococcal vaccination records (n = 42), the mean pneumococcal vaccination rate was 31.1%, with the rate being higher for the influenza (93.1%; n = 234) and COVID-19 (94.3%; n = 285) vaccines. Overall, excluding facilities that answered that the corresponding vaccine status at their sites was unknown, the percentage of facilities with high vaccination rates (80% to 100%) was substantially higher for the influenza (80.5%; 351/436) and COVID-19 (89.6%; 396/442) vaccines than for the pneumococcal vaccine (6.5%; 24/370). Multivariable analysis showed that major factors associated with a high pneumococcal vaccination rate (≥15%) were "managing director's willingness to recommend" and "pneumococcal vaccination request from the residents." The most common reason for their willingness to recommend the pneumococcal vaccine was that it is an effective disease prevention strategy (83.3%; 65/78) and for their unwillingness to recommend the pneumococcal vaccine was the inability to understand the effectiveness of the vaccine (43.6%; 17/39). In conclusion, there is a need to improve pneumococcal vaccination rates in elderly care facilities in Japan. Strategies such as increasing awareness and encouraging pneumococcal vaccine recommendation among managing directors, especially for residents not eligible for the national subsidy program, and providing regular training on the pneumococcal vaccine for staff and residents are required.

{"title":"Pneumococcal vaccination in elderly care facilities in Japan: A cross-sectional, web-based survey.","authors":"Youngju Kim, Hironori Taniguchi, Kotoba Okuyama, Junpei Kamimoto, Kenji Kawakami","doi":"10.1080/21645515.2025.2461814","DOIUrl":"10.1080/21645515.2025.2461814","url":null,"abstract":"<p><p>This study evaluated pneumococcal vaccination status using evaluable data collected from 445 of 1,313 managing directors of elderly care facilities in Japan through an online survey (September 5, 2022-November 25, 2022; UMIN000048747); comparisons were made with the influenza (2021-2022 vaccination only) and coronavirus disease 2019 (COVID-19) vaccination status. Among facilities who kept pneumococcal vaccination records (<i>n</i> = 42), the mean pneumococcal vaccination rate was 31.1%, with the rate being higher for the influenza (93.1%; <i>n</i> = 234) and COVID-19 (94.3%; <i>n</i> = 285) vaccines. Overall, excluding facilities that answered that the corresponding vaccine status at their sites was unknown, the percentage of facilities with high vaccination rates (80% to 100%) was substantially higher for the influenza (80.5%; 351/436) and COVID-19 (89.6%; 396/442) vaccines than for the pneumococcal vaccine (6.5%; 24/370). Multivariable analysis showed that major factors associated with a high pneumococcal vaccination rate (≥15%) were \"managing director's willingness to recommend\" and \"pneumococcal vaccination request from the residents.\" The most common reason for their willingness to recommend the pneumococcal vaccine was that it is an effective disease prevention strategy (83.3%; 65/78) and for their unwillingness to recommend the pneumococcal vaccine was the inability to understand the effectiveness of the vaccine (43.6%; 17/39). In conclusion, there is a need to improve pneumococcal vaccination rates in elderly care facilities in Japan. Strategies such as increasing awareness and encouraging pneumococcal vaccine recommendation among managing directors, especially for residents not eligible for the national subsidy program, and providing regular training on the pneumococcal vaccine for staff and residents are required.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2461814"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11810092/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143366366","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}
引用次数: 0
Evaluating the impact of the vaccination prescription program on herpes zoster vaccine coverage in Ningbo, China: An interrupted time series analysis.
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-03-05 DOI: 10.1080/21645515.2025.2474889
Jianmei Wang, Jiaxin Wang, Ning Li, Dongkai Du, Dandan Zhang, Rui Ma

