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    Summary
    EudraCT Number:2022-002352-39
    Sponsor's Protocol Code Number:APHP220580
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-20
    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 number2022-002352-39
    A.3Full title of the trial
    Follow-up of Contact Persons at Risk of Monkeypox infection: prospective cohort study (MONKEY VAX)
    Suivi des Personnes Contacts à Risque d’infection Monkeypox : étude de cohorte prospective (MONKEY VAX)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Follow-up of Contact Persons at Risk of Monkeypox infection
    Suivi des Personnes Contacts à Risque d’infection Monkeypox
    A.3.2Name or abbreviated title of the trial where available
    MONKEY VAX
    MONKEY VAX
    A.4.1Sponsor's protocol code numberAPHP220580
    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 SponsorAssistance Publique – Hôpitaux de Paris (AP-HP)
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique – Hôpitaux de Paris (AP-HP)
    B.5.2Functional name of contact pointChristophe AUCAN
    B.5.3 Address:
    B.5.3.1Street Address1, avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number330144841709
    B.5.6E-mailchristophe.aucan@aphp.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 JYNNEOS
    D.2.1.1.2Name of the Marketing Authorisation holderBavarian Nordic
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.1Product nameJYNNEOS
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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) Yes
    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.IMP: 2
    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 IMVANEX
    D.2.1.1.2Name of the Marketing Authorisation holderBavarian Nordic
    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.3.1Product nameIMVANEX
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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) Yes
    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
    The research is proposed to people at risk of infection with the monkey pox virus (Monkey pox), and to whom an anti-pox vaccine is proposed according to the health authorities recommandations (JYNNEOS or IMVANEX).
    La recherche est proposée aux personnes à risque d'infection par le virus de la variole simienne (Monkey pox), et à qui un vaccin anti-variole est proposé selon les recommandations des autorités de santé (JYNNEOS ou IMVANEX).
    E.1.1.1Medical condition in easily understood language
    people at risk of infection with the monkey pox virus
    Personnes à risque d'infection par le virus de la variole simienne (Monkey pox)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the post-exposure vaccination failure rate after one dose of the vaccine in Monkeypox contact subjects at risk
    Estimer le taux d’échec d’une VPE après 1 dose par le vaccin MVA chez les participants sujet contact Monkeypox à risque.
    E.2.2Secondary objectives of the trial
    1. Assess early vaccine humoral immunogenicity
    2. Assess vaccine humoral immunogenicity after one, two or even three doses of vaccine administered post-exposure
    3. Assess Factors Associated with the Immune Response
    4. Assess the proportion of failures and their clinical presentations according to the time between exposure and vaccination
    5. Effectiveness of PEV
    6. Assess vaccine reactogenicity after each dose of vaccine
    7. Assess the acceptability of post-exposure vaccination
    8. Prevalence of sexually transmitted infections at baseline
    9. Assess the transmissibility of asymptomatic forms
    10. Cellular immunity to MVA vaccination (under study on 30 subjects)
    1. Évaluer l’immunogénicité humorale vaccinale précoce
    2. Évaluer l’immunogénicité humorale vaccinale après une, deux, voire trois doses de vaccin MVA administrées en post exposition
    3. Évaluer les facteurs associés à la réponse immunitaire
    4. Evaluer la proportion d’échecs et leurs présentations cliniques en fonction du délai entre l’exposition et la vaccination
    5. Efficacité de la VPE
    6. Évaluer la réactogénicité du vaccin après chaque dose de vaccin
    7. Évaluer l’acceptabilité de la vaccination en post exposition
    8. Prévalence d’infections sexuellement transmissible à l’inclusion
    9. Évaluer la transmissibilité de formes asymptomatiques
    10. Immunité cellulaire à la vaccination MVA (sous étude sur 30 sujets)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years old
    - Be a contact person at risk of exposure to the Monkeypox virus as validated by Public Health France (SPF) for less than 14 days following the last contact with the case and not vaccinated
    OR
