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    Summary
    EudraCT Number:2012-002966-11
    Sponsor's Protocol Code Number:116427
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-002966-11
    A.3Full title of the trial
    A phase II/III, randomised, observer-blind, placebo-controlled, multicentre, clinical trial to assess the immunogenicity and safety of GSK Biologicals’ herpes zoster HZ/su candidate vaccine when administered intramuscularly on a 0 and 1 to 2 months schedule to adults ≥18 years of age with solid tumours receiving chemotherapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster (HZ/su) vaccine in adults with solid tumours receiving chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-028
    A.4.1Sponsor's protocol code number116427
    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 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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l'Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameHerpes Zoster vaccine (GSK 1437173A)
    D.3.2Product code HZ/su
    D.3.4Pharmaceutical form Powder and solvent for 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 INN-
    D.3.9.2Current sponsor codegE
    D.3.9.3Other descriptive namegE antigen
    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) 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 placeboPowder and solution for solution 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
    Herpes Zoster and related complications
    E.1.1.1Medical condition in easily understood language
    Herpes Zoster (shingles) 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 17.0
    E.1.2Level PT
    E.1.2Classification code 10019974
    E.1.2Term Herpes zoster
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLT
    E.1.2Classification code 10019972
    E.1.2Term Herpes viral infections
    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
    The study will be randomised into two groups based on the vaccination schedule in relation to the start of a chemotherapy cycle:
    - The OnChemo group receives their first HZ/su vaccination at the start of a chemotherapy cycle
    - The PreChemo group receives their first HZ/su vaccination at least 10 days before the start of a chemotherapy cycle

    •To evaluate anti-gE humoral immune responses at Month 2 (M2), following a two-dose administration of the HZ/su vaccine (post-dose 2), as compared to placebo, in subjects with solid tumours receiving chemotherapy (PreChemo groups only)
    •To evaluate the safety and reactogenicity following administration of the HZ/su vaccine as compared to placebo up to 30 days post last vaccination in subjects with solid tumours receiving chemotherapy
    E.2.2Secondary objectives of the trial
    PreChemo groups only:
    •To evaluate vaccine response rate (VRR) in anti-gE humoral immunogenicity responses at post-dose 2 of HZ/su vaccine (M2)
    •To evaluate gE-specific CD4+ T-cell immunogenicity responses at post-dose 2 of HZ/su vaccine (M2), versus placebo (in CMI sub-cohort)
    •To evaluate VRR in gE-specific CD4+ T-cell mediated immunogenicity at post-dose 2 of HZ/su vaccine (M2) (in CMI sub-cohort)
    •To characterize gE-specific CD4+ T-cell mediated immunogenicity responses at M0, M1 and M13 (in CMI sub-cohort)

    PreChemo and OnChemo groups:
    •To evaluate the anti-gE humoral response at post-dose 2 of HZ/su vaccine (M2), versus placebo (all subjects)
    •To evaluate VRR in anti-gE humoral immunogenicity responses at post-dose 2 of HZ/su vaccine (all subjects HZ/su)
    •To evaluate safety following administration of HZ/su vaccine, versus placebo, from 30 days post last vaccination until study end
    •To characterize anti-gE humoral immunogenicity responses at M0, M1, M2, M6 and M13
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
    •Written informed consent obtained from the subject
    •A male or female aged 18 years or older (and has reached the age of legal consent) at the time of study entry (i.e., when informed consent is signed)
    •Subject who has been diagnosed with one or more solid tumours (defined as a solid malignancy, i.e., not a blood element malignancy)
    •Subject who is receiving or will receive a cytotoxic or immunosuppressive chemotherapy (such that the study vaccine can be administered at the latest at the start of the second cycle of chemotherapy)
    •Life expectancy of greater than one year
    •Female subjects of non-childbearing potential may be enrolled in the study;
    -Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause;
    •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.
