Combination Viral Vectored Malaria Vaccine Approaches

• Research type

  Research Study

• Full title

  A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches using the ChAd63 and MVA vectors encoding the antigens ME-TRAP, CS and AMA1.

• IRAS ID

  116648

• Contact name

  Adrian V S Hill

• Sponsor organisation

  University of Oxford

• Eudract number

  2012-004416-66

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a clinical trial in which healthy volunteers will be administered experimental malaria vaccines. One group of volunteers will receive a vaccination composed of a mixture of the ChAd63 ME-TRAP and ChAd63 CS vaccines, followed by another vaccination 8 weeks later with a mixture of the MVA CS and MVA ME-TRAP vaccines. Another group will receive a vaccination composed of a mixture of the ChAd63 ME-TRAP, ChAd63 CS and ChAd63 AMA1 vaccines, followed by another vaccination 8 weeks later with a mixture of the MVA CS, MVA ME-TRAP and MVA AMA1 vaccines. The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples. Volunteers will be infected with malaria by mosquito bites. In addition, a group of volunteers not receiving vaccines will also be infected with malaria the same way. These infection experiments will be used to assess vaccine efficacy: how well the vaccines act to prevent malaria disease. A further group of up to three volunteers will also be infected with malaria; these volunteers participated in a previous trial where they received vaccines and were completely protected against malaria disease after infection by mosquito bite. The vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they can not multiply. The viruses have extra DNA in them so that after injection, the body makes malaria proteins (but malaria does not develop), so that the immune system builds a response to malaria without having been infected by it. Healthy volunteers will be recruited in England at two research sites: in Oxford, and in Southampton.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0597

• Date of REC Opinion

  7 Nov 2012

• REC opinion

  Favourable Opinion