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Immunogenicity and safety of ‘Comvigen’, a bivalent SARS-CoV-2 vaccine, in comparison to Comirnaty bivalent vaccine in Thailand: a phase 2, non-inferiority randomised trial 与泰国Comvigen二价SARS-CoV-2疫苗相比,Comvigen二价疫苗的免疫原性和安全性:一项2期非劣效性随机试验
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-08-15 DOI: 10.1016/j.lansea.2025.100650
Watsamon Jantarabenjakul , Rapisa Nantanee , Thanyawee Puthanakit , Sivaporn Gatechompol , Anchalee Avihingsanon , Suda Punrin , Terapong Tantawichien , Sorachai Nitayaphan , Arunee Thitithanyanont , Supranee Buranapraditkun , Anan Jongkaewwattana , Chutitorn Ketloy , Eakachai Prompetchara , Saranath Lawpoolsri , Wassana Wijagkanalan , Mohamad-Gabriel Alameh , Lina Hong , Mijo Samija , Drew Weissman , Kiat Ruxrungtham , Nanthida Wonglertnirant

Background

Strengthening mRNA vaccine development in LMICs is essential for enhancing global pandemic preparedness. This study evaluated the safety and immunogenicity of Comvigen, a bivalent SARS-CoV-2 vaccine, in comparison to the Comirnaty bivalent vaccine (Comirnaty).

Methods

This phase II, randomised, open-label, non-inferiority trial was conducted in Thailand across four centres. Participants (n = 450) were randomly assigned (2:1) to receive either Comvigen (50 μg) or Comirnaty (30 μg), using block randomisation (size = 9). Eligible participants had completed at least 2 doses of any approved COVID-19 vaccine, with the last mRNA-vaccine dose given over 3 months before enrolment. The non-inferiority margin of a geometric mean ratio (GMR) of 0.67. The primary immunogenicity endpoint was pseudovirus neutralisation titres (psVNT-50) against SARS-CoV-2 wild-type and Omicron BA.4/BA.5 at Day 29. Safety outcomes included local and systemic adverse reactions up to six months post-vaccination. Immunogenicity analyses were conducted on the Per-Protocol (PP) population and the modified Intent-to-Treat (mITT) population; safety analyses included all participants. Laboratory personnel were blinded to vaccine assignment (ClinicalTrials.gov: NCT05930730).

Findings

Between October and November 2023, 450 participants were enrolled (median age of 36 years, IQR 30–45). At day 29, the geometric mean titre (GMT) of psVNT-50 against wild-type virus increased from 475.9 to 2062.9 for Comvigen and from 458.8 to 1905.1 for Comirnaty (GMR 1.1, 95% CI: 1.0–1.2), meeting non-inferiority criteria. Against Omicron BA.4/BA.5, GMTs were 3909.8 for Comvigen and 3288.6 for Comirnaty (GMR 1.2, 95% 1.0–1.4). Local and systemic reactions were more frequent with Comvigen (91% vs. 78%, p = 0.0002, 79% vs. 70%, p = 0.028) but were mild or moderate and transient with no difference in fever (6% vs. 5%, p = 0.84).

Interpretation

Comvigen demonstrated non-inferiority immunogenicity to Comirnaty and had a comparable safety profile, supporting mRNA vaccine development for global access and pandemic preparedness.

Funding

Covid-19 Pandemic Emergency Fund granted by Thailand's National Economic and Social Development Council provided major funding. Supplementary funding was provided by National Vaccine Institute (NVI), Thailand; Center of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University; Chulalongkorn University Second Century Fund (C2F); BioNet-Asia and Public Donation through Covid-19 vaccine development fund of the Faculty of Medicine, Chulalongkorn University and the Thai Red Cross Society, Thailand.
背景:加强中低收入国家mRNA疫苗的开发对于加强全球大流行防范至关重要。本研究评估了Comvigen(一种二价SARS-CoV-2疫苗)与Comirnaty二价疫苗(Comirnaty)的安全性和免疫原性。该II期随机、开放标签、非劣效性试验在泰国的4个中心进行。参与者(n = 450)被随机分配(2:1)接受Comvigen (50 μg)或Comirnaty (30 μg),采用分组随机(size = 9)。符合条件的参与者已完成至少2剂任何批准的COVID-19疫苗,最后一次mrna疫苗剂量在入组前3个多月进行。几何平均比(GMR)的非劣效边际为0.67。主要免疫原性终点是针对SARS-CoV-2野生型和Omicron BA.4/BA的假病毒中和效价(psVNT-50)。第29天。安全性指标包括接种疫苗后6个月的局部和全身不良反应。免疫原性分析对按方案(PP)群体和改良意向治疗(mITT)群体进行;安全性分析包括所有参与者。实验室人员对疫苗分配不知情(ClinicalTrials.gov: NCT05930730)。在2023年10月至11月期间,有450名参与者被纳入研究(中位年龄36岁,IQR 30-45岁)。在第29天,psVNT-50对野生型病毒的几何平均滴度(GMT)从Comvigen的475.9增加到2062.9,comiry的458.8增加到1905.1 (GMR 1.1, 95% CI: 1.0-1.2),符合非劣效性标准。抗欧米克隆BA.4/BA。5、Comvigen的GMTs为3909.8,comirity的GMTs为3288.6 (GMR为1.2,95%为1.0 ~ 1.4)。Comvigen的局部和全身反应更频繁(91%对78%,p = 0.0002, 79%对70%,p = 0.028),但轻度或中度和短暂性反应,发热无差异(6%对5%,p = 0.84)。comvigen显示出对Comirnaty的非劣效性免疫原性,并且具有相当的安全性,支持mRNA疫苗开发用于全球可及性和大流行防范。泰国国家经济和社会发展理事会批准的2019冠状病毒病大流行应急基金提供了主要资金。补充资金由泰国国家疫苗研究所提供;朱拉隆功大学医学院疫苗研究与开发卓越中心;朱拉隆功大学第二世纪基金;亚洲生物网与朱拉隆功大学医学院和泰国红十字会新冠病毒疫苗开发基金的公众捐赠。
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引用次数: 0
Epidemiology and determinants of stillbirth disparities in India: a geospatial hotspot clustering study using integrated population-level data. 印度死产差异的流行病学和决定因素:使用综合人口水平数据的地理空间热点聚类研究。
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-08-08 eCollection Date: 2025-09-01 DOI: 10.1016/j.lansea.2025.100647
U Venkatesh, Om Prakash Bera, Ashoo Grover, Siddhant Shastri, Sayantan Chakraborty

Background: Stillbirth is a significant public health issue worldwide, with India bearing a substantial burden. While male fetuses are biologically more vulnerable, the geographic distribution of sex-specific stillbirth rates remains underexplored. This study investigates district-level stillbirth patterns across India and evaluates their spatial association with maternal, socio-demographic, and delivery care factors.

Methods: This ecological study employed data integration using the Civil Registration System (CRS-2020) and the National Family Health Survey (NFHS-5) to compile district-level estimates of stillbirth rates (SBRs) along with maternal, delivery care, and socio-demographic indicators. SBR was calculated as the number of stillbirths per 1000 total births for each sex. Spatial autocorrelation was assessed using Global and Local Moran's I. Additionally, univariate and bivariate Local Indicators of Spatial Association (LISA) were conducted separately for male and female stillbirth rates to examine spatial clustering and associations with selected correlates, identifying hotspot and cold-spot regions across districts.

Findings: The nationwide stillbirth rate (SBR) in 2020 was 6.548 per 1000 total births (female: 6.54; male: 6.63). Stillbirth rates were higher among urban mothers compared to rural mothers. Northern India, particularly Chandigarh, Jammu & Kashmir, and Rajasthan, recorded the highest SBR. Spatial analysis identified stillbirth hotspots primarily in Northern and Central India. Univariate Moran's I indicated strong spatial clustering for maternal factors, including below-normal BMI (Moran's I = 0.62) and iron-folic acid supplementation (Moran's I = 0.551). Bivariate Moran's I showed similar spatial trends for both sexes, with stillbirth rates positively correlated with anemia (female: 0.087; male: 0.078) and institutional births in public facilities (female: 0.084; male: 0.086), and negatively correlated with literacy (female: -0.069; male: -0.063) and cesarean deliveries in private facilities (female: -0.055; male: -0.090).

Interpretation: This study found no significant geospatial disparity in sex-specific stillbirth rates across Indian districts, with similar clustering patterns for both sexes. Key determinants included literacy, wealth status, anemia, and cesarean deliveries. District-specific strategies, guided by geospatial insights, are essential for focused public health measures. Strengthening stillbirth registration and utilizing advanced spatial methods are crucial for improved monitoring and intervention planning.

Funding: No funding was issued for this research.

