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    Summary
    EudraCT Number:2012-002281-12
    Sponsor's Protocol Code Number:CT-BI-Vacc-4x-2012/1
    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:2012-08-06
    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 ConcernedGermany - PEI
    A.2EudraCT number2012-002281-12
    A.3Full title of the trial
    Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 2007/1 Study. An Open, Multicenter, Immunogenicity, Follow-up Reboosting Study with Vacc-4x in Subjects Infected with HIV-1 Who Have Maintained an Adequate Response to ART
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Additional vaccination of Vacc-4x to people with HIV and responding to ART who have received Vacc-4x in a previous clinical study
    A.4.1Sponsor's protocol code numberCT-BI-Vacc-4x-2012/1
    A.5.4Other Identifiers
    Name:INDNumber:13619
    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 SponsorBionor Immuno AS
    B.1.3.4CountryNorway
    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 supportBionor Immuno AS
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBionor Pharma AS
    B.5.2Functional name of contact pointVidar Wendel-Hansen
    B.5.3 Address:
    B.5.3.1Street AddressKronprinsesse Märthas Plass 1, P.O.Box 1477 Vika
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeNO-0116
    B.5.3.4CountryNorway
    B.5.4Telephone number+472301 09 66
    B.5.5Fax number+472301 09 70
    B.5.6E-mailvwh@bionorpharma.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 nameVacc-4x (A combination of four synthetic peptides: Vacc-10, Vacc-11, Vacc-12 and Vacc-13)
    D.3.2Product code Vacc-4x
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVacc-10
    D.3.9.2Current sponsor codeVacc-10
    D.3.9.3Other descriptive nameVacc-10
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVacc-11
    D.3.9.2Current sponsor codeVacc-11
    D.3.9.3Other descriptive nameVacc-11
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVacc-12
    D.3.9.2Current sponsor codeVacc-12
    D.3.9.3Other descriptive nameVacc-12
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVacc-13
    D.3.9.2Current sponsor codeVacc-13
    D.3.9.3Other descriptive nameVacc-13
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.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 Leukine(R)
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Inc
    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 nameLeukine(R)
    D.3.2Product code Sargramostim (GM-CSF)
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARGRAMOSTIM
    D.3.9.1CAS number 123774-72-1
    D.3.9.3Other descriptive nameGM-CSF
    D.3.9.4EV Substance CodeSUB10450MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects Infected with HIV-1 Who Have Maintained an Adequate Response to ART
    E.1.1.1Medical condition in easily understood language
    HIV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 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
    to evaluate if a re-boost with Vacc-4x could
    a) reduce the viral load set-point, and
    b) increase the immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1 (EudraCT Number 2007-006302-13).
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of a re-boost with Vacc-4x on CD4 counts and CD8 counts.
    • To assesses in vivo immunogenicity of Vacc-4x by evaluation of DTH and to compare the DTH response to the DTH response observed in the initial study; CT-BI Vacc-4x 2007/1
    (EudraCT Number 2007-006302-13).
    • To evaluate the safety and tolerability of re-boosting with Vacc-4x
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completed immunization regimen with Vacc-4x active and stopped ART (at Week 28) in the CT-BI Vacc-4x 2007/1 study. (No re-start of ART is required).
    2. Documented pre-study CD4 cell count ≥400x10e6/L.
    3. Documented pre-study viral load < 300 000 copies/mL.
    4. Signed informed consent.
    E.4Principal exclusion criteria
    1. Reported AIDS-defining illness within the previous year.
    2. Malignant disease.
    3. On chronic treatment with immune-suppressive therapy.
    4. Unacceptable values of the hematologic and clinical chemistry parameters, as judged by the Investigator, including creatinine values >1.5 x upper limit of normal (ULN), and AST, ALT and alkaline phosphatase (ALP) values >2.5 x ULN.
    5. Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.
    6. Pregnant or breastfeeding women.
    7. Women of childbearing potential not using reliable and adequate contraceptive methods
    (defined as: use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; practicing abstinence; sterile) during the 5 weeks re-boosting
    period including the DTH and for 2 weeks after the DTH test, or sexually active male subjects with partners of child bearing potential unwilling to practice effective contraception during the 5 weeks re-boosting period including the DTH and for 12 weeks after the DTH-test.
    8. Current participation in other clinical therapeutic studies.
    9. Incapability of compliance to treatment protocol, in the opinion of the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    • Viral load set point (mean of VL count week 25 and 29) for subjects discontinuing ART according to protocol and not resuming ART until week 29 compared to:
    - viral load set point* for subjects not resuming ART before week 52 or later in the CT-BI Vacc-4x 2007/1 study and who entered this study, or if week 52 not reached in the previous study
    - viral load set point** for subjects resuming ART at the earliest week 40 in the CT-BI Vacc-4x 2007/1 study and who entered this study.
    * The VL set point was defined as the mean of VL count week 48 and week 52 week in subjects who did not resume ART.
    **The VL set point was defined as the week 40 VL count for subject resuming ART week
    40 or the mean of the last two VL counts prior to ART resumption for subjects resuming
    ART week 44 or later but before week 52.
    Comparison will also be made to pre-ART viral load values, if available from the CT-BI Vacc-4x 2007/1 study.
    • T-cell response will be measured by ELISPOT as well as by T-cell proliferative response assay (Flow Cytometry) and intracellular cytokine staining at Week 1 (before re-boosting), Week 5 (two weeks after re-boosting), Week 17, Week 29 and Week 37. These will be compared to the responses reported in the study CT-BI Vacc-4x 2007/1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Viral load set point (mean of VL count week 25 and 29)
    • T-cell response will be measured at Week 1 (before re-boosting), Week 5 (two weeks after re-boosting), Week 17, Week 29 and Week 37
    E.5.2Secondary end point(s)
    • CD4 counts at Screening, Weeks 1, 3, 5, 13, 17, 21, 25, 29 and 37 (End of Study), absolute numbers of CD4 counts, and treatment emergent changes of CD4 counts from mean of Screening and Week 1.
    • Change (and percent change) in CD4 count from Week 13 (discontinue ART) to Weeks 17, 21, 25, 29 and 37.
    • CD8 counts at Screening, Weeks 1, 3, 5, 13, 17, 21, 25, 29 and 37 (End of Study), absolute numbers of CD8 counts, and treatment emergent changes of CD8 from mean of Screening and Week 1.
    • Change (and percent change) in CD8 count from Week 13 (discontinue ART) to Weeks 17, 21, 25, 29 and 37 (End of Study).
    • DTH (both induration and erythema) at Week 1 and Week 5, in terms of observed areas (mm2 length x height) and also in terms of a positive test, defined as an area ≥ 10mm2 DTH-tests, both areas and number of positive tests registered at Week 1 will be compared with the
    corresponding values registered at Week 5.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • CD4 counts at Screening, Weeks 1, 3, 5, 13, 17, 21, 25, 29 and 37 (End of Study
    • Change (and percent change) in CD4 count from Week 13 (discontinue ART) to Weeks 17, 21, 25, 29 and 37.
    • CD8 counts at Screening, Weeks 1, 3, 5, 13, 17, 21, 25, 29 and 37 (End of Study)
    • Change (and percent change) in CD8 count from Week 13 (discontinue ART) to Weeks 17, 21, 25, 29 and 37 (End of Study).
    • DTH (both induration and erythema) at Week 1 and Week 5.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    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.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months22
    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: 40
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 40
    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 Decision2012-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-08
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