NPJ VaccinesPub Date : 2025-03-17DOI: 10.1038/s41541-025-01100-5
Aileen Ebenig, Mona V Lange, Michelle Gellhorn Serra, Alexandra Kupke, Roland Plesker, Bingqian Qu, Richard J P Brown, Thorsten J Maier, Michael D Mühlebach
{"title":"Differential efficacy of first licensed western vaccines protecting without immunopathogenesis Wuhan-1-challenged hamsters from severe COVID-19.","authors":"Aileen Ebenig, Mona V Lange, Michelle Gellhorn Serra, Alexandra Kupke, Roland Plesker, Bingqian Qu, Richard J P Brown, Thorsten J Maier, Michael D Mühlebach","doi":"10.1038/s41541-025-01100-5","DOIUrl":"10.1038/s41541-025-01100-5","url":null,"abstract":"<p><p>Four COVID-19 vaccines were developed, tested, and authorized early in Europe and the US. Comirnaty and Spikevax are mRNA-based, whereas Jcovden and Vaxzevria utilize adenoviral vectors (AdV). We described a hamster model of COVID-19 utilizing Wuhan-1 strain SARS-CoV-2, in which vaccine-associated immunopathogenesis can be induced by Alum-adjuvanted Spike protein (Alum+S). Such animals were vaccinated with the authorized vaccines or Alum+S, challenged, and examined. All vaccinated hamsters produced antibodies targeting S. Neutralizing antibodies (nAb) were induced only by authorized vaccines. While nAbs were present after one vaccination with AdV-vaccines, mRNA vaccines needed a boost immunization. Upon challenge, all authorized vaccines protected from severe disease. Less tissue damage and no live virus (one exception) were detectable in the lungs. In contrast, Alum+S immunized hamsters developed VAERD. Our data reveal the absence of induction of VAERD by early commercial vaccines in hamsters, while animals´ immune responses and protection seem to match the clinical vaccine efficacy.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"51"},"PeriodicalIF":6.9,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11914482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143649597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A randomized phase I trial of intranasal SARS-CoV-2 vaccine dNS1-RBD in children aged 3-17 years.","authors":"Kai Chu, Jiali Quan, Xiaohui Liu, Qi Chen, Xia Zang, Hanmin Jiang, Donglin Liu, Xiafei Chu, Chunlan Zhuang, Jinle Han, Xiangzhong Ye, Hongxing Pan, Shoujie Huang, Ting Wu, Jun Zhang, Ningshao Xia","doi":"10.1038/s41541-025-01096-y","DOIUrl":"10.1038/s41541-025-01096-y","url":null,"abstract":"<p><p>The intranasal SARS-CoV-2 vaccine dNS1-RBD (Pneucolin®), based on a live-attenuated influenza virus vector, has obtained Emergency Use Authorization in China for individuals aged 18 years and older. Here, we conducted a single-center, double-blind, placebo-controlled, age de-escalation phase 1 clinical trial to evaluate the safety of the dNS1-RBD in children aged 3-17 years (ChiCTR2300068044). Sixty-three participants received 2 intranasal doses of the vaccine or placebo at days 0 and 14. Safety assessments included adverse events/reactions within 30 days and serious adverse events (SAEs) over 12 months. Blood and nasal secretion samples were collected to further monitor blood indices and viral shedding. The vaccine group showed similar adverse reaction rates to the placebo group (39.0% vs 36.4%), with no SAEs related to vaccination. Data suggested that the dNS1-RBD vaccine is well-tolerated in children aged 3-17 years, and warrants further studies on its safety, immunogenicity and efficacy in this population.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"50"},"PeriodicalIF":6.9,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11914604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143649552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2025-03-14DOI: 10.1038/s41541-025-01093-1
Raquel Munoz-Moreno, Viola Allaj, Eddie Gadee, Julie M Button, Fernando Diaz, Mohan S Maddur, Wei Chen, Cheng Hui Hu, Lyndsey Martinez, Andreas Giannakou, Adam Lee Campbell, Yana Miteva, Pengbo Guo, Bridget Huang, Shuai Shi, Jason Lotvin, Kristin Tompkins, Pirada Suphaphiphat Allen, Alicia Solórzano
