Adjuvanting viral vectored malaria vaccines with Matrix M™ (v 1.0)

• Research type

  Research Study

• Full title

  Safety and Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime boost malaria vaccination adjuvanted with Matrix M™. A Phase I Controlled Clinical Trial.

• IRAS ID

  97731

• Contact name

  Adrian V S Hill

• Sponsor organisation

  Clinical Trials and Research Governance, University of Oxford

• Eudract number

  2011-005418-12

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  ChAd63 ME-TRAP and MVA ME-TRAP 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?½ can be used in efforts to improve on how well the vaccines work at preventing malaria. Matrix M?½ is a vaccine adjuvant, a compound used to improve the immune responses to vaccines. In this trial, Matrix M?½ will be combined with each of the vaccines. The objectives are to assess the safety of the vaccines when combined with Matrix M?½, and to determine what effect Matrix M?½ has on the immune responses to the vaccines. We will assess the safety of the vaccines (ChAd63 ME-TRAP combined with Matrix M?½; and MVA ME-TRAP combined with Matrix M?½) 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?½, eight will receive the vaccines with the standard dose of Matrix M?½, and six volunteers will receive the vaccines alone as a comparison group. We will also look at what effect Matrix M?½ 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.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0036

• Date of REC Opinion

  8 Feb 2012

• REC opinion

  Favourable Opinion