As the population ages, herpes zoster (HZ) and postherpetic neuralgia, which are associated with a substantial disease burden, are expected to increase. Ningbo began to implement the Vaccination Prescription Program for community individuals in April 2022. The anonymized HZ vaccination records of individuals aged above 50 during 2020-2023 were extracted from the Ningbo Immunization Information Management System. We applied interrupted time series analyses controlling for long-term trends and seasonality to assess the effects of the program on HZ vaccination coverage. Effect modification from demographic characteristics was investigated. Totally 18,133 doses of the HZ vaccine were administered. The cumulative coverage increased from 0.16‰ to 2.97‰, and the full series cumulative coverage from 0.04‰ to 2.48‰. Relatively higher coverage and full series coverage were observed among residents, females, individuals residing in inner districts and high socioeconomic regions, and those aged 50-59 years. During the transition period, a 468.7% increase in HZ vaccination coverage was evident (Rate Ratio [RR], 5.687; 95% Confidence Interval [CI], 2.334-13.857), and significant impact was detected among all demographic characteristics. During the post-implementation period, a 261.3% increase in coverage was evident (RR, 3.613; 95% CI, 1.202-10.858), while no effect was found among migrants, individuals living in regions with high socioeconomic status, and those aged above 70 years. Although the positive effect of the program, it is imperative to implement key strategies for providing affordable HZ vaccines, such as government funding, subsidies, and vaccination prescriptions from healthcare professionals, alongside peer initiatives and family members' education.

{"title":"Evaluating the impact of the vaccination prescription program on herpes zoster vaccine coverage in Ningbo, China: An interrupted time series analysis.","authors":"Jianmei Wang, Jiaxin Wang, Ning Li, Dongkai Du, Dandan Zhang, Rui Ma","doi":"10.1080/21645515.2025.2474889","DOIUrl":"10.1080/21645515.2025.2474889","url":null,"abstract":"<p><p>As the population ages, herpes zoster (HZ) and postherpetic neuralgia, which are associated with a substantial disease burden, are expected to increase. Ningbo began to implement the Vaccination Prescription Program for community individuals in April 2022. The anonymized HZ vaccination records of individuals aged above 50 during 2020-2023 were extracted from the Ningbo Immunization Information Management System. We applied interrupted time series analyses controlling for long-term trends and seasonality to assess the effects of the program on HZ vaccination coverage. Effect modification from demographic characteristics was investigated. Totally 18,133 doses of the HZ vaccine were administered. The cumulative coverage increased from 0.16‰ to 2.97‰, and the full series cumulative coverage from 0.04‰ to 2.48‰. Relatively higher coverage and full series coverage were observed among residents, females, individuals residing in inner districts and high socioeconomic regions, and those aged 50-59 years. During the transition period, a 468.7% increase in HZ vaccination coverage was evident (Rate Ratio [RR], 5.687; 95% Confidence Interval [CI], 2.334-13.857), and significant impact was detected among all demographic characteristics. During the post-implementation period, a 261.3% increase in coverage was evident (RR, 3.613; 95% CI, 1.202-10.858), while no effect was found among migrants, individuals living in regions with high socioeconomic status, and those aged above 70 years. Although the positive effect of the program, it is imperative to implement key strategies for providing affordable HZ vaccines, such as government funding, subsidies, and vaccination prescriptions from healthcare professionals, alongside peer initiatives and family members' education.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2474889"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11901373/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568658","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}
引用次数: 0
The characterization of technical design of a virus-like structure (VLS) nanodelivery system as vaccine candidate against SARS-CoV-2 variants.
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-03-05 DOI: 10.1080/21645515.2025.2473183
Jingjing Zhang, Fengyuan Zeng, Yanmei Li, Changyong Mu, Change Liu, Lichun Wang, Xiaowu Peng, Liping He, Yanrui Su, Hongbing Li, An Wang, Lin Feng, Dongxiu Gao, Zhixiao Zhang, Gang Xu, Yixuan Wang, Rong Yue, Junbo Si, Lichun Zheng, Xiong Zhang, Fuyun He, Hongkun Yi, Zhongshu Tang, Gaocan Li, Kaili Ma, Qihan Li

The constant mutation of SARS-CoV-2 has led to the continuous appearance of viral variants and their pandemics and has improved the development of vaccines with a broad spectrum of antigens to curb the spread of the virus. The work described here suggested a novel vaccine with a virus-like structure (VLS) composed of combined mRNA and protein that is capable of stimulating the immune system in a manner similar to that of viral infection. This VLS vaccine is characterized by its ability to specifically target dendritic cells and/or macrophages through S1 protein recognition of the DC-SIGN receptor in cells, which leads to direct mRNA delivery to these innate immune cells for activation of robust immunity with a broad spectrum of neutralizing antibodies and immune protective capacity against variants. Research on its composition characteristics and structural features has suggested its druggability. Compared with the current mRNA vaccine, the VLS vaccine was identified as having no cytotoxicity at its effective application dosage, while the results of safety observations in animals revealed fewer adverse reactions during immunization.

