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Annual trends and risk factors of late presentation of HIV at 19 referral hospitals in Indonesia: findings from the INA-PROACTIVE cohort 印度尼西亚19家转诊医院晚期出现艾滋病毒的年度趋势和危险因素:来自INA-PROACTIVE队列的调查结果
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-03-04 DOI: 10.1016/j.lansea.2026.100742
Dona Arlinda , Evy Yunihastuti , Agnes Rengga Indrati , Tuti Parwati Merati , Emmanuelle Papot , Deborah Cromer , Aly Diana , Adhella Menur Naysilla , Riza Danu Dewantara , Nugroho Harry Susanto , Nurhayati Lukman , I Wayan Adi Pranata , Herman Kosasih , Dewi Lokida , Muhammad Karyana , Teguh Sarry Hartono , I Gede Rai Kosa , Deborah Theresia , Dwiana Savitri , Dwi Kurniawan Nugroho , Katie Watkins

Background

People living with HIV (PLWH) presenting with advanced HIV have worse outcomes than those diagnosed earlier. The proportion of PLWH in Indonesia who are late presenters is unknown but likely high. Identifying factors associated with late presentation is key to earlier diagnosis and intervention.

Methods

Adult PLWH were enrolled at 19 centers across Indonesia (2018–2020) in the INA-PROACTIVE observational cohort study. Late presentation was defined as having a CD4+ count <350 cells/μl within 3 months of diagnosis. Risk factors were assessed using multivariable logistic regression.

Findings

Among 3201 eligible participants, 2790 (87·2%) were late presenters. High proportion of late presenters was observed from 2015 to 2019 (83·3%–89·8%). Characteristics associated with late presentation included age 30–39 (aOR = 1·47, 95% CI: 1·15–1·90) or age ≥40 (aOR = 1·71, 95% CI: 1·21–2·46) vs. age 18–29; male sex (aOR = 2·93, 95% CI: 2·07–4·24); diagnosis in ≤2015 (aOR = 1·45, 95% CI: 1·12–1·89); and diagnosis through Provider-Initiated Testing and Counseling (aOR = 2·38, 95% CI: 1·86–3·04) vs. Voluntary Counseling and Testing (VCT). Suspected MSM transmission was associated with lower odds of late presentation (aOR = 0·57, 95% CI: 0·39–0·82) compared to heterosexual transmission.

Interpretation

Late presentation remains highly prevalent in Indonesia. Expanded efforts are needed to promote testing among those at risk. Targeted interventions for older adults, men, and non-MSM populations, alongside VCT and MSM-focused programs, may help reduce late HIV diagnosis and improve early management.

Funding

This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, under contract No. 75N91019D00024 Task orders 75N91020F00004, 75N91020F000012.
HIV感染者(PLWH)表现为晚期HIV的预后比早期诊断的患者更差。印度尼西亚的PLWH迟交者的比例尚不清楚,但可能很高。确定与迟发相关的因素是早期诊断和干预的关键。方法:在印度尼西亚的19个中心(2018-2020年),在INA-PROACTIVE观察队列研究中招募了成年PLWH。晚期诊断定义为诊断3个月内CD4+计数<;350细胞/μl。采用多变量logistic回归评估危险因素。在3201名符合条件的参与者中,有2790名(87.2%)是迟交者。2015 - 2019年,参会人员迟到的比例较高(83.3% - 89.8%)。与晚期就诊相关的特征包括年龄30-39岁(aOR = 1.47, 95% CI: 1.15 - 1.90)或年龄≥40岁(aOR = 1.71, 95% CI: 1.21 - 2.46) vs.年龄18-29岁;男性(aOR = 2.93, 95% CI: 2.07 - 4.24);诊断≤2015年(aOR = 1.45, 95% CI: 1.12 - 1.89);以及通过提供者发起的检测和咨询进行诊断(aOR = 2.38, 95% CI: 1.86 - 3.04)与自愿咨询和检测(VCT)相比。与异性恋传播相比,疑似MSM传播与较低的迟发率相关(aOR = 0.57, 95% CI: 0.39 - 0.82)。在印度尼西亚,迟交仍然非常普遍。需要加大努力,促进在高危人群中进行检测。针对老年人、男性和非男同性恋人群的有针对性的干预措施,以及以VCT和男同性恋者为重点的项目,可能有助于减少艾滋病的晚期诊断和改善早期管理。本项目全部或部分由美国国立卫生研究院国家过敏和传染病研究所的联邦基金资助,合同编号为75n9101019d00024,任务订单为75N91020F00004、75N91020F000012。
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引用次数: 0
Comprehensive tuberculosis screening and preventive treatment in schools and congregate settings of India (2017–2024): a prospective study 2017-2024年印度学校和人群结核病综合筛查和预防治疗的前瞻性研究
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-02-06 DOI: 10.1016/j.lansea.2026.100725
Kunchok Dorjee , Sonam Topgyal , Rajesh K. Sood , Tenzin Namdon , Ravinder Kumar , Ugen Gyatso , Jigme Kalsang , Tenzin Thinley , Tenzin Dechen , Tenzin Tsomo , Tenzin Kalsang , Rachel C. Sadoff , Sangyal Dorjee , Sheriza Baksh , Tenzin Yangkyi , Tenzin Khachoe , Tenzin Dolker , Tsering Wangmo , Dekyi Lhadon , Lobsang Tsering , Tsetan D. Sadutshang

Background

Existing Tuberculosis (TB) elimination strategies show limited impact, with suboptimal uptake of tuberculosis preventive treatment (TPT) and increasing TB incidence after the COVID-19 pandemic. Real-world evidence on reduction of tuberculosis in high-burden communities is needed to inform future TB elimination strategies.

