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    Summary
    EudraCT Number:2019-000643-27
    Sponsor's Protocol Code Number:VAC071
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-000643-27
    A.3Full title of the trial
    A Phase IIa challenge study to assess efficacy of the Plasmodium vivax malaria vaccine candidates ChAd63 PvDBP and MVA PvDBP in healthy adults living in the UK
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    VAC071: A study to assess efficacy of the ChAd63/MVA PvDBP vaccines
    A.3.2Name or abbreviated title of the trial where available
    VAC071: A study to assess efficacy of the ChAd63/MVA PvDBP vaccines
    A.4.1Sponsor's protocol code numberVAC071
    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 / Clinical Trials and Research Governance
    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 organisationUniversity of Oxford
    B.5.2Functional name of contact pointAngela Minassian
    B.5.3 Address:
    B.5.3.1Street AddressChurchill Hospital, Old Road, Headington
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7LE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865611338
    B.5.5Fax number01865 289694
    B.5.6E-mailangela.minassian@ndm.ox.ac.uk
    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 nameChAd63 PvDBP
    D.3.4Pharmaceutical form 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.3.9.4EV Substance CodeAS1
    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.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 nameMVA PvDBP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Plasmodium vivax malaria
    E.1.1.1Medical condition in easily understood language
    Malaria (Plasmodium vivax)
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047665
    E.1.2Term Vivax malaria (benign tertian)
    E.1.2System Organ Class 100000004862
    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 efficacy of the ChAd63 and MVA PvDBP vaccines, administered in a heterologous prime-boost regimen, as assessed by a reduced parasite multiplication rate in vaccinated subjects following a blood-stage parasite inoculum
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability of the ChAd63 and MVA PvDBP vaccine candidates, administered in a heterologous prime-boost regimen in a CHMI study in healthy volunteers
    To assess the humoral and cellular immunogenicity of ChAd63 and MVA PvDBP vaccine candidates, administered in a heterologous prime-boost regimen
    To assess immunological readouts for association with a reduced parasite multiplication rate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Healthy adult aged 18 to 45 years.
    • Red blood cells positive for the Duffy antigen/chemokine receptor (DARC).
    • Normal serum levels of Glucose-6-phosphate dehydrogenase (G6PD).
    • Negative haemoglobinopathy screen
    • 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.
    • Women only: Must practice continuous effective contraception* for the duration of the study
    • Agreement to permanently refrain from blood donation
    • Written informed consent to participate in the trial.
    • Reachable (24/7) by mobile phone during the period between CHMI and completion of all antimalarial treatment.
    • Willing to take a curative anti-malarial regimen following CHMI.
    • Willing to reside in Oxford for the duration of the study, until antimalarials have been completed.
    • Answer all questions on the informed consent quiz correctly.
    E.4Principal exclusion criteria
    • History of clinical malaria (any species).
    • Travel to a clearly malaria endemic locality during the study period or within the preceding six months.
    • Current or planned treatment with long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
    • Chronic use of antibiotics with antimalarial effects (e.g. tetracyclines for dermatologic patients, trimethoprim-sulfamethoxazole for recurrent urinary tract infections, etc.).
    • Weight less than 50kg, as measured at the screening visit
    • Receipt of immunoglobulins within the three months prior to planned administration of the vaccine candidate.
    • Receipt of immunoglobulins of blood products (e.g., blood transfusion) at any time in the past.
    • Peripheral venous access unlikely to allow twice daily blood testing (as determined by the Investigator).
    • Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
    • Concurrent involvement in another clinical trial or planned involvement during the study period
    • Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data or the P. vivax parasite as assessed by the Investigator.
    • 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).
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine e.g. egg products, Kathon, aminoglycosides
    • History of allergic disease or reactions likely to be exacerbated by malaria infection.
    • History of clinically significant contact dermatitis
    • Any history of anaphylaxis in reaction to vaccinations
    • Pregnancy, lactation or intention to become pregnant during the study.
    • Use of medications known to cause prolongation of the QT interval and existing contraindication to the use of Malarone.
    • Use of medications known to have a potentially clinically significant interaction with Riamet and Malarone.
    • Any clinical condition known to prolong the QT interval.
    • History of cardiac arrhythmia, including clinically relevant bradycardia.
    • Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
    • Family history of congenital QT prolongation or sudden death.
    • Contraindications to the use of both of the proposed anti-malarial medications; Riamet Malarone.
    • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
    • History of serious psychiatric condition that may affect participation in the study.
    • Any other serious chronic illness requiring hospital specialist supervision.
    • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 25 standard UK units every week.
    • Suspected or known injecting drug abuse in the 5 years preceding enrolment.
    • Hepatitis B surface antigen (HBsAg) detected in serum.
    • Seropositive for hepatitis C virus (antibodies to HCV) at screening or (unless has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study).
    • Positive family history in both 1st AND 2nd degree relatives < 50 years old for cardiac disease.
    • Volunteers unable to be closely followed for social, geographic or psychological reasons.
    • Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.
    • Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
    • Inability of the study team to contact the volunteer’s GP to confirm medical history and safety to participate
    E.5 End points
    E.5.1Primary end point(s)
    Quantitative PCR (qPCR)-derived parasite multiplication rate (PMR) will be the primary efficacy endpoint and a comparison of the endpoint between Groups 1 and 2 (pooled data) and malaria-naïve controls partaking in simultaneous CHMI, under identical conditions, will constitute the primary analysis for efficacy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The efficacy evaluation using qPCR measurement of parasitaemia will begin at 7 days following blood-stage challenge and will continue until diagnosis or for up to 28 days post challenge if diagnosis is not made before then.
    E.5.2Secondary end point(s)
    1. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. The following parameters will be assessed:
    • Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination
    • Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination
    • Occurrence of unsolicited adverse events for 28 days following the vaccination
    • Change from baseline for safety laboratory measures for 28 days following vaccination
    • Occurrence of serious adverse events during the whole study duration

    2. PvDBP_RII -specific immunogenicity will be assessed by a variety of immunological assays, with comparison before and after vaccination. The main outcome measures will be humoral and B cell responses to the P. vivax Duffy-binding protein (PvDBP) – total IgG, isotypes and avidity; T cell responses to PvDBP by ex-vivo ELISpot and flow cytometry assays and in vitro functional PvDBP_RII inhibitory binding assays. Other established and exploratory immunology assays may be carried out, including through collaboration with other specialist laboratories.

    The relationship between PMR in vaccinated subjects and anti-PvDBP_RII antibody responses induced by the ChAd63 PvDBP and MVA PvDBP vaccines and PMR will also be assessed.

    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Evaluation of the adverse events following vaccination will begin as soon as the first dose of vaccine is given, as per the schedule outlined above, and will continue throughout the remainder of the trial. It will be assessed by analysing adverse event data collected from diary cards, clinical review of volunteers, and laboratory measurements. Any adverse events persisting at the end of the trial will be followed up until there is a satisfactory resolution or stabilisation occurs or until a non study related causality is found.

    2) The immunology investigations detailed above will be collected on blood specimens taken from volunteers across the course of their participation in the trial.
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Unvaccinated volunteers who undergo malaria
    E.8.2.4Number of treatment arms in the trial1
    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 No
    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 days31
    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 days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state19
    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)
    Not applicable to vaccination or malaria challenge
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-22
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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