NCT01739036

A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches Using the ChAd63 and MVA Vectors Encoding the Antigens ME-TRAP, CS and AMA1

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open label, multi-centre phase I/IIa sporozoite-challenge trial to assess the safety, immunogenicity and efficacy of two combination ChAd63-MVA heterologous prime-boost vaccination regimens. All volunteers recruited will be healthy, malaria naïve adults aged between 18 and 45 years. To determine the efficacy of each of two combinations of heterologous prime-boost immunisation strategies: 1. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS 2. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS and ChAd63-MVA AMA1 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 CS/ME-TRAP	Mixture of ChAd63 CS 5 x 1010 vp and ChAd63 ME-TRAP 5 x 1010 vp. Intramuscular needle injection.
BIOLOGICAL	MVA CS/ME-TRAP	Mixture of MVA CS 2 x 108 pfu and MVA ME-TRAP 2 x 108 pfu. Intramuscular needle injection.
BIOLOGICAL	ChAd63 CS/ME-TRAP/AMA1	Mixture of ChAd63 CS 5 x 1010 vp, ChAd63 ME-TRAP 5 x 1010 vp, and ChAd63 AMA1 5 x 1010 vp. Intramuscular needle injection.
BIOLOGICAL	MVA CS/ME-TRAP/AMA1	Mixture of MVA CS 1.33 x 108 pfu, MVA ME-TRAP 1.33 x 108 pfu, and MVA AMA1 1.33 x 108 pfu. Intramuscular needle injection.
OTHER	Controlled Human Malaria Infection Administered by Mosquito Bite	Approximately three weeks post MVA dosing.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-11-30
• Last updated: 2013-11-11

Locations

3 sites across 1 country: United Kingdom