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MalariaPhase 1/2NCT00890760

A Study to Assess the Effectiveness of a New Malaria Vaccine Candidate by Infecting Vaccinated Volunteers With Malaria Parasites

A Phase 1/2 study testing AdCh63 ME-TRAP, MVA ME-TRAP and Sporozoite challenge in people with Malaria, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Malaria affects around 515 million people each year, about a million of whom die from the disease. It is a major problem for those who live in affected areas as well as for travellers to affected areas. There is a great need for a safe, effective malaria vaccine. 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, MVA ME-TRAP and Sporozoite challenge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2009to Feb 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

  • 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 females only: willingness to practise effective contraception throughout the study
  • 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 an investigational malaria vaccine encoding ME-TRAP 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)
  • Pregnancy, lactation or intention to become pregnant during the study
  • Contraindication to both anti-malarial drugs (Riamet® and chloroquine)
Show all 23Show fewer
  • o concomitant use with other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc)
  • 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 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 ( EXCEPT CONTROL VOLUNTEERS)
  • 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.
  • History of clinical P. falciparum malaria
  • 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 or impair interpretation of the study data.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford

    Oxford, Headington, OX3 7LJ

Other trials in United Kingdom

About this study

Official title: Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With AdCh63 ME-TRAP and MVA ME-TRAP

Malaria affects around 515 million people each year, about a million of whom die from the disease. It is a major problem for those who live in affected areas as well as for travellers to affected areas. There is a great need for a safe, effective malaria vaccine. The purpose of this study is to test 2 new vaccination regimes that include a new malaria vaccine candidate, for their ability to prevent malaria infection.

The vaccines are different types of virus which contain genetic information (DNA) from the malaria parasite. This genetic material is named ME-TRAP. The aim is to use these viruses to help the body make an immune response against the malaria parasite. Both viruses are inactivated so that they are unable to multiply within the body.

Read more

The first vaccine virus is a weakened version of a common cold virus. Such adenoviruses occur in many strain types and commonly infect chimpanzees as well as people and this vaccine uses a strain originally derived from a chimpanzee. The vaccine is called AdCh63 ME-TRAP.

The other virus is Modified Vaccinia Ankara Virus, (MVA), which is a safer form of the vaccine virus previously widely used for smallpox vaccination. The vaccine is called MVA ME-TRAP.

This study will enable the investigators to assess:

  1. The ability of different vaccine combinations to prevent malaria infection
  2. The safety of the vaccine combinations in healthy volunteers
  3. The response of the human immune system to the vaccines
Conditions
Malaria
Being tested
AdCh63 ME-TRAP, MVA ME-TRAP, Sporozoite challenge, Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly
Keywords
Malaria, Vaccine
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

    5 x 10*10 vp IM

  • MVA ME-TRAPBiological

    2 x 10*8 pfu ID

  • Sporozoite challengeOther

    Infected mosquito bite

  • Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularlyBiological

    AdCh63 ME-TRAP 5 x 10*10 vp MVA ME-TRAP 2 x 10*8 pfu

Study groups in NCT00890760
Study groupRoleWhat they receive
Group 1ExperimentalAdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
Receives: Biological: AdCh63 ME-TRAP; Biological: MVA ME-TRAP; Other: Sporozoite challenge
Group 2ExperimentalAdCh63 ME-TRAP alone followed by sporozoite challenge 3 weeks later
Receives: Biological: AdCh63 ME-TRAP; Other: Sporozoite challenge
Group 3ExperimentalNon-vaccinated Control for Groups 1 and 2 challenged with sporozoite
Receives: Other: Sporozoite challenge
Group 4ExperimentalAdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 11 weeks after boost
Receives: Biological: AdCh63 ME-TRAP; Biological: MVA ME-TRAP; Other: Sporozoite challenge
Group 5ExperimentalAdCh63 ME-TRAP prime followed by MVA ME-TRAP boost 8 weeks later and challenged by sporozoite 3 weeks after boost
Receives: Biological: AdCh63 ME-TRAP; Biological: MVA ME-TRAP; Other: Sporozoite challenge
Group 6ExperimentalProtected volunteers from Group 1 re-challenged with sporozoite after 6 months
Receives: Biological: AdCh63 ME-TRAP; Other: Sporozoite challenge
Group 7ExperimentalNon vaccinated control for Groups 4-6, 8-10 challenged with sporozoite
Receives: Other: Sporozoite challenge
Group 8Experimental3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
Receives: Other: Sporozoite challenge; Biological: Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly
Group 9Experimental2 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 8 weeks interval followed by sporozoite challenge 3 weeks after last vaccination
Receives: Other: Sporozoite challenge; Biological: Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly
Group 10Experimental3 vaccinations of mixture formulation AdCh63 ME-TRAP and MVA ME-TRAP give at 4 weeks interval each followed by sporozoite challenge 3 weeks after last vaccination
Receives: Other: Sporozoite challenge; Biological: Mixture of AdCh63 ME-TRAP and MVA ME-TRAP intramuscularly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccine prevention (partial or complete) of malaria infection by sporozoite challenge

    Measured: Approxiamately 5-16 months following last intervention

Secondary outcomes (1)

  1. Safety of vaccine

    Measured: Approxiamately 5-16 months following last intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2011

Resources

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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00890760
Sponsor's protocol ID
MAL 034
Status last verified
Nov 2012
First submitted
29 Apr 2009
Last updated
29 Nov 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Ewer KJ, O'Hara GA, Duncan CJ, Collins KA, Sheehy SH, Reyes-Sandoval A, Goodman AL, Edwards NJ, Elias SC, Halstead FD, Longley RJ, Rowland R, Poulton ID, Draper SJ, Blagborough AM, Berrie E, Moyle S, Williams N, Siani L, Folgori A, Colloca S, Sinden RE, Lawrie AM, Cortese R, Gilbert SC, Nicosia A, Hill AV. Protective CD8+ T-cell immunity to human malaria induced by chimpanzee adenovirus-MVA immunisation. Nat Commun. 2013;4:2836. doi: 10.1038/ncomms3836.

    PubMed 24284865

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AdCh63 ME-TRAP, MVA ME-TRAP and Sporozoite challenge in people with Malaria, 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 5 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 29 Nov 2012. 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 prevention (partial or complete) of malaria infection by sporozoite challenge (time frame: Approxiamately 5-16 months following last intervention). 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 NCT00890760, 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 29 Nov 2012.

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