Pub Date : 2024-12-31Epub Date: 2024-05-09DOI: 10.1080/21645515.2024.2343552
Vladimír Dvořák, Marek Petráš, Vladimír Dvořák, Danuše Lomozová, Pavel Dlouhý, Ivana Králová Lesná, Radovan Pilka
The main aim of our study was to investigate the specific contribution of a 9-valent human papillomavirus vaccine (9vHPV) to the recurrence risk of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women vaccinated post-excision. Therefore, we conducted a retrospective monocentric cohort study in women aged 22-49 years undergoing conization between 2014 and 2023. The 9vHPV-vaccinated women were matched to unvaccinated women for age and follow-up duration in a 1:2 ratio to eliminate allocation bias. The risk of CIN2+ recurrence was estimated by the incidence rate ratio using Poisson regression with adjustment for comorbidities, smoking status, nulliparity, CIN grade, positive cone margin, and HPV genotypes. The CIN2+ recurrence rates in 147 women enrolled in the analysis were 18 and 2 cases per 100,000 person-days for unvaccinated and vaccinated women, respectively, during a mean follow-up period of 30 months (±22 months). A reduction in CIN2+ recurrences by 90% (95% confidence interval: 12-99%) was documented in 9vHPV-vaccinated participants compared to women undergoing only surgical excision. Moreover, vaccinated women with a positive cone margin showed a 42% (though non-significant) reduction in relapse (p = .661). Full post-conization vaccination with the 9vHPV contributed to an additional reduction in the risk of CIN2+ recurrence. This finding is consistent with current knowledge and suggests a high adjuvant effect of the 9vHPV vaccine.
{"title":"Reduced risk of CIN2+ recurrence in women immunized with a 9-valent HPV vaccine post-excision: Retrospective cohort study.","authors":"Vladimír Dvořák, Marek Petráš, Vladimír Dvořák, Danuše Lomozová, Pavel Dlouhý, Ivana Králová Lesná, Radovan Pilka","doi":"10.1080/21645515.2024.2343552","DOIUrl":"10.1080/21645515.2024.2343552","url":null,"abstract":"<p><p>The main aim of our study was to investigate the specific contribution of a 9-valent human papillomavirus vaccine (9vHPV) to the recurrence risk of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women vaccinated post-excision. Therefore, we conducted a retrospective monocentric cohort study in women aged 22-49 years undergoing conization between 2014 and 2023. The 9vHPV-vaccinated women were matched to unvaccinated women for age and follow-up duration in a 1:2 ratio to eliminate allocation bias. The risk of CIN2+ recurrence was estimated by the incidence rate ratio using Poisson regression with adjustment for comorbidities, smoking status, nulliparity, CIN grade, positive cone margin, and HPV genotypes. The CIN2+ recurrence rates in 147 women enrolled in the analysis were 18 and 2 cases per 100,000 person-days for unvaccinated and vaccinated women, respectively, during a mean follow-up period of 30 months (±22 months). A reduction in CIN2+ recurrences by 90% (95% confidence interval: 12-99%) was documented in 9vHPV-vaccinated participants compared to women undergoing only surgical excision. Moreover, vaccinated women with a positive cone margin showed a 42% (though non-significant) reduction in relapse (<i>p</i> = .661). Full post-conization vaccination with the 9vHPV contributed to an additional reduction in the risk of CIN2+ recurrence. This finding is consistent with current knowledge and suggests a high adjuvant effect of the 9vHPV vaccine.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899702","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}
The potential impact of combined COVID-19 and influenza vaccination on long COVID remains uncertain. In the present cross-sectional study, we aimed to investigate the plausible association between them in middle-aged and older Europeans based on the Survey of Health, Ageing, and Retirement in Europe (SHARE). A total of 1910 participants were recruited in the analyses. The study outcome was long COVID. Participants were divided into 4 groups through the self-reported status of COVID-19 and influenza vaccination. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. 1397 participants experienced long COVID. After multivariable adjustment, those vaccinated with neither COVID-19 nor influenza vaccine had higher risk of long COVID (OR, 1.72; 95% CI, 1.26-2.35) compared to those vaccinated with both vaccines. Furthermore, adding the 4 statuses of COVID-19 vaccination/influenza vaccination to conventional risk model improved risk reclassification for long COVID (continuous net reclassification improvement was 16.26% [p = .003], and integrated discrimination improvement was 0.51% [p = .005]). No heterogeneity was found in the subgroup analyses (all p-interaction ≥0.05). Our study might provide a strategy for people aged 50 and over to reduce the occurrence of long COVID, that is, to combine the use of the COVID-19 vaccine and influenza vaccines.
