Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, Headington, OX3 7LJ, United Kingdom
NCT Number: NCT00890760
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
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1 / Phase 2
Oxford, Headington, OX3 7LJ, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
o concomitant use with other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)
5 x 10*10 vp IM
2 x 10*8 pfu ID
Infected mosquito bite
AdCh63 ME-TRAP 5 x 10*10 vp MVA ME-TRAP 2 x 10*8 pfu
Time frame: Approxiamately 5-16 months following last intervention
Time frame: Approxiamately 5-16 months following last intervention
University of Oxford
Other
Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With AdCh63 ME-TRAP and MVA ME-TRAP
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