{"doc_desc":{"title":"NaNO-DENGUE_ddi","producers":[{"name":"RACINE, C\u00e9line","abbreviation":"","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Metadata editor"}],"prod_date":"2023-12-13"},"study_desc":{"title_statement":{"idno":"10.16909-DATASET-43","title":"A Phase I, double-blind, randomized, vehicle-controlled, dose-finding, safety study of a synthetic nanoparticle-based, T cell priming peptide vaccine against Dengue virus in healthy adults in Switzerland","translated_title":"naNO-DENGUE: \u00c9tude de phase I randomis\u00e9e, contr\u00f4l\u00e9e par nano-vecteur, en double-aveugle, 19 \u00e9valuant la s\u00e9curit\u00e9 d\u2019emploi et la dose ad\u00e9quate d\u2019un vaccin synth\u00e9tique peptidique contre le virus de la dengue \u00e0 base de nanoparticules induisant les lymphocytes T, chez des adultes en bonne sant\u00e9 en Suisse"},"authoring_entity":[{"name":"GENTON, Blaise","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health"},{"name":"HARTLEY, Mary-Anne","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health"}],"oth_id":[{"name":"BESSON, Juliette","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","email":"","role":"Research physician"},{"name":"MABY EL HAJJAMI, H\u00e9l\u00e8ne","affiliation":"Lausanne University Hospital (CHUV)","email":"","role":"Regulatory support"},{"name":"KARLEN, Maxime","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","email":"","role":"Research physician"},{"name":"WARPELIN DECRAUSAZ, Loane","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health & Lausanne University Hospital (CHUV)","email":"","role":"Regulatory support"},{"name":"SENE, Loredana","affiliation":"Lausanne University Hospital (CHUV)","email":"","role":"Study nurse"},{"name":"SCHAUFELBERGER, Sylvain","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","email":"","role":"Data management"},{"name":"FAIVRE, Vincent","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","email":"","role":"Data management"}],"production_statement":{"producers":[{"name":"MIAUTON, Alix","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Project coordinator"},{"name":"FAOUZI, Mohamed","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Statistician"},{"name":"SPERTINI, Fran\u00e7ois","affiliation":"Lausanne University Hospital (CHUV)","role":"Lead for immunological analyses"},{"name":"AUDRAN, R\u00e9gine","affiliation":"Lausanne University Hospital (CHUV)","role":"Immunological analyses"}],"funding_agencies":[{"name":"Emergex Vaccines Holding Limited","abbreviation":"","role":""}]},"study_info":{"keywords":[{"keyword":"Dengue vaccine","vocab":"","uri":""},{"keyword":"Dengue virus","vocab":"","uri":""},{"keyword":"T cell immunity","vocab":"","uri":""},{"keyword":"Nanoparticle-based vaccine","vocab":"","uri":""}],"abstract":"Background\nVaccines that minimize the risk of vaccine-induced antibody-dependent enhancement and severe dengue are needed to address the global health threat posed by dengue. This study assessed the safety and immunogenicity of a gold nanoparticle (GNP)-based, multi-valent, synthetic peptide dengue vaccine candidate (PepGNP-Dengue), designed to provide protective CD8+ T cell immunity, without inducing antibodies. \nMethods\nIn this randomized, double-blind, vehicle-controlled, phase 1 trial (NCT04935801), healthy na\u00efve individuals aged 18-45 years recruited at the Centre for primary care and public health, Lausanne, Switzerland, were randomly assigned to receive PepGNP-Dengue or comparator (GNP without peptides [vehicle-GNP]). Randomization was stratified into four groups (low dose [LD] and high dose [HD]), allocation was double-blind from participants and investigators. Two doses were administered by intradermal microneedle injection 21 days apart. Primary outcome was safety, secondary outcome immunogenicity. Analysis was by intention-to-treat for safety, intention-to-treat and per protocol for immunogenicity. \nFindings\n26 participants were enrolled (Aug-Sep 2021) to receive PepGNP-Dengue (LD or HD, n=10 each) or vehicle-GNP (LD or HD, n=3 each). No vaccine-related serious adverse events occurred. Most (90%) related adverse events were mild; injection site pain and transient discoloration were most frequently reported. Injection site erythema occurred in 58% of participants. As expected, PepGNP-Dengue did not elicit anti-DENV antibodies of significance. Significant increases were observed in specific CD8+ T cells and dengue dextramer+ memory cell subsets in the LD PepGNP-Dengue but not in the HD PepGNP-Dengue or Vehicle-GNP groups, specifically PepGNP-activated CD137+CD69+CD8+ T cells (day 90, +0\u00b70318%, 95% CI: 0\u00b70088-0\u00b71723, p= 0\u00b7046), differentiated effector memory (TemRA) and central memory (Tcm) CD8+ T cells (day 35, +0\u00b78 \/105 CD8+, 95% CI: 0\u00b719-5\u00b713, p= 0\u00b7014 and +1\u00b734 \/105 CD8+, 95% CI: 0\u00b71-7\u00b734, p= 0\u00b7024, respectively). \nInterpretation\nResults provide proof of concept that a synthetic nanoparticle-based peptide vaccine can successfully induce virus-specific CD8+ T cells. The favourable safety profile and cellular responses observed support further development of PepGNP-Dengue. \nFunding \nEmergex Vaccines Holding Limited.","coll_dates":[{"start":"2021-07-26","end":"2022-03-11","cycle":""}],"nation":[{"name":"Switzerland","abbreviation":"CHE"}],"geog_coverage":"Switzerland","analysis_unit":"Individuals. 26 participants were enrolled.","data_kind":"Clinical data and laboratory data (safety)"},"data_access":{"dataset_use":{"contact":[{"name":"RACINE, C\u00e9line (repository manager)","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","email":"udd.data@unisante.ch","uri":""},{"name":"GENTON, Blaise","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","email":"blaise.genton@unisante.ch","uri":""}],"cit_req":"MIAUTON A, AUDRAN R, BESSON J, MABY-EL HAJJAMI H, KARLEN M, WARPELIN-DECRAUSAZ L, SENE L, SCHAUFELBERGER S, FAIVRE V, FAOUZI M, HARTLEY MA, SPERTINI F, GENTON B. Safety and immunogenicity of a synthetic nanoparticle-based, T cell priming peptide vaccine against dengue in healthy adults in Switzerland: a double-blind, randomized, vehicle-controlled, phase 1 study. Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland. Version 1.0 of the data dictionary, provided by the Unisant\u00e9 Research Data Repository. DOI:10.16909\/DATASET\/43","conditions":"The dataset can't be share due to ethical restriction. Only the codebook is made available."}}},"schematype":"survey"}