MalariaPhase 1NCT00890019
A Study of AdCh63 ME-TRAP Alone and With MVA ME-TRAP
A Phase 1 study testing AdCh63 ME-TRAP and AdCh63 ME-TRAP; MVA ME-TRAP in people with Malaria, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 ME-TRAP, simian adenovirus encoding Plasmodium falciparum antigens. This follows promising phase I clinical studies of MVA ME-TRAP and preclinical studies of AdCh63 and MVA ME-TRAP used together in prime-boost regimes. 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 ME-TRAP and AdCh63 ME-TRAP; MVA ME-TRAP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2007to Sep 2011
- 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
- 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
- Willing to use barrier contraception until three months after the last vaccination
- For females only negative pregnancy test on the day(s) of vaccination
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
Who cannot join
- 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 a recombinant MVA vaccine containing a relevant antigen (for those in B groups) or adenoviral vaccine, (all volunteers).
- 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)
- 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
Show all 21Show fewer
- Any history of anaphylaxis in reaction to vaccination
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition
- 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
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Seropositive for simian adenovirus 63 (antibodies to AdCh63) at a titre >1 ;200
- Pregnancy, lactation or willingness/intention to become pregnant during the study
- Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study.
- Any history of malaria or
- Travel to a malaria endemic region during the study period or within the previous six months
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Lister Ward, Department of Infection and Tropical Medicine, Northwick Park Hospital
Harrow, Middlesex, HA1 3UJ
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
Oxford, Oxfordshire, OX3 7LJ
About this study
Official title: A Phase I Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidate AdCh63 ME-TRAP, Alone and With MVA ME-TRAP, Using a Prime-boost Delivery Schedule
This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 ME-TRAP, simian adenovirus encoding Plasmodium falciparum antigens. This follows promising phase I clinical studies of MVA ME-TRAP and preclinical studies of AdCh63 and MVA ME-TRAP used together in prime-boost regimes. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 ME-TRAP administered intradermally or intramuscularly. Some of the volunteers will receive a booster vaccination with MVA ME-TRAP at various doses administered via the intradermal or intramuscular route. Safety data will be collected for each of the eight regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.
Read the detailed description
ME-TRAP insert contains a fusion protein of multiple epitopes (ME) and the Plasmodium falciparum pre-erythrocytic thrombospondin-related adhesion protein (TRAP). The 'ME' is a string of 20 epitopes fused to the thrombospondin-related adhesion protein. TRAP was selected as it is well characterized and has a protective homologue in rodents. We have safely administered ME-TRAP to over 700 volunteers in the UK and Africa.
MVA vector proved to be non-contagious and avirulent. Viral replication is blocked late during infection of cells but importantly viral and recombinant protein synthesis is unimpaired even during this abortive infection. Replication-deficient recombinant MVA has been viewed as an exceptionally safe viral vector. When tested in animal model studies recombinant MVAs have been shown to be avirulent, yet protectively immunogenic as vaccines against viral diseases and cancer. Recent studies in macaques severely immuno-suppressed by SIV infection have further supported the view that MVA should be safe in immuno-compromised humans.
Simian adenoviruses have not been used previously in a clinical trial in humans. However, they are under active development as vaccines for HIV, (by GSK), and for HCV, (Merck).
