Malaria, FalciparumPhase 1/2NCT00375128
Sporozoite Challenge of Polyprotein Vaccinees
A Phase 1/2 study testing FP9-PP (FP9 polyprotein) and MVA-PP (Modified Virus Ankara polyprotein) in people with Malaria, Falciparum and Malaria, run by European Vaccine Initiative at 2 sites in United Kingdom.
Trial summary
This study examines the ability of two new malaria vaccines (FP9-PP and MVA-PP) to prevent the development of malaria infection after controlled exposure to the parasite. Volunteers for this trial will have received these vaccines in the preceding trial VAC027.1. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum, Malaria
- What is being tested?
- FP9-PP (FP9 polyprotein) and MVA-PP (Modified Virus Ankara polyprotein)
- How many people
- 26 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2006to Apr 2007
- 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 non-pregnant adults aged 18 to 50 years
- The vaccinated group will be subjects who have received the vaccine regime described for group 6 or 7 in VAC027.1
- Resident in or near Oxford, UK for the duration of the challenge study
- For females only, willingness to practice effective contraception during the challenge study.
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
- Willingness to allow the investigators to access hospital and General Practitioner medical notes
- 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 (unless administered in VAC027.1)
- Use of any investigational or non-registered drug, live 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 30Show fewer
- Travel to a malaria endemic country within the previous 3 months prior to the planned challenge
- 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
- Evidence of cardiovascular disease
- 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 requiring ongoing specialist supervision
- Chronic gastrointestinal disease requiring ongoing specialist supervision
- History of > 2 hospitalisations for invasive bacterial infections (pneumonia, meningitis)
- 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 other on-going chronic illness requiring hospital specialist supervision
- Acute disease at the time of enrolment
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Pregnant or lactating female
- Female who is willing or intends to become pregnant during the study
- History of severe reactions or allergy to mosquito bites
- PI 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
2 sites in 1 country.
United Kingdom2 sites
Imperial College, University of London
London, SW7 2AZ
Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford
Oxford, OX3 7LJ
About this study
Official title: Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With the Polyprotein Malaria Vaccines 'FP9-PP, MVA-PP' and Control Non-Vaccinated Volunteers
This study examines the ability of two new malaria vaccines (FP9-PP and MVA-PP) to prevent the development of malaria infection after controlled exposure to the parasite. Volunteers for this trial will have received these vaccines in the preceding trial VAC027.1.
Read the detailed description
Malaria infection kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is clearly a great need for a safe effective malaria vaccine.
The purpose of this study is to test the clinical efficacy of two candidate malaria vaccines (FP9-PP and MVA-PP). These live viral vector vaccines were administered in a 'prime boost' regime in the preceding trial VAC027.1.
Volunteers will now be exposed to 5 infective bites from mosquitoes carrying P. falciparum malaria.
This trial will:
- Measure efficacy as the time in hours from malaria exposure to blood film positive for malaria parasites
- Examine immunogenicity before and after malaria infection
- Measure longer term vaccine efficacy by re-challenging any protected volunteers 6 - 12 months later
- Conditions
- Malaria, Falciparum, Malaria
- Being tested
- FP9-PP (FP9 polyprotein), MVA-PP (Modified Virus Ankara polyprotein)
- Keywords
- Malaria, Vaccine, Prime-boost, Challenge
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP9-PP (FP9 polyprotein)Biological
MVA-PP (Modified Virus Ankara polyprotein)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (time in hours to parasitaemia)
Secondary outcomes (1)
Immunogenicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startSep 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- 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
- 26 participants
Sponsor and investigators
- Lead sponsor
- European Vaccine Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Wellcome Trust, 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
- NCT00375128
- Sponsor's protocol ID
- VAC027.2
- Other IDs
- EudraCT number: 2006-000629-67, EMVI trial identifier: PP_2_04
- Status last verified
- Oct 2007
- First submitted
- 10 Sep 2006
- Last updated
- 19 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. 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 Polyprotein Malaria Vaccines 'FP9-PP, MVA-PP' and Control Non-Vaccinated Volunteers
- ClinicalTrials.gov ID
- NCT00375128
- Acronym / sponsor ID
- VAC027.2
- Conditions
- Malaria, Falciparum, Malaria
- Keywords
- Malaria, Vaccine, Prime-boost, Challenge
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants
- Lead sponsor
- European Vaccine InitiativeUniversity, hospital or other
- Collaborators
- University of Oxford, Wellcome Trust, Walter Reed Army Institute of Research (WRAIR)
- Study start
- Sep 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 12 Sep 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.
This study examines the ability of two new malaria vaccines (FP9-PP and MVA-PP) to prevent the development of malaria infection after controlled exposure to the parasite. Volunteers for this trial will have received these vaccines in the preceding trial VAC027.1.
Detailed description
Malaria infection kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is clearly a great need for a safe effective malaria vaccine.
The purpose of this study is to test the clinical efficacy of two candidate malaria vaccines (FP9-PP and MVA-PP). These live viral vector vaccines were administered in a 'prime boost' regime in the preceding trial VAC027.1.
Volunteers will now be exposed to 5 infective bites from mosquitoes carrying P. falciparum malaria.
This trial will:
- Measure efficacy as the time in hours from malaria exposure to blood film positive for malaria parasites
- Examine immunogenicity before and after malaria infection
- Measure longer term vaccine efficacy by re-challenging any protected volunteers 6 - 12 months later
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 (8 listed)
- Healthy non-pregnant adults aged 18 to 50 years
- The vaccinated group will be subjects who have received the vaccine regime described for group 6 or 7 in VAC027.1
- Resident in or near Oxford, UK for the duration of the challenge study
- For females only, willingness to practice effective contraception during the challenge study.
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (30 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 (unless administered in VAC027.1)
- Use of any investigational or non-registered drug, live 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 |
|---|---|---|
| FP9-PP (FP9 polyprotein) | Biological | – |
| MVA-PP (Modified Virus Ankara polyprotein) | Biological | – |
Primary outcome
Efficacy (time in hours to parasitaemia)
1 secondary outcome
Immunogenicity
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 19 Oct 2007.
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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
2 sites 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 FP9-PP (FP9 polyprotein) and MVA-PP (Modified Virus Ankara polyprotein) in people with Malaria, Falciparum and Malaria, run by European Vaccine Initiative at 2 sites 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 8 inclusion and 30 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 19 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Efficacy (time in hours to parasitaemia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2007.