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Rabies post-exposure prophylaxis in India: a SWOT analysis. 印度狂犬病暴露后预防:SWOT分析。
Q2 Medicine Pub Date : 2026-01-02 eCollection Date: 2026-01-01 DOI: 10.1177/25151355251410780
Geeta Pardeshi, Priyanka Sharma, Anjana Ittiel

Rabies remains a pressing public health issue, particularly in countries like India, where it inflicts a significant toll on marginalised communities. With approximately 20,000 deaths annually due to rabies, the disease underscores the urgency for effective prevention strategies. Despite the existence of post-exposure prophylaxis (PEP), rabies continues to claim lives, highlighting the importance of understanding and addressing the challenges in its implementation. This study aims to conduct a comprehensive analysis of strengths, weaknesses, opportunities and threats (SWOT) of India's rabies PEP programme, emphasising the urgent need for enhanced strategies to combat this preventable yet incurable disease. A thorough review of scientific literature, governmental guidelines, programme documents and media reports related to rabies and PEP was undertaken. The SWOT matrix was employed to categorise the identified factors influencing PEP administration. The analysis revealed both strengths and weaknesses inherent in the current PEP programme. Despite the availability of effective biological products and political commitment, challenges such as inadequate inventory management, delayed dissemination of guidelines, poor awareness, inadequate infrastructure and budgetary constraints persist. However, opportunities for improvement, including information dissemination and technological innovations, were identified. Threats such as pandemics and misleading media reports pose additional challenges to rabies control efforts. By emphasising the preventable yet incurable nature of rabies and highlighting the annual toll it exacts on human lives, this study underscores the urgency for effective and coordinated public health interventions to achieve the goal of dog-mediated rabies elimination by 2030. The findings underscore the critical importance of addressing weaknesses and capitalising on opportunities to strengthen rabies control strategies in India. Proactive measures are essential to enhance inventory management, ensure guidelines' dissemination, improve awareness levels, strengthen infrastructure and leverage technological advancements. Additionally, addressing threats such as pandemics and media misinformation requires collaborative efforts and proactive risk communication strategies. Through a targeted approach focused on enhancing rabies PEP implementation along with other measures such as community engagement to build awareness about rabies, and canine vaccination, including mass dog vaccination, India can significantly reduce the burden of rabies-related mortality.

狂犬病仍然是一个紧迫的公共卫生问题,特别是在印度等国家,它给边缘化社区造成了重大损失。每年约有20 000人死于狂犬病,这一疾病凸显了制定有效预防战略的紧迫性。尽管存在暴露后预防措施(PEP),但狂犬病仍在夺去生命,这凸显了理解并应对其实施过程中的挑战的重要性。本研究的目的是对印度狂犬病PEP计划的优势、劣势、机会和威胁(SWOT)进行全面分析,强调迫切需要加强战略,以对抗这种可预防但无法治愈的疾病。对与狂犬病和人PEP有关的科学文献、政府指南、规划文件和媒体报道进行了全面审查。运用SWOT矩阵对确定的影响PEP管理的因素进行分类。分析揭示了当前人培方案固有的优点和缺点。尽管有有效的生物制品和政治承诺,但诸如库存管理不足、准则传播延迟、认识不足、基础设施不足和预算限制等挑战仍然存在。但是,已经确定了改进的机会,包括信息传播和技术革新。流行病和误导性媒体报道等威胁对狂犬病控制工作构成了额外的挑战。通过强调狂犬病可预防但无法治愈的性质,并强调狂犬病每年给人类生命造成的损失,本研究强调亟须采取有效和协调的公共卫生干预措施,以实现到2030年消除犬类狂犬病的目标。研究结果强调了解决弱点和利用机会加强印度狂犬病控制战略的关键重要性。积极主动的措施对于加强库存管理、确保指南的传播、提高认识水平、加强基础设施和利用技术进步至关重要。此外,应对流行病和媒体错误信息等威胁需要合作努力和积极主动的风险沟通战略。通过有针对性的方法,重点加强狂犬病预防措施的实施,以及社区参与以提高对狂犬病的认识和犬类疫苗接种(包括大规模犬类疫苗接种)等其他措施,印度可以显著减轻与狂犬病相关的死亡率负担。
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引用次数: 0
Exploring the safety and immunogenicity of the VLA15 vaccine among healthy or high-risk population: a systematic review and meta-analysis of randomized controlled trials. 探索VLA15疫苗在健康或高危人群中的安全性和免疫原性:随机对照试验的系统回顾和荟萃分析
Q2 Medicine Pub Date : 2025-10-28 eCollection Date: 2025-01-01 DOI: 10.1177/25151355251387927
Tayyaba Naseem Abbasi, Muhammad Saad Khan, Erum Siddiqui, Muhammad Ahmed Zaheer, Areeba Tabassum, Naila Zainab, Aminath Waafira

