A Challenge study to assess four new malaria vaccine candidates

• Research type

  Research Study

• Full title

  A Phase I/IIa Sporozoite Challenge Study to Assess the Protective Efficacy of Two Prime-boost Malaria Vaccine Candidates: ChAd63 and MVA encoding ME-TRAP and the same Viral Vectors encoding CS

• IRAS ID

  98099

• Contact name

  Adrian Hill

• Sponsor organisation

  Oxford University Hospitals NHS Trust

• Eudract number

  2011-005477-24

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study aims to assess the safety, immunogenicity and protective efficacy of four new candidate malaria vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS & 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 (CS & 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. Safety and efficacy studies have been conducted previously with ChAd63 ME-TRAP & MVA TRAP (VAC033 & MAL034) with promising results (5/14 vaccines (57%) demonstrated some degree of protection against malaria following challenge). A safety study of ChAd63 CS and MVA CS is currently underway in Dublin (VAC038) and safety and immunogenicity data will be available in early 2012.This proposed study will assess the effectiveness of these four vaccines following malaria challenge and will only proceed when adequate safety data is available from VAC038. 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. Malaria challenge administered by mosquito bite 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) and the Welcome Trust Clinical Research Facility in Southampton. The challenge part of the study (mosquito bites) will take place at the insectary at Imperial College (Infection and Immunity Section) in London.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0037

• Date of REC Opinion

  28 Feb 2012

• REC opinion

  Further Information Favourable Opinion