{"title":"Association between combination COVID-19-influenza vaccination and long COVID in middle-aged and older Europeans: A cross-sectional study.","authors":"Wenyan Wu, Xiaowei Zheng, Huan Ding, Tongtong Miao, Yuhan Zang, Suwen Shen, Yumeng Gao","doi":"10.1080/21645515.2024.2345505","DOIUrl":"10.1080/21645515.2024.2345505","url":null,"abstract":"<p><p>The potential impact of combined COVID-19 and influenza vaccination on long COVID remains uncertain. In the present cross-sectional study, we aimed to investigate the plausible association between them in middle-aged and older Europeans based on the Survey of Health, Ageing, and Retirement in Europe (SHARE). A total of 1910 participants were recruited in the analyses. The study outcome was long COVID. Participants were divided into 4 groups through the self-reported status of COVID-19 and influenza vaccination. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. 1397 participants experienced long COVID. After multivariable adjustment, those vaccinated with neither COVID-19 nor influenza vaccine had higher risk of long COVID (OR, 1.72; 95% CI, 1.26-2.35) compared to those vaccinated with both vaccines. Furthermore, adding the 4 statuses of COVID-19 vaccination/influenza vaccination to conventional risk model improved risk reclassification for long COVID (continuous net reclassification improvement was 16.26% [<i>p</i> = .003], and integrated discrimination improvement was 0.51% [<i>p</i> = .005]). No heterogeneity was found in the subgroup analyses (all <i>p</i>-interaction ≥0.05). Our study might provide a strategy for people aged 50 and over to reduce the occurrence of long COVID, that is, to combine the use of the COVID-19 vaccine and influenza vaccines.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11085989/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899740","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}
Pub Date : 2024-12-31Epub Date: 2024-03-22DOI: 10.1080/21645515.2024.2324549
Shant H Mahrokhian, Lisa H Tostanoski, Samuel J Vidal, Dan H Barouch
Severe disease due to COVID-19 has declined dramatically as a result of widespread vaccination and natural immunity in the population. With the emergence of SARS-CoV-2 variants that largely escape vaccine-elicited neutralizing antibody responses, the efficacy of the original vaccines has waned and has required vaccine updating and boosting. Nevertheless, hospitalizations and deaths due to COVID-19 have remained low. In this review, we summarize current knowledge of immune responses that contribute to population immunity and the mechanisms how vaccines attenuate COVID-19 disease severity.
{"title":"COVID-19 vaccines: Immune correlates and clinical outcomes.","authors":"Shant H Mahrokhian, Lisa H Tostanoski, Samuel J Vidal, Dan H Barouch","doi":"10.1080/21645515.2024.2324549","DOIUrl":"10.1080/21645515.2024.2324549","url":null,"abstract":"<p><p>Severe disease due to COVID-19 has declined dramatically as a result of widespread vaccination and natural immunity in the population. With the emergence of SARS-CoV-2 variants that largely escape vaccine-elicited neutralizing antibody responses, the efficacy of the original vaccines has waned and has required vaccine updating and boosting. Nevertheless, hospitalizations and deaths due to COVID-19 have remained low. In this review, we summarize current knowledge of immune responses that contribute to population immunity and the mechanisms how vaccines attenuate COVID-19 disease severity.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962618/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140186121","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}
Pub Date : 2024-12-31Epub Date: 2024-05-23DOI: 10.1080/21645515.2024.2357214
Bertin Mindje Kolomba, Francois Kalenga Luhembwe, Deca Blood Banza Ndala, Pacifique Kanku Wa Ilunga, Paul Ciamala Mukendi, Amide Ngongo Kitenge, John Ngoy Lumbule, Elie Kilolo Ngoy, Antoine Umba Ilunga, Judith Mbidi Miema, Christelle Kalikat Mwavita, Guillaume Ngoy Mwamba, Aime Cikomola Wa Bene, Audry Mulumba Wakamba, Alain Ngashi Ngongo, Michel Kabamba Nzaji
The COVID-19 booster dose is considered an important adjunct for the control of the COVID-19 pandemic due to reports of reduced immunity in fully vaccinated individuals. The aims of this study were to assess healthcare workers' intention to receive the booster dose of COVID-19 vaccine and to identify predictive factors among healthcare workers. A cross-sectional study was conducted among healthcare workers selected in two provinces, Kasai Oriental, and Haut-Lomami. Data were collected using a questionnaire administered through structured face-to-face interviews, with respondents using a pre-tested questionnaire set up on the Open Data Kit (ODK Collect). All data were analyzed using SPSS v26.0 (IBM Corporation, Armonk, NY, USA). Vaccination coverage for COVID-19, considering declarations by health workers, is around 85.9% for the province of Kasai Oriental and 85.8% for Haut-Lomami. A total of 975 responses were collected, 71.4% of health workers at Kasai Oriental and 66.4% from Haut-Lomami declared a definite willingness to receive a COVID-19 vaccine booster. The duration of protection was the main reason for accepting a booster COVID-19 dose for 64.6% of the respondents. Logistic regression analysis showed that having chronic diseases (aOR = 2.95 [1.65-5.28]), having already received one of the COVID-19 vaccines (aOR = 2.72 [1.43-5. 19]); the belief that only high-risk individuals, such as healthcare professionals and elderly people suffering from other illnesses, needed a booster dose (aOR = 1.75 [1.10-2.81]). Considering the burden of COVID-19, a high acceptance rate for booster doses could be essential to control the pandemic. Our results are novel and could help policymakers design and implement specific COVID-19 vaccination programs to reduce reluctance to seek booster vaccination.
