The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at different doses and alone or in combination. The study will enable us to assess the safety of the vaccines and the extent of the immune response in healthy volunteers. We will do this by giving volunteers one or two vaccinations, doing blood tests and collecting information about any symptoms that occur after vaccination. This is the first trial to use these vaccines in humans.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
26
ChAd63 RH5 at 5 x 10\^9 vp
ChAd63 RH5 at 5 x 10\^10 vp
MVA RH5 at 1 x 10\^8 pfu
MVA RH5 at 2 x 10\^8 pfu
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, United Kingdom
Wellcome Trust CRF, Southampton General Hospital, University of Southampton
Southampton, United Kingdom
To assess the safety of ChAd63 RH5 when administered alone and in heterologous prime-boost with MVA RH5
Occurrence of solicited and unsolicited adverse events will be monitored at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results.
Time frame: 240 days
To assess the cellular and humoral immunogenicity of ChAd63 RH5 when administered alone, and in heterologous prime-boost with MVA RH5 in healthy volunteers.
P. falciparum RH5-specific immunogenicity will be assessed by a variety of immunological assays. These may include ex vivo ELISpot assays for interferon gamma and flow cytometry assays, as well as antibody ELISAs, functional antibody assays and B cell analyses. Other exploratory immunological assays including cytokine analysis, other antibody assays, anti-adenovirus antibodies, DNA analysis of genetic polymorphisms potentially relevant to vaccine immunogenicity and gene expression studies amongst others may be performed at the discretion of the Investigators.
Time frame: 240 days
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