MalariaPhase 1/2NCT01142765
Study to Assess Efficacy of New Malaria Vaccine Candidates AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP & MVA ME-TRAP
A Phase 1/2 study testing AdCh63 MSP1, MVA MSP1, challenge, AdCh63 AMA1, MVA AMA1, challenge and AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challenge in people with Malaria, run by University of Oxford at 3 sites in United Kingdom.
Trial summary
This study aims to test the safety and efficacy of six new malaria vaccines - AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP \& MVA ME-TRAP. These vaccines consist of inactivated viruses which have been modified - so they cannot reproduce (replicate) in humans, and also to include genetic material… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- AdCh63 MSP1, MVA MSP1, challenge, AdCh63 AMA1, MVA AMA1, challenge and AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challenge
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jun 2010to Mar 2011
- 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
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For female volunteers, willingness to practice continuous effective contraception for the duration of the study.
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
Who cannot join
- History of clinical P. falciparum malaria
- Travel to a malaria endemic region during the study period or within the preceding six months with a risk of malaria exposure.
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period.
- Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
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- Pregnancy, lactation or intention to become pregnant during the study
- Contraindication to both anti-malarial drugs; Riamet \& chloroquine
- Concomitant use with other drugs known to cause QT-interval prolongation (e.g. macrolides, quinolones, amiodarone etc)
- History of epilepsy
- History of arrhythmia or prolonged QT interval.
- Family history for sudden cardiac death.
- An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system 107
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine e.g. egg products, Kathon.
- History of clinically significant contact dermatitis
- Any history of anaphylaxis post vaccination
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition that may affect participation in the study
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Any clinically significant abnormal finding on biochemistry or haematology blood tests or urinalysis
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Hospital for Tropical Diseases Mortimer Market
London, WC1E 6JB
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, OX3 7LJ
Wellcome Trust Clinical Research Facility, University of Southampton
Southampton, SO16 6YD
About this study
Official title: A Phase I/IIa Sporozoite Challenge Study to Assess the Protective Efficacy of New Malaria Vaccine Candidates AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP & MVA ME-TRAP
This study aims to test the safety and efficacy of six new malaria vaccines - AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP \& MVA ME-TRAP. These vaccines consist of inactivated viruses which have been modified - so they cannot reproduce (replicate) in humans, and also to include genetic material (genes) for malaria proteins which are expressed by the malaria parasite during both liver and blood stage infection. The vaccines are designed to stimulate an immune response to these malaria proteins (immunogenicity describes the nature and magnitude of this immune response) and thus provide protection against malaria infection. The protective efficacy of vaccines will be evaluated by challenging a small number of volunteers who have received the vaccines with malaria infection from the bites of infected mosquitos(sporozoite challenge).
- Conditions
- Malaria
- Being tested
- AdCh63 MSP1, MVA MSP1, challenge, AdCh63 AMA1, MVA AMA1, challenge, AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challenge, AdCh63 MSP1, AdCh63 ME-TRAP, MVA MSP1, MVA ME-TRAP, challenge, Sporozoite challenge
- Keywords
- Vaccine, Safety, Immunogenicity, Protection, Sporozoite challenge
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdCh63 MSP1, MVA MSP1, challengeBiological
1 dose of AdCh63 MSP1 5 x 1010 vp intramuscularly and 1 dose MVA MSP1 2.5 x 108 pfu intramuscularly 8 weeks later (range 6-12 weeks) followed by sporozoite challenge 12-28 days later
AdCh63 AMA1, MVA AMA1, challengeBiological
1 dose of AdCh63 AMA1 5 x 1010 vp intramuscularly and 1 dose MVA AMA1 2.5 x 108 pfu intramuscularly 8 weeks later (range 6-12 weeks) followed by sporozoite challenge 12-28 days later
AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challengeBiological
1 dose of AdCh63 AMA1 5 x 1010 vp intramuscularly and 1 dose AdCh63 MSP1 5 x 1010 vp intramuscularly co-administered into separate arms followed 8 weeks later (range 6-12 weeks) by 1 dose of MVA AMA1 2.5 x 108 pfu intramuscularly and 1 dose MVA MSP1 2.5 x 108 pfu intramuscularly co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge 12-28 days later.
