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A Study to Assess the Effectiveness of a New Malaria Vaccine Candidate by Infecting Vaccinated Volunteers With Malaria Parasites

NCT00890760 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2012-11-29

No results posted yet for this study

Summary

Malaria affects around 515 million people each year, about a million of whom die from the disease. It is a major problem for those who live in affected areas as well as for travellers to affected areas. There is a great need for a safe, effective malaria vaccine. The purpose of this study is to test 2 new vaccination regimes that include a new malaria vaccine candidate, for their ability to prevent malaria infection.

The vaccines are different types of virus which contain genetic information (DNA) from the malaria parasite. This genetic material is named ME-TRAP. The aim is to use these viruses to help the body make an immune response against the malaria parasite. Both viruses are inactivated so that they are unable to multiply within the body.

The first vaccine virus is a weakened version of a common cold virus. Such adenoviruses occur in many strain types and commonly infect chimpanzees as well as people and this vaccine uses a strain originally derived from a chimpanzee. The vaccine is called AdCh63 ME-TRAP.

The other virus is Modified Vaccinia Ankara Virus, (MVA), which is a safer form of the vaccine virus previously widely used for smallpox vaccination. The vaccine is called MVA ME-TRAP.

This study will enable the investigators to assess:

1. The ability of different vaccine combinations to prevent malaria infection
2. The safety of the vaccine combinations in healthy volunteers
3. The response of the human immune system to the vaccines

Conditions

Interventions

BIOLOGICAL

AdCh63 ME-TRAP

5 x 10\*10 vp IM

BIOLOGICAL

MVA ME-TRAP

2 x 10\*8 pfu ID

OTHER

Sporozoite challenge

Infected mosquito bite

BIOLOGICAL

Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly

AdCh63 ME-TRAP 5 x 10\*10 vp MVA ME-TRAP 2 x 10\*8 pfu

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill, D.Phil, FRCP · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-02-28
Completion
2011-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00890760 on ClinicalTrials.gov