{"title":"A highly stable lyophilized mRNA vaccine for Herpes Zoster provides potent cellular and humoral responses.","authors":"Raquel Munoz-Moreno, Viola Allaj, Eddie Gadee, Julie M Button, Fernando Diaz, Mohan S Maddur, Wei Chen, Cheng Hui Hu, Lyndsey Martinez, Andreas Giannakou, Adam Lee Campbell, Yana Miteva, Pengbo Guo, Bridget Huang, Shuai Shi, Jason Lotvin, Kristin Tompkins, Pirada Suphaphiphat Allen, Alicia Solórzano","doi":"10.1038/s41541-025-01093-1","DOIUrl":"10.1038/s41541-025-01093-1","url":null,"abstract":"<p><p>Herpes zoster (HZ) is a painful vesicular rash that occurs upon varicella-zoster virus (VZV) reactivation in older adults and immunocompromised individuals. Although there is currently an approved vaccine for the prevention of shingles, its administration is commonly associated with high reactogenicity. This highlights the need to develop new vaccine alternatives with long lasting immunity and improved tolerability upon administration. In the present study, 10 different vaccine candidate designs using two different codon optimizations targeting the VZV glycoprotein E (gE) were generated. A subset of mRNA constructs were formulated into lipid nanoparticles and assessed for their ability to induce specific cellular and humoral immune responses following vaccination in mice. Notably, the selected mRNA vaccine candidates induced high levels of antibodies and robust CD4<sup>+</sup> but also CD8<sup>+</sup> immune responses. Moreover, we showed that our alternate lyophilized vaccine provides comparable immunogenicity to current liquid frozen formulations and is stable under long-term storage conditions.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"49"},"PeriodicalIF":6.9,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909110/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2025-03-13DOI: 10.1038/s41541-024-01044-2
Desalegn W Kifle, Mumtaz Y Balkhi, Yasuko Ono, Jenn Davis, Naoko Doi, Aryandra Arya, Jiho Kim, Aravindan Kalyanasundaram, Sourav Nandy, Njariharinjakamampionona Rakotozandrindrainy, Bart Staker, Justin Craig, Raphaël Rakotozandrindrainy, Birkneh T Tadesse, Florian Marks, Lisa Jackson, Darrick Carter, Sean A Gray, Afzal A Siddiqui
{"title":"A functional enzymatic assay as potential readout for a clinical trial of a schistosomiasis vaccine.","authors":"Desalegn W Kifle, Mumtaz Y Balkhi, Yasuko Ono, Jenn Davis, Naoko Doi, Aryandra Arya, Jiho Kim, Aravindan Kalyanasundaram, Sourav Nandy, Njariharinjakamampionona Rakotozandrindrainy, Bart Staker, Justin Craig, Raphaël Rakotozandrindrainy, Birkneh T Tadesse, Florian Marks, Lisa Jackson, Darrick Carter, Sean A Gray, Afzal A Siddiqui","doi":"10.1038/s41541-024-01044-2","DOIUrl":"10.1038/s41541-024-01044-2","url":null,"abstract":"<p><p>An estimated 200 million people are currently infected with schistosomiasis and an additional 800 million reside in high transmission-risk areas in 78 endemic countries. In this report we describe a functional enzymatic assay based on the core calpain antigen (Sm-p80) of the schistosomiasis vaccine, SchistoShield®. A 44 kDa soluble variant of the core Sm-p80 antigen (B7), was assessed for its enzymatic activity using a fluorescent synthetic substrate. Inhibition of the B7 enzymatic activity by Sm-p80-specific antibodies obtained from pre-clinical trials in rodents, non-human primates as well as from participants of the human clinical trials was measured. The B7 enzyme activity followed a Michaelis-Menten-like kinetic behavior. Statistically significant inhibition of the B7 activity was observed by Sm-p80-specific antibodies produced by immunized mice, non-human primates and humans. This quantitative serological assay could be of value in assessing the effectiveness of the SchistoShield® vaccine in human trials in Africa.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"48"},"PeriodicalIF":6.9,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11906860/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143625531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2025-03-12DOI: 10.1038/s41541-025-01102-3
Changyoun Kim, Armine Hovakimyan, Karen Zagorski, Tatevik Antonyan, Irina Petrushina, Hayk Davtyan, Gor Chailyan, Jonathan Hasselmann, Michiyo Iba, Anthony Adame, Edward Rockenstein, Marcell Szabo, Mathew Blurton-Jones, David H Cribbs, Anahit Ghochikyan, Eliezer Masliah, Michael G Agadjanyan
