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    Summary
    EudraCT Number:2009-017809-11
    Sponsor's Protocol Code Number:112673
    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:2010-06-28
    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 number2009-017809-11
    A.3Full title of the trial
    A phase I/IIa randomized, observer-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of the GSK Biologicals’ herpes zoster vaccine, gE/AS01B in comparison to placebo when administered as 3 doses to adult HIV-infected subjects.
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-015
    A.4.1Sponsor's protocol code number112673
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namegE recombinant protein formulated in AS01B Adjuvant System
    D.3.2Product code gE/AS01B
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codegE
    D.3.9.3Other descriptive namegE recombinant protein
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Vaccination against herpes zoster (HZ) in adult HIV-infected subjects.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019974
    E.1.2Term Herpes zoster
    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 the safety and reactogenicity of the gE/AS01B study vaccine in HIV-infected subjects, by ART (antiretroviral therapy) ART and CD4 count cohorts, and overall (ART/CD4/overall)
    •To estimate the gE-specific humoral and cellular immune responses (hum/cell imm resp) at Month 7 (one month post-final vaccination) in subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6) in comparison to subjects who received placebo (pl), in ART and non-ART cohorts presenting high CD4 counts at enrolment
    E.2.2Secondary objectives of the trial
    •To estimate the gE-specific hum/cell imm resp at Month 7 after 3 doses of gE/AS01B versus pl, by ART/CD4/overall
    •To estimate the VZV-specific hum/cell imm resp at Month 7 after 3 doses of gE/AS01B versus pl, by ART/CD4/overall
    •To estimate gE- and VZV-specific hum/cell imm resp after the 1st and 2nd vaccinations in comparison to after 3 doses in subjects who received gE/AS01B and in comparison to subjects who received pl, by ART/CD4/overall
    •To estimate gE- and VZV-specific hum/cell imm resp at Month 18 (12 months post-final vaccination) after 3 doses of gE/AS01B versus pl, by ART/CD4/overall
    •To evaluate the occurrence, duration and severity of HZ cases and complications from administration of the 1st dose of vaccine/placebo until end of the trial, by ART/CD4/overall
    •To evaluate the effect of the gE/AS01B on CD4 T cell count and HIV viral load (VL) versus pl at Months 1, 2, 3, 6, 7 and 18, by ART and CD4 count cohorts
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, etc.);
    •Male and female subjects at least 18 years old at the time of vaccination;
    •Subjects born before 1985 and not from a tropical region. Subjects born in 1985 or later and subjects born before 1985 in tropical regions must have a history of VZV infection or serological evidence of prior VZV infection;
    •Written informed consent obtained from the subject;
    •Female subjects of non-childbearing potential may be enrolled in the study;
    Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause,OR
    Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
    •Known to be HIV-1 infected, diagnosed at least 1 year prior to enrolment;
    •For the ART High CD4 and ART Low CD4 cohorts:Stable on ART for at least one year (i.e. no change in therapy due to virologic or immunologic failure); CD4 T cell count ≥ 50 cells /mm3 at screening; Undetectable VL (i.e. < 40 copies/mL, based on the cut-off of the HIV VL test used) at screening;
    •For the non-ART High CD4 cohort:ART-naïve subjects who have never received anti-retroviral therapy after HIV diagnosis (except for pregnant women receiving ART temporarily to prevent mother –to-child HIV transmission), and for whom commencement of ART is not expected based on current assessment within next seven months; HIV viral load (VL) 1000 -100 000 copies/mL at screening; CD4 T cell count ≥ 500 cells/mm3 at screening.