{"title":"The characterization of technical design of a virus-like structure (VLS) nanodelivery system as vaccine candidate against SARS-CoV-2 variants.","authors":"Jingjing Zhang, Fengyuan Zeng, Yanmei Li, Changyong Mu, Change Liu, Lichun Wang, Xiaowu Peng, Liping He, Yanrui Su, Hongbing Li, An Wang, Lin Feng, Dongxiu Gao, Zhixiao Zhang, Gang Xu, Yixuan Wang, Rong Yue, Junbo Si, Lichun Zheng, Xiong Zhang, Fuyun He, Hongkun Yi, Zhongshu Tang, Gaocan Li, Kaili Ma, Qihan Li","doi":"10.1080/21645515.2025.2473183","DOIUrl":"10.1080/21645515.2025.2473183","url":null,"abstract":"<p><p>The constant mutation of SARS-CoV-2 has led to the continuous appearance of viral variants and their pandemics and has improved the development of vaccines with a broad spectrum of antigens to curb the spread of the virus. The work described here suggested a novel vaccine with a virus-like structure (VLS) composed of combined mRNA and protein that is capable of stimulating the immune system in a manner similar to that of viral infection. This VLS vaccine is characterized by its ability to specifically target dendritic cells and/or macrophages through S1 protein recognition of the DC-SIGN receptor in cells, which leads to direct mRNA delivery to these innate immune cells for activation of robust immunity with a broad spectrum of neutralizing antibodies and immune protective capacity against variants. Research on its composition characteristics and structural features has suggested its druggability. Compared with the current mRNA vaccine, the VLS vaccine was identified as having no cytotoxicity at its effective application dosage, while the results of safety observations in animals revealed fewer adverse reactions during immunization.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2473183"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11901403/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143568659","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}
引用次数: 0
Lyophilized monkeypox mRNA lipid nanoparticle vaccines with long-term stability and robust immune responses in mice.
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-03-11 DOI: 10.1080/21645515.2025.2477384
Bin Wang, Quanyi Yin, Li Yi, Caixia Su, Yang Wen, Man Qiao, Yingchen Ju, Zhihua Liu, Yelin Xiong, Zhilei Liu

The World Health Organization (WHO) has recently declared another global health emergency due to the rapidly spreading monkeypox (Mpox) outbreak in numerous African countries. To address the unmet need to contain the outbreak using the existing vaccines, this study developed a lyophilization process for an effective, scalable and affordable Mpox mRNA-LNP vaccine candidate to address the global health crisis. A comprehensive evaluation and optimization of the vaccine formulation (the type/concentration of cryoprotectants, the type/concentration of buffer system, as well as the mRNA concentration and reconstitution solvent) and the freeze-drying process parameters (freezing method, temperature, cooling rate and primary/secondary drying conditions) were conducted. The freeze-dried product exhibits a uniform appearance and a moisture content of less than 1%. Reconstitution of the lyophilized mRNA-LNP resulted in equivalent particle size/polydispersity index, encapsulation efficiency and mRNA integrity compared to that of freshly prepared mRNA-LNP. Furthermore, the lyophilization process can be scaled up 100-fold to 2000 vials/batch. Notably, the lyophilized mRNA-LNP demonstrated a storage stability of at least 12 months at 4°C, and at ambient temperature for a minimum of 8 h post-reconstitution, exhibiting minimal deterioration in product quality. The in vitro biological activity and in vivo immunogenicity of the lyophilized mRNA-LNP was comparable to that of the freshly prepared mRNA-LNP. These results provide a compelling rationale for the utilization of lyophilization technology in enhancing the accessibility of the Mpox mRNA vaccine in developing countries, a strategy that is crucial for containing the global epidemic of Mpox infection.

