AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Adults and Children in a Malaria Endemic Area

Summary

The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in The Gambia.

Conditions

• Malaria

Interventions

BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 1 x 10\^8 pfu IM 8 weeks later

BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 1 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

BIOLOGICAL

HDCRV

HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 1 x 10\^8 pfu IM 8 weeks later

BIOLOGICAL

AdCh63 ME-TRAP, MVA ME-TRAP

AdCh63 ME-TRAP 5 x 10\^10vp IM followed by MVA ME-TRAP 2 x 10\^8 pfu IM 8 weeks later

BIOLOGICAL

HDCRV

HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later

Sponsors & Collaborators

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• University of Oxford

  lead OTHER

Principal Investigators

• Kalifa Bojang · Medical Research Council PO Box 273, Banjul The Gambia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2011-12-31

Completion

2011-12-31

Countries

• The Gambia

Study Locations