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    Summary
    EudraCT Number:2023-001124-42
    Sponsor's Protocol Code Number:EBSICV317004
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2024-02-13
    Trial results View 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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2023-001124-42
    A.3Full title of the trial
    A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Clinical Trial to evaluate PXVX0317, a virus-like particle vaccine for active immunization to prevent disease caused by chikungunya virus.
    A.3.2Name or abbreviated title of the trial where available
    A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317
    A.4.1Sponsor's protocol code numberEBSICV317004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05072080
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/159/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBavarian Nordic A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBavarian Nordic A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBavarian Nordic
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressPhilip Heymans Alle 3
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.6E-mailmedical.information_eu@bavarian-nordic.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 nameCHIKV VLP vaccine
    D.3.2Product code PXVX0317
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHIKV VLP
    D.3.9.1CAS number 2986379-37-5
    D.3.9.2Current sponsor codeCHIKV VLP
    D.3.9.3Other descriptive nameChikungunya virus virus-like particle
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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 Yes
    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
    Healthy Volunteers (Chikungunya disease. Prevention of Chikungunya disease by use of a vaccine)
    E.1.1.1Medical condition in easily understood language
    Healthy Volunteers (Prevention of Chikungunya disease)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10067256
    E.1.2Term Chikungunya virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Coprimary Objectives:
    1. To evaluate the safety of PXVX0317 in healthy adult and adolescent participants 12 to <65 years of age.
    2. To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate.
    3. To demonstrate the consistency of the anti-CHIKV SNA response across three lots of PXVX0317 at Day 22.
    E.2.2Secondary objectives of the trial
    1. To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 15, Day 183, and Day 8 as measured by GMT and seroresponse rate.
    2. To compare the GMT fold increase in anti-CHIKV SNA response and number and percentage of participants with an anti-CHIKV SNA titer >=15 and 4-fold rise over baseline, both at Day 8, 15, 22, and 183.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable).
    2. Males or females, 12 to <65 years of age.
    3. Generally healthy, in the opinion of the investigator, based on medical history, physical examination, and screening laboratory assessments.
    4. Women who are either: (i) Not of childbearing potential (CBP): pre-menarche, surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment) or (ii) Meeting all the below criteria: Negative serum pregnancy test at screening visit, Negative urine pregnancy test immediately prior to dosing at Day 1, Using an acceptable method of contraception (if women of CBP) for the duration of participation, such as hormonal contraceptives (eg, implants, pills, patches) initiated ≥30 days prior to dosing, intrauterine device (IUD) inserted ≥30 days prior to dosing, double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap), Abstinence is acceptable only for adolescents (12 to <18 years old) who are not sexually active.
    E.4Principal exclusion criteria
    1. Currently pregnant, breastfeeding, or planning to become pregnant during the study.
    2. Body Mass Index (BMI) ≥35 kg/m2.
    3. Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV).
    4. History of severe allergic reaction or anaphylaxis to any component of the vaccine.
    5. History of any known congenital or acquired immunodeficiency that could impact response to vaccination (eg, leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis).
    6. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to screening through Day 22. Note: For systemic corticosteroids, use at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within three months of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, ocular, or intraocular steroids is allowed.
    7. Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 22.
    8. Acute disease within the last 14 days (participants with an acute mild febrile illness can be considered for a deferral of vaccination two weeks after the illness has resolved and treatment has been completed).
    9. Clinically significant cardiac, pulmonary, rheumatologic, or other chronic disease, in the opinion of the investigator. This may include chronic illness requiring hospitalization in the last 30 days prior to screening.
    10. Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation.
    11. Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22.
    12. Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
    13. Prior receipt of an investigational CHIKV vaccine/product.
    14. Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of solicited AEs through Day 8 for PXVX0317 and placebo for all age strata combined (safety population).
    2. Incidence of unsolicited AEs through Day 29 for PXVX0317 and placebo for all age strata combined (safety population).
    3. Incidence of AESIs, through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
    4. Incidence of MAAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
    5. Incidence of SAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
    6. Anti-CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% confidence interval (CI) at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.
    7. Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 and placebo for the IEP, all age strata combined.
    8. Anti-CHIKV SNA GMT ratios and associated 95% CIs between all three pairs of PXVX0317 lots (A:B, A:C, B:C) in adults 18 to <46 years of age in the IEP at Day 22.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 8, 22, 29, and 183
    E.5.2Secondary end point(s)
    1. Anti-CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% CIs at Day 15, Day 183, and Day 8, in that order, for the IEP, all age strata combined.
    2. Anti-CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 and placebo for the IEP, all age strata combined.
    3. Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
    4. Number and percentage of participants with anti-CHIKV SNA titers ≥15 at Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
    5. Number and percentage of participants with anti-CHIKV SNA titers having a 4-fold rise over baseline at Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 8, 15, 22, and 183
    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 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 Yes
    E.6.13.1Other scope of the trial description
    1. Immunogenicity
    2. To demonstrate the consistency of the anti-CHIKV SNA response across three consecutively manufactured lots of CHIKV VLP vaccine
    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 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 Yes
    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 trial4
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months12
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 245
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 245
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2905
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 3150
    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 Johnson County ClinTrials
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Alliance for Multispecialty Research
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Coastal Carolina Research Center
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Velocity Clinical Research
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Elite Research Network
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Aventiv Research
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation Emory University School of Medicine
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation Rochester Clinical Research
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation Global AES
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 10
    G.4.1Name of Organisation Palm Beach Research Center
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 11
    G.4.1Name of Organisation Cincinnati Children's Hospital Medical Center - The Gamble Vaccine Research Center
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 12
    G.4.1Name of Organisation Saint Louis University
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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