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    Summary
    EudraCT Number:2021-003191-14
    Sponsor's Protocol Code Number:21CH135
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-003191-14
    A.3Full title of the trial
    Cohort assessing the immunogenicity and the safety of the COVID-19 Vaccine Janssen in healthy volunteers based on 3 age groups: 65 years or older - 55 to 65 years - 18 to 45 years - Covicompare-Janssen
    Cohorte évaluant l’immunogénicité et la sécurité du vaccin « COVID-19 Vaccine Janssen » chez des volontaires sains en fonction de 3 tranches d’âge :
    65 ans ou plus - 55 à 65 ans - de 18 à 45 ans
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cohort assessing the immunogenicity and the safety of the COVID-19 Vaccine Janssen in healthy volunteers based on 3 age groups: 65 years or older - 55 to 65 years - 18 to 45 years - Covicompare-Janssen
    Cohorte évaluant l’immunogénicité et la sécurité du vaccin « COVID-19 Vaccine Janssen » chez des volontaires sains en fonction de 3 tranches d’âge :
    65 ans ou plus - 55 à 65 ans - de 18 à 45 ans
    A.3.2Name or abbreviated title of the trial where available
    Covicompare-J
    A.4.1Sponsor's protocol code number21CH135
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU SAINT-ETIENNE
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportminister of health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Saint-Etienne
    B.5.2Functional name of contact pointCarine LABRUYERE
    B.5.3 Address:
    B.5.3.1Street AddressURCIP Hôpital Nord CHU Saint-Etienne
    B.5.3.2Town/ citySaint-Etienne
    B.5.3.3Post code42390
    B.5.3.4CountryFrance
    B.5.4Telephone number+330477120469
    B.5.5Fax number+330477127820
    B.5.6E-mailcarine.labruyere@chu-st-etienne.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name COVID-19 Vaccine Janssen
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    volunteers
    volontaires
    E.1.1.1Medical condition in easily understood language
    volunteers
    volontaires
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084465
    E.1.2Term COVID-19 vaccination
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the humoral immune response to the COVID-19 vaccine viral vector Janssen 28 days after single dose in volunteers aged:
    - more than 65 years
    - 55 to 65 years
    - 18 to 45 years
    Evaluer la réponse immune humorale au vaccin à vecteur viral Janssen 28 jours après l’injection unique, dans 3 tranches d’âge :
    - chez des personnes âgées de 65 ans ou plus,
    - chez des personnes de 55 à 65 ans
    - chez des personnes jeunes (18 à 45 ans),
    E.2.2Secondary objectives of the trial
    1. To assess humoral immune response after single dose vaccine and its maintenance or decay until M24
    2. To assess and characterize antigen-specific T cell response
    3. To evaluate mucosal immunity
    4. To determine the repertoire and polyclonality of humoral response
    5. To compare the various post-vaccinal immune response between young and old groups and more generally to assess the effect of age on markers of immune response.
    6. To evaluate clinical safety
    7. To collect occurrence of COVID-19
    8. To biobank biological materials (plasma, serum, PBMC…) to address to other secondary ancillary projects
    1. Evaluer la réponse immune humorale après l’injection unique et sa durée jusqu’à M24
    2. Evaluer les réponses immunes des cellules T spécifiques de SARS-COV-2
    3. Evaluer l’immunité mucosale
    4. Déterminer le répertoire et la poly-clonalité de la réponse humorale
    5. Comparer les différentes réponses immunitaires post-vaccinales entre les groupes jeunes et âgés et plus généralement évaluer l'effet de l'âge sur les marqueurs de la réponse immunitaire
    6. Évaluer la sécurité clinique et biologique
    7. Collecter l’occurrence de la COVID-19
    8. Constituer une biobanque de matériel biologique (plasma, sérum, PBMC…) pour d’éventuelles études ancillaires futures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - At least 18 years old: >65 years old or 55 to 65 years old, or 18 to 45 years old, depending on the group of inclusion.
