{"doc_desc":{"title":"A gold nanoparticle\/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland","producers":[{"name":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","abbr":"Unisant\u00e9","affiliation":"","role":""}]},"study_desc":{"title_statement":{"idno":"10.16909-dataset-54","title":"A gold nanoparticle\/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland"},"authoring_entity":[{"name":"GENTON, Blaise","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health"}],"production_statement":{"producers":[{"name":"Juliette Besson","abbr":"","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Project coordinator"},{"name":"R\u00e9gine Audran","abbr":"","affiliation":"CHUV, University Hospital of Lausanne","role":"Immunological analyses"},{"name":"Maxime Karlen","abbr":"","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Research physician"},{"name":"Alix Miauton","abbr":"","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Project coordinator"},{"name":"H\u00e9l\u00e8ne Maby-El Hajjami","abbr":"","affiliation":"CHUV, University Hospital of Lausanne","role":"Regulatory support"},{"name":"Loane Warpelin-Decrausaz","abbr":"","affiliation":"CHUV, University Hospital of Lausanne","role":"Regulatory support"},{"name":"Loredana Sene","abbr":"","affiliation":"CHUV, University Hospital of Lausanne","role":"Research nurse"},{"name":"Sylvain Schaufelberger","abbr":"","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Data management"},{"name":"Vincent Faivre","abbr":"","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Data management"},{"name":"Mohamed Faouzi","abbr":"","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Statistician"},{"name":"Mary-Anne Hartley","abbr":"","affiliation":"Unisant\u00e9, University Center for Primary Care and Public Health","role":"Co-investigator"},{"name":"Fran\u00e7ois Spertini","abbr":"","affiliation":"CHUV, University Hospital of Lausanne","role":"Immunological evaluator"}],"funding_agencies":[{"name":"Emergex Vaccines Holding Limited","abbr":"","role":""}]},"version_statement":{"version_date":" "},"study_info":{"keywords":[{"keyword":"SARS-CoV-2","vocab":"","uri":""},{"keyword":"Nano-Covid","vocab":"","uri":""},{"keyword":"Vaccine","vocab":"","uri":""},{"keyword":"T cell immunity","vocab":"","uri":""},{"keyword":"Nanoparticle-based vaccine","vocab":"","uri":""}],"abstract":"**Background\/Objectives**\nNew vaccines with broader protection against SARS-CoV-2 are needed to reduce the risk of immune escape and provide broad and long-lasting cellular immunity. The objectives of the naNO-COVID trial were to evaluate the safety and immunogenicity of a CD8+ T cell, gold nanoparticle (GNP)-based, peptide COVID-19 vaccine.\n\n**Methods**\nA randomized, double-blind, vehicle-controlled, phase 1 trial in healthy adults to receive PepGNP-Covid19 or Vehicle-GNP, followed over 180 days, using a dose-escalation strategy (ClinicalTrials.gov NCT05113862). \n\n**Results**\n20 participants received PepGNP-Covid19 [low dose (LD) or high dose (HD), n=10 each] and 6 Vehicle-GNP (LD or HD, n=3 each). \nVaccinations were safe. No SAEs were reported. Most of the AEs were mild, two AEs of special interest related to the product (fever and fatigue). Reactogenicity was similar overall between vaccine, comparator, and doses. \nVirus-specific humoral responses in LD PepGNP-Covid19 and Vehicle-GNP groups coincided with SARS-CoV-2 infections. PepGNP-Covid19 vaccination induced the modulation of Covid19-specific CD137+CD69+CD8+, and an increase at day 35 particularly in central and effector memory T cells in LD group, and in late effector memory cells in HD group.\n\n**Conclusions**\nThe favourable safety profile and cellular responses observed support further development of PepGNP-Covid19.","coll_dates":[{"start":"2021.12.03","end":"2022.09.15","cycle":""}],"nation":[{"name":"Switzerland","abbreviation":"CHE"}],"analysis_unit":"Individuals. 26 participants enrolled.","data_kind":"Clinical data [cli]"},"method":{"data_collection":{"coll_mode":["--"],"sources":[{"name":"","origin":"","characteristics":""}]}},"data_access":{"dataset_use":{"contact":[{"name":"RACINE, C\u00e9line (Repository manager)","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","email":"udd.data@unisante.ch","uri":""},{"name":"GENTON, Blaise","affiliation":"Unisant\u00e9","email":"Blaise.Genton@unisante.ch","uri":""}],"cit_req":"BESSON J, AUDRAN R, KARLEN M, MIAUTON A, MABY-EL HAJJAMI H, WARPELIN-DECRAUSAZ L, SENE L, SCHAUFELBERGER S, FAIVRE V, FAOUZI M, HARTLEY MA, SPERTINI F, GENTON B. A gold nanoparticle\/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland. 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\/54","conditions":"The dataset can't be share due to ethical restriction. Only the codebook is made available."}}},"schematype":"survey","tags":[{"tag":"COVID-19"}]}