Background: Lyme disease, the most common vector-borne illness in the Northern Hemisphere, is caused by Borrelia burgdorferi and transmitted via tick bites. With rising global incidence and no approved human vaccine, VLA15, a novel recombinant vaccine targeting six OspA serotypes, shows promise as an effective preventive strategy.

Objective: This study aims to assess the safety and immunogenicity of the VLA15 vaccine among healthy or high-risk populations.

Design: We conducted a systematic review and meta-analysis of three randomized controlled trials.

Methods: This systematic review and meta-analysis, registered in PROSPERO (CRD420251058818), was conducted following PRISMA guidelines. A thorough search of PubMed, EMBASE, Cochrane Library, Scopus, ScienceDirect, and ClinicalTrials.gov was performed up to May 2025. Data extraction and quality assessment (using Cochrane ROB 2) were performed independently by reviewers. Risk ratios (RR) with 95% confidence intervals (CI) were calculated using random-effects models.

Results: Three RCTs, including 5907 participants (4500 VLA15; 1407 placebo), met inclusion criteria. VLA15 recipients showed a significantly higher risk of adverse events: fever (RR 2.65, 95% CI: 1.77-3.96), headache (RR 1.40, 95% CI: 1.21-1.62), fatigue (RR 1.33, 95% CI: 1.15-1.55), and arthralgia (RR 2.50, 95% CI: 1.67-3.76), all with p < 0.0001. Subgroup analysis revealed a dose-response trend for arthralgia, particularly at 135 μg and 180 μg doses. However, nausea (RR = 1.34, p = 0.10) and severe unsolicited AEs (RR = 1.22, p = 0.42) were not statistically significant, suggesting no meaningful increase in these risks. Immunogenicity outcomes consistently favored VLA15, showing elevated IgG levels, GMTs, and seroconversion rates.

Conclusion: VLA15 exhibits strong immunogenicity and acceptable safety, despite an increased risk of mild-to-moderate adverse events. Continued research and monitoring are warranted to support its use in Lyme disease prevention.

背景:莱姆病是北半球最常见的媒介传播疾病,由伯氏疏螺旋体引起,并通过蜱叮咬传播。随着全球发病率的上升和没有批准的人类疫苗,一种针对6种OspA血清型的新型重组疫苗VLA15显示出作为有效预防策略的希望。目的:本研究旨在评估VLA15疫苗在健康或高危人群中的安全性和免疫原性。设计:我们对三个随机对照试验进行了系统回顾和荟萃分析。方法:该系统评价和荟萃分析,注册于PROSPERO (CRD420251058818),遵循PRISMA指南进行。对PubMed, EMBASE, Cochrane Library, Scopus, ScienceDirect和ClinicalTrials.gov进行了彻底的搜索,直到2025年5月。数据提取和质量评估(使用Cochrane ROB 2)由审稿人独立进行。使用随机效应模型计算95%置信区间(CI)的风险比(RR)。结果:3项rct,包括5907名受试者(4500名VLA15; 1407名安慰剂),符合纳入标准。接受VLA15治疗的患者出现不良事件的风险明显增加:发热(RR 2.65, 95% CI: 1.77-3.96)、头痛(RR 1.40, 95% CI: 1.21-1.62)、疲劳(RR 1.33, 95% CI: 1.15-1.55)、关节痛(RR 2.50, 95% CI: 1.67-3.76),均p = 0.10)和严重的主动不良事件(RR = 1.22, p = 0.42)均无统计学意义,表明这些风险没有显著增加。免疫原性结果一致支持VLA15,显示IgG水平、GMTs和血清转化率升高。结论:尽管轻度至中度不良事件的风险增加,但VLA15显示出强大的免疫原性和可接受的安全性。有必要继续进行研究和监测,以支持其在莱姆病预防中的应用。
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引用次数: 0
Immunization safety monitoring: addressing vaccine hesitancy and enhancing coverage in crisis-affected regions-insights from Lebanon, Ukraine, and Sudan. 免疫安全监测:在受危机影响的地区解决疫苗犹豫问题并提高覆盖率——来自黎巴嫩、乌克兰和苏丹的见解
Q2 Medicine Pub Date : 2025-09-25 eCollection Date: 2025-01-01 DOI: 10.1177/25151355251380220
Ramona Nasr, Eman Swaidan, Samah Hachem, Noura Yazbek, Mahdi Rizk, Abir Abdel Rahman, Nael H Alami

