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    Summary
    EudraCT Number:2011-000381-35
    Sponsor's Protocol Code Number:OVG 2011/02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-08-18
    Trial 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 number2011-000381-35
    A.3Full title of the trial
    Understanding typhoid disease after vaccination: a single centre, randomised, double-blind, placebo-controlled study to evaluate M01ZH09 in a healthy adult challenge model, using Ty21a vaccine as a positive control.
    A.3.2Name or abbreviated title of the trial where available
    Understanding typhoid disease after vaccination; version 1.
    A.4.1Sponsor's protocol code numberOVG 2011/02
    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 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.2.1.1.2Name of the Marketing Authorisation holderEmergent Biosolutions
    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 nameOral typhoid vaccine M01ZH09
    D.3.2Product code M01ZH09
    D.3.4Pharmaceutical form Powder and solvent for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlive attenuated Salmonella Typhi strain S. Typhi (Ty2 aroC- ssaV-) ZH9
    D.3.9.3Other descriptive nameM01ZH09
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 17
    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 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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Vivotif
    D.2.1.1.2Name of the Marketing Authorisation holderCrucell Italy S.r.I
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameN/A
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSalmonella Typhi Ty21a
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2
    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 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 placeboPowder and solvent for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active immunisation for the prevention of typhoid infection in healthy adults.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10045275
    E.1.2Term Typhoid fever
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10045272
    E.1.2Term Typhoid
    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
    Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, we will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.
    E.2.2Secondary objectives of the trial
    1) To compare the clinical and laboratory features of the response to typhoid infection in participants who have previously been vaccinated with M01ZH09, vaccine-placebo or Ty21a. These features will include the course of the illness, the point at which participants may develop typhoid bloodstream infection, and the level of inflammation produced in response to infection. 2) To compare the response of the immune systems to typhoid infection in participants who have previously been vaccinated with M01ZH09, vaccine-placebo or Ty21a. 3)To assess the safety and side-effects of the novel vaccine (M01ZH09) and to compare these with the other two groups (those receiving vaccine-placebo and those receiving the Ty21a vaccine). 4) To develop new methods for diagnosing typhoid infection, which are currently poor. 5) To explore how the genetic response (which protein encoding-genes within the participants DNA are switched on and off) to vaccination in the three groups varies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant is willing and able to give informed consent for participation after the nature of the study has been explained. 2. Male or female, aged 18-60 years inclusive. 3. In good health as determined by medical history, history-directed physical examination and the clinical judgment of the investigators. 4. Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception for one month prior to challenge and continue to do so until a negative stool sample has been obtained at least 3 months after completion of antibiotic treatment. 5. Able and willing (in the Investigator’s opinion) to comply with all study requirements, including the capacity for good personal hygiene. 6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. 7. Willing to allow the Health Protection Unit to be informed of participation in the study. 8. For those involved in provision of health or social care to vulnerable groups only – willing to allow his or her employer to be notified of participation in the study. 9. Willing to give his or her contacts (defined as someone who is likely to have been exposed to the excreta of a challenged participant, usually a household or sexual contact) letters informing them of the participants involvement in the study and offering the contact screening for Salmonella Typhi carriage. 10. Agree to refrain from future blood donation. 11. Be willing to have 24-hr contact with study staff during the four weeks post-challenge.
    E.4Principal exclusion criteria
    1. Are unwilling or unable to give written informed consent to participate in the study. 2. Have previously received any typhoid vaccine or been diagnosed with laboratory confirmed typhoid. 4. Have known/suspected autoimmune disease or impairment/alteration of immune function resulting from (for example): a) Congenital or acquired immunodeficiency (including IgA deficiency) b) Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy. c) HIV infection. 5. History of significant cardiovascular disease, respiratory disease, endocrine disorder, renal or bladder disease, biliary tract disease, gastrointestinal disease (including hepatitis B or C), neurological disease, metabolic disease, haematological diagnosis, psychiatric illness (requiring hospitalisation), current known or suspected drug abuse or alcohol abuse, history of moderate or severe depression or anxiety, infectious disease, cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). 6. Have implants or prostheses in situ. 7. Have any clinically significant abnormal finding on biochemistry or haematology blood tests or urine analysis. 8. Contra-indication to taking ciprofloxacin, β-lactam antibiotics, or trimethoprim/sulfamethoxazole. 9. Female participant who is pregnant, lactating or who is unwilling to ensure that they or their partner use effective contraception for one month prior to challenge and continue to do so until a negative stool sample, a minimum of 3 months after completion of antibiotic treatment, has been obtained. 10. Current occupation involving clinical or social work involving direct contact with: a)young children (those attending pre-school groups, nursery or under the age of 2 years) b)highly susceptible patients or persons in whom typhoid infectious would have particularly serious consequences, including the elderly (unless willing not to work until demonstrated to not be infected with Salmonella Typhi in accordance with guidance from the Health Protection Agency). 11. Current occupation as a commercial food handler (involving preparing or serving unwrapped foods not subjected to further heating). 12. Household contact under 2 years of age or who is immunocompromised by treatment or disease. 13. Have elective surgery or other procedures requiring general anaesthesia scheduled during the vaccine/challenge period, at time of enrollment. 14. Have participated in another research study involving an IMP that might affect risk of typhoid infection or compromise the integrity of the study within the 30 days prior to enrolment (e.g. significant volumes of blood already taken in previous study) as assessed by both participant questioning and the TOPS Over Volunteering Prevention System database. 15. Have donated blood in the preceeding 3 months (temporary exclusion only). 16. Have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months. 17. Have any other significant disease or disorder which, in the opinion of the investigators, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the relative protective effect of M01ZH09 vaccine compared to placebo using a healthy adult typhoid challenge model, with Ty21a vaccine as a positive control.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 trial will be when the last assay has been completed on the last cellular participant sample. This has been chosen as some assays may be performed in North America and there may be delays due to transportation problems etc.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 0
    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 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 state99
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 99
    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)
    This is not relevant as the intervention is a single course of vaccination.
    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 Decision2011-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-18
    P. End of Trial
    P.End of Trial StatusOngoing
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