Methods

Since 2017, a comprehensive TB screening and TPT program known as Zero TB in Kids (ZTBK) was implemented in congregate settings of Tibetan communities in India. TB disease, TB infection (TBI), tuberculin skin test (TST) conversion, and TPT uptake were measured periodically.

Findings

Schoolchildren and adults in 63 institutes (n = 20,068; 67,637 person-years) were screened. TPT was given to 3847 participants. TB incidence decreased 83% between 2017 [576 (95% CI: 455–718)/100,000] and 2024 [97 (47–179)/100,000]. TB infection (TBI) prevalence decreased 32% between 2017 [22% (95% CI: 21–23%)] and 2024 [15.5% (14–17%)]. TB incidence (640/100,000) and TBI prevalence (28%) were higher in the institutes that were never screened before under ZTBK. Among participants who did not receive TPT, TB disease prevalence decreased 84% between 2017 [910 (95% CI: 675–1204)/100,000] and 2024 [147 (48–343)/100,000], indicating a herd benefit. After one round of TB screening and TPT, between 2018 and 2019, TST conversion decreased 59% for children and 47% for adolescents. Risk of TBI was greater for males (aPR: 1.23; 95% CI: 1.16–1.30). TB risk was 82% lower for schoolchildren receiving TPT. Participants with seizure disorder [aPR: 0.31 (95% CI: 0.15–0.65)] and hepatitis B [0.71 (0.6–0.84)] were less likely to receive TPT.

Interpretation

Significant reduction of TB transmission and burden can be achieved using the existing tools of TB control. Surveillance of TBI and TPT must be widely adopted for schools and congregate settings with high TB burden.

Funding

National Institutes of Health-National Institute of Allergy and Infectious Diseases (NIAID) (K01-AI148583), STOP TB Partnership (STBP/TBREACH/GSA/W7-7692), NIAID-Johns Hopkins Center for AIDS Research (90100777), Foundations, and Philanthropy.
背景现有的结核病消除策略效果有限,在2019冠状病毒病大流行后,结核病预防治疗(TPT)的接受程度不理想,结核病发病率上升。需要在高负担社区减少结核病的真实证据,以便为未来的结核病消除战略提供信息。方法自2017年以来,在印度藏族社区的聚集环境中实施了一项名为儿童零结核病(ZTBK)的综合结核病筛查和TPT计划。定期检测结核病、结核感染(TBI)、结核菌素皮肤试验(TST)转换和结核菌素摄取情况。研究结果:对63个研究所的学童和成人(n = 20,068; 67,637人年)进行了筛查。对3847名参与者进行了TPT。在2017年[576 (95% CI: 455-718)/10万]至2024年[97(47-179)/10万]期间,结核病发病率下降了83%。结核病感染(TBI)患病率在2017年[22% (95% CI: 21-23%)]至2024年[15.5%(14-17%)]期间下降了32%。结核病发病率(640/10万)和TBI患病率(28%)在从未接受过ZTBK筛查的机构中更高。在未接受TPT治疗的参与者中,结核病患病率在2017年[910 (95% CI: 675-1204)/10万]和2024年[147(48-343)/10万]期间下降了84%,表明群体受益。在2018年至2019年期间,经过一轮结核病筛查和TPT后,儿童TST转化率下降了59%,青少年TST转化率下降了47%。男性发生TBI的风险更高(aPR: 1.23; 95% CI: 1.16-1.30)。接受破伤风三联疫苗的学童患结核病的风险降低了82%。癫痫发作障碍[aPR: 0.31 (95% CI: 0.15-0.65)]和乙型肝炎[0.71(0.6-0.84)]患者接受TPT的可能性较小。利用现有的结核病控制工具可以显著减少结核病的传播和负担。对TBI和TPT的监测必须在结核病负担高的学校和聚集场所广泛采用。美国国立卫生研究院(nih)——国家过敏和传染病研究所(NIAID) (K01-AI148583),控制结核病合作伙伴关系(STBP/TBREACH/GSA/W7-7692), NIAID-约翰霍普金斯艾滋病研究中心(90100777),基金会和慈善事业。
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引用次数: 0
Emergence of a novel zoonotic brugian filarial infection during post-validation surveillance for lymphatic filariasis in Sri Lanka 斯里兰卡淋巴丝虫病验证后监测期间出现一种新型人畜共患布鲁氏丝虫病感染
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-03-04 DOI: 10.1016/j.lansea.2026.100735
Indeewarie E. Gunaratna , Lucas G. Huggins , Ushani Atapattu , Lakmini Liyanage , Nipuni Shilpeswarage , Murali Vallipuranathan , Vito Colella

Background

Lymphatic filariasis (LF) affects approximately 120 million people globally and is caused by Wuchereria bancrofti, Brugia malayi and Brugia timori. Sri Lanka was historically endemic for both bancroftian and brugian filariasis, with B. malayi presumed eliminated by the late 1960s. The country achieved validation of LF elimination as a public health problem in 2016. However, sporadic Brugia infections have been detected in microfilaria surveys from the mid-2000s onwards; the sub-periodic periodicity of which is suggestive of a zoonotic origin and warrants further research.

