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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Regimen | Active Comparator | ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56 6 Volunteers |
|
| Low Dose Matrix M Regimen | Experimental | ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56 8 Volunteers |
|
| Standard Dose Matrix M Regimen | Experimental | ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56 8 Volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Regimen | Biological | ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination adjuvanted with Matrix M™ | Analysis of all solicited and unsolicited local and general vaccine-linked adverse events (AEs) occurring in Low Dose Matrix M™ and Standard Dose Matrix M™ Group volunteers. | 24 weeks from first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effects of Matrix M™ on the immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost vaccination | Comparison of immunogenicity of the Matrix M™ - adjuvanted vaccination regimens, versus the Control regimen. | 24 weeks from first vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Hill, MD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28941620 | Derived | Venkatraman N, Anagnostou N, Bliss C, Bowyer G, Wright D, Lovgren-Bengtsson K, Roberts R, Poulton I, Lawrie A, Ewer K, V S Hill A. Safety and immunogenicity of heterologous prime-boost immunization with viral-vectored malaria vaccines adjuvanted with Matrix-M. Vaccine. 2017 Oct 27;35(45):6208-6217. doi: 10.1016/j.vaccine.2017.09.028. Epub 2017 Sep 21. |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| Low Dose Matrix M Regimen | Biological | ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56 |
|
| Standard Dose Matrix M Regimen | Biological | ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56 |
|
| D000079426 |
| Vector Borne Diseases |