A Study to Assess the Effectiveness of a New Malaria Vaccine Candidate by Infecting Vaccinated Volunteers With Malaria Parasites
NCT ID: NCT00890760
Last Updated: 2012-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
55 participants
INTERVENTIONAL
2009-03-31
2011-02-28
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
AdCh63 ME-TRAP
5 x 10\*10 vp IM
MVA ME-TRAP
2 x 10\*8 pfu ID
Sporozoite challenge
Infected mosquito bite
Group 2
AdCh63 ME-TRAP alone followed by sporozoite challenge 3 weeks later
AdCh63 ME-TRAP
5 x 10\*10 vp IM
Sporozoite challenge
Infected mosquito bite
Group 3
Non-vaccinated Control for Groups 1 and 2 challenged with sporozoite
Sporozoite challenge
Infected mosquito bite
Group 4
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 11 weeks after boost
AdCh63 ME-TRAP
5 x 10\*10 vp IM
MVA ME-TRAP
2 x 10\*8 pfu ID
Sporozoite challenge
Infected mosquito bite
Group 5
AdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
AdCh63 ME-TRAP
5 x 10\*10 vp IM
MVA ME-TRAP
2 x 10\*8 pfu ID
Sporozoite challenge
Infected mosquito bite
Group 6
Protected volunteers from Group 1 re-challenged with sporozoite after 6 months
AdCh63 ME-TRAP
5 x 10\*10 vp IM
Sporozoite challenge
Infected mosquito bite
Group 7
Non vaccinated control for Groups 4-6, 8-10 challenged with sporozoite
Sporozoite challenge
Infected mosquito bite
Group 8
3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
Sporozoite challenge
Infected mosquito bite
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
Group 9
2 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval followed by sporozoite challenge 3 weeks after last vaccination
Sporozoite challenge
Infected mosquito bite
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
Group 10
3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 4 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
Sporozoite challenge
Infected mosquito bite
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
Interventions
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AdCh63 ME-TRAP
5 x 10\*10 vp IM
MVA ME-TRAP
2 x 10\*8 pfu ID
Sporozoite challenge
Infected mosquito bite
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
Eligibility Criteria
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Inclusion Criteria
* Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
* For females only: willingness to practise effective contraception throughout the study
* Agreement to refrain from blood donation during the course of the study
* Written informed consent
Exclusion Criteria
* Prior receipt of an investigational malaria vaccine encoding ME-TRAP or any other investigational vaccine likely to impact on interpretation of the trial data
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
* Pregnancy, lactation or intention to become pregnant during the study
* Contraindication to both anti-malarial drugs (Riamet® and chloroquine)
o concomitant use with other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon.
* History of clinically significant contact dermatitis
* Any history of anaphylaxis in reaction to vaccination
* History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
* History of serious psychiatric condition
* Any other serious chronic illness requiring hospital specialist supervision
* Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
* Suspected or known injecting drug abuse
* Seropositive for hepatitis B surface antigen (HBsAg)
* Seropositive for hepatitis C virus (antibodies to HCV)
* Seropositive for simian adenovirus 63 (antibodies to AdCh63) at a titre \> 1: 200 ( EXCEPT CONTROL VOLUNTEERS)
* Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study.
* History of clinical P. falciparum malaria
* Travel to a malaria endemic region during the study period or within the previous six months
* Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
* Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol or impair interpretation of the study data.
18 Years
50 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Centre for Clinical Vaccinology and Tropical Medicine University of Oxford
Principal Investigators
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Adrian VS Hill, D.Phil, FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, Headington, United Kingdom
Countries
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References
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Ewer KJ, O'Hara GA, Duncan CJ, Collins KA, Sheehy SH, Reyes-Sandoval A, Goodman AL, Edwards NJ, Elias SC, Halstead FD, Longley RJ, Rowland R, Poulton ID, Draper SJ, Blagborough AM, Berrie E, Moyle S, Williams N, Siani L, Folgori A, Colloca S, Sinden RE, Lawrie AM, Cortese R, Gilbert SC, Nicosia A, Hill AV. Protective CD8+ T-cell immunity to human malaria induced by chimpanzee adenovirus-MVA immunisation. Nat Commun. 2013;4:2836. doi: 10.1038/ncomms3836.
Other Identifiers
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MAL 034
Identifier Type: -
Identifier Source: org_study_id