- Conditions
- Malaria
- Being tested
- AdCh63 ME-TRAP, AdCh63 ME-TRAP; MVA ME-TRAP
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdCh63 ME-TRAPBiological
Also called Simian adenovirus expressing P. falciparum antigens ME-TRAP
- A:Intradermal injection 1x10^8 vp at day 0
- A:Intradermal injection 1x10^9 vp at day 0
- A:Intradermal injection 1x10^10 vp at day 0
- A:Intradermal injection 5x10^10 vp at day 0
5:Intramuscular injection 1x10^10 vp at day 0
6A:Intramuscular injection 5x10^10 vp at day 0
7A: Intramuscular injection 2x10^11 vp at day 0
AdCh63 ME-TRAP; MVA ME-TRAPBiological
Also called Simian adenovirus, modified vaccinia Ankara virus
- B: AdCh63 ME-TRAP intradermally at dose of 1x10^8 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
- B: AdCh63 ME-TRAP intradermally at dose of 1x10^9 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
- B: AdCh63 ME-TRAP intradermally at dose of 1x10^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
- B: AdCh63 ME-TRAP intradermally at dose of 5x10^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
6B: AdCh63 ME-TRAP intramuscularly at dose of 5x10^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
7B and 7C: AdCh63 ME-TRAP intramuscularly at dose of 2x10^11 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days)
| Study group | Role | What they receive |
|---|---|---|
| 1A, 2A, 3A, 4A, 5A, 6A, 7A | Experimental | AdCh63 ME-TRAP Receives: Biological: AdCh63 ME-TRAP |
| 1B, 2B, 3B, 4B, 6B, 7B, 7C | Experimental | AdCh63 ME-TRAP; MVA ME-TRAP Receives: Biological: AdCh63 ME-TRAP; MVA ME-TRAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of a new malaria vaccine, AdCh63 ME-TRAP, when administered individually and sequentially with MVA ME-TRAP in a prime-boost regime to healthy volunteers
Measured: 24 months
Secondary outcomes (1)
To assess the cellular immune response generated, and whether this is affected by immunity to human adenovirus, by AdCh63 ME-TRAP when administered individually and sequentially with MVA ME-TRAP in a prime-boost regime to healthy volunteers
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJul 2007
- Primary completionAug 2011
- Study completionSep 2011
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian VS Hill, Professor, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890019
- Sponsor's protocol ID
- VAC033
- Status last verified
- Aug 2012
- First submitted
- 28 Apr 2009
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Hara GA, Duncan CJ, Ewer KJ, Collins KA, Elias SC, Halstead FD, Goodman AL, Edwards NJ, Reyes-Sandoval A, Bird P, Rowland R, Sheehy SH, Poulton ID, Hutchings C, Todryk S, Andrews L, Folgori A, Berrie E, Moyle S, Nicosia A, Colloca S, Cortese R, Siani L, Lawrie AM, Gilbert SC, Hill AV. Clinical assessment of a recombinant simian adenovirus ChAd63: a potent new vaccine vector. J Infect Dis. 2012 Mar 1;205(5):772-81. doi: 10.1093/infdis/jir850. Epub 2012 Jan 24.
PubMed 22275401
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. 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 New Malaria Vaccine Candidate AdCh63 ME-TRAP, Alone and With MVA ME-TRAP, Using a Prime-boost Delivery Schedule
- ClinicalTrials.gov ID
- NCT00890019
- Acronym / sponsor ID
- VAC033
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Apr 2009 (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 is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 ME-TRAP, simian adenovirus encoding Plasmodium falciparum antigens. This follows promising phase I clinical studies of MVA ME-TRAP and preclinical studies of AdCh63 and MVA ME-TRAP used together in prime-boost regimes. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 ME-TRAP administered intradermally or intramuscularly. Some of the volunteers will receive a booster vaccination with MVA ME-TRAP at various doses administered via the intradermal or intramuscular route. Safety data will be collected for each of the eight regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.
Detailed description
ME-TRAP insert contains a fusion protein of multiple epitopes (ME) and the Plasmodium falciparum pre-erythrocytic thrombospondin-related adhesion protein (TRAP). The 'ME' is a string of 20 epitopes fused to the thrombospondin-related adhesion protein. TRAP was selected as it is well characterized and has a protective homologue in rodents. We have safely administered ME-TRAP to over 700 volunteers in the UK and Africa.
MVA vector proved to be non-contagious and avirulent. Viral replication is blocked late during infection of cells but importantly viral and recombinant protein synthesis is unimpaired even during this abortive infection. Replication-deficient recombinant MVA has been viewed as an exceptionally safe viral vector. When tested in animal model studies recombinant MVAs have been shown to be avirulent, yet protectively immunogenic as vaccines against viral diseases and cancer. Recent studies in macaques severely immuno-suppressed by SIV infection have further supported the view that MVA should be safe in immuno-compromised humans.
