David Hillus, Ngoc Han Le, Pinkus Tober-Lau, Anne-Katrin Fietz, Christian Hoffmann, Regina Stegherr, Leu Huang, Axel Baumgarten, Florian Voit, Markus Bickel, Gal Goldstein, Christoph Wyen, Hartmut Stocker, Thomas Wünsche, Marcel Lee, Hubert Schulbin, Mathias Vallée, Ulrich Bohr, Anja Potthoff, Christiane Cordes, Leif Erik Sander
{"title":"Safety and effectiveness of MVA-BN vaccination against mpox in at-risk individuals in Germany (SEMVAc and TEMVAc): a combined prospective and retrospective cohort study","authors":"David Hillus, Ngoc Han Le, Pinkus Tober-Lau, Anne-Katrin Fietz, Christian Hoffmann, Regina Stegherr, Leu Huang, Axel Baumgarten, Florian Voit, Markus Bickel, Gal Goldstein, Christoph Wyen, Hartmut Stocker, Thomas Wünsche, Marcel Lee, Hubert Schulbin, Mathias Vallée, Ulrich Bohr, Anja Potthoff, Christiane Cordes, Leif Erik Sander","doi":"10.1016/s1473-3099(25)00018-0","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00018-0","url":null,"abstract":"<h3>Background</h3>More than 115 000 cases of mpox have been confirmed since the onset of a global outbreak in 2022. In addition to global transmission of clade II monkeypox virus (MPXV), the recent spread of clade I has caused a Public Health Emergency of International Concern. The third-generation smallpox vaccine modified vaccinia Ankara–Bavarian Nordic (MVA-BN) was recommended for at-risk populations in 2022, despite a scarcity of data on safety and effectiveness against mpox.<h3>Methods</h3>We did a prospective, multicentre, observational study, enrolling men who have sex with men and transgender people aged 18 years or older with changing sexual partners in Germany (Safety and Effectiveness of MVA-BN Vaccination Against MPXV Infection [SEMVAc]) between July 7, 2022, and Dec 31, 2023, evaluating safety and reactogenicity of one and two doses of subcutaneous MVA-BN. Vaccine effectiveness was estimated using risk ratios from the Kaplan–Meier estimator in an emulated retrospective target trial (Emulated Target Trial for Effectiveness of MVA-BN Vaccination Against mpox Infection in At-risk Individuals [TEMVAc]) from 3027 vaccinated individuals matched (1:1) to 3027 unvaccinated controls. SEMVAc and TEMVAc were registered in the HMA-EMA Catalogue, EUPAS50093, and the German Clinical Trials Register, DRKS00029638, and are complete.<h3>Findings</h3>6459 individuals were prospectively enrolled in SEMVAc. Adverse reactions were infrequent (first dose: 0·35% [95% CI 0·20–0·60] and second dose: 0·14% [0·06–0·33]). Local reactions were more frequent after the first dose (70·2% [95% CI 68·5–71·8]) compared with the second dose (56·8% [54·6–59]), as were systemic reactions (first dose, 22·3% [95% CI 20·9–23·9]; second dose, 17·6% [15·9–19·4]). In TEMVAc, 16 mpox cases were reported in vaccinated individuals versus 32 cases in matched unvaccinated individuals (median follow-up 55 days [IQR 23–89]). Effectiveness by 14 days or later after one dose was 57·8% (95% CI 11·8 to 83·0) overall, 84·1% (42·0 to 100) in people without HIV, but 34·9% (–72·8 to 79·0) in people living with HIV. Breakthrough infections were associated with reduced symptoms, compared with infections in unvaccinated individuals.<h3>Interpretation</h3>MVA-BN vaccination was safe and well tolerated. One dose of MVA-BN offered protection against mpox but effectiveness was reduced in people living with HIV. Although randomised controlled trials remain the preferred approach for assessing vaccine efficacy, combining prospective and retrospective study designs can be valuable during dynamic public health emergencies.<h3>Funding</h3>European Medicines Agency.<h3>Translation</h3>For the German translation of the abstract see Supplementary Materials section.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"183 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143653654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Future immunisation strategies to prevent Streptococcus pneumoniae infections in children and adults","authors":"Bernice Ramos, Nirma Khatri Vadlamudi, Crystal Han, Manish Sadarangani","doi":"10.1016/s1473-3099(24)00740-0","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00740-0","url":null,"abstract":"<em>Streptococcus pneumoniae</em> is a major respiratory pathogen, causing 1·2 million deaths and 197 million pneumonia episodes globally in 2016. The spread of <em>S pneumoniae</em> to sterile sites, such as the blood and brain, leads to invasive pneumococcal disease. The best approach available for prevention of invasive pneumococcal disease in children and, more recently, adults is the use of pneumococcal conjugate vaccines (PCVs). PCVs are also highly effective at preventing colonisation and, thus, transmission, offering indirect protection to non-target immunisation groups such as adults—a characteristic that has been crucial in their success. However, PCVs only include and protect up to 20 of the 100 serotypes that can cause disease. The rise in adult cases of invasive pneumococcal disease from serotypes included in PCVs suggests indirect protection might be limited. Additionally, non-vaccine serotypes and some vaccine types that persist, some linked to antibiotic resistance, continue to cause disease. Future vaccine strategies include increasing the number of serotypes covered in PCVs for use in children and adults, broader vaccine use in adults, the development of adult-specific conjugate vaccines containing serotypes different from those covered in PCVs used in children, and protein vaccines, all of which will be explored in this Review. These strategies are expected to help mitigate the global burden of invasive pneumococcal disease in future years.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"69 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143640808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Virak Eng, Dysoley Lek, Sitha Sin, Lionel Brice Feufack-Donfack, Agnes Orban, Jeremy Salvador, Dynang Seng, Sokleap Heng, Nimol Khim, Kieran Tebben, Claude Flamand, Cecile Sommen, Rob W van der Pluijm, Michael White, Benoit Witkowski, David Serre, Jean Popovici
