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
- Are there results?
- None posted in the registry
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
Show all 28Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00408668
- Acronym / sponsor ID
- VAC030
- Conditions
- Malaria, Malaria, Falciparum
- Keywords
- Malaria Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Medical Research Council, Pevion Biotech Ltd, Swiss Tropical & Public Health Institute, Walter Reed Army Institute of Research (WRAIR)
- Study start
- Aug 2005
- Study completion
- Feb 2006
- First posted
- 7 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEV3A | Biological | – |
| FP9 ME-TRAP | Biological | – |
| MVA ME-TRAP | Biological | – |
Primary outcome
Vaccine efficacy: The primary outcome is protection against malaria infection in a P. falciparum sporozoite challenge model.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2006.
- Derived from this study: PubMed 18231580Thompson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian VS Hill, MA, BM BCh, DPhil, DM principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine efficacy: The primary outcome is protection against malaria infection in a P. falciparum sporozoite challenge model.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00408668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2006.