    Be a contact person at risk of exposure to the Monkeypox virus as validated by SPF and having received a first post-exposure injection less than 28 days ago
    - Signature of informed consent
    - Age ≥ 18 ans
    - Être personne-contact à risque d’exposition au virus de Monkeypox tel que validé par Santé Publique France (SPF) depuis moins de 14 jours suivant le dernier contact avec le cas et non vacciné
    OU
    Être personne-contact à risque d’exposition au virus de Monkeypox tel que validé par SPF et ayant reçu une première injection post-exposition il y a moins de 28 jours
    - Signature du consentement éclairé
    E.4Principal exclusion criteria
    - Being under guardianship or curatorship
    - No coverage by social security
    - Subject subject to a legal protection measure
    - Have a contraindication to Monkeypox vaccination
    - Present a known or suspected allergy to one of the components of the vaccine
    - Diagnosis of Monkeypox
    - Être sous tutelle ou sous curatelle
    - Pas de prise en charge par la sécurité sociale
    - Sujet faisant l'objet d’une mesure de protection de justice
    - Présenter une contre-indication à la vaccination Monkeypox
    - Présenter une allergie connue ou suspectée à l'un des composants du vaccin
    - Diagnostic de Monkeypox
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with post-exposure vaccination failure, failure being defined by a positive MKPXV PCR within 28 days after the 1st vaccine dose (blood, or urine, or skin or oropharyngeal PCR).
    Proportion de participants avec un échec de la VPE, l’échec étant défini par une PCR MKPXV positive dans les 28 jours après la 1ere dose VPE (PCR sang, ou urine, ou cutanée ou oro-pharyngée).
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after the first dose of vaccine
    28 jours après la première dose de vaccin.
    E.5.2Secondary end point(s)
    1. Anti-poxvirus antibody titer on the day of the first dose, 7 days and 14 days after the 1st dose
    2. Anti-poxvirus antibody titer at 1 month, 43 days, 3 months after the 1st dose
    3. Factors found to be statistically associated with immune response or failure against MKPXV
    4. Proportions of failures and clinical presentation in vaccinees <4 days after exposure, 4 to 9 days, > 10 days
    5. Comparison of the number of infections in vaccinated and unvaccinated
    6. Any adverse effects occurring up to 3 months after the 1st dose
    7. Proportion of people accepting vaccination
    8. HIV, HAV, HBV, HCV, Syphilis seropositivity at baseline
    9. Detection of monkeypox virus in samples
    10. Study of cellular immunity (30 subjects)
    1. Titre d’anticorps anti-poxvirus le jour de la première dose, à 7j et 14j après 1ère dose
    2. Titre d’anticorps anti-poxvirus à 1 mois, 43 jours, 3 mois après la 1ère dose
    3. Facteurs trouvés comme statistiquement associés à une réponse immunitaire ou à un échec contre MKPXV
    4. Proportions d’échecs et présentation clinique chez les vaccinés <4j après exposition, 4 à 9j, > 10j
    5. Comparaison du nb d’infections chez les vaccinés et chez les non vaccinés
    6. Tout effet indésirable survenues jusqu’à 3 mois après la 1ère dose
    7. Proportion de personnes acceptant la vaccination
    8. Séropositivité VIH, VHA, VHB, VHC, Syphilis à l’inclusion
    9. Détection de virus monkeypox dans les prélèvements
    10. Étude de l’immunité cellulaire (30 sujets)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3 month after the first dose of vaccine
    Jusqu'à trois mois après la première dose de vaccin.
    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 Yes
    E.6.5Efficacy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    To estimate the post-exposure vaccination failure rate after one dose of the MVA vaccine in Monkeypox contact subject participants at risk.
    Estimer le taux d’échec d’une vaccination post exposition après une dose par le vaccin MVA chez les participants sujet contact monkeypox à risque.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Suivi d'une cohorte de patient vaccinés contre la variole
    Cohort follow-up
    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
    LVLS
    Dernière visite du dernier patient.
    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 months12
    E.8.9.1In the Member State concerned days
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state226
    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)
    The patients will be followed by the recruiting centers as required by health authorities
    Les patients seront suivis par les centres recruteurs tel que prévu dans les recommandations des autorités de santé.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
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