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Safety and Immunogenicity of Novel Vaccination Schedules With Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP

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ClinicalTrials.gov Identifier: NCT01364883
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : July 29, 2013
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
This is an open label phase I study, to assess the safety and immunogenicity of novel schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP. These vaccines have been evaluated previously in a number of clinical trials proved to be safe and capable of inducing protective cellular immune response following challenge with the parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of the seven regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.

Condition or disease Intervention/treatment Phase
Malaria Biological: Vaccination Schedule One Biological: Vaccination Schedule Two Biological: Vaccination Schedule Three Biological: Vaccination Schedule Four Biological: Vaccination Schedule Five Biological: Vaccination Schedule Six Biological: Vaccination Schedule Seven Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I Study to Assess the Safety and Immunogenicity of Novel Schedules for Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP
Study Start Date : July 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16
Biological: Vaccination Schedule One
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
Experimental: Group 2
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24
Biological: Vaccination Schedule Two
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
Experimental: Group 3
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W4, MVA ME-TRAP boost W8, MVA ME-TRAP boost W12
Biological: Vaccination Schedule Three
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
Experimental: Group 4
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, MVA ME-TRAP boost W16, MVA ME-TRAP boost W24
Biological: Vaccination Schedule Four
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
Experimental: Group 5
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W16
Biological: Vaccination Schedule Five
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
Experimental: Group 6
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W4, AdCh63 ME-TRAP boost W8, MVA ME-TRAP boost W12
Biological: Vaccination Schedule Six
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
Experimental: Group 7
AdCh63 ME-TRAP prime D0, MVA ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
Biological: Vaccination Schedule Seven
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24



Primary Outcome Measures :
  1. Vaccine Safety [ Time Frame: Participants will be followed for the duration of the study, an expected average of 21 months ]
    To assess the safety of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7


Secondary Outcome Measures :
  1. Vaccine immunogenicity [ Time Frame: Participants will be followed for the duration of the study, an expected average of 21months ]
    To assess the immunogenicity of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 18 to 50 years
  • 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:

  • Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364883


Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Adrian VS Hill University of Oxford

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01364883     History of Changes
Other Study ID Numbers: VAC043
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013

Keywords provided by University of Oxford:
Vaccine
Immune response

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs