Blood & Liver Stage Viral Vectored Vaccines Challenge Study

• Research type

  Research Study

• Full title

  A phase I/IIa sporozoite challenge study to assess the safety, immunogenicity and protective efficacy of new malaria vaccine candidates; AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP & MVA ME-TRAP.

• IRAS ID

  44802

• Contact name

  Adrian V S Hill

• Sponsor organisation

  University of Oxford

• Eudract number

  2010-018341-56

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to assess the safety, immunogenicity and protective efficacy of six new candidate malaria vaccines; AdCh63 MSP1, AdCh63 AMA1, AdCh63 ME-TRAP, MVA MSP1, MVA AMA1 & MVA ME-TRAP. These vaccines consist of inactivated viruses which have been modified so they cannot reproduce (replicate) in humans. They include genetic material (genes) for malaria proteins (MSP1, AMA1, ME-TRAP) which are expressed by the malaria parasite during human infection. The vaccines are designed to stimulate an immune response to these malaria proteins (immunogenicity describes the nature and magnitude of this immune response) in order to provide protection against malaria infection. This protection has been demonstrated in non-human studies. Safety and efficacy studies have been conducted with AdCh63 ME-TRAP & MVA TRAP (VAC033 & MAL034) with promising results. A safety study of AdCh63 MSP1 and MVA MSP1 is currently underway in Oxford (VAC037) with promising immunogenicity and safety data. A safety study of AdCh63 AMA1 and MVA AMA1 (VAC036) is due to start in March 2010. This proposed study will assess the effectiveness of these vaccines on sporozoite challenge and will only proceed when adequate safety data is available from VAC036 & VAC037. Volunteers will receive varying vaccine regimens and will then be infected with malaria to see how effective the vaccines are at preventing malaria infection. This will be determined by comparing time to the development of malaria infection in people who receive the vaccinations compared with un-vaccinated control volunteers. Sporozoite challenge has been widely used in humans to test the effectiveness of malaria vaccines and is considered a well established, reliable, predictable and safe system. The study will be conducted at the University of Oxford??s Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). The challenge part of the study will take place at the insectary at Imperial College, (Infection and Immunity Section) in London.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/30

• Date of REC Opinion

  7 May 2010

• REC opinion

  Further Information Favourable Opinion