Methods

Night blood survey (NBS) surveillance was conducted by the Anti-Filariasis Campaign, Ministry of Health, Sri Lanka, from 2019 to 2023. Brugia-positive human samples and archived canine samples were analysed using a next-generation sequencing metabarcoding platform targeting mitochondrial and nuclear loci. Bayesian and neighbour-joining phylogenetic analyses and minimum-spanning network approaches were used to characterise lineage relationships.

Findings

Among 1,855,165 individuals screened, 52 were identified with Brugia-like microfilariae. Metabarcoding generated 1.2 million high-quality reads with both mitochondrial cox1 and ribosomal DNA markers confirming a single Brugia lineage circulating in humans, mainly in children. Sequences of the cox1 gene showed 99.4–100 percent nucleotide identity to the Brugia Sri Lanka (SL) genotype previously detected in dogs in Sri Lanka and Tamil Nadu (India). rDNA sequences showed low similarity to B. malayi or Brugia pahangi, indicating that the parasite represents a distinct Brugia taxon lacking a reference rDNA sequence.

Interpretation

The findings provide evidence that human brugian filariasis in Sri Lanka is caused by a previously unrecognised zoonotic Brugia species maintained in dogs. This has important clinical and public health implications given that human infections have occurred in children despite LF being declared eliminated as a public health problem. Crucially, the incorrect classification of circulating filarioid species may lead to inappropriate clinical and programmatic responses. For example, the newly identified canine reservoir of this Brugia genotype means that human-only mass drug administration might not be sufficient to interrupt this species’ transmission. These results underscore the need for integrated One Health surveillance to prevent re-establishment of LF and safeguard regional elimination goals.

Funding

No specific funding was received for the present study. This study was supported by a consulting funding (PRJ_002971).
淋巴丝虫病(LF)影响全球约1.2亿人,由bancroffti乌切里氏菌、马来布鲁吉亚菌和蒂莫里布鲁吉亚菌引起。斯里兰卡历来是班氏丝虫病和布鲁氏丝虫病的流行地,马来亚B.丝虫病被认为在20世纪60年代末已被消灭。该国于2016年确认将消除LF作为一项公共卫生问题。然而,从2000年代中期开始,在微丝虫调查中发现了散发的布鲁吉亚感染;其次周期的周期性暗示了人畜共患的起源,值得进一步研究。方法2019 - 2023年斯里兰卡卫生部抗丝虫病运动开展夜间血液调查(NBS)监测。使用针对线粒体和核位点的下一代测序元条形码平台分析布鲁吉亚病毒阳性的人类样本和存档的犬样本。贝叶斯和邻居连接系统发育分析和最小跨越网络方法被用来表征谱系关系。在筛选的1,855,165例个体中,有52例被鉴定为布鲁吉亚样微丝蚴。元条形码产生了120万个高质量的读取,线粒体cox1和核糖体DNA标记证实了人类(主要是儿童)中存在单一的布鲁吉亚谱系。cox1基因序列显示,与此前在斯里兰卡和印度泰米尔纳德邦(Tamil Nadu)犬中检测到的Brugia Sri Lanka (SL)基因型核苷酸同源性为99.4 - 100%。rDNA序列显示,该寄生虫与B. malayi或Brugia pahangi的相似性较低,表明该寄生虫是一个独特的Brugia分类单元,缺乏参考rDNA序列。研究结果提供证据表明,斯里兰卡的人类布鲁氏丝虫病是由以前未被识别的犬类人畜共患布鲁氏菌种引起的。这具有重要的临床和公共卫生意义,因为尽管作为公共卫生问题已被宣布消除,但儿童中仍发生了人类感染。至关重要的是,对循环丝虫病种的不正确分类可能导致不适当的临床和程序性反应。例如,新发现的犬类布鲁吉亚病毒基因型宿主意味着仅对人类进行大规模药物治疗可能不足以阻断该物种的传播。这些结果突出表明,需要开展“同一个健康”综合监测,以防止LF的重新建立并保障区域消除目标。经费本研究没有收到特别的经费。本研究由咨询基金(PRJ_002971)支持。
{"title":"Emergence of a novel zoonotic brugian filarial infection during post-validation surveillance for lymphatic filariasis in Sri Lanka","authors":"Indeewarie E. Gunaratna ,&nbsp;Lucas G. Huggins ,&nbsp;Ushani Atapattu ,&nbsp;Lakmini Liyanage ,&nbsp;Nipuni Shilpeswarage ,&nbsp;Murali Vallipuranathan ,&nbsp;Vito Colella","doi":"10.1016/j.lansea.2026.100735","DOIUrl":"10.1016/j.lansea.2026.100735","url":null,"abstract":"<div><h3>Background</h3><div>Lymphatic filariasis (LF) affects approximately 120 million people globally and is caused by <em>Wuchereria bancrofti</em>, <em>Brugia malayi</em> and <em>Brugia timori</em>. Sri Lanka was historically endemic for both bancroftian and brugian filariasis, with <em>B. malayi</em> presumed eliminated by the late 1960s. The country achieved validation of LF elimination as a public health problem in 2016. However, sporadic <em>Brugia</em> infections have been detected in microfilaria surveys from the mid-2000s onwards; the sub-periodic periodicity of which is suggestive of a zoonotic origin and warrants further research.</div></div><div><h3>Methods</h3><div>Night blood survey (NBS) surveillance was conducted by the Anti-Filariasis Campaign, Ministry of Health, Sri Lanka, from 2019 to 2023. <em>Brugia</em>-positive human samples and archived canine samples were analysed using a next-generation sequencing metabarcoding platform targeting mitochondrial and nuclear loci. Bayesian and neighbour-joining phylogenetic analyses and minimum-spanning network approaches were used to characterise lineage relationships.</div></div><div><h3>Findings</h3><div>Among 1,855,165 individuals screened, 52 were identified with <em>Brugia</em>-like microfilariae. Metabarcoding generated 1.2 million high-quality reads with both mitochondrial <em>cox1</em> and ribosomal DNA markers confirming a single <em>Brugia</em> lineage circulating in humans, mainly in children. Sequences of the <em>c</em><em>ox1</em> gene showed 99.4–100 percent nucleotide identity to the <em>Brugia</em> Sri Lanka (SL) genotype previously detected in dogs in Sri Lanka and Tamil Nadu (India). rDNA sequences showed low similarity to <em>B. malayi</em> or <em>Brugia pahangi</em>, indicating that the parasite represents a distinct <em>Brugia</em> taxon lacking a reference rDNA sequence.</div></div><div><h3>Interpretation</h3><div>The findings provide evidence that human brugian filariasis in Sri Lanka is caused by a previously unrecognised zoonotic <em>Brugia</em> species maintained in dogs. This has important clinical and public health implications given that human infections have occurred in children despite LF being declared eliminated as a public health problem. Crucially, the incorrect classification of circulating filarioid species may lead to inappropriate clinical and programmatic responses. For example, the newly identified canine reservoir of this <em>Brugia</em> genotype means that human-only mass drug administration might not be sufficient to interrupt this species’ transmission. These results underscore the need for integrated One Health surveillance to prevent re-establishment of LF and safeguard regional elimination goals.</div></div><div><h3>Funding</h3><div>No specific funding was received for the present study. This study was supported by a consulting funding (PRJ_002971).</div></div>","PeriodicalId":75136,"journal":{"name":"The Lancet regional health. Southeast Asia","volume":"46 ","pages":"Article 100735"},"PeriodicalIF":6.2,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147449624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Immunogenicity and safety of biological E's 14-valent pneumococcal conjugate vaccine (PNEUBEVAX 14®) administered in a 2p + 1 schedule to healthy infants: a multicenter, randomized, active controlled, single-blind, phase III trial 生物E公司14价肺炎球菌结合疫苗(PNEUBEVAX 14®)的免疫原性和安全性:一项多中心、随机、主动对照、单盲、III期试验,按2p + 1计划给药于健康婴儿
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-03-03 DOI: 10.1016/j.lansea.2026.100746
Subhash Thuluva , Ramesh V. Matur , Subbareddy Gunneri , Siddalingaiah Ningaiah , Vijay Yerroju , Rammohan Reddy Mogulla , Chirag Dhar , Kamal Thammireddy , Piyush Paliwal , Anand Kawade , Pradeep Nanjappa , Jog Pramod , Manish Narang , Bheemisetty S. Chakravarthy , Prashanth M. Virupakashappa

