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  <docDscr>
    <citation>
      <titlStmt>
        <titl>
           A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland
        </titl>
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		<othId role="Metadata and DDI creator" affiliation="Center for Primary Care and Public Health (Unisanté)">
            Racine, Céline
        </othId>
      </rspStmt>
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        <producer abbr="Unisanté">
          Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland
        </producer>
        <software version="1.2" date="2011-01-07">
          Metadata Editor
        </software>
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    </citation>
    <guide>
      <![CDATA[ ]]>
    </guide>
    <notes>
      <![CDATA[ ]]>
    </notes>
  </docDscr>
  <stdyDscr>
    <citation>
      <titlStmt>
        <titl>
          A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland
        </titl>
        <subTitl>
          
        </subTitl>
        <altTitl>
          
        </altTitl>
        <parTitl>
          
        </parTitl>
        <IDNo>
          10.16909-dataset-54
        </IDNo>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="Unisanté, University Center for Primary Care and Public Health">GENTON, Blaise</AuthEnty>

        
      </rspStmt>
      <prodStmt>
        <producer abbr="" affiliation="Unisanté, University Center for Primary Care and Public Health" role="Project coordinator">Juliette Besson</producer>
<producer abbr="" affiliation="CHUV, University Hospital of Lausanne" role="Immunological analyses">Régine Audran</producer>
<producer abbr="" affiliation="Unisanté, University Center for Primary Care and Public Health" role="Research physician">Maxime Karlen</producer>
<producer abbr="" affiliation="Unisanté, University Center for Primary Care and Public Health" role="Project coordinator">Alix Miauton</producer>
<producer abbr="" affiliation="CHUV, University Hospital of Lausanne" role="Regulatory support">Hélène Maby-El Hajjami</producer>
<producer abbr="" affiliation="CHUV, University Hospital of Lausanne" role="Regulatory support">Loane Warpelin-Decrausaz</producer>
<producer abbr="" affiliation="CHUV, University Hospital of Lausanne" role="Research nurse">Loredana Sene</producer>
<producer abbr="" affiliation="Unisanté, University Center for Primary Care and Public Health" role="Data management">Sylvain Schaufelberger</producer>
<producer abbr="" affiliation="Unisanté, University Center for Primary Care and Public Health" role="Data management">Vincent Faivre</producer>
<producer abbr="" affiliation="Unisanté, University Center for Primary Care and Public Health" role="Statistician">Mohamed Faouzi</producer>
<producer abbr="" affiliation="Unisanté, University Center for Primary Care and Public Health" role="Co-investigator">Mary-Anne Hartley</producer>
<producer abbr="" affiliation="CHUV, University Hospital of Lausanne" role="Immunological evaluator">François Spertini</producer>

        <copyright>
          
        </copyright>
        <fundAg abbr="" role="">Emergex Vaccines Holding Limited</fundAg>
<grantNo agency="Emergex Vaccines Holding Limited" role=""></grantNo>

      </prodStmt>
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        <serName>
          
        </serName>
        <serInfo>
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        <version date=" ">
          <![CDATA[]]>
        </version>
        <verResp affiliation=" "/>
        <notes>
          <![CDATA[]]>
        </notes>
      </verStmt>
    </citation>
    <stdyInfo>
      <subject>
        <keyword>SARS-CoV-2</keyword>
        <keyword>Nano-Covid</keyword>
		<keyword>Vaccine</keyword>
		<keyword>T cell immunity</keyword>
		<keyword>Nanoparticle-based vaccine</keyword>
      </subject>
      <abstract>
        <![CDATA[**Background/Objectives**
New 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.

**Methods**
A 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). 

**Results**
20 participants received PepGNP-Covid19 [low dose (LD) or high dose (HD), n=10 each] and 6 Vehicle-GNP (LD or HD, n=3 each). 
Vaccinations 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. 
Virus-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.

**Conclusions**
The favourable safety profile and cellular responses observed support further development of PepGNP-Covid19. 
]]>
      </abstract>
      <sumDscr>
        <collDate date="2021.12.03" event="start" cycle="" />
<collDate date="2022.09.15" event="end" cycle="" />

        
        <nation abbr="CHE">Switzerland</nation>

        <geogCover>
          <![CDATA[]]>
        </geogCover>
        <anlyUnit>
          <![CDATA[Individuals. 26 participants enrolled. ]]>
        </anlyUnit>
        <universe>
          <![CDATA[]]>
        </universe>
        <dataKind>
          Clinical data [cli]
        </dataKind>
      </sumDscr>
      <notes>
        <![CDATA[]]>
      </notes>
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        <sampProc>
          <![CDATA[]]>
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        <deviat>
          <![CDATA[]]>
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        <collMode>
          --
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        <resInstru>
          <![CDATA[]]>
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        <sources/>
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          <![CDATA[]]>
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        <actMin>
          <![CDATA[]]>
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        <weight>
          <![CDATA[]]>
        </weight>
        <cleanOps>
          <![CDATA[]]>
        </cleanOps>
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      <notes>
        <![CDATA[]]>
      </notes>
      <anlyInfo>
        <respRate>
          <![CDATA[]]>
        </respRate>
        <EstSmpErr>
          <![CDATA[]]>
        </EstSmpErr>
        <dataAppr>
          <![CDATA[]]>
        </dataAppr>
      </anlyInfo>
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    <dataAccs>
      <useStmt>
        <contact affiliation="Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland" email="udd.data@unisante.ch" URI="">RACINE, Céline (Repository manager)</contact>
		<contact affiliation="Unisanté" email="Blaise.Genton@unisante.ch" URI="">GENTON, Blaise</contact>
        <citReq>
          <![CDATA[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 (Unisanté), University of Lausanne, Switzerland. Version 1.0 of the data dictionary, provided by the Unisanté Research Data Repository. DOI:10.16909/DATASET/54]]>
        </citReq>
        <conditions>
          <![CDATA[The dataset can't be share due to ethical restriction. Only the codebook is made available.]]>
        </conditions>
        <disclaimer>
          <![CDATA[]]>
        </disclaimer>
      </useStmt>
    </dataAccs>
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