Safety and Immunogenicity of two novel P. vivax malaria vaccines

• Research type

  Research Study

• Full title

  A phase Ia clinical trial to assess the safety and immunogenicity of new Plasmodium vivax malaria vaccine candidates ChAd63 PvDBP alone and with MVA PvDBP

• IRAS ID

  119618

• Contact name

  Adrian V S Hill

• Sponsor organisation

  University of Oxford

• Eudract number

  2012-004440-30

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study aims to assess the safety and immunogenicity of two novel Plasmodium vivax malaria vaccines: ChAd63 PvDBP and MVA PvDBP. The vaccines consist of viruses which have been modified so that they are unable to replicate in humans and include genetic material for the vivax malaria Duffy-binding protein (PvDBP). This protein is vital for vivax malaria parasites to be able to invade human red blood cells. The vaccines are designed to stimulate an immune response to this malaria protein (immunogenicity describes the nature and magnitude of this immune response) to provide protection against malaria infection by preventing the malaria parasites from entering red blood cells. This vaccine has not been used in humans before, but the viruses (ChAd63 and MVA) have been used in multiple vaccine studies in Oxford with Plasmodium falciparum malaria proteins and have been safe and immunogenic. Pre-clinical studies have also demonstrated that the vaccine's safe and immunogenic. Two doses of each vaccine will be used in this study. A lower dose of each vaccine will be given first, and only if safe will a higher dose be given. Four volunteers will receive a low dose of the ChAd63 PvDBP vaccine initially, and if this is safe the dose will be escalated. A further four volunteers will receive a higher dose of ChAd63 PvDBP. If this dose is safe eight more volunteers will receive the same (higher) dose, followed eight weeks later by a low dose of the MVA PvDBP vaccine. If this regimen with the 2 vaccines is safe we will go on to vaccinate a further 8 volunteers. These eight will receive the higher dose of ChAd63 PvDBP and a higher dose of MVA PvDBP eight weeks later. The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM).

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  13/SC/0001

• Date of REC Opinion

  18 Feb 2013

• REC opinion

  Further Information Favourable Opinion