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    Summary
    EudraCT Number:2015-003556-44
    Sponsor's Protocol Code Number:IMEA048
    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:2018-09-20
    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 number2015-003556-44
    A.3Full title of the trial
    Phase 2 Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Chikungunya Virus-Like Particle Vaccine,VRC-CHKVLP059-00-VP, in Healthy Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    investigational Chikungunya virus (CHIKV) vaccine study to evaluate the safety and Immunogenicity of a Chikungunya Virus
    A.4.1Sponsor's protocol code numberIMEA048
    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 SponsorIMEA Fondation Leon Mba
    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 supportFHI360
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIMEA Fondation Leon Mba
    B.5.2Functional name of contact pointStudy coordinator
    B.5.3 Address:
    B.5.3.1Street AddressHopital Bichat Claude Bernard 46 rue Henri Huchard
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75018
    B.5.3.4CountryFrance
    B.5.4Telephone number33140256365
    B.5.5Fax number33140256356
    B.5.6E-mailaida.benalycherif@gmail.com
    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 No
    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 nameVRC-CHKVLP059-00-VP
    D.3.2Product code VRC-CHKVLP059-00-VP
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To evaluate the safety and tolerability of VRC-CHKVLP059-00-VP vaccin in healthy adults that reside in CHIKV endemic .
    E.1.1.1Medical condition in easily understood language
    To evaluate the safety and tolerability of VRC-CHKVLP059-00-VP in healthy adults that reside in CHIKV endemic
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PRIMARY OBJECTIVE:
    • To evaluate the safety and tolerability of VRC-CHKVLP059-00-VP in healthy adults that reside in CHIKV endemic areas when administered intramuscularly by needle and syringe at a dose of 20 mcg compared to placebo.
    E.2.2Secondary objectives of the trial
    • To evaluate the immune response to VRC-CHKVLP059-00-VP by neutralization assay at 4 weeks after the second 20 mcg dose (Study Week 8).
    • To compare rates of CHIKV infection that occur at Study Week 6 or later in vaccine and placebo recipients as assessed by PCR specific for the CHIKV virus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject must meet all of the following criteria:
    1. 18 to 60 years old
    2. Available for clinical follow-up through Study Week 72
    3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
    4. Able and willing to complete the informed consent process
    5. Willing to donate blood for sample storage to be used for future research
    6. In good general health, with a BMI ≤40, without clinically significant medical history, and has satisfactorily completed screening
    7. Physical examination and laboratory results without clinically significant findings within the 56 days prior to enrollment
    Laboratory Criteria within 56 days prior to enrollment:
    8. Hemoglobin either within institutional normal limits or accompanied by site physician approval as consistent with healthy adult status
    9. White blood cells either within institutional normal range or accompanied by site physician approval as consistent with healthy adult status
    10. Platelets = 125,000 – 500,000/mm3
    11. Alanine aminotransferase (ALT) ≤ 1.25 x upper limit of normal (ULN)
    12. Serum creatinine ≤ 1.1 x ULN based on site institutional normal range
    13. Negative FDA-approved HIV blood test
    14. Negative result on the [name assay kit for CHIKV screening]
    Criteria applicable to women of childbearing potential:
    15. Negative human chorionic gonadotropin pregnancy test (urine or serum) on day of enrollment
    16. Agree to use an effective means of birth control from 21 days prior to enrollment through 12 weeks after the last study injection
    E.4Principal exclusion criteria
    A subject will be excluded if one or more of the following conditions apply:
    Women Specific:
    1. Planning to become pregnant during the 16 weeks after enrollment in the study
    Subject has received any of the following substances:
    2. Systemic immunosuppressive medications within 2 weeks prior to enrollment
    3. Blood products within 16 weeks prior to enrollment
    4. Immunoglobulin within 8 weeks prior to enrollment
    5. Prior vaccinations with an investigational CHIKV vaccine
    6. Investigational research agents within 4 weeks prior to enrollment
    7. Any vaccination within 2 weeks prior to enrollment
    8. Current anti-TB prophylaxis or therapy
    Subject has a history of any of the following clinically significant conditions:
    9. A history of immune-mediated or clinically significant arthritis
    10. Serious reactions to vaccines that preclude receipt of study injections as determined by the investigator
    11. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
    12. Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids
    13. Diabetes mellitus (type I or II), with the exception of gestational diabetes
    14. Idiopathic urticaria within the past year
    15. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
    16. Malignancy that is active or history of a malignancy that is likely to recur during the period of the study
    17. Seizure in the past 3 years or treatment for a seizure disorder within the last 3 years
    18. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
    19. Psychiatric condition that may preclude compliance with the protocol; past or present psychoses; or a history of suicide plan or attempt within the five years prior to enrollment
    20. Any medical or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer’s ability to give informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    Assessment of product safety will include clinical observation and monitoring of hematological and chemical parameters. Reactogenicity will be closely monitored for 7 days after injection and safety evaluated by seven or more clinical visits through the study duration of 72 weeks.
    The following parameters will be assessed:
    • Local reactogenicity signs and symptoms
    • Systemic reactogenicity signs and symptoms
    • Laboratory measures of safety
    • Adverse and serious adverse experiences
    • Chikungunya infection event
    Immunogenicity
    The principle immunogenicity endpoints are measured at Week 0 and 8 by neutralization assay. Exploratory immunogenicity endpoints are measured at Week 4, 16, 24, 48, and 72 by neutralization assay, ELISA and other exploratory research tests.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 72
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 72
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Guadeloupe
    Martinique
    E.8.7Trial has a data monitoring committee Yes
    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
    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 months
    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: 100
    F.1.3Elderly (>=65 years) No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 400
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-08
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