{"title":"Healthcare workers' willingness to receive COVID-19 booster dose and associated factors in the Democratic Republic of the Congo.","authors":"Bertin Mindje Kolomba, Francois Kalenga Luhembwe, Deca Blood Banza Ndala, Pacifique Kanku Wa Ilunga, Paul Ciamala Mukendi, Amide Ngongo Kitenge, John Ngoy Lumbule, Elie Kilolo Ngoy, Antoine Umba Ilunga, Judith Mbidi Miema, Christelle Kalikat Mwavita, Guillaume Ngoy Mwamba, Aime Cikomola Wa Bene, Audry Mulumba Wakamba, Alain Ngashi Ngongo, Michel Kabamba Nzaji","doi":"10.1080/21645515.2024.2357214","DOIUrl":"10.1080/21645515.2024.2357214","url":null,"abstract":"<p><p>The COVID-19 booster dose is considered an important adjunct for the control of the COVID-19 pandemic due to reports of reduced immunity in fully vaccinated individuals. The aims of this study were to assess healthcare workers' intention to receive the booster dose of COVID-19 vaccine and to identify predictive factors among healthcare workers. A cross-sectional study was conducted among healthcare workers selected in two provinces, Kasai Oriental, and Haut-Lomami. Data were collected using a questionnaire administered through structured face-to-face interviews, with respondents using a pre-tested questionnaire set up on the Open Data Kit (ODK Collect). All data were analyzed using SPSS v26.0 (IBM Corporation, Armonk, NY, USA). Vaccination coverage for COVID-19, considering declarations by health workers, is around 85.9% for the province of Kasai Oriental and 85.8% for Haut-Lomami. A total of 975 responses were collected, 71.4% of health workers at Kasai Oriental and 66.4% from Haut-Lomami declared a definite willingness to receive a COVID-19 vaccine booster. The duration of protection was the main reason for accepting a booster COVID-19 dose for 64.6% of the respondents. Logistic regression analysis showed that having chronic diseases (aOR = 2.95 [1.65-5.28]), having already received one of the COVID-19 vaccines (aOR = 2.72 [1.43-5. 19]); the belief that only high-risk individuals, such as healthcare professionals and elderly people suffering from other illnesses, needed a booster dose (aOR = 1.75 [1.10-2.81]). Considering the burden of COVID-19, a high acceptance rate for booster doses could be essential to control the pandemic. Our results are novel and could help policymakers design and implement specific COVID-19 vaccination programs to reduce reluctance to seek booster vaccination.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11135840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141089161","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}
Pub Date : 2024-12-31Epub Date: 2024-05-17DOI: 10.1080/21645515.2024.2345943
Bowen Liu, Min Li, Xian Li, Jingyi Yang, Huimin Yan
Dental caries is a prevalent oral disease that mainly results from Streptococcus mutans. Susceptibility to S. mutans decreased rapidly after weaning in a well-known rat model. However, owing to the lack of time to establish protective immunity ahead of challenge, the weaning rat model is suboptimal for assessing prophylactic vaccines against S. mutans infection. In this study, we found that, in adult rats, S. mutans cultured under air-restricted conditions showed dramatically increased colonization efficacy and accelerated development of dental caries compared with those cultured under air-unrestricted conditions. We propose that S. mutans cultured under air-restricted conditions can be used to develop an optimal caries model, especially for the evaluation of prophylactic efficacy against S. mutans. Therefore, we used the anti-caries vaccine, KFD2-rPAc, to reevaluate the protection against the challenge of S. mutans. In immunized rats, rPAc-specific protective antibodies were robustly elicited by KFD2-rPAc before the challenge. In addition to inhibiting the initial and long-term colonization of S. mutans in vivo, KFD2-rPAc immunization showed an 83% inhibitory efficacy against the development of caries, similar to that previously evaluated in a weaning rat model. These results demonstrate that culturing under air-restricted conditions can promote S. mutans infection in adult rats, thereby helping establish a rat infection model to evaluate the prophylactic efficacy of vaccines and anti-caries drugs.