{"title":"Lyophilized monkeypox mRNA lipid nanoparticle vaccines with long-term stability and robust immune responses in mice.","authors":"Bin Wang, Quanyi Yin, Li Yi, Caixia Su, Yang Wen, Man Qiao, Yingchen Ju, Zhihua Liu, Yelin Xiong, Zhilei Liu","doi":"10.1080/21645515.2025.2477384","DOIUrl":"10.1080/21645515.2025.2477384","url":null,"abstract":"<p><p>The World Health Organization (WHO) has recently declared another global health emergency due to the rapidly spreading monkeypox (Mpox) outbreak in numerous African countries. To address the unmet need to contain the outbreak using the existing vaccines, this study developed a lyophilization process for an effective, scalable and affordable Mpox mRNA-LNP vaccine candidate to address the global health crisis. A comprehensive evaluation and optimization of the vaccine formulation (the type/concentration of cryoprotectants, the type/concentration of buffer system, as well as the mRNA concentration and reconstitution solvent) and the freeze-drying process parameters (freezing method, temperature, cooling rate and primary/secondary drying conditions) were conducted. The freeze-dried product exhibits a uniform appearance and a moisture content of less than 1%. Reconstitution of the lyophilized mRNA-LNP resulted in equivalent particle size/polydispersity index, encapsulation efficiency and mRNA integrity compared to that of freshly prepared mRNA-LNP. Furthermore, the lyophilization process can be scaled up 100-fold to 2000 vials/batch. Notably, the lyophilized mRNA-LNP demonstrated a storage stability of at least 12 months at 4°C, and at ambient temperature for a minimum of 8 h post-reconstitution, exhibiting minimal deterioration in product quality. The in vitro biological activity and in vivo immunogenicity of the lyophilized mRNA-LNP was comparable to that of the freshly prepared mRNA-LNP. These results provide a compelling rationale for the utilization of lyophilization technology in enhancing the accessibility of the Mpox mRNA vaccine in developing countries, a strategy that is crucial for containing the global epidemic of Mpox infection.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2477384"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11901372/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143598049","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}
引用次数: 0
Targeting murine metastatic cancers with cholera toxin A1-adjuvanted peptide vaccines.
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-01-23 DOI: 10.1080/21645515.2025.2455240
Sanchari Paul, Mustafa Kaya, Olivia Johnsson, Hanna Grauers Wiktorin, Andreas Törnell, Mohammad Arabpour, Kristoffer Hellstrand, Anna Martner

The dissemination of tumor cells with ensuing metastasis is responsible for most cancer-related deaths. Cancer vaccines may, by inducing tumor-specific effector T cells, offer a strategy to eliminate metastasizing tumor cells. However, several obstacles remain in the development of effective cancer vaccines, including the identification of adjuvants that enhance the evolvement and efficacy of tumor-specific T cells. Cholera toxin-based adjuvants have shown efficacy in vaccines for infectious diseases, but their role in cancer vaccine therapies remains to be elucidated. Here, we explored the potential of cholera toxin A1 (CTA1)-based adjuvants to boost anti-tumor T cell responses and protect against metastasis. We report that an adjuvant where CTA1 was fused to a dimer from Staphylococcus aureus protein A (DD) enhanced immune responses against the tumor-associated antigens TRP2 and Twist1 in mice, providing protection against B16F1 melanoma and 4T1 breast cancer metastasis, respectively. Both mucosal (intranasal) and systemic (intraperitoneal) vaccine administration provided effective protection against intravenously injected tumor cells, with intranasal administration leading to superior induction of CD4+ T cells at metastatic sites. When comparing antigens admixed with CTA1-DD to those fused with a CTA1-based adjuvant, the fusion construct elicited the strongest immunogenicity. Nevertheless, by administrating a 20-fold higher antigen dose also the admix formulation provided efficient protection against metastasis.