Global vaccine hesitancy, intensified by crises such as the COVID-19 pandemic, represents a significant threat to immunization coverage. This narrative review discusses immunization safety monitoring frameworks and vaccine hesitancy in crisis-affected regions, particularly in Lebanon, Ukraine, and Sudan. By examining and reflecting on these case studies, this review aims to examine challenges, highlight context-specific strategies, and propose solutions for enhancing vaccine uptake and trust in fragile and conflict-affected areas. A structured narrative review was conducted, collecting evidence from global frameworks and region-specific case studies. The review explored factors impacting vaccine hesitancy, the role of adverse events following immunization (AEFI) monitoring systems, and innovative technological interventions. Key sources included peer-reviewed articles, reports from humanitarian organizations, and systematic reviews. The review showed that vaccine hesitancy is affected by interconnected factors, including sociopolitical and cultural conflicts, and misinformation. Lebanon's persistent economic and political instability, Ukraine's disruptions caused by the ongoing war, and Sudan's fragile healthcare infrastructure pose challenges to vaccine coverage. Successful interventions to address hesitancy included transparency in AEFI reporting, integration of real-time monitoring systems, and community-led initiatives. It is critical to mitigate vaccine hesitancy in crisis-affected regions through robust safety monitoring frameworks and tailored communication strategies. Global cooperation and frameworks, technological innovations, and context-specific approaches are imperative for improving the resilience of immunization systems and ensuring health security in fragile settings. Furthermore, these insights are crucial in informing public health communication policies and behavior change interventions to improve public trust and thus reduce vaccine hesitancy.

COVID-19大流行等危机加剧了全球疫苗犹豫,对免疫覆盖构成重大威胁。本综述讨论了受危机影响地区,特别是黎巴嫩、乌克兰和苏丹的免疫安全监测框架和疫苗犹豫问题。通过审查和反思这些案例研究,本综述旨在审查挑战,突出针对具体情况的战略,并提出解决方案,以加强脆弱和受冲突影响地区的疫苗接种和信任。进行了有组织的叙述性审查,从全球框架和特定区域的案例研究中收集证据。这篇综述探讨了影响疫苗犹豫的因素、免疫后不良事件(AEFI)监测系统的作用以及创新技术干预措施。主要来源包括同行评议的文章、人道主义组织的报告和系统评论。审查表明,疫苗犹豫受到相互关联的因素的影响,包括社会政治和文化冲突以及错误信息。黎巴嫩持续的经济和政治不稳定、乌克兰持续的战争造成的破坏以及苏丹脆弱的卫生保健基础设施对疫苗覆盖构成挑战。解决犹豫的成功干预措施包括提高AEFI报告的透明度、整合实时监测系统和社区主导的倡议。至关重要的是,通过强有力的安全监测框架和量身定制的沟通战略,减轻受危机影响地区的疫苗犹豫。全球合作与框架、技术创新和因地制宜的方法对于提高免疫系统的复原力和确保脆弱环境中的卫生安全至关重要。此外,这些见解对于为公共卫生传播政策和行为改变干预提供信息,以提高公众信任,从而减少疫苗犹豫至关重要。
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引用次数: 0
The urgent need for a licensed dengue vaccine in the Philippines. 菲律宾迫切需要获得许可的登革热疫苗。
Q2 Medicine Pub Date : 2025-09-23 eCollection Date: 2025-01-01 DOI: 10.1177/25151355251380216
Dalmacito A Cordero
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引用次数: 0
Uptake of human papillomavirus vaccination and associated factors among high school female students in Dessie City Administration, North East Ethiopia: a cross-sectional study. 埃塞俄比亚东北部德西市政府高中女生人乳头瘤病毒疫苗接种情况及其相关因素:一项横断面研究
Q2 Medicine Pub Date : 2025-09-17 eCollection Date: 2025-01-01 DOI: 10.1177/25151355251375970
Abdu Hussen, Nigusie Tadesse, Endalew Minwuye Andargie, Yonas Fissha Adem

Background: The vaccination for human papillomavirus (HPV) is a widely acknowledged global measure aimed at preventing cervical cancer. However, the rate of vaccine adoption differs across various regions and countries due to a number of discouraging factors. Therefore, this study aimed to assess the uptake of HPV vaccination and associated factors among high school female students in Dessie City Administration, Northeast Ethiopia, 2023.

