Efficacy of Combined PEV3A Virosomal Vaccine and FP9-MVA ME-TRAP Prime Boost Regimen
NCT ID: NCT00408668
Last Updated: 2006-12-07
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
30 participants
INTERVENTIONAL
2005-08-31
2006-02-28
Brief Summary
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Detailed Description
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We aim to test these vaccines by:
* assessing their ability to prevent malaria infection
* determining how good they are at triggering a detectable immune response against malaria
* studying their safety further
Volunteers will be given up to six vaccinations over three months and will then be exposed to malaria infection. We do this by allowing mosquitoes infected with malaria to bite them under closely regulated conditions and observing if and when they develop blood stage malaria. If the vaccines provide some protection from malaria infection then either they will not develop malaria after the bites or the time taken to develop malaria will be longer. If not all volunteers are protected then we will be able to try and improve our vaccines by comparing the immune responses of volunteers who are protected to those not protected.
The information we get from this study may help to prevent malaria infection and disease in those who live in endemic areas and in travellers. The results of this study will be published in scientific journals and may be presented at professional meetings.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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PEV3A
FP9 ME-TRAP
MVA ME-TRAP
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Resident in or near Oxford for the duration of the vaccination study
* For women only, willingness to practice continuous effective contraception during the study and (if participating) during the subsequent challenge study.
* Agreement to refrain from blood donation during the course of the study
* Willingness to undergo an HIV test
Exclusion Criteria
* Prior receipt of an investigational malaria vaccine
* Use of any investigational or non-registered drug, vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
* Administration of chronic immunosuppressive drugs or other immune modifying drugs within six months of vaccination.
* History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet® within 2 weeks prior to the challenge
* Any history of malaria
* Travel to a malaria endemic area within the previous 6 months
* Planned travel to malarious areas during the study period
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
* History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
* History of haemoglobinopathies
* History of diabetes mellitus
* Chronic or active neurological disease
* History of \> 2 hospitalisations for invasive bacterial infections
* Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
* Seropositive for hepatitis B surface antigen (HBsAg)
* Seropositive for hepatitis C virus (antibodies to HCV)
* Hepatomegaly, right upper quadrant abdominal pain or tenderness
* Evidence of serious psychiatric condition
* Any on-going chronic illness requiring hospital specialist supervision
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
* Pregnant or lactating woman
* Any woman who is willing or intends to become pregnant during the study
* Any history of anaphylaxis in reaction to vaccination
* Principal Investigator assessment of lack of willingness to participate and comply with all requirements of the protocol
* History or clinical evidence of intravenous drug abuse
* Any other finding which in the opinion of the investigator would significantly increase the risk of having an adverse outcome from participating in this protocol
18 Years
50 Years
ALL
Yes
Sponsors
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Medical Research Council
OTHER_GOV
Pevion Biotech Ltd
INDUSTRY
Swiss Tropical & Public Health Institute
OTHER
Walter Reed Army Institute of Research (WRAIR)
FED
University of Oxford
OTHER
Principal Investigators
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Adrian VS Hill, MA, BM BCh, DPhil, DM
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom
Countries
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References
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Thompson FM, Porter DW, Okitsu SL, Westerfeld N, Vogel D, Todryk S, Poulton I, Correa S, Hutchings C, Berthoud T, Dunachie S, Andrews L, Williams JL, Sinden R, Gilbert SC, Pluschke G, Zurbriggen R, Hill AV. Evidence of blood stage efficacy with a virosomal malaria vaccine in a phase IIa clinical trial. PLoS One. 2008 Jan 30;3(1):e1493. doi: 10.1371/journal.pone.0001493.
Other Identifiers
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MRC agreement ID 74636
Identifier Type: -
Identifier Source: secondary_id
VAC030
Identifier Type: -
Identifier Source: org_study_id