Safety and immunogenicity of novel routes of ChAd63 ME-TRAP (VAC064)
Research type
Research Study
Full title
A Phase I Study to assess the safety and immunogenicity of novel routes of administration of Plasmodium falciparum malaria vaccine candidate ChAd63 encoding ME-TRAP
IRAS ID
215475
Contact name
Adrian Hill
Contact email
Sponsor organisation
University of Oxford
Eudract number
2016-003811-36
Duration of Study in the UK
0 years, 7 months, 13 days
Research summary
A study to assess new routes of administration for the malaria vaccine ChAd63 ME-TRAP in healthy UK adults.
Plasmodium falciparum Malaria remains a major global health problem with approximately 200 million cases and 500,000 deaths worldwide annually, mostly in Africa. The majority of these deaths are in children under the age of 5 years old. Current malarial control strategies confront numerous complex challenges including emergence of parasite resistance to drug treatment and the development of resistance of the mosquito vector to certain insecticides. A deployable malaria vaccine is therefore a key strategy for reducing malaria mortality and achieving the greater goal of global eradication of the disease. Clinical trials of vaccine candidates have only delivered partial efficacy someway short of the target 75% protective efficacy outlined for a deployable malaria vaccine by 2030.
ChAd63 ME-TRAP is a leading candidate vaccine being developed by Adrian Hill’s group at the University of Oxford, and collaborators. Since 2007, testing of the vaccine intramuscularly in over 900 volunteers has shown it to be safe, well tolerated and capable of delivering partial efficacy against malaria infection. This study will be the first time studying in humans, the delivery of the vaccine by alternative routes including intravenously. It follows very encouraging pre-clinical work showing this route can deliver desirable immune responses to the liver to fight a crucial stage of malaria infection. The study will recruit 15 healthy UK adult volunteers who will be allocated into 5 groups of escalating doses to receive a single dose of the vaccine, either intravenously or into fat tissues (subcutaneously). During a follow up period of 3 months where participants will have regular assessment and blood tests, we will profile the safety and immune response when delivering the vaccine by these routes. All trial activity will take place at the University of Oxford and is funded by Wellcome Trust.REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0555
Date of REC Opinion
22 Nov 2016
REC opinion
Favourable Opinion