Background

Pneumococcal conjugate vaccines (PCVs) have markedly reduced childhood pneumococcal diseases, yet serotype replacement and regional heterogeneity remain important challenges. The World Health Organization recommends either a 3p + 0 or 2p + 1 schedule for PCV immunization programmes. BE-PCV14, a 14-valent vaccine, has previously been shown to be non-inferior to PCV13 in a 3p + 0 regimen. In this Phase III trial, we aimed to descriptively compare the immunogenicity and safety of BE-PCV14 and PCV13 in a 2p + 1 schedule in Indian infants.

Methods

In this randomized, single-blind, multicenter trial, 400 PCV-naïve infants (6–8 weeks old) were randomized 1:1 to receive either BE-PCV14 or PCV13; at 6 and 14 weeks, with a booster at 9 months. Serum IgG against 14 vaccine serotypes plus cross-protective 6 A were measured at post primary (28 days post dose 2), pre booster (at 9 months) and post booster (30 days post dose 3) time points. The primary endpoint was the proportion achieving IgG ≥0.35 μg/mL (seroresponse rate) for the 12 serotypes common to both vaccines at post primary, pre booster and post booster time points. Solicited local and systemic reactions were recorded for 7 days after each dose; unsolicited, and serious adverse events (SAEs) were captured throughout.

Findings

Between May 2023 and July 2024, 400 participants were enrolled of which 380 (95%) completed the study. Post primary seroresponse rates in the BE-PCV14 arm for common serotypes ranged from 72.6% (95% CI: 65.8, 78.5) (serotype 3) to 100% (95% CI: 98.0, 100.0) (14, 19 F); PCV13 rates ranged from 71.6% (95% CI: 64.9, 77.5) to 100% (95% CI: 98.1, 100.0) (14, 19 F, 19 A). Post booster rates were 87.6% (95% CI: 82.1, 91.6) to 100% (95% CI: 98.0, 100.0) for BE-PCV14 and 85.0% (95% CI: 79.4, 89.4) to 100% (95% CI: 98.1, 100.0) for PCV13. BE-PCV14 elicited high responses against the two additional serotypes, i.e., 22 F: 96.8% (95% CI: 93.1, 98.5), 33 F: 92.5% (95% CI: 87.8, 95.5), and cross-protective 6 A: 93.0% (95% CI: 88.4, 95.9). Of the participants that received BE-PCV14 or PCV13, 33.5% (95% CI: 27.3, 40.3) and 38% (95% CI: 31.6, 44.9) had mild AEs and 11.5% (95% CI: 7.8, 16.7) and 10.5% (95% CI: 7.0, 15.5) had moderate AEs, respectively. Two unrelated SAEs occurred in the BE-PCV14 arm.