AdCh63 MSP1, AdCh63 ME-TRAP, MVA MSP1, MVA ME-TRAP, challengeBiological
1 dose of AdCh63 MSP1 5 x 1010 vp intramuscularly and 1 dose AdCh63 ME-TRAP 5 x 1010 vp intramuscularly co-administered into separate arms followed 8 weeks later (range 6-12 weeks) by 1 dose of MVA MSP1 2.5 x 108 pfu intramuscularly and 1 dose MVA ME-TRAP 2 x 108 pfu intramuscularly co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge 12-28 days later.
Sporozoite challengeBiological
Non-vaccinated controls for sporozoite challenge
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1 dose of AdCh63 MSP1 and 1 dose MVA MSP1 followed by sporozoite challenge Receives: Biological: AdCh63 MSP1, MVA MSP1, challenge |
| Group 2 | Experimental | 1 dose of AdCh63 AMA1 and 1 dose MVA AMA1 followed by sporozoite challenge Receives: Biological: AdCh63 AMA1, MVA AMA1, challenge |
| Group 3 | Experimental | 1 dose of AdCh63 AMA1 and 1 dose AdCh63 MSP1 co-administered into separate arms followed by 1 dose of MVA AMA1 and 1 dose MVA MSP1 co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge Receives: Biological: AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challenge |
| Group 4 | Experimental | 1 dose of AdCh63 MSP1 and 1 dose AdCh63 ME-TRAP co-administered into separate arms followed by 1 dose of MVA MSP1 and 1 dose MVA ME-TRAP co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge Receives: Biological: AdCh63 MSP1, AdCh63 ME-TRAP, MVA MSP1, MVA ME-TRAP, challenge |
| Group 5 | Other | Non-vaccinated controls for sporozoite challenge Receives: Biological: Sporozoite challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of vaccine
To assess if volunteers who receive the novel vaccine candidates; AdCh63 MSP1, MVA MSP1, AdCh63 AMA1, MVA AMA1, AdCh63 ME-TRAP and MVA ME-TRAP in heterologous prime boost regimens are protected wholly or partially against malaria infection in a sporozoite challenge model. This will be determined by noting the number of subjects who develop malaria infection and the time in hours between exposure and parasitaemia as detected by thick-film blood smear compared with controls.
To assess the safety of the immunisation regimens alone and during co-administration.
Measured: Up to 18 months
Secondary outcomes (1)
Immunogenicity of vaccine
To assess immunogenicity of the vaccine regimes by measuring IFN-γ ELISPOT, flow cytometry and antibody responses to MSP1, AMA1 and ME-TRAP antigens before and after malaria infection. If there is evidence of partial or complete protection, we will explore immunological correlates of protective immunity.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Investigators
- Adrian VS Hill, D.Phil, FRCP, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142765
- Sponsor's protocol ID
- VAC039
- Status last verified
- Mar 2011
- First submitted
- 7 Jun 2010
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Sporozoite Challenge Study to Assess the Protective Efficacy of New Malaria Vaccine Candidates AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP & MVA ME-TRAP
- ClinicalTrials.gov ID
- NCT01142765
- Acronym / sponsor ID
- VAC039
- Conditions
- Malaria
- Keywords
- Vaccine, Safety, Immunogenicity, Protection, Sporozoite challenge
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jun 2010 (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 aims to test the safety and efficacy of six new malaria vaccines - AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP \& MVA ME-TRAP. These vaccines consist of inactivated viruses which have been modified - so they cannot reproduce (replicate) in humans, and also to include genetic material (genes) for malaria proteins which are expressed by the malaria parasite during both liver and blood stage infection. The vaccines are designed to stimulate an immune response to these malaria proteins (immunogenicity describes the nature and magnitude of this immune response) and thus provide protection against malaria infection. The protective efficacy of vaccines will be evaluated by challenging a small number of volunteers who have received the vaccines with malaria infection from the bites of infected mosquitos(sporozoite challenge).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: AdCh63 MSP1, MVA MSP1, challenge1 dose of AdCh63 MSP1 and 1 dose MVA MSP1 followed by sporozoite challenge |
| Group 2 | Experimental | Biological: AdCh63 AMA1, MVA AMA1, challenge1 dose of AdCh63 AMA1 and 1 dose MVA AMA1 followed by sporozoite challenge |
| Group 3 | Experimental | Biological: AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challenge1 dose of AdCh63 AMA1 and 1 dose AdCh63 MSP1 co-administered into separate arms followed by 1 dose of MVA AMA1 and 1 dose MVA MSP1 co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge |
| Group 4 | Experimental | Biological: AdCh63 MSP1, AdCh63 ME-TRAP, MVA MSP1, MVA ME-TRAP, challenge1 dose of AdCh63 MSP1 and 1 dose AdCh63 ME-TRAP co-administered into separate arms followed by 1 dose of MVA MSP1 and 1 dose MVA ME-TRAP co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge |
| Group 5 | Other | Biological: Sporozoite challengeNon-vaccinated controls for sporozoite challenge |
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
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For female volunteers, willingness to practice continuous effective contraception for the duration of the study.