{"title":"Retraction Note: Efficacy and immunogenicity of MultiTEP-based DNA vaccines targeting human α-synuclein: prelude for IND enabling studies.","authors":"Changyoun Kim, Armine Hovakimyan, Karen Zagorski, Tatevik Antonyan, Irina Petrushina, Hayk Davtyan, Gor Chailyan, Jonathan Hasselmann, Michiyo Iba, Anthony Adame, Edward Rockenstein, Marcell Szabo, Mathew Blurton-Jones, David H Cribbs, Anahit Ghochikyan, Eliezer Masliah, Michael G Agadjanyan","doi":"10.1038/s41541-025-01102-3","DOIUrl":"10.1038/s41541-025-01102-3","url":null,"abstract":"","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"47"},"PeriodicalIF":6.9,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11903769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143616562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2025-03-06DOI: 10.1038/s41541-025-01099-9
Erwin van den Born, Ferenc Olasz, István Mészáros, Eszter Göltl, Barbara Oláh, Jui Joshi, Emma van Kilsdonk, Ruud Segers, Zoltán Zádori
{"title":"African swine fever virus vaccine strain Asfv-G-∆I177l reverts to virulence and negatively affects reproductive performance.","authors":"Erwin van den Born, Ferenc Olasz, István Mészáros, Eszter Göltl, Barbara Oláh, Jui Joshi, Emma van Kilsdonk, Ruud Segers, Zoltán Zádori","doi":"10.1038/s41541-025-01099-9","DOIUrl":"10.1038/s41541-025-01099-9","url":null,"abstract":"<p><p>ASFV-G-ΔI177L is a modified-live African swine fever virus (ASFV) strain that has been incorporated into a commercially available vaccine. Its safety in pregnant sows and genetic stability in an in vivo passaging experiment were investigated. Upon inoculation of two pregnant sows with ASFV-G-ΔI177L, one developed moderate ASF-related clinical signs. In terms of reproductive performance, 43% of the offspring was born dead and the live-born piglets developed ASF-specific clinical signs, became viremic, and only 17% survived until the end of study. During passaging in pigs, ASFV-G-ΔI177L reverted to virulence with severe ASF-specific clinical signs at passages 3 and 4, associated with increased viremia. Whole genome sequencing identified C257L mutations as a potential driver of increased replication fitness and virulence. The data show that ASFV-G-ΔI177L is not genetically stable and, therefore not safe for use in ASF vaccines and suggest that ASF vaccine candidates should be tested for safety in pregnant animals.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"46"},"PeriodicalIF":6.9,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11885574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2025-03-05DOI: 10.1038/s41541-025-01092-2
Yugenia K Hong-Nguyen, Joseph Toerner, Lucia Lee, Maria C Allende, David C Kaslow
{"title":"Author Correction: Regulatory review of benefits and risks of preventing infant RSV disease through maternal immunization.","authors":"Yugenia K Hong-Nguyen, Joseph Toerner, Lucia Lee, Maria C Allende, David C Kaslow","doi":"10.1038/s41541-025-01092-2","DOIUrl":"10.1038/s41541-025-01092-2","url":null,"abstract":"","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"45"},"PeriodicalIF":6.9,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882992/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
NPJ VaccinesPub Date : 2025-03-05DOI: 10.1038/s41541-025-01094-0
Asisa Volz, Sabrina Clever, Alina Tscherne, Astrid Freudenstein, Sylvia Jany, Jan H Schwarz, Leonard Limpinsel, William G Valiant, Georgia Kalodimou, Gerd Sutter, Joseph J Mattapallil
{"title":"Efficacy of emergency maternal MVA-ZIKV vaccination in a rapid challenge model of lethal Zika infection.","authors":"Asisa Volz, Sabrina Clever, Alina Tscherne, Astrid Freudenstein, Sylvia Jany, Jan H Schwarz, Leonard Limpinsel, William G Valiant, Georgia Kalodimou, Gerd Sutter, Joseph J Mattapallil","doi":"10.1038/s41541-025-01094-0","DOIUrl":"10.1038/s41541-025-01094-0","url":null,"abstract":"<p><p>Zika virus (ZIKV) outbreak of 2015 was associated with microcephaly and congenital birth defects in children born to pregnant women infected with ZIKV. Using the highly susceptible Type I Interferon Receptor-deficient mouse-model, we demonstrate that a single emergency vaccination with a non-replicating MVA-ZIKV vaccine, when administered as early as 2-days before challenge fully protected non-pregnant and pregnant mice and fetuses against lethal ZIKV-infection. Early protection was associated with the rapid emergence of ZIKV-specific CD8+ T cell responses; depletion of CD8+ T cells resulted in the loss of protection supporting a critical role for CD8+ T cells in the early protective efficacy of MVA-ZIKV. Neutralizing antibody responses were induced later than the CD8+ T cell responses, suggesting that it may play a role in later stages of infection. Our results suggest that MVA-ZIKV induces potent anamnestic cellular immunity early after infection, contributing to its protective efficacy against rapid ZIKV challenge.