Interpretation

Administered in a 2p + 1 schedule, BE-PCV14 was highly immunogenic, well tolerated, and comparable to PCV13 while broadening serotype coverage. These findings support consideration of BE-PCV14 for routine infant immunization programmes using a 2p + 1 schedule, particularly in settings where the additional serotypes contribute to ongoing pneumococcal disease.

Funding

This clinical research was exclusively funded by Biological E. Limited, Hyderabad, India.
肺炎球菌结合疫苗(PCVs)显著减少了儿童肺炎球菌疾病,但血清型替代和区域异质性仍然是重要的挑战。世界卫生组织建议PCV免疫规划采用3p + 0或2p + 1时间表。be - pcv14是一种14价疫苗,先前已证明在3p + 0方案中不劣于PCV13。在这项III期试验中,我们旨在描述性地比较BE-PCV14和PCV13在印度婴儿中2p + 1计划的免疫原性和安全性。方法在这项随机、单盲、多中心试验中,400名PCV-naïve婴儿(6-8周龄)按1:1的比例随机接受BE-PCV14或PCV13;6周和14周时注射,9个月时注射加强剂。在初次接种后(剂量2后28天)、加强前(9个月)和加强后(剂量3后30天)时间点检测14种疫苗血清型和交叉保护性6a的血清IgG。主要终点为两种疫苗共有的12种血清型在初次接种后、增强前和增强后时间点达到IgG≥0.35 μg/mL的比例(血清有效率)。每次给药后7天记录征求的局部和全身反应;和严重不良事件(SAEs)。在2023年5月至2024年7月期间,400名参与者被招募,其中380人(95%)完成了研究。BE-PCV14组常见血清型的原发性后血清反应率从72.6% (95% CI: 65.8, 78.5)(血清型3)到100% (95% CI: 98.0, 100.0) (14,19 F);PCV13的发生率从71.6% (95% CI: 64.9, 77.5)到100% (95% CI: 98.1, 100.0) (14, 19 F, 19 A)。BE-PCV14的后增强率为87.6% (95% CI: 82.1, 91.6)至100% (95% CI: 98.0, 100.0), PCV13的后增强率为85.0% (95% CI: 79.4, 89.4)至100% (95% CI: 98.1, 100.0)。BE-PCV14对另外两种血清型引起高应答,即22 F: 96.8% (95% CI: 93.1, 98.5), 33 F: 92.5% (95% CI: 87.8, 95.5),交叉保护性6 A: 93.0% (95% CI: 88.4, 95.9)。在接受BE-PCV14或PCV13治疗的参与者中,分别有33.5% (95% CI: 27.3, 40.3)和38% (95% CI: 31.6, 44.9)发生轻度ae, 11.5% (95% CI: 7.8, 16.7)和10.5% (95% CI: 7.0, 15.5)发生中度ae。BE-PCV14组发生2例不相关的sae。BE-PCV14采用2p + 1方案,具有高度免疫原性,耐受性良好,与PCV13相当,同时扩大了血清型覆盖率。这些发现支持考虑将BE-PCV14纳入使用2p + 1计划的常规婴儿免疫规划,特别是在额外血清型导致持续肺炎球菌疾病的环境中。本临床研究由印度海德拉巴的Biological E. Limited独家资助。
{"title":"Immunogenicity and safety of biological E's 14-valent pneumococcal conjugate vaccine (PNEUBEVAX 14®) administered in a 2p + 1 schedule to healthy infants: a multicenter, randomized, active controlled, single-blind, phase III trial","authors":"Subhash Thuluva ,&nbsp;Ramesh V. Matur ,&nbsp;Subbareddy Gunneri ,&nbsp;Siddalingaiah Ningaiah ,&nbsp;Vijay Yerroju ,&nbsp;Rammohan Reddy Mogulla ,&nbsp;Chirag Dhar ,&nbsp;Kamal Thammireddy ,&nbsp;Piyush Paliwal ,&nbsp;Anand Kawade ,&nbsp;Pradeep Nanjappa ,&nbsp;Jog Pramod ,&nbsp;Manish Narang ,&nbsp;Bheemisetty S. Chakravarthy ,&nbsp;Prashanth M. Virupakashappa","doi":"10.1016/j.lansea.2026.100746","DOIUrl":"10.1016/j.lansea.2026.100746","url":null,"abstract":"<div><h3>Background</h3><div>Pneumococcal conjugate vaccines (PCVs) have markedly reduced childhood pneumococcal diseases, yet serotype replacement and regional heterogeneity remain important challenges. The World Health Organization recommends either a 3p + 0 or 2p + 1 schedule for PCV immunization programmes. BE-PCV14, a 14-valent vaccine, has previously been shown to be non-inferior to PCV13 in a 3p + 0 regimen. In this Phase III trial, we aimed to descriptively compare the immunogenicity and safety of BE-PCV14 and PCV13 in a 2p + 1 schedule in Indian infants.</div></div><div><h3>Methods</h3><div>In this randomized, single-blind, multicenter trial, 400 PCV-naïve infants (6–8 weeks old) were randomized 1:1 to receive either BE-PCV14 or PCV13; at 6 and 14 weeks, with a booster at 9 months. Serum IgG against 14 vaccine serotypes plus cross-protective 6 A were measured at post primary (28 days post dose 2), pre booster (at 9 months) and post booster (30 days post dose 3) time points. The primary endpoint was the proportion achieving IgG ≥0.35 μg/mL (seroresponse rate) for the 12 serotypes common to both vaccines at post primary, pre booster and post booster time points. Solicited local and systemic reactions were recorded for 7 days after each dose; unsolicited, and serious adverse events (SAEs) were captured throughout.</div></div><div><h3>Findings</h3><div>Between May 2023 and July 2024, 400 participants were enrolled of which 380 (95%) completed the study. Post primary seroresponse rates in the BE-PCV14 arm for common serotypes ranged from 72.6% (95% CI: 65.8, 78.5) (serotype 3) to 100% (95% CI: 98.0, 100.0) (14, 19 F); PCV13 rates ranged from 71.6% (95% CI: 64.9, 77.5) to 100% (95% CI: 98.1, 100.0) (14, 19 F, 19 A). Post booster rates were 87.6% (95% CI: 82.1, 91.6) to 100% (95% CI: 98.0, 100.0) for BE-PCV14 and 85.0% (95% CI: 79.4, 89.4) to 100% (95% CI: 98.1, 100.0) for PCV13. BE-PCV14 elicited high responses against the two additional serotypes, i.e., 22 F: 96.8% (95% CI: 93.1, 98.5), 33 F: 92.5% (95% CI: 87.8, 95.5), and cross-protective 6 A: 93.0% (95% CI: 88.4, 95.9). Of the participants that received BE-PCV14 or PCV13, 33.5% (95% CI: 27.3, 40.3) and 38% (95% CI: 31.6, 44.9) had mild AEs and 11.5% (95% CI: 7.8, 16.7) and 10.5% (95% CI: 7.0, 15.5) had moderate AEs, respectively. Two unrelated SAEs occurred in the BE-PCV14 arm.