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    Summary
    EudraCT Number:2009-015877-11
    Sponsor's Protocol Code Number:DV2-HBV-17
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-11
    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
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-015877-11
    A.3Full title of the trial
    An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) among Adults (18 to 75 Years of Age) with Chronic Kidney Disease (CKD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in Chronic Kidney Disease Patients
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in Chronic Kidney Disease Patients
    A.4.1Sponsor's protocol code numberDV2-HBV-17
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00985426
    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 SponsorDynavax Technologies Corporation
    B.1.3.4CountryUnited States
    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 supportDynavax Technologies Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPaul-Ehrlich-Institut (PEI)
    B.5.2Functional name of contact pointReferat Klinische Prüfung
    B.5.3 Address:
    B.5.3.1Street AddressPaul-Ehrlich-Straße 51-59
    B.5.3.2Town/ cityLangen
    B.5.3.3Post code63225
    B.5.3.4CountryGermany
    B.5.4Telephone number49610377 1811
    B.5.5Fax number49610377 1275
    B.5.6E-mailklinpruefung@pei.de
    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 nameHEPLISAV™
    D.3.2Product code 1018 ISS-HBsAg
    D.3.4Pharmaceutical form Solution 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 INNHepatitis B Surface Antigen
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeHBsAg
    D.3.9.3Other descriptive nameRecombinant Hepatitis B Surface Antigen (rHBsAg)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Engerix-B®
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 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 INNHepatitis B Surface Antigen
    D.3.9.1CAS number 8000051027
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN
    D.3.9.4EV Substance CodeSUB14083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 placeboInjection
    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
    Prevention of hepatitis B virus (HBV) infection
    E.1.1.1Medical condition in easily understood language
    Prevention of hepatitis B virus (HBV) infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10054181
    E.1.2Term Hepatitis B immunization
    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 demonstrate the noninferiority of the immune response to a 3-dose regimen of HEPLISAV compared to the standard 4-dose regimen of Engerix-B in subjects with chronic kidney disease (CKD) at 4 weeks after the last injection (Week 28)

    E.2.2Secondary objectives of the trial
    • Conditional on the demonstration of the above primary objective: to demonstrate the superiority of the immune response to a 3-dose regimen of HEPLISAV compared to the standard 4-dose regimen of Engerix-B in subjects with CKD at 4 weeks after the last injection (Week 28)

    • To evaluate the safety of HEPLISAV compared to Engerix-B in subjects with CKD

    • To compare immunogenicity with HEPLISAV and Engerix-B as measured by SPR at Weeks 4, 8, 12, 18, 24, 36, 44, and 52

    • To compare immunogenicity of HEPLISAV and Engerix-B as measured by percentage of subjects with anti-HBsAg ≥ 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44 and 52

    • To evaluate the immunogenicity of HEPLISAV compared to Engerix-B as measured by serum anti-HBsAg GMC at Weeks 4, 8, 12, 18, 24, 28, 36, 44 and 52

    • To evaluate the immune response as measured by SPR of subjects with type II diabetes mellitus who receive HEPLISAV compared to Engerix-B at 4 weeks after the last injection (Week 28)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject must meet all of the following inclusion criteria to participate in the study:

    1. be 18 to 75 years of age;

    2. has loss of renal function as defined by a GFR ≤ 45 mL/min/1.73 m2;

    3. be clinically stable in the opinion of the investigator;

    4. be serum negative for HBsAg, anti-HBsAg, anti-HBcAg, HCV, and HIV;

    5. if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection;

    6. is not scheduled to undergo a kidney transplant in the next 12 months;

    7. be able and willing to provide informed consent.
    E.4Principal exclusion criteria
    A subject who meets any 1 of the following exclusion criteria is not permitted to participate in the study:

    1. if female, is pregnant, breastfeeding, or planning a pregnancy;

    2. has a history of or is considered by the investigator to be at high risk for recent exposure to HBV, HCV, or HIV; for example, current intravenous drug use, unprotected sex with known HBV/HIV positive partner;

    3. has known history of autoimmune disease;

    4. has previously received any hepatitis B vaccine;

    5. has a history of sensitivity to any component of study vaccines;

    6. has current illness other than renal disease or has substance or alcohol abuse that, in the opinion of the investigator, would interfere with compliance or with interpretation of the study results;

    7. is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin;

    8. has uncontrolled diabetes or hypertension;

    9. is unwilling or unable to comply with all the requirements of the protocol;

    10. has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;

    11. has received the following prior to the first injection:

    • 3 days: erythropoietin (exclusionary window does not apply for subjects on dialysis)

    • 7 days: intravenous iron

    • 21 days: any inactivated virus vaccine

    • 28 days:
    – any live virus vaccine

    – systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids

    – granulocyte or granulocyte-macrophage colony-stimulating factor (G/GM-CSF)

    – any other investigational medicinal agent

    • At any time: an injection of DNA plasmids or oligonucleotides.
    E.5 End points
    E.5.1Primary end point(s)
    • seroprotection rate, defined as the percentage of subjects with anti-HBsAg serum concentration ≥ 10 mIU/mL, measured at Week 28

    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 28
    E.5.2Secondary end point(s)
    • incidence of SAEs and potential new onset autoimmune AEs through Week 52

    • incidence of post-injection reactions

    • incidence of AEs through Week 28

    • seroprotection rates at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 for each treatment group

    • percentage of subjects with anti-HBsAg ≥ 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44 and 52

    • serum anti-HBsAg geometric mean concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44 and 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 4, 8, 12, 18, 24, 28, 36, 44 and 52
    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) 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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer-blinded including investigator, sponsor and subject
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned9
    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
    Canada
    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
    The end of study date is defined as the date at which the last data point required for statistical analysis (ie, key safety and efficacy results for decision making) from the last patient is received at Dynavax.

    The justification for the end of trial not being the last visit of the last subject is to allow the reporting of any key safety information (ie, laboratory values) that may have been previously overlooked.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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: 282
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 237
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 600
    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)
    For subjects on hemodialysis only, seroprotection will be assessed in a blinded fashion at Week 28 (Visit 7), Week 36 (Visit 8), and Week 44 (Visit 9). Hemodialysis subjects who are not seroprotected as indicated by an anti-HBsAg titer of < 10 mIU/mL will be terminated from the study and will be encouraged to enroll in another study that will offer subjects additional hepatitis B immunizations (as per their initial radomization), in accordance with CDC recommendations in this population.
    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 Decision2010-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
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