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    Summary
    EudraCT Number:2005-004833-17
    Sponsor's Protocol Code Number:CBD VP 128/05
    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:2007-06-03
    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 number2005-004833-17
    A.3Full title of the trial
    Assessment of the effect of prior anthrax vaccine precipitated (AVP) vaccination on the immune response to booster AVP vaccination.
    A.4.1Sponsor's protocol code numberCBD VP 128/05
    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 SponsorDstl
    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 Yes
    D.2.1.1.1Trade name Anthrax vaccine (alum precipitated sterile filtrate)
    D.2.1.1.2Name of the Marketing Authorisation holderSecretary of State for Health, Department of Health.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.2Product code AVP
    D.3.4Pharmaceutical form Suspension for 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.3.9.3Other descriptive nameAnthrax antigens
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0.25ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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
    Vaccination against potential exposure to anthrax (Bacillus anthracis).
    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 evaluate immune responses to booster doses (annual compared with delayed) of the current UK licensed anthrax vaccine (Anthrax Vaccine Precipitated (AVP)).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of booster doses of AVP, annual compared with delayed. To obtain information on correlates of protection against anthrax, to inform the recombinant anthrax vaccine development programme.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To participate in this study, subjects must meet the following criteria: 1. Ability and willingness to give written informed consent prior to study participation. 2. Healthy male and female subjects aged between 18 and 60 years (inclusive). 3. Must have, in the opinion of the Investigator, completed a satisfactory primary series of AVP vaccination (four doses usually given at 0, 3, 6 and 32 weeks); Individuals who have subsequently received one or more booster vaccinations may also be included. 4. Subjects must be eligible to enter one of the following groups: • Group A: Annual booster recipients (subjects scheduled to receive their annual booster of AVP – i.e. had their last dose 12 months +/- one month previously). • Group B: Delayed booster recipients (subjects who have not received a dose of AVP for at least two years). 5. Ability to communicate well with the Investigator and to comply with the requirements of the study. 6. Females of child bearing potential must have a negative urinary pregnancy test at screening. 7. Females of child bearing potential must be using a reliable method of contraception (as agreed at the Investigator’s discretion) and must agree to continue to do so from the screening visit until four weeks after the vaccination.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will be excluded from participation in the study: 1. Presence of any clinically significant medical condition as determined by the Investigator. Minor deviations outside the relevant reference range, in the absence of overt clinical disease would not exclude a subject if it is considered that such findings would not affect the immune response to vaccination. 2. Any clinically significant haematological or biochemical abnormality as determined by the Investigator. 3. Any surgical or medical condition which might significantly alter the immune response to the vaccine, as determined by the investigator. 4. Known or suspected hypersensitivity or idiosyncratic reaction related to any AVP vaccine components. 5. History or evidence of alcohol abuse defined as an intake of more than 28 units per week for men and 21 units per week for women, where 1 unit corresponds to 250 mL beer, 20 mL spirits/liqueur or one glass (100 mL) of wine. 6. Participation in another clinical trial within the three months prior to dosing. 7. Donation of blood or blood products within the three months prior to dosing, or the intention to donate blood or blood products during the course of the study. 8. Subjects who, in the opinion of the Investigator, have not received a satisfactory primary series of AVP vaccination (0, 3, 6 and 32 weeks). 9. Subjects who have received any other vaccination in the three weeks prior to dosing, or who require any vaccination within four weeks of the AVP vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    The pharmacodynamic changes in immune response will measure blood antibody concentrations and serum toxin neutralisation assay (TNA). Blood samples will be taken up to 29 days and an additional blood sample collected after 4 months. Physical examination and laboratory safety screening will be undertaken pre-study and physical examination and symptom assessment post-study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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 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
    Not defined in protocol, but last patient, last visit will be the end of the trial.
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 state200
    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, healthy volunteer study.
    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 Decision2007-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-01
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