{"title":"14 days of high-dose versus low-dose primaquine treatment in patients with Plasmodium vivax infection in Cambodia: a randomised, single-centre, open-label efficacy study","authors":"Virak Eng, Dysoley Lek, Sitha Sin, Lionel Brice Feufack-Donfack, Agnes Orban, Jeremy Salvador, Dynang Seng, Sokleap Heng, Nimol Khim, Kieran Tebben, Claude Flamand, Cecile Sommen, Rob W van der Pluijm, Michael White, Benoit Witkowski, David Serre, Jean Popovici","doi":"10.1016/s1473-3099(25)00033-7","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00033-7","url":null,"abstract":"<h3>Background</h3>Most malaria-endemic countries, including Cambodia, use a total dose of 3·5 mg/kg of primaquine to eliminate <em>Plasmodium vivax</em> hypnozoites and prevent relapses. There are, however, indications that the lower dose of 3·5 mg/kg is insufficient for tropical <em>P vivax</em> isolates, particularly in southeast Asia, and WHO now recommends a total dose of 7·0 mg/kg in most countries. We aimed to determine the most effective regimen to eliminate <em>P vivax</em> hypnozoites to support elimination efforts of this malaria parasite.<h3>Methods</h3>We conducted an open-label, randomised controlled trial in Kampong Speu province, western Cambodia. Patients infected with <em>P vivax</em> aged at least 15 years were offered to participate. Exclusion criteria were severe malaria or other diseases requiring treatment, low haemoglobin (<8·0 g/dL), pregnancy or breastfeeding, sensitivity to study drugs, and use of antimalarials in the preceding month. Enrolled patients were treated with an artesunate regimen of 2 mg/kg per day for 7 days. Patients with normal glucose-6-phosphate dehydrogenase (G6PD) levels were randomly assigned (2:2:1) to receive 3·5 mg/kg (low dose [0·25 mg/kg per day]), 7·0 mg/kg (high dose [0·5 mg/kg per day]), or no primaquine for 14 days. Patients with deficient G6PD levels were assigned to the no primaquine comparator arm. Patients were relocated to the study site in Aoral town where no malaria transmission occurs to ensure that they were not reinfected during their 90-day follow-up. After 90 days of relocation, G6PD-normal patients in the no primaquine arm were provided 3·5 mg/kg of primaquine for 14 days to be taken unsupervised. At day 90, relocation was terminated, and patients were followed up monthly for 3 months until day 180. The primary outcome was <em>P vivax</em> recurrence within 90 days of relocated follow-up, assessed in all patients who completed treatment and complied with relocation without interruption. All patients enrolled and assigned to an intervention arm were included in the safety analysis. The study is registered on <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> and recruitment is completed (<span><span>NCT04706130</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>).<h3>Findings</h3>Between Nov 10, 2021, and Feb 10, 2024, 160 patients were enrolled and 147 were included in the primary analysis—59 were assigned to the no primaquine arm (37 assigned as G6PD deficient [median age 22 years, IQR 18–28]; 22 randomly assigned [18, 17–25]), 45 to the low-dose primaquine arm (23, 19–30), and 43 to the high-dose primaquine arm (22, 18–25). Part","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"55 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143640809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The history of a pandemic","authors":"Henrietta Dunsmuir","doi":"10.1016/s1473-3099(25)00179-3","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00179-3","url":null,"abstract":"No Abstract","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"1 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143618652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to Lancet Infect Dis 2017; 17: 804–05","authors":"","doi":"10.1016/s1473-3099(25)00167-7","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00167-7","url":null,"abstract":"<em>Raoult D, Abat C. Developing new insecticides to prevent chaos: the real future threat.</em> Lancet Infect Dis <em>2017;</em> 17: <em>804–05</em>—The declaration of interests section of this Correspondence has been updated to add a competing interest and now reads ‘DR is a founder of Arthrobac Pharma. CA declares no competing interests.’ The authors of the article have been contacted about the correction and have not replied. This correction has been made as of March 12, 2025.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"49 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143608518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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