{"title":"Targeting murine metastatic cancers with cholera toxin A1-adjuvanted peptide vaccines.","authors":"Sanchari Paul, Mustafa Kaya, Olivia Johnsson, Hanna Grauers Wiktorin, Andreas Törnell, Mohammad Arabpour, Kristoffer Hellstrand, Anna Martner","doi":"10.1080/21645515.2025.2455240","DOIUrl":"10.1080/21645515.2025.2455240","url":null,"abstract":"<p><p>The dissemination of tumor cells with ensuing metastasis is responsible for most cancer-related deaths. Cancer vaccines may, by inducing tumor-specific effector T cells, offer a strategy to eliminate metastasizing tumor cells. However, several obstacles remain in the development of effective cancer vaccines, including the identification of adjuvants that enhance the evolvement and efficacy of tumor-specific T cells. Cholera toxin-based adjuvants have shown efficacy in vaccines for infectious diseases, but their role in cancer vaccine therapies remains to be elucidated. Here, we explored the potential of cholera toxin A1 (CTA1)-based adjuvants to boost anti-tumor T cell responses and protect against metastasis. We report that an adjuvant where CTA1 was fused to a dimer from <i>Staphylococcus aureus</i> protein A (DD) enhanced immune responses against the tumor-associated antigens TRP2 and Twist1 in mice, providing protection against B16F1 melanoma and 4T1 breast cancer metastasis, respectively. Both mucosal (intranasal) and systemic (intraperitoneal) vaccine administration provided effective protection against intravenously injected tumor cells, with intranasal administration leading to superior induction of CD4<sup>+</sup> T cells at metastatic sites. When comparing antigens admixed with CTA1-DD to those fused with a CTA1-based adjuvant, the fusion construct elicited the strongest immunogenicity. Nevertheless, by administrating a 20-fold higher antigen dose also the admix formulation provided efficient protection against metastasis.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2455240"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11760229/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143030119","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}
引用次数: 0
Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China.
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-02 DOI: 10.1080/21645515.2025.2458831
Yiqing Zhu, Yihan Wang, Jinghui Wang, Yafei Wang, Li Sun, Shiheng Cui, Jing Li, Yu Guo

To comprehensively assess the safety and difference of two types of EV71 vaccines: EV71-Vero, produced using Vero cells and EV71-H2, using human diploid cells. Our research included children of the recommended age who voluntarily received the EV71 vaccine in Hebei Province from 2019 to 2023. Detailed data on adverse events following immunization (AEFI) were collected, analyzed and compared for EV71-Vero and EV71-H2 vaccines. With 477 AEFI reported, the reported rate was 14.21 per 100,000 doses. Most cases occurred in infants under one year of age (45.91%). No significant differences in the AEFI reported rate were found between two types of EV71 vaccines across various demographic. However, a higher number of AEFI was reported in children under 1-year old following EV71-Vero compared to EV71-H2 with a reversal in 4-5 years- group (χ2 = 13.90, p = .01). The prognosis of cured took higher proportion for EV71-Vero than for EV71-H2 while inversely with improved outcome. The EV71 vaccine is advisable recommend to the appropriate age children to prevent EV7l infection. Both the EV71-Vero and EV71-H2 vaccines have good safety profiles. The reported AEFI, primarily high fever and allergic reactions, showed no significant differences in reported rates or case characteristics between the two types.

{"title":"Adverse events following immunization surveillance on two types of enterovirus 71 vaccines: A real-world comparative study in China.","authors":"Yiqing Zhu, Yihan Wang, Jinghui Wang, Yafei Wang, Li Sun, Shiheng Cui, Jing Li, Yu Guo","doi":"10.1080/21645515.2025.2458831","DOIUrl":"10.1080/21645515.2025.2458831","url":null,"abstract":"<p><p>To comprehensively assess the safety and difference of two types of EV71 vaccines: EV71-Vero, produced using Vero cells and EV71-H2, using human diploid cells. Our research included children of the recommended age who voluntarily received the EV71 vaccine in Hebei Province from 2019 to 2023. Detailed data on adverse events following immunization (AEFI) were collected, analyzed and compared for EV71-Vero and EV71-H2 vaccines. With 477 AEFI reported, the reported rate was 14.21 per 100,000 doses. Most cases occurred in infants under one year of age (45.91%). No significant differences in the AEFI reported rate were found between two types of EV71 vaccines across various demographic. However, a higher number of AEFI was reported in children under 1-year old following EV71-Vero compared to EV71-H2 with a reversal in 4-5 years- group (<i>χ</i><sup><i>2</i></sup> = 13.90, <i>p</i> = .01). The prognosis of cured took higher proportion for EV71-Vero than for EV71-H2 while inversely with improved outcome. The EV71 vaccine is advisable recommend to the appropriate age children to prevent EV7l infection. Both the EV71-Vero and EV71-H2 vaccines have good safety profiles. The reported AEFI, primarily high fever and allergic reactions, showed no significant differences in reported rates or case characteristics between the two types.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2458831"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081696","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}
引用次数: 0
Pertussis epidemiological surveillance and immunization history in children under five years in a megacity in China from 2019 to 2023.
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-02-09 DOI: 10.1080/21645515.2025.2460273
Yang Liu, Jing Chen, Ning Yao, Xiaoxiao Hu, Nian Yu, Qing Wang, Jiawei Xu