    - Healthy adults, or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future.
    - Understands and agrees to comply with the study procedures (visits, phone calls) and provides written free informed consent.
    - Able to comply with study procedures based on Investigator judgement.
    - Affiliated to a social security system, (except state medical aid)
    - Volontaire âgé de 18 ans ou plus
    - Adultes en bonne condition de santé ou avec des antécédents médicaux stabilisés ou contrôlés. Un antécédent médical contrôlé signifie une maladie n’ayant pas nécessité un changement de traitement ou une hospitalisation pour aggravation dans les 3 mois précédents l’inclusion dans l’étude et pour lequel il n’est prévu aucun changement significatif du traitement ni hospitalisation pour aggravation de la maladie
    - Comprend et accepte de respecter les procédures de la recherche (visites, appels téléphonique) et ayant donné son consentement libre, éclairé et écrit.
    - Capable de respecter les procédures de la recherche selon le jugement de l’investigateur
    - Affilié à un système de sécurité sociale (hors AME)
    E.4Principal exclusion criteria
    - Subject is ill or febrile (body temperature ≥ 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 within the past 14 days at enrolment visit
    - History of documented COVID-19 (PCR+, antigenic test+ or chest TDM+ or serology SARS-CoV- 2+) prior to the vaccine administration
    - Subjects with positive serology to SARS-CoV-2 at the enrolment visit.
    - Subjects who already received another anti-SARS-CoV-2-vaccine
    - Subjects who received BCG given within the last year.
    - An immediate family member or household member of study staff.
    - Use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg/day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies
    - Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion.
    - Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection.
    - History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2- vaccine.
    - History of severe allergic event
    - Participation in another investigational clinical study (Jardé 1 or Jardé 2) within 4 weeks before the enrolment visits or planned before the study completion.
    - Known HIV, active HCV or HBV infection
    - Any pathological condition, such as cancer, which may be susceptible of reducing immunity response
    - History of heparin-induced thrombocytopenia (HIT)
    - Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy
    - The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study
    - Any condition which in the opinion of the investigator may interfere with the aim of the study
    - Pregnant or breastfeeding or positive pregnancy urine test at enrolment visit.
    - Woman in childbearing without efficacious contraception (in the opinion of the investigator) for 31 days after treatment
    - People under legal protection measure (tutorship, curatorship or safeguard measures)
    - Sujet malade ou fébrile (température ≥ 38.0°C) durant les 72 heures précédant la visite d’inclusion ou ayant présenté des symptômes significatifs de la COVID-19 dans les 14 jours précédents la visite d’inclusion.
    - Antécédents de COVID-19 documenté (PCR+ ou TDM du Thorax+ ou sérologie+ au SARS-CoV-2)
    - Sujet ayant une sérologie positive au SARS-Cov-2 à la visite d’inclusion
    - Sujet ayant reçu un autre anti-SARS-Cov-2 vaccin,
    - Sujets ayant reçu le vaccin BCG au cours de l’année précédente
    - Membre de la famille ou proche faisant partie de l’équipe en charge de la recherche
    - Administration d’immuno-supresseurs comme les corticoïdes à un dosage >10mg/jour (sauf à usage topique ou par inhalation) dans les 3 mois précédents l’inclusion, dans les 6 mois pour les chimiothérapies.
    - Ayant reçu des immunoglobulines ou produits dérivés du sang dans les 3 mois précédents l’inclusion dans l’étude ou prévoit d’en recevoir avant la fin de la recherche.
    - Ayant reçu un autre vaccin dans les 4 semaines précédant la première injection du vaccin à l’étude ou ayant prévu de recevoir un autre vaccin dans les 4 semaines suivant l’injection du vaccin à l’étude
    - Antécédents d’effets indésirables sévères après l’administration d’un vaccin incluant une réaction anaphylactique et les symptômes associés, comme un rash, une difficulté respiratoire un angioedème et une douleur abdominale, ou des antécédents de réaction allergique pouvant être exacerbée par un composant du vaccin anti-SARS-COV-2
    - Antécédent d’évènement allergique sévère
    - Participation à un autre essai clinique (jardé1) dans les 4 semaines précédant la visite d’inclusion ou participation planifiée à un autre essai clinique avant la fin de la recherche.