{"title":"An optimized caries model of <i>Streptococcus mutans</i> in rats and its application for evaluating prophylactic vaccines.","authors":"Bowen Liu, Min Li, Xian Li, Jingyi Yang, Huimin Yan","doi":"10.1080/21645515.2024.2345943","DOIUrl":"10.1080/21645515.2024.2345943","url":null,"abstract":"<p><p>Dental caries is a prevalent oral disease that mainly results from <i>Streptococcus mutans</i>. Susceptibility to <i>S. mutans</i> decreased rapidly after weaning in a well-known rat model. However, owing to the lack of time to establish protective immunity ahead of challenge, the weaning rat model is suboptimal for assessing prophylactic vaccines against <i>S. mutans</i> infection. In this study, we found that, in adult rats, <i>S. mutans</i> cultured under air-restricted conditions showed dramatically increased colonization efficacy and accelerated development of dental caries compared with those cultured under air-unrestricted conditions. We propose that <i>S. mutans</i> cultured under air-restricted conditions can be used to develop an optimal caries model, especially for the evaluation of prophylactic efficacy against <i>S. mutans</i>. Therefore, we used the anti-caries vaccine, KFD2-rPAc, to reevaluate the protection against the challenge of <i>S. mutans</i>. In immunized rats, rPAc-specific protective antibodies were robustly elicited by KFD2-rPAc before the challenge. In addition to inhibiting the initial and long-term colonization of <i>S. mutans in vivo</i>, KFD2-rPAc immunization showed an 83% inhibitory efficacy against the development of caries, similar to that previously evaluated in a weaning rat model. These results demonstrate that culturing under air-restricted conditions can promote <i>S. mutans</i> infection in adult rats, thereby helping establish a rat infection model to evaluate the prophylactic efficacy of vaccines and anti-caries drugs.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11110711/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140960468","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}
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in young children and associated with most bronchiolitis- and pneumonia-related hospitalizations. A new preventive monoclonal antibody (MAb), nirsevimab, has been launched in the United States, Luxembourg, and France, and was recently approved to be given in a population-based manner throughout Spain. This study aimed to have a first pre-immunization insight into the Spanish parental knowledge about bronchiolitis, RSV, and nirsevimab immunization. Parents in Murcia with children <2 years of age up to the date of September 1, 2023, were selected to complete a questionnaire. The primary endpoint was the parental knowledge about bronchiolitis, RSV, and nirsevimab. A total of 3,217 responses were analyzed. The majority (95.8%) were aware of bronchiolitis. Meanwhile, 46.6% of the respondents knew about RSV, most of them only after the first child's birth. Information about RSV or bronchiolitis was mainly obtained from family members, with only 4.8% reporting having been informed by Health care Professionals (HCPs). Only 11.2% of respondents were aware of nirsevimab. Nonetheless, these were not entirely satisfied with the information received (score of 3.3 out of 5) and shared that HCPs should be the primary source of information. The present survey then highlights the need for better and more efficient educational strategies directed to all parents/legal guardians. It also sheds some light on the different factors that should be considered to improve awareness of RSV immunization to decrease its burden in Spain and beyond.
