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    Summary
    EudraCT Number:2007-005389-11
    Sponsor's Protocol Code Number:VAC035
    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:2009-05-22
    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 number2007-005389-11
    A.3Full title of the trial
    A Phase I/IIa Study of the Safety, Immunogenicity and Parasite Growth Inhibitory Activity of AMA1-C1/Alhydrogel® + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium falciparum Malaria
    A.3.2Name or abbreviated title of the trial where available
    AMA1-C1/CPG Blood Stage Challange
    A.4.1Sponsor's protocol code numberVAC035
    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 nameAMA1-C1/Alhydrogel®+CPG7909
    D.3.2Product code AMA1-C1/Alhydrogel®+CPG7909
    D.3.4Pharmaceutical form 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 codeAMA1-C1
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number157
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAlhydrogel®
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1445
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCPG 7909
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1025
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Plasmodium falciparum malaria
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10036655
    E.1.2Term Prevention of malaria
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate a correlation between in vitro growth inhibition assay and parasite multiplication rate in vivo
    E.2.2Secondary objectives of the trial
    To detect differences in the multiplication rate responses between unvaccinated control subjects and volunteers vaccinated with AMA1-C1/Alhydrogel + CPG7909.
    To assess levels of protection from blood stage malaria in volunteers vaccinated with AMA1-C1/Alhydrogel + CPG7909.

    Tertiary Objectives
    To assess the safety, reactogenicity of the AMA1-C1/Alhydrogel® + CPG 7909 vaccine.
    To perform exploratory studies of B and T cell populations both before and after vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject is willing and able to give informed consent for participation in the study
    • Healthy, non pregnant adult aged 18 - 50 years
    • Resident in or near Oxford for the duration of the challenge study
    • Seropositive for CMV and EBV
    • Female subjects of child bearing potential must be willing to ensure that they practice
    effective contraception during the study
    Males must be willing to use barrier contraception from day of first vaccination onwards until 3 months after the second vaccination
    • Able (in the Investigator’s opinion) and willing to comply with all study requirements
    • Willing to allow his or her General Practitioner and consultant, if appropriate, to be
    notified of participation in the study
    • Agreement to permanently refrain from blood donation.
    E.4Principal exclusion criteria
    • Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or
    in urine analysis as defined in Appendix B
    • Female patient/subject who is pregnant, lactating or planning pregnancy during the
    course of the study
    • Healthy volunteers who have participated in another research study involving an
    investigational product in the past 12 weeks
    • Subjects who have previously received an investigational malaria vaccine
    • History of malaria chemoprophylaxis with chloroquine within 5 months prior to the
    planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet®
    within 2 weeks prior to the challenge
    • Travel to a malaria endemic area within the previous 6 months
    • Planned travel to malarious areas during the study period
    • Any history of malaria
    Contraindication to both ant-malarial drugs (Riamet and Chloroquine)
    Concomitant use of other drugs known to cause QT-interval prolongation (e.g. macrolides, quinolones, amiodarone etc)
    An estimated ten year risk of fatal cardiovascular disease of greater than or equal to 5%, as estimated by the Systemic Coronary Risk Evaluation (SCORE) system (Conroy 2003)
    • Any history of severe allergic reaction or anaphylaxis
    • History of a known allergy to nickel
    • 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
    • History or evidence of pre-existing autoimmune or antibody mediated disease or
    laboratory evidence of possible autoimmune disease (defined as anti-dsDNA ≥ 25
    IU/mL)
    • Seropositive for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C virus
    • Any on-going chronic illness requiring hospital specialist supervision
    • Administration of immunoglobulins and/or any blood products within the three
    months preceding the planned administration of the vaccine candidate
    • History of or current intravenous drug abuse
    • Suspected or known current alcohol abuse as defined by an alcohol intake of greater
    than 42 units every week
    • Any other significant disease or disorder which, in the opinion of the Investigator,
    may either put the subject at risk because of participation in the study, or may
    influence the result of the study, or the subject’s ability to participate in the study.
    • Investigator assessment of lack of willingness to participate and comply with all
    requirements of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy end point:
    One thick smear positive for one or more parasites during the 12 day observation period
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    There is no control drug but there will be unvaccinated control volunteers for the malaria challenge
    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 concerned2
    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 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
    The last visit of the last subject to the trial centre
    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 months3
    E.8.9.1In the Member State concerned days
    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) Yes
    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 Yes
    F.3.2Patients No
    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 state10
    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 Decision2009-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-28
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