Phase Ia study: Safety and Immunogenicity of ChAd63 CS and MVA CS

• Research type

  Research Study

• Full title

  A Phase Ia Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 CS administered alone and with MVA CS

• IRAS ID

  83611

• Eudract number

  2011-001875-38

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study aims to test the safety of two new malaria vaccines; ChAd63 CS and MVA CS. These vaccines consist of inactivated viruses (ChAd63 & MVA) which have been modified so (i) they cannot reproduce (replicate) in humans, and (ii) they include genetic material for the malaria circumsporozoite protein (CS). The vaccines are designed to stimulate an immune response to CS (immunogenicity describes the nature and magnitude of this immune response) in order to provide protection against malaria infection. Although these vaccines have not been given to humans before, similar vaccines using the same viruses (ChAd63 & MVA) with different malaria genes have been given to humans before and have been shown to be safe, inducing strong immune responses. In this study our main aim is to ensure these new vaccines given alone and in combination are safe. If the initial, lower dose of ChAd63 CS is shown to be well tolerated when given to volunteers, the dose of ChAd63 CS will be increased. In the study we will also look for evidence of immunogenicity of these new vaccines by performing laboratory assays on blood samples taken at various time points following vaccination(s). The study will be conducted at the University of Oxfords Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Royal College of Surgeons in Ireland (RCSI) Clinical Research Unit, Beaumont Hospital, Dublin, Ireland.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0289

• Date of REC Opinion

  12 Aug 2011

• REC opinion

  Further Information Favourable Opinion