<?xml version='1.0' encoding='UTF-8'?>
<codeBook version="1.2.2" ID="10.16909-DATASET-43" xml-lang="en" xmlns="http://www.icpsr.umich.edu/DDI" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.icpsr.umich.edu/DDI http://www.icpsr.umich.edu/DDI/Version1-2-2.xsd">
  <docDscr>
    <citation>
      <titlStmt>
        <titl>
          NaNO-DENGUE_ddi
        </titl>
      </titlStmt>
      <prodStmt>
        <producer affiliation="Unisanté, University Center for Primary Care and Public Health" role="Metadata editor">
          RACINE, Céline
        </producer>
        <prodDate date="2023-12-13">
          2023-12-13
        </prodDate>
        <software version="4.0.10" date="2018-05-02">
          Nesstar Publisher
        </software>
      </prodStmt>
    </citation>
  </docDscr>
  <stdyDscr>
    <citation>
      <titlStmt>
        <titl>
          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
        </titl>
        <parTitl>
          naNO-DENGUE: Étude de phase I randomisée, contrôlée par nano-vecteur, en double-aveugle, 19 évaluant la sécurité d’emploi et la dose adéquate d’un vaccin synthétique peptidique contre le virus de la dengue à base de nanoparticules induisant les lymphocytes T, chez des adultes en bonne santé en Suisse
        </parTitl>
        <IDNo>
          10.16909-DATASET-43
        </IDNo>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="Unisanté, University Center for Primary Care and Public Health">
          GENTON, Blaise
        </AuthEnty>
        <AuthEnty affiliation="Unisanté, University Center for Primary Care and Public Health">
          HARTLEY, Mary-Anne
        </AuthEnty>
        <othId role="Research physician" affiliation="Unisanté, University Center for Primary Care and Public Health">
          <p>
            BESSON, Juliette
          </p>
        </othId>
        <othId role="Regulatory support" affiliation="Lausanne University Hospital (CHUV)">
          <p>
            MABY EL HAJJAMI, Hélène
          </p>
        </othId>
        <othId role="Research physician" affiliation="Unisanté, University Center for Primary Care and Public Health">
          <p>
            KARLEN, Maxime
          </p>
        </othId>
        <othId role="Regulatory support" affiliation="Unisanté, University Center for Primary Care and Public Health &amp; Lausanne University Hospital (CHUV)">
          <p>
            WARPELIN DECRAUSAZ, Loane
          </p>
        </othId>
        <othId role="Study nurse" affiliation="Lausanne University Hospital (CHUV)">
          <p>
            SENE, Loredana
          </p>
        </othId>
        <othId role="Data management" affiliation="Unisanté, University Center for Primary Care and Public Health">
          <p>
            SCHAUFELBERGER, Sylvain
          </p>
        </othId>
        <othId role="Data management" affiliation="Unisanté, University Center for Primary Care and Public Health">
          <p>
            FAIVRE, Vincent
          </p>
        </othId>
      </rspStmt>
      <prodStmt>
        <producer affiliation="Unisanté, University Center for Primary Care and Public Health" role="Project coordinator">
          MIAUTON, Alix
        </producer>
        <producer affiliation="Unisanté, University Center for Primary Care and Public Health" role="Statistician">
          FAOUZI, Mohamed
        </producer>
        <producer affiliation="Lausanne University Hospital (CHUV)" role="Lead for immunological analyses">
          SPERTINI, François
        </producer>
        <producer affiliation="Lausanne University Hospital (CHUV)" role="Immunological analyses">
          AUDRAN, Régine
        </producer>
        <software version="4.0.10" date="2018-05-02">
          Nesstar Publisher
        </software>
        <fundAg>
          Emergex Vaccines Holding Limited
        </fundAg>
      </prodStmt>
    </citation>
    <stdyInfo>
      <subject>
        <keyword>
          Dengue vaccine
        </keyword>
        <keyword>
          Dengue virus
        </keyword>
        <keyword>
          T cell immunity
        </keyword>
        <keyword>
          Nanoparticle-based vaccine
        </keyword>
      </subject>
      <abstract>
        <![CDATA[Background
Vaccines 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. 
Methods
In this randomized, double-blind, vehicle-controlled, phase 1 trial (NCT04935801), healthy naïve 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. 
Findings
26 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, +0·0318%, 95% CI: 0·0088-0·1723, p= 0·046), differentiated effector memory (TemRA) and central memory (Tcm) CD8+ T cells (day 35, +0·8 /105 CD8+, 95% CI: 0·19-5·13, p= 0·014 and +1·34 /105 CD8+, 95% CI: 0·1-7·34, p= 0·024, respectively). 
Interpretation
Results 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. 
Funding 
Emergex Vaccines Holding Limited.]]>
      </abstract>
      <sumDscr>
        <collDate date="2021-07-26" event="start"/>
        <collDate date="2022-03-11" event="end"/>
        <nation abbr="CHE">
          Switzerland
        </nation>
        <geogCover>
          Switzerland
        </geogCover>
        <anlyUnit>
          Individuals. 26 participants were enrolled.
        </anlyUnit>
        <dataKind>
          Clinical data and laboratory data (safety)
        </dataKind>
      </sumDscr>
    </stdyInfo>
    <method>
      <dataColl>
        <collMode>
        </collMode>
        <sources/>
      </dataColl>
    </method>
    <dataAccs>
      <useStmt>
        <contact affiliation="Unisanté, University Center for Primary Care and Public Health" email="udd.data@unisante.ch">
          RACINE, Céline (repository manager)
        </contact>
        <contact affiliation="Unisanté, University Center for Primary Care and Public Health" email="blaise.genton@unisante.ch">
          GENTON, Blaise
        </contact>
        <citReq>
          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 (Unisanté), University of Lausanne, Switzerland. Version 1.0 of the data dictionary, provided by the Unisanté Research Data Repository. DOI:10.16909/DATASET/43
        </citReq>
        <conditions>
          The dataset can't be share due to ethical restriction. Only the codebook is made available.
        </conditions>
      </useStmt>
    </dataAccs>
  </stdyDscr>
</codeBook>
