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    Summary
    EudraCT Number:2009-018097-64
    Sponsor's Protocol Code Number:114083
    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:2010-01-08
    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 number2009-018097-64
    A.3Full title of the trial
    Long-term follow-up of study participants from GlaxoSmithKline (GSK) Biologicals’-sponsored clinical trials evaluating Human Immunodeficiency Virus vaccine [F4co (p24-RT-Nef-p17)/AS01B vaccine] (732461) for therapeutic use.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term follow-up of participants from studies evaluating the HIV vaccine
    A.3.2Name or abbreviated title of the trial where available
    Th-HIV-011
    A.4.1Sponsor's protocol code number114083
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01092611
    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.3.2Product code F4co/AS01B
    D.3.4Pharmaceutical form Powder and solvent for 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.3.9.2Current sponsor codeF4co
    D.3.9.3Other descriptive nameF4co
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    ART-treated and ART-naïve HIV-infected adults (ART: anti-retroviral therapy)
    E.1.1.1Medical condition in easily understood language
    ART-treated and ART-naïve HIV-infected adults (ART: anti-retroviral therapy)
    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 PT
    E.1.2Classification code 10020161
    E.1.2Term HIV 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 assess the health status of HIV-infected persons who have been previously
    enrolled in studies evaluating the F4co/AS01B vaccine
    • To assess CD4 count and viral load kinetics of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine
    • To assess time to (re)initiation of ART of HIV-infected persons who have been
    previously enrolled in studies evaluating the F4co/AS01B vaccine
    • To assess the incidence of specific clinical events (cardiovascular, end stage renal
    and hepatic events, opportunistic infections, cancers) of HIV-infected persons who
    have been previously enrolled in studies evaluating the F4co/AS01B vaccine
    • To evaluate the safety of the F4co/AS01B vaccine and to check the
    safety of study participation
    E.2.2Secondary objectives of the trial
    • To evaluate the HIV-specific cellular and humoral immune responses of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine
    • To explore associations between health status and HIV-specific immune responses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must satisfy ALL the following criteria at study entry:
    • HIV-infected subject
    • Previous participation in a study evaluating F4co/AS01B vaccine
    • Written informed consent obtained from the subject
    E.4Principal exclusion criteria
    • Subjects who did not receive a complete vaccination course in the previous study
    E.5 End points
    E.5.1Primary end point(s)
    • Occurrence of ART (re)-initiation or ART modification, and reason (for ART modification)
    • CD4 count
    • VL and method of measurement
    • Occurrence of HIV disease progression
    • Occurrence of each separate defining condition for HIV-disease progression
    • Occurrence of specific clinical events and death and date
    • Occurrence of adverse events (AEs) or serious adverse events (SAEs)
    considered by the Investigator to be related to vaccination (performed in
    the preceding vaccination study)
    • Occurrence of potential immune-mediated diseases (pIMDs)
    • Occurrence of SAEs related to study participation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Yearly
    E.5.2Secondary end point(s)
    •Time between dose 1 and ART (re)-initiation or ART modification
    •Time between dose 1 and CD4 count measurement
    •Time between dose 1 and viral load measurement
    •Time between dose 1 and occurrence of HIV disease progression
    •Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression
    •Antibody concentrations to vaccine antigens
    •CMI responses (ICS)
    Breadth
    Intensity
    Cytokine co-expression profile
    •Additional exploratory immuno endpoints (other T-cell immune markers or T-cell functional assays)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Yearly
    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 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 No
    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
    Lg Term safety follow-up of HIV-infected subjects who previously participated in vaccination studies
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    France
    Germany
    Spain
    United States
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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: 229
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 229
    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)
    Subjects will continue to receive HIV care with their health care provider. All decisions with regard to management of their HIV infection including antiretrovirals if required will continue to be made by their health care provider in discussion with the subjects.
    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 Decision2010-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-19
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