NCT02532049

A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313

A Phase Ia Clinical Trial to Assess the Safety, Immunogenicity and Ex-vivo Efficacy of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 Pfs-IMX313 Alone and With MVA Pfs25-IMX313

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime. All vaccines will be administered intramuscularly. Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x10\^9 vp. Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x10\^10 vp. Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x10\^10 vp and one dose of MVA Pfs25-IMX313 at 1x10\^8 pfu eight weeks later. Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x10\^10 vp and one dose of MVA Pfs25-IMX313 at 2x10\^8 pfu eight weeks later. The study will assess the safety of the vaccinations, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples. Healthy volunteers will be recruited in Oxford and Southampton, England.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	ChAd63 Pfs25-IMX313
BIOLOGICAL	MVA Pfs25-IMX313

Timeline

• Start date: 2015-10-12
• Primary completion: 2017-05-25
• Completion: 2017-05-25
• First posted: 2015-08-25
• Last updated: 2017-07-17

Locations

2 sites across 1 country: United Kingdom