Methods: School-based cross-sectional study was conducted among 410 high school female students in Dessie City Administration from April 1, 2023, to May 1, 2023. Participants were selected using a simple random sampling technique. The data were collected using self-administered questionnaires. Data were entered using EPI data version 4.6 and exported to SPSS version 26 for analysis. Data were presented with frequency tables, graphs, and pie charts. To determine the factors associated with the outcome, a two-step logistic regression approach was employed. Initially, a bivariable analysis identified potential predictor variables with a p-value of less than 0.25, which were then included in a multivariable model. A p-value of less than 0.05 and an adjusted odds ratio at a 95% confidence level were used to confirm associations. In addition, the Hosmer-Lemeshow test was used to assess the model's goodness of fit.

Results: The overall uptake of the HPV vaccine among female high school students in Dessie City was 54.9% with 95% CI (50.2, 59.8). In this study finding, fathers' educational level (AOR = 5.00, 95% CI: (1.59, 15.73)), source of information (AOR = 2.08, 95% CI: (1.13, 3.83)), and having positive attitude toward HPV vaccination (AOR = 1.88, 95% CI: 1.23, 2.87) were variables that showed a significant association with uptake of HPV vaccine.

Conclusion: In this study, nearly half a percent of female high school students did not uptake the HPV vaccine. Fathers' education level, source of information, and positive attitude were positively associated with the uptake of the HPV vaccine among female high school students. Therefore, schools should provide continuous school-based training about the HPV vaccine to foster attitudinal change among female high school students.

