Novel Schedules for Vaccination with AdCh63 ME-TRAP and MVA ME-TRAP

• Research type

  Research Study

• Full title

  A Phase I Study to Assess the Safety and Immunogenicity of Novel Schedules of Vaccination with the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP.

• IRAS ID

  68425

• Contact name

  Adrian V S Hill

• Sponsor organisation

  University of Oxford

• Eudract number

  2010-023824-26

• ISRCTN Number

  n/a

• Research summary

  AdCh63 ME-TRAP and MVA ME-TRAP are candidate malaria vaccines. They are inactivated viruses which have been modified so that they cannot reproduce in humans. Genetic information, ME-TRAP, has been added to make them express proteins of the malaria parasite. The vaccines are designed to stimulate an immune response against malaria which protects against malaria infection.In previous research in the UK (VAC033, MAL034) and ongoing research in Africa (VAC040 and VAC041) these vaccines have been given to people in the following sequences, or schedules: AdCh63 ME-TRAP followed by MVA ME-TRAP; AdCh63 ME-TRAP followed by MVA ME-TRAP followed by AdCh63 ME-TRAP again; and AdCh63 ME-TRAP followed by MVA ME-TRAP followed by MVA ME-TRAP again. These studies show promising results in the areas of safety, immunogenicity (ability to induce the desired immune response) and efficacy (ability to protect people from malaria).These vaccines may achieve even better immunogenicity and efficacy, while maintaining safety, when they are given according to different schedules to those already studied. This study will therefore evaluate seven new vaccination schedules. Each participant will receive one of the schedules. Each schedule contains a total of four vaccinations, and each schedule contains both vaccines. The schedules differ in the timing and sequence of vaccinations.The objectives of the study are to assess the safety and immunogenicity of each different schedule to try and develop the best vaccination schedule possible using these two vaccine candidates. The participants will be followed by health care professionals to get information about the safety of vaccination and will have blood taken to test immunogenicity.The study will be conducted at Oxford's Clinical Centre for Vaccinology and Tropical Medicine, and at the University of Southampton's Wellcome Trust Clinical Research Facility.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/96

• Date of REC Opinion

  17 Dec 2010

• REC opinion

  Favourable Opinion