A Study to Assess the Effectiveness of a New Malaria Vaccine Candidate by Infecting Vaccinated Volunteers With Malaria Parasites
Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With AdCh63 ME-TRAP and MVA ME-TRAP
1 other identifier
interventional
55
1 country
1
Brief Summary
Malaria affects around 515 million people each year, about a million of whom die from the disease. It is a major problem for those who live in affected areas as well as for travellers to affected areas. There is a great need for a safe, effective malaria vaccine. The purpose of this study is to test 2 new vaccination regimes that include a new malaria vaccine candidate, for their ability to prevent malaria infection. The vaccines are different types of virus which contain genetic information (DNA) from the malaria parasite. This genetic material is named ME-TRAP. The aim is to use these viruses to help the body make an immune response against the malaria parasite. Both viruses are inactivated so that they are unable to multiply within the body. The first vaccine virus is a weakened version of a common cold virus. Such adenoviruses occur in many strain types and commonly infect chimpanzees as well as people and this vaccine uses a strain originally derived from a chimpanzee. The vaccine is called AdCh63 ME-TRAP. The other virus is Modified Vaccinia Ankara Virus, (MVA), which is a safer form of the vaccine virus previously widely used for smallpox vaccination. The vaccine is called MVA ME-TRAP. This study will enable the investigators to assess:
- 1.The ability of different vaccine combinations to prevent malaria infection
- 2.The safety of the vaccine combinations in healthy volunteers
- 3.The response of the human immune system to the vaccines
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 29, 2009
CompletedFirst Posted
Study publicly available on registry
April 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedNovember 29, 2012
November 1, 2012
11 months
April 29, 2009
November 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vaccine prevention (partial or complete) of malaria infection by sporozoite challenge
Approxiamately 5-16 months following last intervention
Secondary Outcomes (1)
Safety of vaccine
Approxiamately 5-16 months following last intervention
Study Arms (10)
Group 1
EXPERIMENTALAdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
Group 2
EXPERIMENTALAdCh63 ME-TRAP alone followed by sporozoite challenge 3 weeks later
Group 3
EXPERIMENTALNon-vaccinated Control for Groups 1 and 2 challenged with sporozoite
Group 4
EXPERIMENTALAdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 11 weeks after boost
Group 5
EXPERIMENTALAdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
Group 6
EXPERIMENTALProtected volunteers from Group 1 re-challenged with sporozoite after 6 months
Group 7
EXPERIMENTALNon vaccinated control for Groups 4-6, 8-10 challenged with sporozoite
Group 8
EXPERIMENTAL3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
Group 9
EXPERIMENTAL2 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval followed by sporozoite challenge 3 weeks after last vaccination
Group 10
EXPERIMENTAL3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 4 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
Interventions
Infected mosquito bite
AdCh63 ME-TRAP 5 x 10\*10 vp MVA ME-TRAP 2 x 10\*8 pfu
Eligibility Criteria
You may qualify if:
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For females only: willingness to practise effective contraception throughout the study
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
You may not qualify if:
- 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 encoding ME-TRAP 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
- Contraindication to both anti-malarial drugs (Riamet® and chloroquine)
- o concomitant use with other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)
- 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 reaction to vaccination
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, Headington, OX3 7LJ, United Kingdom
Related Publications (1)
Ewer KJ, O'Hara GA, Duncan CJ, Collins KA, Sheehy SH, Reyes-Sandoval A, Goodman AL, Edwards NJ, Elias SC, Halstead FD, Longley RJ, Rowland R, Poulton ID, Draper SJ, Blagborough AM, Berrie E, Moyle S, Williams N, Siani L, Folgori A, Colloca S, Sinden RE, Lawrie AM, Cortese R, Gilbert SC, Nicosia A, Hill AV. Protective CD8+ T-cell immunity to human malaria induced by chimpanzee adenovirus-MVA immunisation. Nat Commun. 2013;4:2836. doi: 10.1038/ncomms3836.
PMID: 24284865DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian VS Hill, D.Phil, FRCP
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 29, 2009
First Posted
April 30, 2009
Study Start
March 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2011
Last Updated
November 29, 2012
Record last verified: 2012-11