背景:死产是世界范围内的一个重大公共卫生问题,印度承受着巨大的负担。虽然男性胎儿在生物学上更脆弱,但性别特异性死产率的地理分布仍未得到充分研究。本研究调查了印度地区的死产模式,并评估了其与孕产妇、社会人口统计学和分娩护理因素的空间关联。方法:本生态研究采用民事登记系统(CRS-2020)和国家家庭健康调查(NFHS-5)的数据整合,编制区级死产率(sbr)以及孕产妇、分娩护理和社会人口指标的估计。SBR是按每1000个出生婴儿中每1000个出生婴儿的死产数计算的。此外,对男性和女性死胎率分别进行了单变量和双变量空间关联局部指标(LISA),以检验空间聚类及其与选定相关因素的关联,从而确定各地区的热点和冷点区域。结果:2020年全国死产率(SBR)为6.548 / 1000,其中女性为6.54 / 1000,男性为6.63 / 1000。与农村母亲相比,城市母亲的死产率更高。印度北部,特别是昌迪加尔、查谟和克什米尔以及拉贾斯坦邦的SBR最高。空间分析确定死产热点主要在印度北部和中部。单变量Moran's I表明,母亲因素具有很强的空间聚类性,包括BMI低于正常水平(Moran's I = 0.62)和叶酸铁补充剂(Moran's I = 0.551)。双变量Moran’s I在两性中显示出相似的空间趋势,死产率与贫血(女性:0.087;男性:0.078)和公共设施机构分娩(女性:0.084;男性:0.086)呈正相关,与识字率(女性:-0.069;男性:-0.063)和私立设施剖宫产(女性:-0.055;男性:-0.090)负相关。解释:本研究发现,在印度各区,不同性别的死产率没有显著的地理空间差异,两性的聚类模式相似。主要决定因素包括识字率、财富状况、贫血和剖宫产。以地理空间见解为指导的具体地区战略对于有重点的公共卫生措施至关重要。加强死胎登记和利用先进的空间方法对改进监测和干预计划至关重要。资助:本研究未获资助。
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引用次数: 0
Correspondence to editorial “Oral health in southeast Asia: addressing inaccessibility” 对“东南亚口腔健康:解决无障碍问题”社论的回信
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-08-01 DOI: 10.1016/j.lansea.2025.100550
Romain Lan , Laurie Fraticelli , Denis Bourgeois , Florence Carrouel
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引用次数: 0
Melioidosis: a call for recognition as a neglected tropical disease under the Southeast Asia regional neglected tropical disease framework 类鼻疽病:呼吁在东南亚区域被忽视的热带病框架下确认为被忽视的热带病
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-08-01 DOI: 10.1016/j.lansea.2025.100625
Prasanta Raghab Mohapatra , Bijayini Behera
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引用次数: 0
Sample representativeness and temporal comparability in SEAR study, and achieving equitable health insurance coverage — Authors' reply SEAR研究的样本代表性和时间可比性,以及实现公平的健康保险覆盖——作者的答复
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-08-01 DOI: 10.1016/j.lansea.2025.100648
Sudheer Kumar Shukla , Pratheeba John , Nishikant Singh , Navin Singh
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引用次数: 0
Health insurance in southeast Asia: is it enough for UHC? 东南亚的医疗保险:全民健康覆盖是否足够?
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-08-01 DOI: 10.1016/j.lansea.2025.100653
The Lancet Regional Health – Southeast Asia
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引用次数: 0
Balancing public health priorities and inclusivity in medical education: a clarification on curriculum revisions 平衡公共卫生优先事项和医学教育的包容性:澄清课程修订
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-08-01 DOI: 10.1016/j.lansea.2025.100563
Mirza Jahanzeb Beg , B. Sai Chaitanya Reddy , Manik Inder Singh Sethi
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引用次数: 0
Diagnostic accuracy of convolutional neural networks in classifying hepatic steatosis from B-mode ultrasound images: a systematic review with meta-analysis and novel validation in a community setting in Telangana, India 卷积神经网络从b超图像中对肝脂肪变性进行分类的诊断准确性:在印度泰伦加纳社区环境中进行的荟萃分析和新验证的系统回顾
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-07-31 DOI: 10.1016/j.lansea.2025.100644
Akshay Jagadeesh , Chanchanok Aramrat , Santosh Rai , Fathima Hana Maqsood , Adarsh Kibballi Madhukeshwar , Santhi Bhogadi , Judith Lieber , Hemant Mahajan , Santosh Kumar Banjara , Alexandra Lewin , Sanjay Kinra , Poppy Mallinson

Background

Ultrasound is a widely available, inexpensive, and non-invasive modality for evaluating hepatic steatosis (HS). However, the scarcity of radiological expertise limits its utility. Convolutional Neural Networks (CNNs) have potential for automated classification of HS using B-mode ultrasound images. We aimed to assess their diagnostic accuracy and generalisability across diverse study settings and populations.

