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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-004360-44
    Sponsor's Protocol Code Number:VAC034
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-03-07
    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 number2007-004360-44
    A.3Full title of the trial
    Assessment of protection against malaria by sporozoite challenge of healthy adults vaccinated with AdCh63 ME-TRAP and MVA ME-TRAP
    A.4.1Sponsor's protocol code numberVAC034
    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 SponsorUniversity of Oxford
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 nameChimapnzee adenovirus expressing ME-TRAP
    D.3.2Product code AdCh63 ME-TRAP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntradermal use
    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 Yes
    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 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 nameModified Vaccinia Ankara expressing ME-TRAP
    D.3.2Product code MVA ME-TRAP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntradermal use
    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 Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Malaria
    MedDRA Classification
    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 if volunteers who received AdCh63 ME-TRAP alone, as a homologous prime and boost, or as a heterologous boost with MVA ME-TRAP are protected wholly or partially against malaria infection in a sporozoite challenge model. This will be determined by noting the number of subjects who develop malaria infection and the time in hours between exposure and parasitaemia as detected by thick-film blood smear or clinical symptoms in the presence of positive PCR, and compared with controls
    E.2.2Secondary objectives of the trial
    To measure the safety of the vaccination regimes and to measure ex-vivo and cultured IFN- ELISPOT responses to the ME-TRAP antigens and anti-sporozoite antibodies before and after malaria infection. If there is evidence of partial or complete protection by the vaccinations then we will explore immunological correlates of protective immunity.
    To assess long term efficacy of AdCh63 ME-TRAP and MVA ME-TRAP in a re-challenge of volunteers protected at initial malaria challenge.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    The volunteer must satisfy all the following criteria to be eligible for the study:
    • Healthy adult aged 18 to 50 years
    • Able and willing (in the Investigator’s opinion) to comply with all study requirements
    • Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner
    • For females only: willingness to practise effective contraception throughout the study
    • Agreement to refrain from blood donation during the course of the study
    • Written informed consent
    E.4Principal exclusion criteria
    Exclusion Criteria
    The volunteer may not enter the study if any of the following apply:
    • Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period.
    • Prior receipt of an investigational malaria vaccine encoding ME-TRAP or any other investigational vaccine likely to impact on interpretation of the trial data
    • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
    • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
    • Pregnancy, lactation or intention to become pregnant during the study
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon.
    • History of clinically significant contact dermatitis
    • Any history of anaphylaxis in reaction to vaccination
    • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
    • History of serious psychiatric condition
    • Any other serious chronic illness requiring hospital specialist supervision
    • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
    • Suspected or known injecting drug abuse
    • Seropositive for hepatitis B surface antigen (HBsAg)
    • Seropositive for hepatitis C virus (antibodies to HCV)
    • Seropositive for simian adenovirus 63 (antibodies to AdCh63) at a titre > 1: 200 ( EXCEPT CONTROL VOLUNTEERS)
    • Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer’s ability to participate in the study.
    • History of clinical P. falciparum malaria
    • Travel to a malaria endemic region during the study period or within the previous six months
    • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
    • Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol or impair interpretation of the study data.
    Re-vaccination exclusion criteria
    • The following adverse events associated with vaccine immunisation constitute absolute contraindications to further administration of vaccine. If any of these events occur during the study, the subject must be withdrawn and followed until resolution of the event, as with any adverse event.
    • Anaphylactic reaction following administration of vaccine
    • Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    Primary Evaluation Criteria
    Definition of the Criteria
    The protection against malaria infection in a sporozoite challenge model will be assessed by measuring the number of subjects who develop malaria infection and the time (in hours) between exposure and parasitaemia as detected by thick-film blood smear, and compared with controls.
    End-points:
    Primary: One thick smear positive for one or more morphologically-normal parasites during the 21 day observation period, OR
    Secondary: Subject is manifesting typical clinical symptoms or signs of malaria in the opinion of the Chief Investigator (such as fever >37.5C, rigors, moderate or severe myalgia, in the absence of another obvious cause) and has negative blood smears but has a PCR result that is positive for malaria.
    Parameters to be Measured
    Clinical Symptoms
    Definitions:

    No solicited adverse events will be recorded, but the following predictable symptoms of malaria will be enquired about at each visit :
    • Symptoms of feverishness
    • Chills
    • Rigors
    • Sweats
    • Headache
    • Anorexia
    • Nausea / vomiting
    • Diarrhoea
    • Myalgia /Arthralgia
    • Low back pain
    Subjects will be instructed to record their oral temperature with the thermometer provided should they feel feverish.
    The subjects will be instructed to contact the investigator immediately should they manifest any signs or symptoms they perceive as serious.





    Assessment of Severity
    Intensity of the general adverse events will be assessed as described:
    GRADE 0 None
    GRADE 1 Mild: Transient or mild discomfort (< 48 hours); no medical intervention/therapy required
    GRADE 2 Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required
    GRADE 3 Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalisation possible
    GRADE 4 Serious, life-threatening: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalisation or hospice care probable (see also 5.4.1.)

    Assessment of Outcome
    Outcome will be assessed as:
    1 = Recovered
    2 = Recovered with sequelae
    3 = Died
    4 = Unknown
    5 = Ongoing at subject study conclusion (active phase)

    Parasitological Parameters
    The parasitaemia will be assessed by thick smears and PCR.
    Method and Timing of Measurement
    Clinical signs:
    The clinical assessment and the check of vital signs will be performed and recorded at each timepoint from visit 4 to visit 29.
    Parasitology parameters:
    Blood smears and PCR will be performed for each volunteer, from visit 1 to visit 27. From D6 to D14, the samples will be taken twice a day (approximately 12 hourly).
    After a positive blood film, blood samples will be collected daily until two consecutive negative thick smears are obtained. These will be examined by blood smear examination immediately. PCR analysis will also be done until the first positive thick smear.
    .
    Secondary Evaluation Criteria
    Immunological assays will be conducted according to the procedures established in the test laboratories. With the volunteers’ informed consent, any leftover cells and serum will be frozen for future immunological analysis of malaria-specific responses.
    Tertiary Evaluation Criteria
    Durability of immunity in protected individuals will be measured by a re-challenge and reassessing primary and secondary criteria as described above.
    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 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 Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 state26
    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 Decision2008-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-11-26
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