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 that 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 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. 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.

Study type: Interventional
Enrollment: 23 participants
Primary purpose: Prevention
Allocation: Non-Randomized
Interventional Model: Parallel assignment
Masking : Open label
NCT number: NCT01669512
Phase: Phase I

Clinical trial registration

Vaccines

Aug 2012 — Dec 2014

United Kingdom