Malaria, FalciparumPhase 1NCT00374998
Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP
A Phase 1 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 1 site in United Kingdom.
Trial summary
This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers to determine their safety and ability to induce a measurable immune response 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, Falciparum, Malaria
- What is being tested?
- FP9-PP (FP9 polyprotein) and MVA-PP (Modified Virus Ankara polyprotein)
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2006to Jan 2007
- Phase
- Phase 1
- 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
- Resident in or near Oxford, UK for the duration of the vaccination study
- Willingness to allow the investigators to access hospital and General Practitioner medical notes
- For females 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
- Written informed consent
- 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 23Show fewer
- Travel to a malaria endemic country within the previous 6 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
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- 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
- Chronic gastrointestinal disease
- History of more than 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 other on-going chronic illness requiring hospital specialist supervision
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford
Oxford, OX3 7LJ
About this study
Official title: A Phase I Study to Assess the Safety and Immunogenicity of the Polyprotein Malaria Vaccine Candidates FP9 PP and MVA PP in Healthy Adults Using a Prime-Boost Delivery Schedule
This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers to determine their safety and ability to induce a measurable immune response against malaria.
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 two candidate malaria vaccines (FP9-PP and MVA-PP) in different concentrations and combinations. These live viral vectors encode a 'polyprotein' of six fused malaria antigens expressed at liver and blood stages of the malaria parasite lifecycle. MVA-PP uses the Modified Virus Ankara vector, a weakened form of the smallpox vaccine, vaccinia. FP9-PP uses a highly attenuated avian pox virus (FP9) as the vector instead. The two vaccines will be used in combination in a 'prime boost' strategy to enhance the response of the cellular immune system.
This study will:
- Examine safety
- Examine immunogenicity
- Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study (VAC027.2)
- Conditions
- Malaria, Falciparum, Malaria
- Being tested
- FP9-PP (FP9 polyprotein), MVA-PP (Modified Virus Ankara polyprotein)
- Keywords
- Malaria, Vaccine, Prime-boost
- 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.
Immediate reactogenicity
Adverse events occurring before the end of the trial
Biological safety (haematological and biochemical indices)
Secondary outcomes (3)
T-cell immunogenicity (prime-boost groups)
Humoral immunogenicity (prime-boost groups)
Gene expression (prime-boost groups)
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 startApr 2006
- Study completionJan 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- European Vaccine Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Wellcome Trust
- Investigators
- Adrian VS Hill, MA, BM BCh, DPhil, DM, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374998
- Sponsor's protocol ID
- VAC027.1
- Other IDs
- EudraCT number: 2004-002424-17, EMVI trial identifier: PP_1_04
- Status last verified
- Feb 2007
- First submitted
- 10 Sep 2006
- Last updated
- 1 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety and Immunogenicity of the Polyprotein Malaria Vaccine Candidates FP9 PP and MVA PP in Healthy Adults Using a Prime-Boost Delivery Schedule
- ClinicalTrials.gov ID
- NCT00374998
- Acronym / sponsor ID
- VAC027.1
- Conditions
- Malaria, Falciparum, Malaria
- Keywords
- Malaria, Vaccine, Prime-boost
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- European Vaccine InitiativeUniversity, hospital or other
- Collaborators
- University of Oxford, Wellcome Trust
- Study start
- Apr 2006
- Study completion
- Jan 2007
- 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 two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers to determine their safety and ability to induce a measurable immune response against malaria.
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 two candidate malaria vaccines (FP9-PP and MVA-PP) in different concentrations and combinations. These live viral vectors encode a 'polyprotein' of six fused malaria antigens expressed at liver and blood stages of the malaria parasite lifecycle. MVA-PP uses the Modified Virus Ankara vector, a weakened form of the smallpox vaccine, vaccinia. FP9-PP uses a highly attenuated avian pox virus (FP9) as the vector instead. The two vaccines will be used in combination in a 'prime boost' strategy to enhance the response of the cellular immune system.
This study will:
- Examine safety
- Examine immunogenicity
- Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study (VAC027.2)
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 (7 listed)
- Healthy adults aged 18 to 50 years
- Resident in or near Oxford, UK for the duration of the vaccination study
- Willingness to allow the investigators to access hospital and General Practitioner medical notes
- For females 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 (23 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 |
|---|---|---|
| FP9-PP (FP9 polyprotein) | Biological | – |
| MVA-PP (Modified Virus Ankara polyprotein) | Biological | – |
Primary outcome
Immediate reactogenicity
Adverse events occurring before the end of the trial
Biological safety (haematological and biochemical indices)
3 secondary outcomes
T-cell immunogenicity (prime-boost groups)
Humoral immunogenicity (prime-boost groups)
Gene expression (prime-boost groups)
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 1 Mar 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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 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 7 inclusion and 23 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 1 Mar 2007. 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 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.
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?
Immediate reactogenicity. The study lists 3 primary outcomes in all. 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 1 Mar 2007.