{"title":"Parental knowledge on the respiratory syncytial virus before the nirsevimab immunization program: Attitudes toward immunization in an autonomous community of Spain.","authors":"Matilde Zornoza Moreno, Jaime Jesús Pérez Martín, Mª Cruz Gómez Moreno, Mª Pilar Ros Abellán","doi":"10.1080/21645515.2024.2357439","DOIUrl":"10.1080/21645515.2024.2357439","url":null,"abstract":"<p><p>Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in young children and associated with most bronchiolitis- and pneumonia-related hospitalizations. A new preventive monoclonal antibody (MAb), nirsevimab, has been launched in the United States, Luxembourg, and France, and was recently approved to be given in a population-based manner throughout Spain. This study aimed to have a first pre-immunization insight into the Spanish parental knowledge about bronchiolitis, RSV, and nirsevimab immunization. Parents in Murcia with children <2 years of age up to the date of September 1, 2023, were selected to complete a questionnaire. The primary endpoint was the parental knowledge about bronchiolitis, RSV, and nirsevimab. A total of 3,217 responses were analyzed. The majority (95.8%) were aware of bronchiolitis. Meanwhile, 46.6% of the respondents knew about RSV, most of them only after the first child's birth. Information about RSV or bronchiolitis was mainly obtained from family members, with only 4.8% reporting having been informed by Health care Professionals (HCPs). Only 11.2% of respondents were aware of nirsevimab. Nonetheless, these were not entirely satisfied with the information received (score of 3.3 out of 5) and shared that HCPs should be the primary source of information. The present survey then highlights the need for better and more efficient educational strategies directed to all parents/legal guardians. It also sheds some light on the different factors that should be considered to improve awareness of RSV immunization to decrease its burden in Spain and beyond.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11168215/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141301904","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}
Pub Date : 2024-12-31Epub Date: 2024-06-17DOI: 10.1080/21645515.2024.2362450
Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani
Biosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities in regulations of biosimilar vaccines and immunotherapeutic products across different nations. It also navigates the benefits of global regulatory alignment and challenges that may be encountered. The current discrepancies in regulations across different countries, which pose significant challenges for the development and approval of biosimilar vaccines and immunotherapeutic products. These disparities often lead to delayed market access, increased development costs, and hindered innovation. The commentary stresses that such obstacles could be mitigated through harmonized regulations, resulting in faster approvals, reduced healthcare costs, and improved patient outcomes. Moreover, the commentary explores the specific complexities associated with biosimilar vaccines and immunotherapeutic, such as the intricate evaluation of biosimilarity due to their molecular composition and immunogenic properties. In conclusion, the editorial advocates for collaborative efforts to overcome the challenges in achieving global regulatory harmonization for biosimilars. This includes establishing uniform standards, fostering international cooperation among regulatory agencies, and promoting educational initiatives for healthcare providers and regulators. The ultimate goal is to ensure that patients worldwide have timely access to safe, effective, and affordable biosimilar treatments.
{"title":"Bridging the gap: The future of biosimilars regulations.","authors":"Anan S Jarab, Shrouq R Abu Heshmeh, Ahmad Z Al Meslamani","doi":"10.1080/21645515.2024.2362450","DOIUrl":"10.1080/21645515.2024.2362450","url":null,"abstract":"<p><p>Biosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities in regulations of biosimilar vaccines and immunotherapeutic products across different nations. It also navigates the benefits of global regulatory alignment and challenges that may be encountered. The current discrepancies in regulations across different countries, which pose significant challenges for the development and approval of biosimilar vaccines and immunotherapeutic products. These disparities often lead to delayed market access, increased development costs, and hindered innovation. The commentary stresses that such obstacles could be mitigated through harmonized regulations, resulting in faster approvals, reduced healthcare costs, and improved patient outcomes. Moreover, the commentary explores the specific complexities associated with biosimilar vaccines and immunotherapeutic, such as the intricate evaluation of biosimilarity due to their molecular composition and immunogenic properties. In conclusion, the editorial advocates for collaborative efforts to overcome the challenges in achieving global regulatory harmonization for biosimilars. This includes establishing uniform standards, fostering international cooperation among regulatory agencies, and promoting educational initiatives for healthcare providers and regulators. The ultimate goal is to ensure that patients worldwide have timely access to safe, effective, and affordable biosimilar treatments.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11188803/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141421514","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}
Pub Date : 2024-12-31Epub Date: 2024-06-27DOI: 10.1080/21645515.2024.2365771
Sara Maria Majernikova
Treating non-small-cell lung cancer (NSCLC) has gained increased importance in recent years due to the high mortality rate and dismal five-year survival rate. Immune checkpoint inhibitors (ICI) are a promising approach with exceptional outcomes in NSCLC thanks to the antigenic nature of cells. Conversely, immune system over-stimulation with ICI is a double-edged sword that can lead to various negative effects ranging from mild to life-threatening. This review explores current breakthroughs in nanoparticle-based ICI and their limitations. The PubMed, Scopus and Web of Science were examined for relevant publications. Thirty-eight trials (N = 16,781) were included in the analyses. The mixed effects analyses on quantifying the treatment effect contributed significantly to the subgroups within studies for ICI treatment effect. Models confirmed ICI's higher impact on treatment effectivity and the decrease in respondents' mortality compared to conventional treatment regiments. ICI might be used as first-line therapy due to their proven effectiveness and safety profile.
