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

NCT01623557 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-02-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian V S Hill, MD · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623557 on ClinicalTrials.gov