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

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.

Timeline

Start

2015-10-12

Primary completion

2017-05-25

Completion

2017-05-25

Publications

• de Graaf H, Payne RO, Taylor I, Miura K, Long CA, Elias SC, Zaric M, Minassian AM, Silk SE, Li L, Poulton ID, Baker M, Draper SJ, Gbesemete D, Brendish NJ, Martins F, Marini A, Mekhaiel D, Edwards NJ, Roberts R, Vekemans J, Moyle S, Faust SN, Berrie E, Lawrie AM, Hill F, Hill AVS, Biswas S. Safety and Immunogenicity of ChAd63/MVA Pfs25-IMX313 in a Phase I First-in-Human Trial. Front Immunol. 2021 Jul 14;12:694759. doi: 10.3389/fimmu.2021.694759. eCollection 2021.

Drugs

Indications