    E.4Principal exclusion criteria
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period;
    •Vaccination against varicella or HZ within the previous 12 months;
    •Occurrence of a varicella or HZ episode within the previous 12 months;
    •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex -gloves, syringes, etc). Please note, the vaccine and vials in this study do not contain latex;
    •Has currently an AIDS defining condition. Reference is made to Appendix A of the ‘Revised surveillance case definitions for HIV infection among adults, adolescents and children aged <18 Months and for HIV infection and AIDS among children aged 18 Months to < 13 years - United States, 2008’[CDC, 2008]);
    •Opportunistic infection (other than oral thrush) or AIDS-associated malignancy in the previous year;
    •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease other than HIV infection (e.g., malignancy) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders)
    •Administration of immunoglobulins, and/or any blood products within 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period;
    •Chronic administration (defined as more than 15 consecutive days) of immunosuppressive or other immune-modifying drugs within 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone < 20 mg/day, or equivalent., is allowed. Inhaled and topical steroids are allowed;
    •Administration and/or planned administration of a vaccine not foreseen by the study protocol within 30 days before dose 1, dose 2 and/or 3 of vaccine and/or within 30 days after any dose. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1, 2 and/or 3, and/or at least 14 days after any dose of study vaccine;
    •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device);
    •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). At the investigator’s discretion, all vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade fevers, i.e., oral/tympanic on oral setting/axillary temperature < 37.5°C (99.5°F) or < 38°C (100.4°F) on rectal setting. The preferred route for recording temperature in this study will be oral;
    •Any contraindication to receiving intramuscular injections;
    •Any condition or illness which might interfere with the evaluation of the safety or immunogenicity of the vaccine;
    •Active hepatitis B (HBV) infection or active hepatitis C (HCV) infection;
    A prospective subject must be evaluated by lab tests (HBsAg, anti-HCV antibody (Ab) and/or HCV RNA) prior to enrolment unless inactive status of infection is known, i.e.:
    1.Subject documented negative HBV and HCV serologic evaluations within 90 days prior to the Screening visit;
    2.Subject has a documented negative HBsAg test, and a documented negative anti-HCV Ab and/or HCV RNA test within 90 days prior to Visit 1;
    Note: Prospective subjects who have been shown to be negative for either HBV or HCV based on the above criteria need only to be tested for the one for which active infection has not been excluded
    •Current use of HIV fusion inhibitors (e.g., enfuvirtide), CCR5 inhibitors (e.g., maraviroc) or IL-2/IL-7/IFN;
    •For subjects in the ART cohorts, any change in anti-retroviral drug regimen within 12 weeks prior to vaccination,
    •Pregnant or lactating female;
    •Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential);
    •Abnormal biochemical and hematological laboratory values obtained for blood samples collected at screening.
    E.5 End points
    E.5.1Primary end point(s)
    •Serious AEs: Occurrence and relationship to vaccination of all SAEs from Month 0 onwards until study end, in each cohort, and overall; Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine during the entire study period in each cohort, and overall; Occurrence of any fatal SAEs during the entire study period in each cohort, and overall.
    •Occurrence of pre-defined AEs: Occurrence and relationship to vaccination of any new onset of autoimmune diseases and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo until end of the trial in each cohort, and overall.
    •Solicited local and general symptoms: Occurrence, intensity of each solicited local symptom (within 7 days after each vaccination), in each cohort, and overall; Occurrence, intensity and relationship to vaccination of each solicited general symptom (within 7 days after each vaccination) in each cohort, and overall.
    •Unsolicited AEs: Occurrence, intensity and relationship to vaccination of unsolicited AEs (within 30 days after each vaccination), according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, in each cohort, and overall.
    •Hematological and biochemical parameters: Hematological and biochemical parameters and changes of hematological and biochemical parameters from baseline at the Screening visit and at Months 1, 2, 3, 6 and 7 in each cohort, and overall.
    •Worsening of the HIV condition: Significant change to ART (including ART initiation in the non-ART High CD4 cohort) from administration of the first dose of vaccine/placebo until end of the trial, in each cohort, and overall. (Note: A change to ART is considered significant when administered due to a failure to control HIV VL or due to a failure to maintain sufficiently high CD4 T cell count levels, as judged by the investigator).Occurrence of an AIDS-defining condition from administration of the first dose of vaccine/placebo until end of the trial, in each cohort, and overall; Occurrence of study pre-defined HIV-related changes in HIV VL at Months 1, 3 and 7, and changes in CD4 count at Months 1, 2, 3, 6 and 7, in each cohort, and overall.
    •Cell-mediated immunogenicity (CMI) at Month 7: Frequency of gE-specific CD4 T cells expressing at least 2 cytokines (among IFN-gamma , IL-2, TNF-alpha and/or CD40L) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment.
    •Humoral immune response at Month 7: Anti-gE Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment.
    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
    reactogenicity, immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Administration to HIV-infected subjects
    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 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-blind
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days21
    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.1.3Elderly (>=65 years) Yes
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 135
    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 their HIV condition, the subjects will continue to receive standard care, as provided by their physician. A plan for treatment or care after the subject has ended the participation in the trial is not provided for prophylactic vaccine studies, as in the case of HZ. A long-term follow-up study in Zoster-015 subjects may be planned for the future.
    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 Decision2010-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-14
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