Simian adenoviruses have not been used previously in a clinical trial in humans. However, they are under active development as vaccines for HIV, (by GSK), and for HCV, (Merck).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1A, 2A, 3A, 4A, 5A, 6A, 7A | Experimental | Biological: AdCh63 ME-TRAPAdCh63 ME-TRAP |
| 1B, 2B, 3B, 4B, 6B, 7B, 7C | Experimental | Biological: AdCh63 ME-TRAP; MVA ME-TRAPAdCh63 ME-TRAP; MVA ME-TRAP |
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
- 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
- Willing to use barrier contraception until three months after the last vaccination
- For females only negative pregnancy test on the day(s) of vaccination
Key exclusion criteria (21 listed)
- 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 a recombinant MVA vaccine containing a relevant antigen (for those in B groups) or adenoviral vaccine, (all volunteers).
- 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)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon.
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 ME-TRAPAlso: Simian adenovirus expressing P. falciparum antigens ME-TRAP1. A:Intradermal injection 1x10^8 vp at day 0 2. A:Intradermal injection 1x10^9 vp at day 0 3. A:Intradermal injection 1x10^10 vp at day 0 4. A:Intradermal injection 5x10^10 vp at day 0 5:Intramuscular injection 1x10^10 vp at day 0 6A:Intramuscular injection 5x10^10 vp at day 0 7A: Intramuscular injection 2x10^11 vp at day 0 | Biological | 1A, 2A, 3A, 4A, 5A, 6A, 7A |
| AdCh63 ME-TRAP; MVA ME-TRAPAlso: Simian adenovirus, modified vaccinia Ankara virus1. B: AdCh63 ME-TRAP intradermally at dose of 1x10^8 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days) 2. B: AdCh63 ME-TRAP intradermally at dose of 1x10^9 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days) 3. B: AdCh63 ME-TRAP intradermally at dose of 1x10^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days) 4. B: AdCh63 ME-TRAP intradermally at dose of 5x10^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days) 6B: AdCh63 ME-TRAP intramuscularly at dose of 5x10^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days) 7B and 7C: AdCh63 ME-TRAP intramuscularly at dose of 2x10^11 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10^8 pfu at day 56 (+/- 7 days) | Biological | 1B, 2B, 3B, 4B, 6B, 7B, 7C |
Primary outcome
To assess the safety of a new malaria vaccine, AdCh63 ME-TRAP, when administered individually and sequentially with MVA ME-TRAP in a prime-boost regime to healthy volunteers
Time frame: 24 months
1 secondary outcome
To assess the cellular immune response generated, and whether this is affected by immunity to human adenovirus, by AdCh63 ME-TRAP when administered individually and sequentially with MVA ME-TRAP in a prime-boost regime to healthy volunteers
Time frame: 24 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 22 Aug 2012.
- Derived from this study: PubMed 22275401O'Hara GA, Duncan CJ, Ewer KJ, Collins KA, Elias SC, Halstead FD, Goodman AL, Edwards NJ, Reyes-Sandoval A, Bird P, Rowland R, Sheehy SH, Poulton ID, Hutchings C, Todryk S, Andrews L, Folgori A, Berrie E, Moyle S, Nicosia A, Colloca S, Cortese R, Siani L, Lawrie AM, Gilbert SC, Hill AV. Clinical assessment of a recombinant simian adenovirus ChAd63: a potent new vaccine vector. J Infect Dis. 2012 Mar 1;205(5):772-81. doi: 10.1093/infdis/jir850. Epub 2012 Jan 24.
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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, Professor 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 study testing AdCh63 ME-TRAP and AdCh63 ME-TRAP; MVA ME-TRAP in people with Malaria, run by University of Oxford 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 7 inclusion and 21 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 22 Aug 2012. 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 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?
To assess the safety of a new malaria vaccine, AdCh63 ME-TRAP, when administered individually and sequentially with MVA ME-TRAP in a prime-boost regime to healthy volunteers (time frame: 24 months). 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 NCT00890019, 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 22 Aug 2012.