背景:接种人乳头瘤病毒(HPV)疫苗是全球广泛认可的预防宫颈癌的措施。然而,由于一些令人沮丧的因素,不同区域和国家的疫苗采用率不同。因此,本研究旨在评估2023年埃塞俄比亚东北部Dessie City Administration高中女生HPV疫苗接种情况及其相关因素。方法:于2023年4月1日至2023年5月1日,对Dessie City Administration的410名高中女生进行校本横断面调查。参与者是通过简单的随机抽样技术选择的。数据是通过自我管理的问卷收集的。使用EPI数据版本4.6输入数据,导出到SPSS版本26进行分析。数据以频率表、图形和饼状图的形式呈现。为了确定与结果相关的因素,采用了两步逻辑回归方法。最初,双变量分析确定了p值小于0.25的潜在预测变量,然后将其纳入多变量模型。使用小于0.05的p值和95%置信水平的校正优势比来证实相关性。此外,采用Hosmer-Lemeshow检验来评估模型的拟合优度。结果:德西市女高中生HPV疫苗的总体接种率为54.9%,95% CI(50.2, 59.8)。本研究发现,父亲的受教育程度(AOR = 5.00, 95% CI:(1.59, 15.73))、信息来源(AOR = 2.08, 95% CI:(1.13, 3.83))和对HPV疫苗接种的积极态度(AOR = 1.88, 95% CI: 1.23, 2.87)是与HPV疫苗接种率显著相关的变量。结论:在这项研究中,近0.5%的女高中生没有接种HPV疫苗。父亲的受教育程度、信息来源和积极态度与女高中生HPV疫苗接种率呈正相关。因此,学校应持续提供有关HPV疫苗的校本培训,以促进女高中生态度的改变。
{"title":"Uptake of human papillomavirus vaccination and associated factors among high school female students in Dessie City Administration, North East Ethiopia: a cross-sectional study.","authors":"Abdu Hussen, Nigusie Tadesse, Endalew Minwuye Andargie, Yonas Fissha Adem","doi":"10.1177/25151355251375970","DOIUrl":"10.1177/25151355251375970","url":null,"abstract":"<p><strong>Background: </strong>The vaccination for human papillomavirus (HPV) is a widely acknowledged global measure aimed at preventing cervical cancer. However, the rate of vaccine adoption differs across various regions and countries due to a number of discouraging factors. Therefore, this study aimed to assess the uptake of HPV vaccination and associated factors among high school female students in Dessie City Administration, Northeast Ethiopia, 2023.</p><p><strong>Methods: </strong>School-based cross-sectional study was conducted among 410 high school female students in Dessie City Administration from April 1, 2023, to May 1, 2023. Participants were selected using a simple random sampling technique. The data were collected using self-administered questionnaires. Data were entered using EPI data version 4.6 and exported to SPSS version 26 for analysis. Data were presented with frequency tables, graphs, and pie charts. To determine the factors associated with the outcome, a two-step logistic regression approach was employed. Initially, a bivariable analysis identified potential predictor variables with a <i>p</i>-value of less than 0.25, which were then included in a multivariable model. A <i>p</i>-value of less than 0.05 and an adjusted odds ratio at a 95% confidence level were used to confirm associations. In addition, the Hosmer-Lemeshow test was used to assess the model's goodness of fit.</p><p><strong>Results: </strong>The overall uptake of the HPV vaccine among female high school students in Dessie City was 54.9% with 95% CI (50.2, 59.8). In this study finding, fathers' educational level (AOR = 5.00, 95% CI: (1.59, 15.73)), source of information (AOR = 2.08, 95% CI: (1.13, 3.83)), and having positive attitude toward HPV vaccination (AOR = 1.88, 95% CI: 1.23, 2.87) were variables that showed a significant association with uptake of HPV vaccine.</p><p><strong>Conclusion: </strong>In this study, nearly half a percent of female high school students did not uptake the HPV vaccine. Fathers' education level, source of information, and positive attitude were positively associated with the uptake of the HPV vaccine among female high school students. Therefore, schools should provide continuous school-based training about the HPV vaccine to foster attitudinal change among female high school students.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"13 ","pages":"25151355251375970"},"PeriodicalIF":0.0,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12446816/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145114237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bridging the gaps in Mpox vaccine equity: insights and imperatives from the Philippine public health landscape. 弥合Mpox疫苗公平方面的差距:来自菲律宾公共卫生领域的见解和必要性。
Q2 Medicine Pub Date : 2025-08-17 eCollection Date: 2025-01-01 DOI: 10.1177/25151355251369156
Danilo V Rogayan
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引用次数: 0
Cervical cancer trends, HPV vaccine utilization, and screening in low- and lower-middle-income countries: an updated review. 低收入和中低收入国家的宫颈癌趋势、HPV疫苗使用和筛查:最新综述
Q2 Medicine Pub Date : 2025-07-24 eCollection Date: 2025-01-01 DOI: 10.1177/25151355251356646
Mohammad Khaled Iqbal Hamid, Subeh Hasneen, Aklima Khan Lima, Shandipon Roy Shawon, Mohammad Shahriar, Ramisa Anjum

Cervical cancer is the fourth most common cancer among women worldwide, with 660,000 new cases and 350,000 deaths reported in 2022. This disease mainly affects women in low- and lower-middle-income countries (LMICs), where 90% of cases occur. This study explored how LMICs are responding to the World Health Organization's (WHO) call to eliminate cervical cancer. It looked at cervical cancer rates, the use of human papillomavirus (HPV) vaccines, and suggested strategies to fight the disease. The study analyzed the rates of cervical cancer and deaths in LMICs, the effectiveness of HPV vaccination programs, and how well screening efforts are working. To compare data across countries, it used age-standardized incidence rates (ASIRs) and age-standardized mortality rates (ASMRs) per 100,000 women per year. In 2022, the ASIR was 25.4% in lower income countries and 16.9% in lower-middle-income countries. The ASMR was also higher in lower income countries (18.5%) compared to lower-middle-income countries (10.3%). HPV vaccine coverage remains low in many LMICs, with significant differences between the rates of first and final doses completed. By 2050, the number of new cervical cancer cases is expected to rise. Although the WHO aims to eliminate cervical cancer by achieving 90% HPV vaccination by age 15, 70% screening coverage, and 90% access to treatment, many challenges remain in LMICs. These include weak healthcare systems, poor infrastructure, and a lack of health education. Overcoming these challenges through better vaccine distribution, improved screening programs, and stronger healthcare systems is essential to eliminate cervical cancer.

