Malaria Clinical Trial
Official title:
Safety and Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP Heterologous Prime Boost Malaria Vaccination Adjuvanted With Matrix M™
ChAd63 METRAP and MVA METRAP are investigational vaccines for malaria which have been
studied in clinical trials for 4 years, and 10 years, respectively. These vaccines are
inactivated viruses which have been modified so that they cannot reproduce in humans.
Genetic information has been added to make them express proteins of the malaria parasite so
that they stimulate an immune response against malaria. This trial examines whether a
compound called Matrix M™ can be used in efforts to improve on how well the vaccines work at
preventing malaria.
Matrix M™ is a vaccine adjuvant, a compound used to improve the immune responses to
vaccines. In this trial, Matrix M™ will be combined with each of the vaccines. The
objectives are to assess the safety of the vaccines when combined with Matrix M™, and to
determine what effect Matrix M™ has on the immune responses to the vaccines.
We will assess the safety of the vaccines (ChAd63 METRAP combined with Matrix M™; and MVA
METRAP combined with Matrix M™) by administering them to healthy volunteers and monitoring
them for 6 months in total. Eight volunteers will receive the vaccines with the low dose of
Matrix M™, eight will receive the vaccines with the standard dose of Matrix M™, and six
volunteers will receive the vaccines alone as a comparison group. We will also look at what
effect Matrix M™ has on the immune responses to the vaccines, as measured from blood tests.
Volunteers will have study visits to the Clinical Centre for Vaccinology and Tropical
Medicine on the Churchill Hospital site, Oxford, where they will have vaccinations, have
blood taken to monitor safety and measure immune responses to vaccination, and be monitored
for symptoms/side effects from vaccination.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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