To analyze the epidemiological characteristics and influencing factors of pertussis in children under five years in Chongqing from 2019 to 2023, providing scientific evidence for further prevention and control. The epidemiological characteristics of pertussis cases in children under five years and vaccination history with pertussis-containing vaccines were described, and the influencing factors and cumulative risk of disease onset after vaccination were analyzed using the Cox proportional hazards regression model. From 2019 to 2023, a total of 4,135 pertussis cases were reported in children under five years in Chongqing, with cases occurring predominantly between April and August. Infants under 1 year accounted for the highest proportion of cases at 66.82% (2,763/4,135); the annual reported incidence was higher in boys (141.26/100,000) than in girls (122.09/100,000). Over half of the cases, 59.78% (2,472/4,135) had received at least one dose of a pertussis-containing vaccine, and there were significant differences in vaccination history among different age groups (χ2 = 483.248, p < .01). Cox's regression analysis indicated that the total number of doses received (p < .01) was an influencing factor for the interval between vaccination and disease onset. The hazard ratios (HRs) for three doses, two doses, and one dose were 0.182 (95% CI: 0.138-0.241), 0.485 (95% CI: 0.359-0.654), and 0.315 (95% CI: 0.233-0.425). Young children, including infants and preschool-aged children, were still a high-risk group for pertussis infection in Chongqing. It is recommended to administer an additional dose of Diphtheria-Tetanus-Pertussis vaccine (DTaP) vaccine to preschool children aged four to six in China.

{"title":"Pertussis epidemiological surveillance and immunization history in children under five years in a megacity in China from 2019 to 2023.","authors":"Yang Liu, Jing Chen, Ning Yao, Xiaoxiao Hu, Nian Yu, Qing Wang, Jiawei Xu","doi":"10.1080/21645515.2025.2460273","DOIUrl":"10.1080/21645515.2025.2460273","url":null,"abstract":"<p><p>To analyze the epidemiological characteristics and influencing factors of pertussis in children under five years in Chongqing from 2019 to 2023, providing scientific evidence for further prevention and control. The epidemiological characteristics of pertussis cases in children under five years and vaccination history with pertussis-containing vaccines were described, and the influencing factors and cumulative risk of disease onset after vaccination were analyzed using the Cox proportional hazards regression model. From 2019 to 2023, a total of 4,135 pertussis cases were reported in children under five years in Chongqing, with cases occurring predominantly between April and August. Infants under 1 year accounted for the highest proportion of cases at 66.82% (2,763/4,135); the annual reported incidence was higher in boys (141.26/100,000) than in girls (122.09/100,000). Over half of the cases, 59.78% (2,472/4,135) had received at least one dose of a pertussis-containing vaccine, and there were significant differences in vaccination history among different age groups (χ<sup>2</sup> = 483.248, <i>p</i> < .01). Cox's regression analysis indicated that the total number of doses received (<i>p</i> < .01) was an influencing factor for the interval between vaccination and disease onset. The hazard ratios (HRs) for three doses, two doses, and one dose were 0.182 (95% CI: 0.138-0.241), 0.485 (95% CI: 0.359-0.654), and 0.315 (95% CI: 0.233-0.425). Young children, including infants and preschool-aged children, were still a high-risk group for pertussis infection in Chongqing. It is recommended to administer an additional dose of Diphtheria-Tetanus-Pertussis vaccine (DTaP) vaccine to preschool children aged four to six in China.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2460273"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11812399/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383645","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}
引用次数: 0
Global research trends on biomarkers for cancer immunotherapy: Visualization and bibliometric analysis. 癌症免疫治疗生物标志物的全球研究趋势:可视化和文献计量分析。
IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Pub Date : 2025-12-01 Epub Date: 2025-01-08 DOI: 10.1080/21645515.2024.2435598
Yuan Qiao, Dong Xie, Zhengxiang Li, Shaohua Cao, Dong Zhao

