A Phase 1 interventional study of ChAd63 RH5 low dose and ChAd63 RH5 full dose in Malaria and Plasmodium Falciparum, sponsored by University of Oxford. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.
Sponsored by University of Oxford · Phase 1, Interventional, and Prevention
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.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 26 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
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Exclusion Criteria:
1 dose of ChAd63 RH5 5 x 10\^9 vp intramuscularly
Biological: ChAd63 RH5 low dose
1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly
Biological: ChAd63 RH5 full dose
1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly and 1 dose MVA RH5 at 1 x 10\^8 pfu 8 weeks later intramuscularly
Biological: ChAd63 RH5 full dose · Biological: MVA RH5 low dose
1 dose of ChAd63 RH5 at 5 x 10\^10 vp intramuscularly and 1 dose MVA RH5 at 2 x 10\^8 pfu 8 weeks later intramuscularly
Biological: ChAd63 RH5 full dose · Biological: MVA RH5 full dose
ChAd63 RH5 at 5 x 10\^9 vp
Also known as: ChAd63 RH5
ChAd63 RH5 at 5 x 10\^10 vp
Also known as: ChAd63 RH5
MVA RH5 at 1 x 10\^8 pfu
Also known as: MVA RH5
MVA RH5 at 2 x 10\^8 pfu
Also known as: MVA RH5
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
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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University of Oxford