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<docDscr>
  <citation>
    <titlStmt>
      <titl>COVID-19 vaccine cohort for special populations</titl>
      <IDNo>FRESH-PEF73983-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNIVERSITE DE BORDEAUX" role="">Aude BARQUIN</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                COVID-19 vaccine cohort for special populations            </titl>
      <altTitl>
                    ANRS 0001 S COV-POPART                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73983-en            </IDNo>
      <IDNo agency="PEF">
                    73983                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73983                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Linda WITTKOP                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
        <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Paul LOUBET                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE MONTPELLIER">
        <ExtLink title="ROR" URI="https://ror.org/051escj72" role="organisation id"/>
        <ExtLink title="SIREN" URI="130029796" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Odile LAUNAY                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE PARIS CITE">
        <ExtLink title="ROR" URI="https://ror.org/05f82e368" role="organisation id"/>
        <ExtLink title="SIREN" URI="130025737" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" email="sophie.guilmin-crepon@aphp.fr">
                    Sophie;GUILMIN-CREPON
                                            <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE DE BORDEAUX" email="aude.barquin@inserm.fr">
                    Aude;BARQUIN
                                            <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Covid-19 vaccines / Immunogenicity / Immunosuppression / At-risk populations</keyword>
      <topcClas vocab="health theme">
                        Clinical immunology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7a3cf568-46ba-4840-be8f-f22fc030139f"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D000486"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Infectious disease medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D055552"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        COVID-19                                            </topcClas>
    </subject>
    <abstract contentType="purpose">Main objectives common to all sub-populations: To evaluate in a standardized way in each sub-population the humoral immune response to Covid-19 vaccination at 1, 6, 12, 24 months after the first injection (one-injection scheme) or after the second injection of the vaccine (two- or three-injection schemes) and to evaluate in a standardized way the humoral response 1 month after receipt of the third injection in participants receiving a third injection according to current recommendations... Secondary objectives common to all sub-populations: 1. to evaluate and characterize the antigen-specific T-lymphocyte cellular immune response (at INC, M06, M12 and M24) induced after the first injection (one-injection regimen) or after the second injection of the vaccine (two- or three-injection regimens) in each subpopulation.. 2. compare the humoral immune response at 1, 6, 12, 24 months after the first injection (single-injection regimen) or after the second injection of the vaccine (two- or three-injection regimens) in each subpopulation with a group of subjects free of the chronic conditions studied or other pathologies/treatments influencing the immune response 3. compare the humoral response after three injections (M02) with that after two injections (M01) in participants who received a third injection in accordance with current recommendations.. 4. to evaluate and characterize the humoral immune response of participants who received a booster dose of mRNA vaccine in accordance with current recommendations 5. in each subpopulation, study the factors associated with the humoral immune response at 1 month and with the persistence of the humoral immune response at 6, 12 and 24 months as a function of age, stage of disease, treatment, type of vaccine (as well as the specific characteristics of the subpopulations studied) 6. compare the humoral immune response between different subpopulations 7. describe seroconversion for anti-nucleoprotein antibodies at inclusion and during follow-up 8. immuno-virological characterization of vaccine failures (SARS-CoV-2 infection within the time frame defined by current protocol) 9. investigate the genetic determinants of the immune response according to the underlying pathology and current treatments, if any (response and resistance to vaccination) Secondary objectives of the subpopulation of subjects not suffering from one of the chronic conditions of interest or other pathologies / under treatment with a known influence on the immune response and vaccinated with a 1st injection of Astra-Zeneca AZD1222 vaccine who will be vaccinated with a 2nd injection of Pfizer BNT162b2 mRNA vaccine 1. compare the immune response (humoral and cellular) obtained before and after the BNT162b2 vaccine dose 2. assess clinical reactogenicity (local and general) after an injection of BNT162b2 vaccine administered in accordance with current recommendations after an injection of AZD1222 vaccine</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2021-01-01"/>
      <collDate event="end" date="2024-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Child, Preschool (2 to 5 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002675"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>Concomitant Pathologies: ICD-10. Ongoing Treatments: WHO Drug</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>CMG-EC quality system (ISO 9001 certified)</otherQualityStatement>
      <otherQualityStatement>consistency checks after data entry</otherQualityStatement>
      <otherQualityStatement>data monitoring according to a monitoring plan: remotely + on site by a specialised CRO (return to source file for data management and verification)</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
      <sources>
        <sources>
          <sourceCitation>
                                    
                                    
                                                                    </sourceCitation>
          <srcOrig>Medico-administrative database</srcOrig>
        </sources>
      </sources>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>Enrolments closed on 31 December 2021 in the adult cohort: 6,112 participants. Enrolments ongoing in the paediatric ancillary study: enrolment target of 810 participants (enrolment expected to close in July 2022).</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Via the PRS form, which must be validated by the cohort&amp;#x27;s Steering Committee and Scientific Board.</conditions>
    </useStmt>
  </dataAccs>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