    E.4Principal exclusion criteria
    •Subjects receiving only newer, more targeted therapies if not taken together with a classical chemotherapy
    •Chronic administration and/or planned administration of systemic glucocorticoids within one month prior to the first vaccine dose and up to Visit 3 (Month 2). Inhaled, intra-articularly injected, and topical steroids are allowed
    •Previous vaccination against HZ or varicella within 12 months preceding the first dose of study vaccine/ placebo
    •Planned administration during the study of a HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine
    •Previous chemotherapy course less than one month before first study vaccination
    •Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/ placebo
    •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment
    •Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
    •HIV infection by clinical history;
    •Acute disease and/or fever at the time of vaccination. Acute disease is defined as the presence of a moderate or severe illness with or without fever, but excludes the underlying malignancy, as well as the expected symptoms/signs associated with that disease or its treatment;
    -Fever is defined as temperature ≥ 37.5°C /99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C /100.4°F on rectal setting. The preferred route for recording temperature in this study will be oral.
    -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever, may receive the first dose of study vaccine/ placebo at the discretion of the investigator.
    •Any condition which, in the judgment of the investigator would make intramuscular injection unsafe;
    •Pregnant or lactating female;
    •Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3 (i.e., 2 months after the last dose of study vaccine/ placebo).
    E.5 End points
    E.5.1Primary end point(s)
    A. Anti-gE humoral immunogenicity with respect to components of the study/investigational vaccine.in terms of antibody (Ab) concentrations.
    -Anti-gE Ab concentrations as determined by ELISA.
    B. Occurrence of solicited local and general symptoms.
    -Occurrence, intensity and duration of each solicited local symptom.
    -Occurrence, intensity, duration and relationship to vaccination of each solicited general symptom.
    C. Occurrence of Unsolicited adverse events (AEs).
    -Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.
    D. Occurrence of Serious Adverse Events (SAEs).
    -Occurrence and relationship to vaccination of SAEs.
    E. Occurrence of AEs of specific interest.
    -Occurrence and relationship to vaccination of any potential Immune Mediated Diseases (pIMDs).
    E.5.1.1Timepoint(s) of evaluation of this end point
    -At Month 2 (for A.)
    Within 7 days (Days 0-6) after each vaccination (for B.)
    -During 30 days (Days 0-29) after each vaccination (for C.)
    -Up to 30 days post last vaccination (for D. and E.)
    E.5.2Secondary end point(s)
    A. For immunogenicity with respect to components of the study/investigational vaccine
    -Anti-gE Ab concentrations as determined by ELISA at Month 0, Month 1, Month2, Month 6 (Visit 4, at the start of the last cycle of chemotherapy between months 4 and 13) and Month 13
    -Vaccine response for anti-gE Abs at Month 1, Month 2, Month 6 (Visit 4, at the start of the last cycle of chemotherapy between months 4 and 13) and Month 13
    -Frequencies of gE-specific CD4+ T-cells, expressing at least 2 activation markers (from among IFN-γ, IL-2, TNF-α and CD40 L), as determined by in vitro intracellular cytokine staining (ICS), at Month 0, Month 1, Month 2, and Month 13
    -Vaccine response for gE-specific CD4+ T-cells expressing at least 2 activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), as determined by in vitro ICS, at Month 1, Month 2 and Month 13
    B. Occurrence of Serious Adverse Events (SAEs)
    -Occurrence and relationship to vaccination of SAEs during the period starting after 30 days post last vaccination until study end
    C. Occurrence of AEs of specific interest
    -Occurrence of any pIMDs during the period starting after 30 days post last vaccination until study end
    E.5.2.1Timepoint(s) of evaluation of this end point
    -At Month 0, Month 1, Month 6 (Visit 4, at the start of the last cycle of chemotherapy between months 4 and 13) and Month 13 (for A)
    -During the period starting after 30 days post last vaccination until study end (Month 13) (for B and C)
    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
    Immunogenicity, Prevention
    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) 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-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.8.2.4Number of treatment arms in the trial4
    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 EEA22
    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
    Czech Republic
    France
    Korea, Republic of
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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 years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days16
    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: 142
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 232
    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 underlying condition, the subjects will continue to receive standard care, as provided by their physician.
    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 Decision2013-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-20
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