MalariaPhase 1/2NCT00408668
Efficacy of Combined PEV3A Virosomal Vaccine and FP9-MVA ME-TRAP Prime Boost Regimen
A Phase 1/2 study testing PEV3A, FP9 ME-TRAP and MVA ME-TRAP in people with Malaria and Malaria, Falciparum, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The purpose of this study is to test three candidate malaria vaccines in new combinations to assess their efficacy at preventing malaria infection and triggering immune responses against malaria. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria, Falciparum
- What is being tested?
- PEV3A, FP9 ME-TRAP and MVA ME-TRAP
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2005to Feb 2006
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 50 years
- 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
Who cannot join
- Any deviation from the protocol defined normal range in biochemistry or haematology blood tests or in urine analysis
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LJ
About this study
Official title: Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With the Virosomal Vaccine PEV3A and FP9-MVA ME-TRAP. A Phase I / IIa Controlled Challenge Trial
The purpose of this study is to test three candidate malaria vaccines in new combinations to assess their efficacy at preventing malaria infection and triggering immune responses against malaria.
Read the detailed description
Two of the vaccines ('FP9 ME-TRAP' and 'MVA ME-TRAP') have been designed at the University of Oxford. The other vaccine (PEV3A) has been designed jointly between the Swiss Tropical Institute and a Swiss company called Pevion Biotech Ltd. These are new vaccines that have been given to only a limited number of people before.
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
- Malaria, Malaria, Falciparum
- Being tested
- PEV3A, FP9 ME-TRAP, MVA ME-TRAP
- Keywords
- Malaria Vaccine
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEV3ABiological
FP9 ME-TRAPBiological
MVA ME-TRAPBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine efficacy: The primary outcome is protection against malaria infection in a P. falciparum sporozoite challenge model.
Secondary outcomes (2)
Immunogenicity - Vaccine immunogenicity assessed by IFN-γ ELISPOT and ELISA for vaccine specific antibodies
Safety - Vaccine safety assessed by collection of local and systemic adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startAug 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Pevion Biotech Ltd, Swiss Tropical & Public Health Institute, Walter Reed Army Institute of Research (WRAIR)
- Investigators
- Adrian VS Hill, MA, BM BCh, DPhil, DM, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408668
- Sponsor's protocol ID
- VAC030
- Other IDs
- MRC agreement ID 74636
- Status last verified
- Oct 2006
- First submitted
- 5 Dec 2006
- Last updated
- 7 Dec 2006
- Results posted
- No
Publications
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.
PubMed 18231580