</div></div><div><h3>Interpretation</h3><div>Administered in a 2p + 1 schedule, BE-PCV14 was highly immunogenic, well tolerated, and comparable to PCV13 while broadening serotype coverage. These findings support consideration of BE-PCV14 for routine infant immunization programmes using a 2p + 1 schedule, particularly in settings where the additional serotypes contribute to ongoing pneumococcal disease.</div></div><div><h3>Funding</h3><div>This clinical research was exclusively funded by <span>Biological E. Limited</span>, Hyderabad, India.</div></div>","PeriodicalId":75136,"journal":{"name":"The Lancet regional health. Southeast Asia","volume":"46 ","pages":"Article 100746"},"PeriodicalIF":6.2,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147424299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
From DOTS to DOST: a new framework for TB elimination in India 从DOTS到DOST:印度消除结核病的新框架
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-02-03 DOI: 10.1016/j.lansea.2026.100721
Urvashi B. Singh , Raghuram Rao , Sanjay Kumar Mattoo , Nishant Kumar , Veena Dhawan , Vinay Garg , Bhawani Singh Kushwaha , Amar Shah , Kiran Rade , Shivani Chandra , Sadie B. Cowan , Madolyn Dauphinais , Pranay Sinha
India bears a quarter of the global tuberculosis (TB) burden and nearly one-third of TB related deaths, but substantial regional heterogeneity demands tailored elimination strategies. We propose the Dual-phase Operational Strategy for Tuberculosis elimination (DOST), a roadmap that explicitly addresses TB as both an infectious disease and a structural challenge. Phase 1 focuses on rapidly reducing transmission through intensified case-finding, upfront molecular diagnosis, and strengthened treatment, as demonstrated by India’s 100-Day TB Campaign, which expanded community screening and accelerated therapy initiation. Phase 2 pivots to preventing disease progression by scaling up TB preventive treatment and addressing key drivers such as undernutrition, HIV, and diabetes. DOST emphasizes subnational adaptation: high-burden states prioritize disease reduction, while states nearing low incidence shift toward preventing flare-ups and sustaining progress. Rooted in the Hindi word dost (friend), this person-centered approach integrates medical and social support, recognizing that eliminating TB in India requires compassion paired with structural action. By sequencing and localizing proven interventions, DOST offers a pragmatic pathway from TB response to TB elimination.
印度承担着全球四分之一的结核病负担和近三分之一的结核病相关死亡,但巨大的区域异质性要求有针对性的消除战略。我们提出了消除结核病的两阶段业务战略(DOST),这是一个明确将结核病视为传染病和结构性挑战的路线图。第一阶段的重点是通过加强病例发现、前期分子诊断和加强治疗来迅速减少传播,印度的100天结核病运动就证明了这一点,该运动扩大了社区筛查和加速了治疗启动。第二阶段的重点是通过扩大结核病预防性治疗和解决营养不良、艾滋病毒和糖尿病等关键驱动因素来预防疾病进展。DOST强调次国家适应:高负担国家优先考虑减少疾病,而接近低发病率的国家则转向预防突发事件和保持进展。这种以人为本的方法源于印地语“朋友”,将医疗和社会支持结合起来,认识到在印度消除结核病需要同情心与结构性行动相结合。通过对已证实的干预措施进行排序和本地化,DOST提供了一条从应对结核病到消除结核病的务实途径。
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引用次数: 0
Reappraising TB preventive treatment in India: programmatic and ethical implications of subclinical tuberculosis in household contacts 重新评估印度的结核病预防治疗:家庭接触者中亚临床结核病的规划和伦理意义
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-02-14 DOI: 10.1016/j.lansea.2026.100730
Saurav Basu , Atul Vashist , Shivani Chandra , Nandini Sharma
India's pursuit of Tuberculosis (TB) elimination is contingent on the rapid universal scale-up of TB Preventive Treatment (TPT) for household contacts. However, current strategies largely neglect the asymptomatic active (subclinical) TB stage in terms of standardized diagnosis and optimized management. Consequently, administering TPT to individuals with unrecognized subclinical TB constitutes inadequate therapy that provides no patient benefit, enables community transmission, and risks minimal chances of iatrogenic drug resistance—violating the fundamental ethical principle of non-maleficence. We examine the tension between utilitarian public health goals and individual biomedical ethics, arguing for a transition within the National TB Elimination Program (NTEP) toward a rights-based framework prioritizing the clinical safety of household contacts. Crucially, the NTEP must institutionalize robust health education for contacts regarding the persistent risk of progression for at least 24 months post-TPT completion, coupled with sustained clinical surveillance to mitigate delayed health-seeking behavior. Further, sustained investment in digital diagnostics and translational research apart from addressing implementation gaps in the private sector is paramount to making TPT safe, evidence-driven, and ethically responsible.