近年来,由于非小细胞肺癌(NSCLC)的高死亡率和令人沮丧的五年生存率,其治疗变得越来越重要。免疫检查点抑制剂(ICI)是一种很有前景的方法,由于细胞的抗原性,它在治疗非小细胞肺癌方面效果显著。相反,免疫系统过度刺激 ICI 是一把双刃剑,可导致轻微到危及生命的各种负面影响。本综述探讨了目前基于纳米粒子的 ICI 取得的突破及其局限性。我们在 PubMed、Scopus 和 Web of Science 上查阅了相关出版物。38项试验(N = 16,781)被纳入分析。量化治疗效果的混合效应分析极大地促进了ICI治疗效果研究中的分组。模型证实,与传统治疗方案相比,ICI 对治疗效果的影响更大,受访者的死亡率也更低。由于 ICI 的有效性和安全性已得到证实,因此可将其用作一线疗法。
{"title":"Risk and safety profile in checkpoint inhibitors on non-small-cel lung cancer: A systematic review.","authors":"Sara Maria Majernikova","doi":"10.1080/21645515.2024.2365771","DOIUrl":"10.1080/21645515.2024.2365771","url":null,"abstract":"<p><p>Treating non-small-cell lung cancer (NSCLC) has gained increased importance in recent years due to the high mortality rate and dismal five-year survival rate. Immune checkpoint inhibitors (ICI) are a promising approach with exceptional outcomes in NSCLC thanks to the antigenic nature of cells. Conversely, immune system over-stimulation with ICI is a double-edged sword that can lead to various negative effects ranging from mild to life-threatening. This review explores current breakthroughs in nanoparticle-based ICI and their limitations. The PubMed, Scopus and Web of Science were examined for relevant publications. Thirty-eight trials (<i>N</i> = 16,781) were included in the analyses. The mixed effects analyses on quantifying the treatment effect contributed significantly to the subgroups within studies for ICI treatment effect. Models confirmed ICI's higher impact on treatment effectivity and the decrease in respondents' mortality compared to conventional treatment regiments. ICI might be used as first-line therapy due to their proven effectiveness and safety profile.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11212564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141460243","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}
Pub Date : 2024-12-31Epub Date: 2024-05-07DOI: 10.1080/21645515.2024.2345940
Zelan Dai, Ruiru Cai, Hong Zeng, Hailian Zhu, Youwei Dou, Shibo Sun
Traditional vaccines have limits against some persistent infections and pathogens. The development of novel vaccine technologies is particularly critical for the future. Exosomes play an important role in physiological and pathological processes. Exosomes present many advantages, such as inherent capacity being biocompatible, non-toxic, which make them a more desirable candidate for vaccines. However, research on exosomes are in their infancy and the barriers of low yield, low purity, and weak targeting of exosomes limit their applications in vaccines. Accordingly, further exploration is necessary to improve these problems and subsequently facilitate the functional studies of exosomes. In this study, we reviewed the origin, classification, functions, modifications, separation and purification, and characterization methods of exosomes. Meanwhile, we focused on the role and mechanism of exosomes for cancer and COVID-19 vaccines.
{"title":"Exosome may be the next generation of promising cell-free vaccines.","authors":"Zelan Dai, Ruiru Cai, Hong Zeng, Hailian Zhu, Youwei Dou, Shibo Sun","doi":"10.1080/21645515.2024.2345940","DOIUrl":"10.1080/21645515.2024.2345940","url":null,"abstract":"<p><p>Traditional vaccines have limits against some persistent infections and pathogens. The development of novel vaccine technologies is particularly critical for the future. Exosomes play an important role in physiological and pathological processes. Exosomes present many advantages, such as inherent capacity being biocompatible, non-toxic, which make them a more desirable candidate for vaccines. However, research on exosomes are in their infancy and the barriers of low yield, low purity, and weak targeting of exosomes limit their applications in vaccines. Accordingly, further exploration is necessary to improve these problems and subsequently facilitate the functional studies of exosomes. In this study, we reviewed the origin, classification, functions, modifications, separation and purification, and characterization methods of exosomes. Meanwhile, we focused on the role and mechanism of exosomes for cancer and COVID-19 vaccines.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11086043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140877748","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}