Safety and Immunogenicity of Novel Vaccination Schedules With Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP
NCT ID: NCT01364883
Last Updated: 2013-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2011-07-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16
Vaccination Schedule One
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Group 2
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24
Vaccination Schedule Two
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Group 3
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, MVA ME-TRAP boost W8, MVA ME-TRAP boost W12
Vaccination Schedule Three
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Group 4
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24
Vaccination Schedule Four
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Group 5
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16
Vaccination Schedule Five
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Group 6
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W12
Vaccination Schedule Six
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Group 7
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
Vaccination Schedule Seven
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
Interventions
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Vaccination Schedule One
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Vaccination Schedule Two
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Vaccination Schedule Three
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Vaccination Schedule Four
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Vaccination Schedule Five
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Vaccination Schedule Six
Intramuscular injection of 5x10\^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10\^8 pfu of MVA ME-TRAP
Vaccination Schedule Seven
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
Eligibility Criteria
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Inclusion Criteria
* Able and willing (in the Investigator's opinion) to comply with all study requirements
* Willing to allow the investigators to discuss their medical history with their General Practitioner
* For female volunteers, willingness to practice continuous effective contraception during the study
* Agreement to refrain from blood donation during the course of the study
* Written informed consent
Exclusion Criteria
* Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
* 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)
* Pregnancy, lactation, or intention to become pregnant during the study
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon History of clinically significant contact dermatitis
* Any history of anaphylaxis in relation to vaccination
* Any history of malaria Travel to a malaria endemic region during the study period or within the six months preceding enrolment in the study
* 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 42 units every week
* Suspected or known injecting drug abuse in the five years preceding enrolment -Seropositive for hepatitis B surface antigen (HBsAg)
* Seropositive for hepatitis C virus (antibodies to HCV)
* Any relevant history of cancer (excludes basal cell carcinoma of the skin and cervical carcinoma in situ)
* Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
* 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 study data
18 Years
50 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Adrian VS Hill
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, , United Kingdom
Countries
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Other Identifiers
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VAC043
Identifier Type: -
Identifier Source: org_study_id
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