NCT01816113

Phase Ia Study of ChAd63/MVA PvDBP

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 \& MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.

Conditions

• Malaria
• Plasmodium Vivax

Interventions

Type	Name	Description
BIOLOGICAL	ChAd63 PvDBP 5 x 10^9	1 dose of ChAd63 PvDBP 5 x 10\^9 vp intramuscularly
BIOLOGICAL	ChAd63 PvDBP 5 x 10^10	1 dose of ChAd63 PvDBP 5 x 10\^10 vp intramuscularly
BIOLOGICAL	MVA PvDBP 1 x 10^8	1 dose MVA PvDBP 1 x 108 pfu 8 weeks later intramuscularly
BIOLOGICAL	MVA PvDBP 2 x 10^8	1 dose MVA PvDBP 2 x 108 pfu 8 weeks later intramuscularly

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-03-21
• Last updated: 2017-05-08

Locations

1 site across 1 country: United Kingdom