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (25 listed)
- History of clinical P. falciparum malaria
- Travel to a malaria endemic region during the study period or within the preceding six months with a risk of malaria exposure.
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period.
- Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
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 |
|---|---|---|
| AdCh63 MSP1, MVA MSP1, challenge1 dose of AdCh63 MSP1 5 x 1010 vp intramuscularly and 1 dose MVA MSP1 2.5 x 108 pfu intramuscularly 8 weeks later (range 6-12 weeks) followed by sporozoite challenge 12-28 days later | Biological | Group 1 |
| AdCh63 AMA1, MVA AMA1, challenge1 dose of AdCh63 AMA1 5 x 1010 vp intramuscularly and 1 dose MVA AMA1 2.5 x 108 pfu intramuscularly 8 weeks later (range 6-12 weeks) followed by sporozoite challenge 12-28 days later | Biological | Group 2 |
| AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challenge1 dose of AdCh63 AMA1 5 x 1010 vp intramuscularly and 1 dose AdCh63 MSP1 5 x 1010 vp intramuscularly co-administered into separate arms followed 8 weeks later (range 6-12 weeks) by 1 dose of MVA AMA1 2.5 x 108 pfu intramuscularly and 1 dose MVA MSP1 2.5 x 108 pfu intramuscularly co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge 12-28 days later. | Biological | Group 3 |
| AdCh63 MSP1, AdCh63 ME-TRAP, MVA MSP1, MVA ME-TRAP, challenge1 dose of AdCh63 MSP1 5 x 1010 vp intramuscularly and 1 dose AdCh63 ME-TRAP 5 x 1010 vp intramuscularly co-administered into separate arms followed 8 weeks later (range 6-12 weeks) by 1 dose of MVA MSP1 2.5 x 108 pfu intramuscularly and 1 dose MVA ME-TRAP 2 x 108 pfu intramuscularly co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge 12-28 days later. | Biological | Group 4 |
| Sporozoite challengeNon-vaccinated controls for sporozoite challenge | Biological | Group 5 |
Primary outcome
Safety and efficacy of vaccine
Time frame: Up to 18 months
To assess if volunteers who receive the novel vaccine candidates; AdCh63 MSP1, MVA MSP1, AdCh63 AMA1, MVA AMA1, AdCh63 ME-TRAP and MVA ME-TRAP in heterologous prime boost regimens are protected wholly or partially against malaria infection in a sporozoite challenge model. This will be determined by noting the number of subjects who develop malaria infection and the time in hours between exposure and parasitaemia as detected by thick-film blood smear compared with controls. To assess the safety of the immunisation regimens alone and during co-administration.
1 secondary outcome
Immunogenicity of vaccine
Time frame: Up to 18 months
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 28 Mar 2011.
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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, D.Phil, FRCP principal investigator
University of Oxford
3 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 AdCh63 MSP1, MVA MSP1, challenge, AdCh63 AMA1, MVA AMA1, challenge and AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challenge in people with Malaria, run by University of Oxford at 3 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 6 inclusion and 25 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 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Safety and efficacy of vaccine (time frame: Up to 18 months). 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 28 Mar 2011.