    - Infection connue par le HIV, HCV ou HBV
    - Toute pathologie, tel qu’un cancer susceptible de réduire la réponse immunitaire
    - Toute pathologie qui selon l’opinion de l’investigateur pourrait interférer avec l’objectif de l’étude.
    - Personne enceinte ou allaitante ou avec un test urinaire de grossesse positif à l’inclusion
    - Femme en âge de procréer et sans contraception efficace pendant toute la durée de l’étude
    - Personne sous mesure légale de protection (tutelle, curatelle ou mesure de sureté)
    E.5 End points
    E.5.1Primary end point(s)
    Anti SARS-CoV-2 Spike IgG (ELISA test)
    IgG anti SARS-CoV-2 (ELISA test) à J29 (28 jours après l’injection)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at day 29, (28 days after singe dose vaccine)
    à J29 (28 jours après l’injection)
    E.5.2Secondary end point(s)
    1. Anti SARS-CoV -2 specific IgG and IgM (total and subclasses IgG 1-4)
    Anti-SARS-CoV-2 -specific neutralizing antibody
    2. Fluorospot assays (TH1, TH2, TH17, Cytotoxicity)
    3. Mucosal SARS-CoV-2 -specific antibody
    4. Determination of the epitope profiling and B cell repertoire (stereotype clonotype) of the humoral response
    5. Pre-existing serology for SARS-CoV-2 or other coronavirus, Immunosenescence profile, transcriptomic analysis, immune cell phenotype.
    6. Immediate reactogenicity defined as any adverse reactions occurring within 30 minutes after injection
    Local and systemic reactogenicity measured by solicited adverse reactions up to day 7 after injection
    Unsolicited adverse events (AE) through 28 days after single dose vaccine.
    Any AEs of grade ≥ 2, until D29, then of grade ≥ 3 throughout the study period.
    Serious adverse events (SAEs) and Adverse events of special interest (AESI) throughout the entire study period.
    7. Occurrence of confirmed COVID-19 cases during the study period.
    1. IgG anti-SARS-CoV-2 (Ig totales et sous-classes 1-4)
    IgA et IgM anti-SARS-CoV-2
    Anticorps neutralisants anti-SARS-CoV-2
    2. Dosages par fluorospot (TH1, TH2, TH17, cytotoxicité)
    3. Anticorps muqueux spécifiques de SARS-CoV-2
    4. Détermination du répertoire antigénique (profil d’épitopes reconnus) et du répertoire des cellules B (profil clonotypique) de la réponse humorale
    5. Sérologie préexistante du SARS-CoV-2 ou d'autres coronavirus,
    profil d'immunosénescence, analyse transcriptomique, phénotype des cellules immunitaires
    6. Réactogénicité immédiate définie comme tout effet indésirable survenant dans les 30 minutes suivant chaque injection.
    Réactogénicité locale et systémique mesurée par les effets indésirables attendus jusqu'au 7ème jour après chaque injection
    Événements indésirables non attendus (EI) jusqu'à 28 jours après la dose unique de vaccin.
    Tout événement indésirable de grade ≥ 2, jusqu'à J29, puis de grade ≥ 3 pendant toute la durée de l'étude.
    Événement indésirable grave tout au long de la période d'étude.
    7. Occurrence de cas confirmés de COVID-19 pendant la période d'étude
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Day 1, D29, D57, M6, M12 and M24
    jour 1, J29, J57, M6, M12, M24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    cohorte
    cohort
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    janssen vaccine is used in this study as part of its aurorization by EMA
    Le vaccin à vecteur viral Janssen est utilisé dans l’étude selon l’autorisation de mise sur le marché délivrée par l’EMA.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months28
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation COVIREIVAC
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
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