NCT01623557

A Challenge Study to Assess the Protective Efficacy of Two Malaria Vaccine Candidates

A Phase I/IIa Sporozoite Challenge Study to Assess the Protective Efficacy of Two Prime-Boost Malaria Vaccine Candidates: ChAd63 and MVA Encoding ME-TRAP and the Same Viral Vectors Encoding CS

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess the safety and effectiveness of four new candidate malaria vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS \& MVA ME-TRAP. These vaccines consist of viruses (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP). The hope is that these vaccines will induce immune responses in vaccinees that are able to prevent malaria. This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP. The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in Southampton, UK. The malaria challenge will take place at the insectary at Imperial College (Infection and Immunity Section) in London, UK.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
BIOLOGICAL	ChAd63-MVA CS	1 dose of ChAd63 CS 5 x 10\^10 vp intramuscularly and 1 dose MVA CS 2 x 10\^8 pfu intramuscularly 8 weeks later.
BIOLOGICAL	ChAd63-MVA ME-TRAP	1 dose of ChAd63 ME-TRAP 5 x 10\^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10\^8 pfu intramuscularly 8 weeks later.
OTHER	Controlled Human Malaria Infection Administered by Mosquito Bite	Approximately 3 weeks post MVA dosing

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-06-20
• Last updated: 2015-02-16

Locations

3 sites across 1 country: United Kingdom