宫颈癌是全球第四大最常见的女性癌症,2022年报告了66万例新病例和35万例死亡。这种疾病主要影响低收入和中低收入国家的妇女,90%的病例发生在这些国家。这项研究探讨了中低收入国家如何响应世界卫生组织(WHO)消除宫颈癌的呼吁。它研究了宫颈癌的发病率、人类乳头瘤病毒(HPV)疫苗的使用情况,并提出了对抗这种疾病的策略。该研究分析了中低收入国家的宫颈癌发病率和死亡率,HPV疫苗接种计划的有效性,以及筛查工作的效果。为了比较各国的数据,它使用了每年每10万名妇女的年龄标准化发病率(asir)和年龄标准化死亡率(ASMRs)。2022年,低收入国家和中低收入国家的ASIR分别为25.4%和16.9%。低收入国家的ASMR(18.5%)也高于中低收入国家(10.3%)。许多中低收入国家的人乳头瘤病毒疫苗覆盖率仍然很低,第一剂和最后一剂的接种率之间存在显著差异。预计到2050年,子宫颈癌的新个案数目会上升。尽管世卫组织的目标是到15岁时实现90%的人乳头瘤病毒疫苗接种、70%的筛查覆盖率和90%的治疗可及性,从而消除宫颈癌,但中低收入国家仍面临许多挑战。这些问题包括卫生保健系统薄弱、基础设施差和缺乏卫生教育。通过更好地分发疫苗、改进筛查项目和加强医疗保健系统来克服这些挑战,对于消除宫颈癌至关重要。
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引用次数: 0
Mpox vaccine in the Philippines: the waiting continues, but until when? 菲律宾的麻疹疫苗:等待仍在继续,但要等到什么时候?
Q2 Medicine Pub Date : 2025-07-06 eCollection Date: 2025-01-01 DOI: 10.1177/25151355251356647
Dalmacito A Cordero
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引用次数: 0
Trends in uptake and impact of thermostable vaccines in Africa. 非洲使用耐热疫苗的趋势和影响。
Q2 Medicine Pub Date : 2025-06-18 eCollection Date: 2025-01-01 DOI: 10.1177/25151355251341662
Sophia Khalayi Kitui, Evans Juma, Maureen Tayamika Ndalama, Dagmawi Chilot, Dejene Tolossa, Betelhiem Woldemedhin, Seke G Y Muzazu, Kidist Digamo, Job Mungania, Tsegahun Manyazewal

Vaccination in Africa faces significant challenges due to inadequate cold chain infrastructure, particularly in regions lacking reliable electricity. Approximately 80% of prequalified vaccines require cold chain systems to maintain their potency, which is often unfeasible in remote areas. Exposure to extreme temperatures can lead to a loss of vaccine potency, making it crucial to explore alternatives. Thermostable vaccines represent a technological advancement that addresses these challenges by eliminating the need for cold chain mechanisms during transport and storage. This narrative review analyzes trends in the uptake of thermostable vaccines and their impact across Africa. A total of 10 studies were reviewed, encompassing 14 African countries, revealing critical insights into the potential of thermostable vaccines to enhance immunization coverage in settings with limited access to traditional cold chain facilities. These vaccines, which maintain their efficacy even when exposed to higher temperatures for short periods, offer a promising solution to the logistical and economic hurdles of vaccine delivery in resource-limited settings.

由于冷链基础设施不足,特别是在缺乏可靠电力的地区,非洲的疫苗接种面临重大挑战。大约80%的资格预审疫苗需要冷链系统来保持其效力,这在偏远地区往往是不可行的。暴露在极端温度下可能导致疫苗效力丧失,因此探索替代方案至关重要。耐热疫苗代表了一项技术进步,通过消除运输和储存过程中对冷链机制的需求,解决了这些挑战。本综述分析了在整个非洲使用耐热性疫苗的趋势及其影响。总共审查了10项研究,涉及14个非洲国家,揭示了耐热疫苗在传统冷链设施有限的环境中提高免疫覆盖率的潜力的重要见解。这些疫苗即使短期暴露在较高温度下也能保持其效力,为解决在资源有限的情况下疫苗交付的后勤和经济障碍提供了一个有希望的解决方案。
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引用次数: 0
Evaluating the immunogenicity and safety of ID93 + GLA-SE in BCG-vaccinated healthy adults: a systematic review and meta-analysis of randomized controlled trials. 评估接种bcg的健康成人ID93 + GLA-SE的免疫原性和安全性:随机对照试验的系统回顾和荟萃分析
Q2 Medicine Pub Date : 2025-06-05 eCollection Date: 2025-01-01 DOI: 10.1177/25151355251344473
Erum Siddiqui, Mohammad Saad Khan, Maliha Khalid, Harshika Khaim Chandani, Umaimah Naeem, Muhammad Mohsin Khan, Syed Owais Wasti