The global burden of cancer continues to grow, posing a significant public health challenge. Although cancer immunotherapy has shown significant efficacy, the response rate is not high. Therefore, the objective of our research was to identify the latest research trends and hotspots on biomarkers from 1993 to 2023. Data were collected from the database Web of Science core collection. Bibliometric analysis and visualization were conducted with CiteSpace(6.3.1), VOSviewer (v1.6.20), R-bibliometrix(v4.3.3), and Microsoft Excel(2019). A total of 2686 literatures were retrieved. The sheer annual volume of publications has shown a rapid upward trend since 2015. The United States has generated the most publications and Harvard University ranked as a leading institution. The global biomarker research on immune checkpoint inhibitors (ICIs) revealed regional differences and in-depth explorations should be promoted in developing countries. Although China has become the second largest country in terms of publication, the average citation per paper and the total link strength were both lower than the other countries. The research on biomarkers mainly concentrated upon the following aspects: PD-1/PD-L1, CTLA-4, gene expression, adverse events, total mutational burden (TMB), body mass index (BMI), gut microbiota, cd8(+)/cd4(+) t-cells, and blood-related biomarkers such as lactate dehydrogenase (LDH), neutrophil-lymphocyte ratio (NLR), cytokines. Furthermore, "artificial intelligence" and "machine learning" have become the most important research hotspot over the last 2 y, which will help us to identify useful biomarkers from complex big data and provide a basis for precise medicine for malignant tumors.

全球癌症负担继续增加,对公共卫生构成重大挑战。虽然肿瘤免疫治疗已显示出显著的疗效,但有效率并不高。因此,我们的研究目的是确定1993年至2023年生物标志物的最新研究趋势和热点。数据来自Web of Science核心馆藏数据库。使用CiteSpace(6.3.1)、VOSviewer (v1.6.20)、R-bibliometrix(v4.3.3)和Microsoft Excel(2019)进行文献计量学分析和可视化。共检索到2686篇文献。自2015年以来,年度出版物数量呈现快速上升趋势。美国发表的论文最多,哈佛大学被列为顶尖学府。免疫检查点抑制剂(ICIs)的全球生物标志物研究显示出地区差异,应在发展中国家促进深入探索。虽然中国已成为论文发表量第二大国,但论文平均被引次数和总链接强度均低于其他国家。生物标志物的研究主要集中在PD-1/PD-L1、CTLA-4、基因表达、不良事件、总突变负担(TMB)、体重指数(BMI)、肠道菌群、cd8(+)/cd4(+) t细胞、血液相关生物标志物乳酸脱氢酶(LDH)、中性粒细胞淋巴细胞比(NLR)、细胞因子等方面。此外,“人工智能”和“机器学习”成为近20年来最重要的研究热点,这将有助于我们从复杂的大数据中识别有用的生物标志物,为恶性肿瘤的精准医疗提供基础。
{"title":"Global research trends on biomarkers for cancer immunotherapy: Visualization and bibliometric analysis.","authors":"Yuan Qiao, Dong Xie, Zhengxiang Li, Shaohua Cao, Dong Zhao","doi":"10.1080/21645515.2024.2435598","DOIUrl":"10.1080/21645515.2024.2435598","url":null,"abstract":"<p><p>The global burden of cancer continues to grow, posing a significant public health challenge. Although cancer immunotherapy has shown significant efficacy, the response rate is not high. Therefore, the objective of our research was to identify the latest research trends and hotspots on biomarkers from 1993 to 2023. Data were collected from the database Web of Science core collection. Bibliometric analysis and visualization were conducted with CiteSpace(6.3.1), VOSviewer (v1.6.20), R-bibliometrix(v4.3.3), and Microsoft Excel(2019). A total of 2686 literatures were retrieved. The sheer annual volume of publications has shown a rapid upward trend since 2015. The United States has generated the most publications and Harvard University ranked as a leading institution. The global biomarker research on immune checkpoint inhibitors (ICIs) revealed regional differences and in-depth explorations should be promoted in developing countries. Although China has become the second largest country in terms of publication, the average citation per paper and the total link strength were both lower than the other countries. The research on biomarkers mainly concentrated upon the following aspects: PD-1/PD-L1, CTLA-4, gene expression, adverse events, total mutational burden (TMB), body mass index (BMI), gut microbiota, cd8(+)/cd4(+) t-cells, and blood-related biomarkers such as lactate dehydrogenase (LDH), neutrophil-lymphocyte ratio (NLR), cytokines. Furthermore, \"artificial intelligence\" and \"machine learning\" have become the most important research hotspot over the last 2 y, which will help us to identify useful biomarkers from complex big data and provide a basis for precise medicine for malignant tumors.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"21 1","pages":"2435598"},"PeriodicalIF":4.1,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730411/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957498","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}
引用次数: 0
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Human Vaccines & Immunotherapeutics
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