This study aims to test the safety of two new malaria vaccines AdCh63 MSP1 and MVA MSP1. These vaccines consist of inactivated viruses which have been modified - so they cannot reproduce (replicate) in humans, and also to include genetic material (genes) for malaria proteins which are expressed by the malaria parasite during blood stage infection. The vaccines are designed to stimulate an immune response to these malaria proteins (immunogenicity describes the nature and magnitude of this immune response), to provide protection against malaria infection. This protection has been demonstrated in nonhuman studies. Although these vaccines have not been given to humans before, similar vaccines using the same viruses with different malaria genes have been given to humans before. In these studies, the vaccines have been shown to be safe. They have also provided evidence from laboratory tests of immunogenicity. In this study the investigators main aim is to ensure these new vaccines given alone and in combination are safe. The investigators will increase the dose of the first vaccine (AdCh63 MSP1) given to volunteers if the initial dose is safe. The investigators also wish to ensure that challenging a small number of volunteers who have received both vaccines with malaria infection from the bites of infected mosquitos(sporozoite challenge) is safe. Sporozoite challenge has been widely used in humans to test the effectiveness of malaria vaccines and is considered a well established, reliable, predictable and safe system.In the study the investigators will also look for evidence of immunogenicity of these new vaccines, and whether there is any delay to developing malaria following sporozoite challenge. The study will be conducted at the University of Oxfords Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). The challenge part of the study will take place at the insectary at Imperial College, (Infection and Immunity Section)in London.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
16
Group 1A: single dose of AdCh63-MSP1 vaccine 5 x 10\^9 vp administered IM. Group 1B: single dose of AdCh63-MSP1 vaccine 5 x 10\^9 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10\^8 vp administered IM 8 weeks later
Group 2A: single dose of AdCh63-MSP1 vaccine 5 x 10\^10 vp administered IM. Group 2B: single dose of AdCh63-MSP1 vaccine 5 x 10\^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10\^8 vp administered IM 8 weeks later. Group 2C: single dose of AdCh63-MSP1 vaccine 5 x 10\^10 vp administered IM followed by a single dose of MVA-MSP1 vaccine 5 x 10\^8 vp administered IM 8 weeks later and subsequent sporozoite malaria challenge 12-28 days post second vaccination
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, United Kingdom
Safety of new candidate malaria vaccines AdCh63 MSP1 administered alone, and with MVA MSP1 in a prime-boost regime, to healthy volunteers. and safety of the prime-boost vaccine strategy following malaria sporozoite challenge.
Time frame: Up to 6 months post enrollment into the study
Humoral and cellular immune responses generated by AdCh63 MSP1, when administered to healthy volunteers alone, with MVA MSP1, and following sporozoite challenge. Efficacy of AdCh63 MSP1 and MVA MSP1 against malaria sporozoite challenge
Time frame: Up to 6 months post enrollment into the study
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