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"44"},"PeriodicalIF":6.9,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882785/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Optimizing rabies mRNA vaccine efficacy via RABV-G structural domain screening and heterologous prime-boost immunization.","authors":"Dongdong Li, Xuan Wang, Gaotian Li, Jingying Zhou, Lijun Bian, Xiaoyan Zhao, Liao Xing, Juanmei Zeng, Jiaxing Cui, Lili Cui, Yong Zhang, Yan Chen","doi":"10.1038/s41541-025-01098-w","DOIUrl":"10.1038/s41541-025-01098-w","url":null,"abstract":"<p><p>mRNA vaccine has become a promising technology platform for rabies prevention. This study explores the roles of different structural domains of rabies virus glycoprotein (RABV-G) and heterologous prime-boost strategies for enhanced immune responses and protection. The results suggested that mRNA vaccines encoding full-length RABV-G (RABV-Full) and RABV-R333Q induced strong immune responses and provided full protection against rabies, while mRNA vaccines encoding ectodomain/transmembrane domain (RABV-TE) and ectodomain (RABV-E) were less effective. Heterologous immunization results revealed that mRNA-primed strategies yielded higher long-lasting VNTs, but lower early VNTs than inactivated rabies virus (IRV)-primed strategies. 2×RABV-Full and IRV > RABV-Full provided 100% protection, while that of RABV-Full>IRV was 90%. Transcriptome analysis showed that rabies mRNA vaccine induced both MHCI and MHCII antigen presentation, as well as B/T cell activation. In conclusion, full-length RABV-G mRNA vaccines, particularly with an 'IRV prime and RABV-Full boost' strategy, hold great potential for rabies prevention.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"43"},"PeriodicalIF":6.9,"publicationDate":"2025-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11873297/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cellular immune breadth of an Omicron-specific, self-amplifying monovalent mRNA vaccine booster for COVID-19.","authors":"Durgesh Kumar, Kshitij Gaikwad, Rushank Gunnale, Sandeep Vishwakarma, Shalu Shukla, Shalini Srivastava, Janhavi Gopal, Bhalchandra Vaidya, Amit Saraf, Rohan Gurjar, Swarnendu Kaviraj, Ajay Singh, Arjun Raghuwanshi, Praveen Agarwal, Laxman Savergave, Sanjay Singh","doi":"10.1038/s41541-025-01076-2","DOIUrl":"10.1038/s41541-025-01076-2","url":null,"abstract":"<p><p>Selecting a booster vaccine strategy that generates cellular immune breadth is crucial for effectively recalling cellular reservoirs upon infection with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants. This post hoc analysis from a multicentre, randomized phase 3 study (CTRI/2022/10/046475) compared the cellular immune breadth induced by self-replicating mRNA (samRNA) vaccine GEMCOVAC-OM, encoding Omicron B.1.1.529 Spike protein, with the adenovector vaccine ChAdOx1 nCoV-19, encoding Wuhan variant Spike protein, when administered as a booster. GEMCOVAC-OM elicited significant expansion of memory B-cells (MBCs) specific to Omicron B.1.1.529, compared to ChAdOx1 nCoV-19. GEMCOVAC-OM also induced more B-cells reactive to Omicron XBB.1.5 and BA.2.86 Spike proteins. Additionally, GEMCOVAC-OM triggered higher frequencies of Omicron-Spike-specific T-cells, including stem cell, central, and effector memory subsets. In summary, while ChAdOx1 nCoV-19 showed some cross-reactivity, GEMCOVAC-OM induced a more targeted immune response. GEMCOVAC-OM offers a broader, longer-lasting immunity, making it a promising candidate for future vaccine development and global distribution.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"42"},"PeriodicalIF":6.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11873296/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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