Methods

We systematically reviewed two biomedical databases up to Dec 12, 2023, to identify studies that applied CNNs in the classification of HS using B-mode ultrasound images as input (PROSPERO: CRD42024501483). We supplemented this review with a novel analysis of the community-based Andhra Pradesh Children and Parents’ Study (APCAPS) in India to address the overrepresentation of hospital samples and lack of data on South Asian populations who exhibit a distinct central adiposity phenotype that could influence CNN performance. We quantitatively synthesised diagnostic accuracy metrics for eligible studies using random-effects meta-analyses.

Findings

Our search returned 289 studies, of which 17 were eligible. All but one of the 17 studies were based in hospital or clinical outpatient settings with curated cases and controls. Studies were conducted exclusively in East Asian, European, or North American populations. Studies employed varying gold standards: seven studies (41.18%) used liver biopsy, three (17.64%) used MRI proton density fat fraction, and seven (41.18%) used clinician-evaluated ultrasound-based HS grades. The APCAPS sample included 219 participants with radiologist-assigned HS grades. Across the range of study settings and populations, CNNs demonstrated good diagnostic accuracy. Meta-analysis of studies with low risk of bias reporting on five unique datasets showed a pooled area under the receiver operating characteristic curve of 0.93 (95% CI 0.73–0.98) for detecting any severity and 0.86 (95% CI 0.77–0.92) for detecting moderate-to-severe HS severity grades, respectively.

Interpretation

CNNs have good diagnostic accuracy and generalisability for HS classification, suggesting potential for real-world application.

Funding

Medical Research Council, UK (MR/T038292/1, MR/V001221/1).
超声是一种广泛可用、廉价且无创的肝脂肪变性(HS)评估方法。然而,放射学专业知识的匮乏限制了它的实用性。卷积神经网络(cnn)具有利用b超图像自动分类HS的潜力。我们的目的是评估它们在不同研究环境和人群中的诊断准确性和普遍性。方法我们系统地回顾了截至2023年12月12日的两个生物医学数据库,以识别将cnn用于HS分类的研究,这些研究使用b超图像作为输入(PROSPERO: CRD42024501483)。我们对以社区为基础的印度安得拉邦儿童和父母研究(APCAPS)进行了一项新的分析,以补充这一综述,以解决医院样本的过度代表性和南亚人群数据的缺乏,这些人群表现出明显的中心肥胖表型,可能影响CNN的表现。我们使用随机效应荟萃分析定量地综合了符合条件的研究的诊断准确性指标。我们检索到289项研究,其中17项符合条件。17项研究中,除了一项研究外,其余研究都是在医院或临床门诊环境中进行的,有精心策划的病例和对照。研究仅在东亚、欧洲或北美人群中进行。研究采用不同的金标准:7项研究(41.18%)使用肝活检,3项研究(17.64%)使用MRI质子密度脂肪分数,7项研究(41.18%)使用临床评估的基于超声的HS分级。APCAPS样本包括219名具有放射科医生指定HS等级的参与者。在研究设置和人群的范围内,cnn表现出良好的诊断准确性。对五个独特数据集报告的低偏倚风险研究的荟萃分析显示,检测任何严重程度的受试者工作特征曲线下的合并面积为0.93 (95% CI 0.73-0.98),检测中度至重度HS严重等级的受试者工作特征曲线下的合并面积为0.86 (95% CI 0.77-0.92)。cnn对HS分类具有良好的诊断准确性和通用性,具有实际应用的潜力。资助医学研究理事会,英国(MR/T038292/1, MR/V001221/1)。
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引用次数: 0
Urgent need to integrate gender-sensitive financing in Southeast Asia's health insurance expansion 迫切需要将对性别问题有敏感认识的融资纳入东南亚医疗保险扩张
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-07-29 DOI: 10.1016/j.lansea.2025.100645
Schawanya Kaewpitoon Rattanapitoon , Natnapa Heebkaew Padchasuwan , Nav La , Nathkapach Kaewpitoon Rattanapitoon
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引用次数: 0
Sample representativeness and temporal comparability in SEAR study SEAR研究的样本代表性和时间可比性
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-07-29 DOI: 10.1016/j.lansea.2025.100646
Jabed Iqbal
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引用次数: 0
期刊
The Lancet regional health. Southeast Asia
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