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    Summary
    EudraCT Number:2010-021356-26
    Sponsor's Protocol Code Number:111679
    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:2010-09-17
    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 number2010-021356-26
    A.3Full title of the trial
    A Phase IIb, randomized, observer-blind, placebo controlled, multicenter primary/booster therapeutic vaccination study to determine efficacy and safety of F4co/ AS01B vaccine, administered intramuscularly according to either a two dose (0, 4 weeks) or a three dose (0, 4, 28 weeks) schedule in ART-naïve HIV-1 infected persons aged 18-55 years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of HIV Vaccine 732462 in ART-naïve HIV-1 Infected Persons
    A.3.2Name or abbreviated title of the trial where available
    TH-HIV-008
    A.4.1Sponsor's protocol code number111679
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01218113
    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 number18773793718
    B.5.6E-mailGSKClinicalSupportHD@gskbio.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 nameF4co/AS01B
    D.3.2Product code F4co/AS01B
    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.3.9.2Current 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-naïve HIV-infected adults (ART: anti-retroviral therapy)
    E.1.1.1Medical condition in easily understood language
    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 show a difference in change from baseline of HIV-1 viral load at Visit 8 (Week 48) between persons who received 2 doses of F4co/AS01B vaccine and persons who received placebo alone or between persons who received 3 doses of F4co/AS01B vaccine and persons who received placebo alone.

    A difference (in favor of the vaccine) will be concluded if the upper limit for the two-sided 97.5%CI for the difference in change between the two arms (vaccine – placebo) is below 0 for at least one vaccine schedule (2 or 3 doses of F4co/AS01B)

    •To evaluate the reactogenicity and safety of the F4co/AS01B vaccine
    E.2.2Secondary objectives of the trial
    •To evaluate the difference in change from baseline of HIV-1 viral load at Visit 8 (Week 48) between persons who received 2 doses of F4co/AS01B vaccine and persons who received 3 doses of F4co/AS01B vaccine
    •To compare HIV-1 viral load and change from baseline of HIV-1 viral load between the three study arms
    •To compare absolute CD4 cells counts and changes in CD4 cell counts from baseline values between the three study arms
    •To compare the incidence of, and time to, either initiation of ART or occurrence of any of the HIV-related clinical events between the three study arms
    •To compare the HIV-specific cellular and humoral immune responses between the three study arms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., compliance with study regimen, visit schedule).
    •Written informed consent obtained from the subject prior to any study procedure.
    •A male or female between and including 18–55 years at the time of first vaccination.
    •Known to be HIV-1 infected and under the care of an HIV physician for a minimum of 6 months. However, subjects who initially presented with a clinical diagnosis of primary HIV-1 infection need to have been diagnosed and under care for at least 12 months.
    Primary HIV infection refers to the very early stages (2-8 weeks) of HIV infection characterized by a clinical syndrome of acute seroconversion illness, very high viral load and negative HIV antibody test. Acute seroconversion illness may include symptoms such as night sweats, fever, exanthema, and general feeling of malaise and fatigue.
    •ART-naïve. Individuals must never have received ART after HIV diagnosis, including lamuvidine used for chronic hepatitis B infection, with the exception of short-term ART for prevention of mother-to-child transmission (PMTCT) at least 12 months prior to enrollment.
    •Commencement of ART is not expected, based on current assessment, within the next 12 months.
    •Viral load level of 2,000-80,000 copies/mL at screening.
    •CD4 count > 500 cells per mm3 at screening.
    •If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal. 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 at screening, and
    -has agreed to continue adequate contraception during the entire study period.
    E.4Principal exclusion criteria
    •Infection with HIV-2. This includes patients with dual infection with HIV-1/HIV-2.
    •Had an AIDS defining clinical illness (CDC Category C event).
    •Use of any investigational or non-registered product (drug or vaccine) within 4 weeks preceding the first dose of study vaccine/placebo, or planned use of any investigational or non-registered product other than the study vaccine during the study period.
    •Drug therapy with immunomodulators or corticosteroids within the 12 weeks preceding the first dose of study vaccine/placebo or planned administration during the study period. Acute use of corticosteroids (i.e. prednisone, or equivalent, < or = 0.5 mg/kg/day for up to 5 days) up to 4 weeks preceding the first dose for treatment of hypersensitivity reactions is allowed. Inhaled and topical corticosteroids are allowed.
    •Administration of immunoglobulins and/ or any blood products within the 12 weeks preceding the first dose of study vaccine/placebo or planned administration during the study period.
    •Planned administration of a vaccine not foreseen by the study protocol during
    - the period starting 2 weeks before the first dose of study vaccine/placebo and
    ending at Visit 3 (Week 6) (after blood sampling),
    -the period starting from 2 weeks prior to Visit 5 (Week 28) and ending at Visit 6
    (Week 30) (after blood sampling)
    -the period starting from 2 weeks prior to Visit 8 (Week 48) and ending at Visit 8
    (Week 48) (after blood sampling),
    with the exception of non-adjuvanted influenza vaccine.
    It is recommended that the vaccination history of all subjects has been reviewed with their health care provider and that they have been encouraged to be fully vaccinated according to their country vaccination schedule for HIV- infected persons at least 4 weeks prior to enrollment into this study (e.g. influenza and travel vaccines).
    •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).
    •Any previous vaccination or immunotherapy against HIV.
    •A family history of hereditary immunodeficiency.
    •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    •Acute or chronic infective hepatitis (a past history of hepatitis B or C is not an exclusion criterion).
    •Acute or chronic, clinically relevant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and/or medical history at screening.
    •Grade 3 or grade 4 laboratory abnormality, as defined by DAIDS grading table, at screening.
    •Pregnant or lactating female.
    •Any condition (including alcohol and drug abuse) which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the study protocol.
    •History of medically confirmed autoimmune disease.
    •History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.
    •Unstable asthma defined as:
    - Sudden acute attacks occurring in less than three hours without an obvious trigger.
    -Hospitalization for asthma in the last two years.
    •Food or wine induced asthma.
    •Known sensitivity to sulfites or aspirin.
    •Known sensitivity to aminoglycoside antibiotics.
    •Contraindication to intramuscular injection


    E.5 End points
    E.5.1Primary end point(s)
    •HIV-1 viral load change
    •Solicited local and general symptoms
    •Unsolicited adverse events
    •Serious Adverse events and potentially immune mediated diseases (pIMDs)
    •Biochemistry and hematology

    E.5.1.1Timepoint(s) of evaluation of this end point
    - HIV-1 viral load change from baseline at Visit 8 (Week 48)
    - Occurrence of solicited local and general symptoms during a 7-day follow-up period after each vaccination
    - Occurrence of unsolicited adverse events within 28 days after any vaccination.
    - Occurrence of all serious adverse events (SAEs) throughout the study period
    - Occurrence of all pIMDs throughout the study period
    - Occurrence of abnormal biochemical and hematological values (any and grade ≥3) throughout the study period.
    E.5.2Secondary end point(s)
    •HIV-1 viral load
    •CD4 cell count
    •Initiation of ART
    •Immunogenicity with respect to components of the investigational vaccine

    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study period (from baseline to Week 48) for all end points.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 189
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 189
    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 healthcare 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 Decision2010-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-11
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