印度实现消除结核病的目标取决于迅速普遍扩大对家庭接触者的结核病预防治疗。然而,在标准化诊断和优化管理方面,目前的策略在很大程度上忽视了无症状活动性(亚临床)结核病阶段。因此,对未被识别的亚临床结核病患者使用TPT是不充分的治疗,不会给患者带来益处,会导致社区传播,而且医源性耐药的风险最小——违反了基本的非恶意伦理原则。我们研究了功利主义公共卫生目标与个人生物医学伦理之间的紧张关系,主张在国家结核病消除计划(NTEP)中向基于权利的框架过渡,优先考虑家庭接触者的临床安全。至关重要的是,在tpt完成后至少24个月,NTEP必须对接触者进行强有力的健康教育,以了解持续的进展风险,并辅以持续的临床监测,以减轻延迟的求医行为。此外,除了解决私营部门的实施差距外,对数字诊断和转化研究的持续投资对于使TPT安全、循证和道德负责至关重要。
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引用次数: 0
Navigating through HPV stigma: an intersectional lens on community engagement for vaccine acceptance in Pakistan 通过HPV耻辱导航:巴基斯坦社区参与疫苗接受的交叉镜头
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-02-24 DOI: 10.1016/j.lansea.2026.100733
Inayat Ali , Abida Sharif , Ayesha Qamar , Salma Sadique , Iffat Elbarazi
Human papillomavirus (HPV) vaccination represents a significant milestone in global public health efforts to prevent cervical cancer. Yet its implementation in some countries such as Pakistan reveals complex sociocultural and geopolitical challenges. Since the staged introduction of the HPV vaccine in Pakistan in 2025, coverage did not fully reach the targeted 9–14-year-old girls—falling short of the national goal of 90% by 2027. This commentary critically examines the intersectional barriers shaping HPV vaccine uptake in Pakistan, arguing that mistrust, stigma, and inequity are rooted in historical, gendered, religious, and geopolitical power dynamics. Applying an intersectional lens, the analysis demonstrates how vaccine resistance is influenced by moral anxieties surrounding adolescent sexuality, diverse religious interpretations, socioeconomic disparities, weak health infrastructure, and digital disinformation. Comparative insights from the United Arab Emirates and Saudi Arabia challenge assumptions that Muslim-majority contexts inherently resist HPV vaccination, highlighting instead the importance of socioculturally responsive strategies. The commentary proposes three policy implications for Pakistan: localized communication tailored to socio-cultural context, investment in social infrastructure and community engagement, and equity-sensitive monitoring frameworks. Addressing hesitancy requires recognizing community concerns as rational responses to lived experience rather than ignorance, for achieving equitable immunization and safeguarding girls’ health rights in comparable settings.
人乳头瘤病毒(HPV)疫苗接种是全球公共卫生努力预防宫颈癌的一个重要里程碑。然而,它在巴基斯坦等一些国家的实施显示出复杂的社会文化和地缘政治挑战。自巴基斯坦于2025年分阶段引入人乳头瘤病毒疫苗以来,覆盖率并未完全达到目标的9 - 14岁女孩,未能达到到2027年达到90%的国家目标。这篇评论批判性地审视了影响巴基斯坦人乳头瘤病毒疫苗接种的交叉障碍,认为不信任、耻辱和不平等根植于历史、性别、宗教和地缘政治权力动态。运用交叉视角,该分析展示了围绕青少年性行为的道德焦虑、不同的宗教解释、社会经济差异、薄弱的卫生基础设施和数字虚假信息如何影响疫苗耐药性。来自阿拉伯联合酋长国和沙特阿拉伯的比较见解挑战了穆斯林占多数的环境固有地抵制HPV疫苗接种的假设,而是强调了社会文化响应战略的重要性。该评论提出了对巴基斯坦的三个政策影响:适合社会文化背景的本地化沟通、对社会基础设施和社区参与的投资以及对公平敏感的监测框架。解决犹豫问题需要认识到社区关切是对生活经验的理性反应,而不是无知,以便在可比环境中实现公平的免疫接种和保障女孩的健康权利。
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引用次数: 0
Mitigating food safety risks in Indonesia's free school meals programme 降低印尼免费校餐计划的食品安全风险。
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-02-18 DOI: 10.1016/j.lansea.2026.100734
Henry Surendra , Arif Sujagat , Grace Wangge
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引用次数: 0
Sexual harassment in India's medical education: need for accountability 印度医学教育中的性骚扰:需要问责制
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-02-17 DOI: 10.1016/j.lansea.2026.100731
Srijani Paul , Nilabho Chakraborty , Ashish Pundhir , Venkatesh Karthikeyan , Vithya Sree M
Sexual harassment in medical education is a global, structurally embedded problem driven by rigid hierarchical cultures, with trainees disproportionately exposed to higher levels of harassment. Policy recommendations reframe harassment as a public health issue, and call for trauma-informed supports, anti-retaliation protections, and psychologically safe training environments.
医学教育中的性骚扰是一个全球性的、结构性的根深蒂固的问题,受到严格的等级文化的驱动,受训者不成比例地受到更高程度的骚扰。政策建议将骚扰重新定义为一个公共卫生问题,并呼吁提供了解创伤的支持、反报复保护和心理安全的培训环境。
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引用次数: 0
COVID-19 vaccination and mortality among coronary care patients with severe acute respiratory infection in Bangladesh: a prospective study (2021–2024) 孟加拉国冠状动脉重症急性呼吸道感染患者的COVID-19疫苗接种和死亡率:一项前瞻性研究(2021-2024)
IF 6.2 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-03-01 Epub Date: 2026-03-02 DOI: 10.1016/j.lansea.2026.100745
Zubair Akhtar , Md Ariful Islam , Mohammad Abdul Aleem , Tanzir Ahmed Shuvo , Md Zakiul Hassan , Asadullah , Mustafizur Rahman , Mohammed Ziaur Rahman , Mohammad Enayet Hossain , Tahmina Shirin , Mahbubur Rahman , Manjur Hossain Khan Jony , Monalisa , Ferdous Rahman Sarker , Ahmed Nawsher Alam , Shah Niaz Md. Rubaid Anwar , Mahmudur Rahman , Awachana Jiamsakul , Aye M. Moa , Timothy C. Tan , C Raina MacIntyre

