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ChAd63-MVA ME-TRAP, CS and AMA1 Combination Malaria Vaccines Sporozoite Challenge Study

NCT01739036Phase 2

Key facts

Status: Completed
Start: Jan 2013
Primary completion: Oct 2013
Countries: 1
Sponsor: University of Oxford
Modality: Viral Vector Vaccines, Viral Vectors, DNA Vaccines

Drugs: ChAd63/MVA ME-TRAPChAd63-MVA CSChAd63-MVA AMA1
Conditions: malaria

Overview

Phase 2, open-label trial of ChAd63/MVA ME-TRAP, ChAd63-MVA CS and ChAd63-MVA AMA1 in malaria (4 arms), sponsored by University of Oxford. Primary endpoint: Effectiveness at preventing malaria infection. Started Jan 2013; status: completed.

Design

4 arms

Study design: Non-randomizedOpen-label

Group 1
ChAd63 CS/ME-TRAP prime, MVA CS/ME-TRAP boost, then CHMI
Group 2
ChAd63 CS/ME-TRAP/AMA1 prime, MVA CS/ME-TRAP/AMA1 boost, then CHMI
Group 3
CHMI rechallenge (previously protected in VAC045)
Group 4
Unvaccinated control CHMI

Who it enrols

Healthy, malaria-naïve adults aged 18-45 years, excluding those with prior malaria exposure, significant cardiovascular risk, or immunosuppression.

Endpoints

Primary

Effectiveness at preventing malaria infection30d post challenge

Secondary

Safety of vaccine combinations7m post first vaccination
Immunogenicity of vaccine combinations7m post first vaccination

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