Background: Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), is an ancient disease that continues to pose a significant threat to global public health. Although the BCG vaccine, developed in the 1920s, remains the only approved TB vaccine, it has limited efficacy, particularly against pulmonary TB in adults. The ID93/GLA-SE vaccine, a recombinant subunit vaccine, shows promise by triggering immune solid responses and could be a key solution in combating TB, particularly in the face of rising drug-resistant strains and suboptimal current vaccines. It has the potential to address the unmet need for more effective interventions against drug-resistant TB, a growing global health issue that continues to challenge existing treatment options.

Objective: To evaluate the immunogenicity and safety of ID93 + GLA-SE in BCG-vaccinated healthy adults.

Methods: A comprehensive electronic search on PubMed (Medline), ScienceDirect, EMBASE, Scopus, and Cochrane Central database was conducted from inception till August 2024 for randomized controlled trials (RCTs) with a target population of BCG-vaccinated healthy adults. This review was conducted according to (PRISMA) criteria and registered with PROSPERO (CRD42024601450). This meta-analysis used Review Manager and forest plots for visual display. The outcomes were displayed as risk ratios (RR) with a 95% confidence interval.

Results: The ID93 + GLA-SE vaccine showed strong immunogenicity, particularly in high doses, with robust IgG responses sustained up to day 421 in all studies, significantly higher than baseline, and seroconversion rates remained high through day 84. CD4 T-cell responses peaked after the third dose and remained elevated through day 421, whereas CD8 T-cell responses were minimal. Regarding adverse effects, the ID93 + GLA-SE vaccine significantly increases fatigue (RR 3.24, p = 0.005), myalgia (RR 5.82, p < 0.0001), and injection site pain (RR 4.12, p < 0.00001), compared to placebo, with consistent results across both high and low doses. However, there were no significant differences for upper respiratory tract infections, 0.83 (95% CI 0.38-1.84, p = 0.87) or 1.77 (95% CI 0.77-4.10, p = 0.18) headaches. Dose optimization remains crucial due to the higher side effect risks of increased doses.

Conclusion: The ID93 + GLA-SE vaccine shows a solid safety profile and enhances immune responses, especially IgG and CD4+ T-cell activity, which is crucial for TB defense. Higher doses improve efficacy but increase side effects, highlighting the need for dose optimization. As a potential alternative to the BCG vaccine, especially in drug-resistant TB regions, further research should refine dosage and assess long-term safety.

