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    Summary
    EudraCT Number:2012-000322-21
    Sponsor's Protocol Code Number:TIP5
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-000322-21
    A.3Full title of the trial
    Controlled human malaria infection after immunization with cryopreserved Plasmodium falciparum sporozoites under chloroquine prophylaxis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Controlled human malaria infection after immunization with frozen Plasmodium falciparum parasites under chloroquine prophylaxis
    A.4.1Sponsor's protocol code numberTIP5
    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 SponsorSanaria Inc.
    B.1.3.4CountryUnited States
    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 supportTop Institute Pharma
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Nijmegen Medical Center
    B.5.2Functional name of contact pointRobert Sauerwein
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein 26-28, Postbus 9101
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500 HB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243610577
    B.5.5Fax number+31243540216
    B.5.6E-mailr.sauerwein@mmb.umcn.nl
    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 namePlasmodium falciparum (Pf) Sporozoite (SPZ) Challenge
    D.3.2Product code PfSPZ Challenge
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPlasmodium falciparum Sporozoite Challenge
    D.3.9.2Current sponsor codePlasmodium falciparum Sporozoite Challenge
    D.3.9.3Other descriptive namePlasmodium falciparum Sporozoite Challenge
    D.3.10 Strength
    D.3.10.1Concentration unit thousand organisms/ml thousand organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeaseptic, purified, vialed, cryopreserved Plasmodium falciparum sporozoites (PfSPZ)
    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 placeboSuspension for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Controlled human malaria infection after immunization with cryopreserved Plasmodium falciparum sporozoites under chloroquine prophylaxis.
    E.1.1.1Medical condition in easily understood language
    Controlled human malaria infection after immunization with frozen Plasmodium falciparum parasites under chloroquine prophylaxis.
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    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 determine safety and tolerability of cryopreserved Plasmodium falciparum sporozoites after intradermal administration in human volunteers under chloroquine prophylaxis (PfSPZ-CVac)
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • To determine protective efficacy of PfSPZ-CVac in a controlled human malaria infection against homologous and heterologous Pf challenge infections by infected mosquitoes
    • To study the time to and development of parasitemia after Pf challenge infections
    Exploratory objective:
    • To analyse immune responses in volunteers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy volunteers (males or females) of ≥ 18 and ≤ 35 years of age
    2. Good health based on history and clinical examination (physical examination and laboratory screening)
    3. Negative pregnancy test
    4. Use of adequate contraception for females
    5. Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study
    6. Agreement to inform the general practitioner and to sign a request to release medical information concerning contraindications for participation in the study
    7. Willingness to undergo administration of PfSPZ Challenge by needle and syringe and willingness to undergo challenge by mosquito bites
    8. For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial centre or living in Nijmegen with a third party that could contact the clinicians in case of alteration of consciousness during a part of the study (day 5 after challenge until treatment is finished)
    9. Reachable (24/7) by mobile phone during the whole study period
    10. For volunteers living in Nijmegen: living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial centre during a part of the study (day 5 after challenge until treatment is finished)
    11. Available to attend all study visits
    12. Agreement to refrain from blood donation to Sanquin or for other purposes, during the whole study period
    13. Willingness to undergo HIV, hepatitis B and hepatitis C tests
    14. Negative urine toxicology screening test at screening visit and the day before challenge
    15. Willingness to take a prophylactic regime of chloroquine and a curative regimen of Malarone®
    16. Willingness to undergo ophthalmologic examination after passing all other inclusion criteria
    E.4Principal exclusion criteria
    1. History of malaria
    2. Plans to travel to malaria endemic areas during the study period
    3. Plans to travel outside of the Netherlands during the challenge period
    4. Previous participation in any malaria vaccine study and/or positive serology for Pf
    5. Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
    6. History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
    7. History of arrhythmias or prolonged QT-interval
    8. Positive family history of 1st and/or 2nd degree relatives who experienced cardiac events when < 50 years old
    9. An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
    10. Clinically significant abnormalities in electrocardiogram (ECG) at screening
    11. Body Mass Index (BMI) below 18 or above 30 kg/m2
    12. Any clinically significant deviation from the normal range in biochemistry or haematology blood tests
    13. Positive HIV, HBV or HCV tests
    14. Participation in any other clinical study within 30 days prior to the onset of the study
    15. Enrolment in any other clinical study during the study period
    16. For women: pregnancy or lactation
    17. Volunteers unable to give written informed consent
    18. Volunteers unable to be closely followed for social, geographic or psychological reasons
    19. History of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
    20. A history of psychiatric disease
    21. A history of convulsions
    22. Known hypersensitivity to Malarone® or chloroquine
    23. The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period
    24. Contraindications to Malarone® or chloroquine including treatment taken by the volunteer that interferes with Malarone® or chloroquine
    25. Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
    26. Co-workers or trainees of the departments of Medical Microbiology or Internal Medicine of the RUNMC
    27. Known history of sickle cell anaemia, sickle cell trait, thalassemia, thalassemia trait or G6PD deficiency. If there is any suspicion of G6PD deficiency (based on medical history during screening or ethnic background (Mediterranean, African, or Asian), we will assess G6PD status of that particular subject before inclusion.
    28. Abnormalities during ophthalmologic examination
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and magnitude of adverse events in study groups
    E.5.1.1Timepoint(s) of evaluation of this end point
    every day after malaria-infection
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Presence of parasitemia after Pf challenge infection as assessed by microscopy
    • Time to parasitemia after Pf challenge infection as assessed by microscopy
    • Kinetics of parasitemia as assessed by RTQ-PCR

    Exploratory endpoints:
    • Immune responses in study groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    every day after malaria-infection
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 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
    The end of the trial is 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 months1
    E.8.9.1In the Member State concerned days2
    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: 30
    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 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 state30
    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)
    at the end of the trial all subjects are treated with Malarone
    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 Decision2012-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-28
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