Background

COVID-19 increases cardiovascular risk, and vaccination reduces adverse outcomes and mortality. We analysed national hospital-based sentinel surveillance data from Bangladesh, and the aim of the study was to identify factors associated with all-cause mortality among patients with cardiovascular complications.

Methods

We included patients from coronary care units in nine tertiary-hospitals between February 2021 and December 2024 with severe acute respiratory infections (SARI). Nasopharyngeal and oropharyngeal swabs were tested for SARS-CoV-2 and influenza viruses by multiplex rRT-PCR. Patients were followed up from hospital admission to 30 days post-discharge. Survival was assessed with Kaplan–Meier estimates stratified by vaccination status and compared using log-rank test. Risk factors for all-cause mortality were analysed using multivariable Cox proportional hazards regression, stratified by hospital type.

Findings

We enrolled 396 patients (median age 60, IQR: 48–65 years), and 70.5% (279/396) were male. The Median follow-up time was 33 days (IQR: 32–34 days). There were 13.9% (55/396) deaths, 41.2% (163/396) had acute myocardial infarction (AMI) and 71.2% (286/396) were COVID-19 vaccinated patients. SARS-CoV-2 and influenza viruses were detected among 6.8% (27/396) and 4.8% (19/396) patients, respectively. At follow-up, the survival rate was 89.6% in COVID-19 vaccinated patients compared to 81.4% in unvaccinated patients (P-value = 0.041). AMI was associated with higher mortality [HR = 1.74, (95% CI: 1.01–3.02), P-value = 0.048] while COVID-19 vaccination was protective [HR = 0.55, (95% CI: 0.32–0.96), P-value = 0.037].

Interpretation

COVID-19 vaccination was associated with reduced all-cause deaths among SARI patients with cardiovascular complications.

Funding

Centres for Disease Control and Prevention (CDC), Atlanta, Georgia, USA (U01GH002259). ZA is supported by UNSW by a UIPA PhD scholarship.
背景:covid -19增加心血管风险,而疫苗接种可减少不良后果和死亡率。我们分析了来自孟加拉国的国家医院哨点监测数据,研究的目的是确定与心血管并发症患者全因死亡率相关的因素。方法纳入2021年2月至2024年12月9所三级医院冠状动脉监护室重症急性呼吸道感染(SARI)患者。采用多重rRT-PCR检测鼻咽拭子和口咽拭子是否存在SARS-CoV-2和流感病毒。患者自入院至出院后30天随访。生存评估采用Kaplan-Meier估计,按疫苗接种状况分层,并采用log-rank检验进行比较。采用多变量Cox比例风险回归分析全因死亡率的危险因素,并按医院类型分层。研究结果:我们纳入396例患者(中位年龄60岁,IQR: 48-65岁),70.5%(279/396)为男性。中位随访时间为33天(IQR: 32-34天)。死亡人数占13.9%(55/396),急性心肌梗死(AMI)占41.2%(163/396),接种疫苗者占71.2%(286/396)。SARS-CoV-2和流感病毒检出率分别为6.8%(27/396)和4.8%(19/396)。随访时,COVID-19疫苗接种患者的生存率为89.6%,未接种疫苗的患者为81.4% (p值= 0.041)。AMI与较高的死亡率相关[HR = 1.74, (95% CI: 1.01-3.02), p值= 0.048],而COVID-19疫苗接种具有保护作用[HR = 0.55, (95% CI: 0.32-0.96), p值= 0.037]。covid -19疫苗接种与伴有心血管并发症的SARI患者全因死亡率降低相关。美国佐治亚州亚特兰大疾病控制和预防中心(CDC)资助(U01GH002259)。ZA由新南威尔士大学提供UIPA博士奖学金。
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引用次数: 0
期刊
The Lancet regional health. Southeast Asia
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