背景:结核(TB)是由结核分枝杆菌(Mtb)引起的一种古老疾病,继续对全球公共卫生构成重大威胁。尽管20世纪20年代开发的卡介苗仍然是唯一被批准的结核病疫苗,但它的疗效有限,特别是对成人肺结核的疗效有限。ID93/GLA-SE疫苗是一种重组亚单位疫苗,通过引发免疫固体反应显示出希望,可能成为对抗结核病的关键解决方案,特别是在面对不断增加的耐药菌株和不理想的现有疫苗的情况下。它有可能解决对更有效的耐药结核病干预措施的未满足需求,这是一个日益严重的全球卫生问题,继续挑战现有的治疗方案。目的:评价接种bcg的健康成人ID93 + GLA-SE的免疫原性和安全性。方法:对PubMed (Medline)、ScienceDirect、EMBASE、Scopus和Cochrane Central数据库进行全面的电子检索,从建立到2024年8月,以接种bcg的健康成人为目标人群进行随机对照试验(RCTs)。本综述按照PRISMA标准进行,并在PROSPERO注册(CRD42024601450)。本meta分析使用Review Manager和森林图进行视觉显示。结果显示为风险比(RR),置信区间为95%。结果:ID93 + GLA-SE疫苗显示出很强的免疫原性,特别是在高剂量的情况下,在所有研究中,稳健的IgG应答持续到421天,显著高于基线,血清转化率在84天保持很高。CD4 t细胞反应在第三次给药后达到峰值,并在第421天保持升高,而CD8 t细胞反应最小。关于不良反应,ID93 + GLA-SE疫苗显著增加疲劳(RR 3.24, p = 0.005)、肌痛(RR 5.82, p p = 0.87)或头痛(95% CI 0.77-4.10, p = 0.18)。剂量优化仍然至关重要,因为增加剂量的副作用风险更高。结论:ID93 + GLA-SE疫苗显示出可靠的安全性,并增强了免疫反应,特别是IgG和CD4+ t细胞活性,这对结核病防御至关重要。高剂量可提高疗效,但会增加副作用,因此需要优化剂量。作为卡介苗的潜在替代品,特别是在耐药结核病地区,进一步的研究应完善剂量并评估长期安全性。
{"title":"Evaluating the immunogenicity and safety of ID93 + GLA-SE in BCG-vaccinated healthy adults: a systematic review and meta-analysis of randomized controlled trials.","authors":"Erum Siddiqui, Mohammad Saad Khan, Maliha Khalid, Harshika Khaim Chandani, Umaimah Naeem, Muhammad Mohsin Khan, Syed Owais Wasti","doi":"10.1177/25151355251344473","DOIUrl":"10.1177/25151355251344473","url":null,"abstract":"<p><strong>Background: </strong>Tuberculosis (TB), caused by <i>Mycobacterium tuberculosis</i> (Mtb), is an ancient disease that continues to pose a significant threat to global public health. Although the BCG vaccine, developed in the 1920s, remains the only approved TB vaccine, it has limited efficacy, particularly against pulmonary TB in adults. The ID93/GLA-SE vaccine, a recombinant subunit vaccine, shows promise by triggering immune solid responses and could be a key solution in combating TB, particularly in the face of rising drug-resistant strains and suboptimal current vaccines. It has the potential to address the unmet need for more effective interventions against drug-resistant TB, a growing global health issue that continues to challenge existing treatment options.</p><p><strong>Objective: </strong>To evaluate the immunogenicity and safety of ID93 + GLA-SE in BCG-vaccinated healthy adults.</p><p><strong>Methods: </strong>A comprehensive electronic search on PubMed (Medline), ScienceDirect, EMBASE, Scopus, and Cochrane Central database was conducted from inception till August 2024 for randomized controlled trials (RCTs) with a target population of BCG-vaccinated healthy adults. This review was conducted according to (PRISMA) criteria and registered with PROSPERO (CRD42024601450). This meta-analysis used Review Manager and forest plots for visual display. The outcomes were displayed as risk ratios (RR) with a 95% confidence interval.</p><p><strong>Results: </strong>The ID93 + GLA-SE vaccine showed strong immunogenicity, particularly in high doses, with robust IgG responses sustained up to day 421 in all studies, significantly higher than baseline, and seroconversion rates remained high through day 84. CD4 T-cell responses peaked after the third dose and remained elevated through day 421, whereas CD8 T-cell responses were minimal. Regarding adverse effects, the ID93 + GLA-SE vaccine significantly increases fatigue (RR 3.24, <i>p</i> = 0.005), myalgia (RR 5.82, <i>p</i> < 0.0001), and injection site pain (RR 4.12, <i>p</i> < 0.00001), compared to placebo, with consistent results across both high and low doses. However, there were no significant differences for upper respiratory tract infections, 0.83 (95% CI 0.38-1.84, <i>p</i> = 0.87) or 1.77 (95% CI 0.77-4.10, <i>p</i> = 0.18) headaches. Dose optimization remains crucial due to the higher side effect risks of increased doses.</p><p><strong>Conclusion: </strong>The ID93 + GLA-SE vaccine shows a solid safety profile and enhances immune responses, especially IgG and CD4+ T-cell activity, which is crucial for TB defense. Higher doses improve efficacy but increase side effects, highlighting the need for dose optimization. As a potential alternative to the BCG vaccine, especially in drug-resistant TB regions, further research should refine dosage and assess long-term safety.</p>","PeriodicalId":33285,"journal":{"name":"Therapeutic Advances in Vaccines and Immunotherapy","volume":"13 ","pages":"25151355251344473"},"PeriodicalIF":0.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12141798/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144249972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Therapeutic Advances in Vaccines and Immunotherapy
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