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Plasmodium Falciparum MalariaPhase 1/2VAC045NCT01623557

A Challenge Study to Assess the Protective Efficacy of Two Malaria Vaccine Candidates

A Phase 1/2 study testing ChAd63-MVA CS and ChAd63-MVA ME-TRAP in people with Plasmodium Falciparum Malaria, run by University of Oxford at 3 sites 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

This study aims to assess the safety and effectiveness of four new candidate malaria vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS \& MVA ME-TRAP. These vaccines consist of viruses (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans and (ii) they include parts of the malaria… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Plasmodium Falciparum Malaria
What is being tested?
ChAd63-MVA CS and ChAd63-MVA ME-TRAP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited Kingdom
Study dates
Apr 2012to Nov 2012
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults aged 18 to 45 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.
  • Women only: Must practice continuous effective contraception for the duration of the study.
  • Agreement to refrain from blood donation during the course of the study and for at least 3 years after the end of their involvement in the study.
  • Written informed consent to participate in the trial.
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  • Reachable (24/7) by mobile phone during the period between CHMI and completion of antimalarial treatment.
  • Willingness to take a curative anti-malaria regimen following CHMI.
  • For volunteers not living in Oxford: agreement to stay in a hotel room close to the trial centre during a part of the study (from at least day 6.5 post mosquito bite until anti-malarial treatment is completed).
  • Answer all questions on the informed consent quiz correctly.

Who cannot join

  • History of clinical malaria (any species).
  • Travel to a malaria endemic region during the study period or within the preceding six months with significant risk of malaria exposure.
  • Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin)
  • Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt 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.
  • 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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  • Use of immunoglobulins or blood products within 3 months prior to enrolment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products, Kathon) or malaria infection.
  • Any history of anaphylaxis post vaccination.
  • History of clinically significant contact dermatitis.
  • History of sickle cell anaemia, sickle cell trait, thalassemia or thalassemia trait or any haematological condition that could affect susceptibility to malaria infection.
  • Pregnancy, lactation or intention to become pregnant during the study.
  • Contraindications to the use of all three proposed anti-malarial medications; Malarone, Riamet and Chloroquine.
  • 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) with positive PCR for hepatitis C at screening.
  • An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system.76
  • Positive family history in 1st and 2nd degree relatives < 50 years old for cardiac disease.
  • Volunteers unable to be closely followed for social, geographic or psychological reasons.
  • Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.
  • 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

  • Infection and Immunity Section, Imperial College of Science, Technology and Medicine

    London, SW7 2AZ

  • Centre for Clinical Vaccinology and Tropical Medicine

    Oxford, Oxfordshire, OX3 7LE

  • Wellcome Trust CRF, Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

About this study

Official title: A Phase I/IIa Sporozoite Challenge Study to Assess the Protective Efficacy of Two Prime-Boost Malaria Vaccine Candidates: ChAd63 and MVA Encoding ME-TRAP and the Same Viral Vectors Encoding CS

This study aims to assess the safety and effectiveness of four new candidate malaria vaccines; ChAd63 CS, ChAd63 ME-TRAP, MVA CS \& MVA ME-TRAP. These vaccines consist of viruses (ChAd63 and MVA) which have been genetically modified so (i) they cannot replicate in humans and (ii) they include parts of the malaria parasite; Plasmodium falciparum (CS and ME-TRAP). The hope is that these vaccines will induce immune responses in vaccinees that are able to prevent malaria.

This proposed study will compare how effective ChAd63-MVA CS is at preventing malaria infection in UK volunteers following malaria challenge compared to ChAd63-MVA ME-TRAP.

The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in Southampton, UK. The malaria challenge will take place at the insectary at Imperial College (Infection and Immunity Section) in London, UK.

Being tested
ChAd63-MVA CS, ChAd63-MVA ME-TRAP, Controlled Human Malaria Infection Administered by Mosquito Bite
Keywords
Malaria, Vaccine, Plasmodium, falciparum
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.

  • ChAd63-MVA CSBiological

    1 dose of ChAd63 CS 5 x 10^10 vp intramuscularly and 1 dose MVA CS 2 x 10^8 pfu intramuscularly 8 weeks later.

  • ChAd63-MVA ME-TRAPBiological

    1 dose of ChAd63 ME-TRAP 5 x 10^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10^8 pfu intramuscularly 8 weeks later.

  • Controlled Human Malaria Infection Administered by Mosquito BiteOther

    Approximately 3 weeks post MVA dosing

Study groups in NCT01623557
Study groupRoleWhat they receive
Group 1: ChAd63-MVA CSActive comparator1 dose of ChAd63 CS 5 x 10^10 vp intramuscularly and 1 dose MVA CS 2 x 10^8 pfu intramuscularly 8 weeks later.
Receives: Biological: ChAd63-MVA CS; Other: Controlled Human Malaria Infection Administered by Mosquito Bite
Group 2: ChAd63-MVA ME-TRAPActive comparator1 dose of ChAd63 ME-TRAP 5 x 10^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10^8 pfu intramuscularly 8 weeks later.
Receives: Biological: ChAd63-MVA ME-TRAP; Other: Controlled Human Malaria Infection Administered by Mosquito Bite
Group 3: Unvaccinated Infectivity ControlsActive comparatorNot described
Receives: Other: Controlled Human Malaria Infection Administered by Mosquito Bite

What is being measured

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

  1. The effectiveness of ChAd63-MVA CS and ChAd63-MVA ME-TRAP at preventing malaria infection

    Comparison of the number of individuals who develop malaria infection between vaccinees and unvaccinated control volunteers.

    Measured: Up to 30 days post challenge

Secondary outcomes (1)

  1. The safety and immunogenicity of ChAd63-MVA CS and ChAd63-MVA ME-TRAP

    The safety of the vaccine regimens will be assessed by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements.

    The ability of the vaccines to induce malaria-specific immune responses (immunogenicity) will be assessed by the following laboratory tests;

    (A) Interferon gamma ELISPOT. (B) Flow cytometry to measure T cell responses

    Other laboratory investigations including microarray analysis may be performed.

    Measured: up to 7 months post first vaccination

Timeline

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

  1. First posted20 Jun 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionNov 2012
  4. Study completionNov 2012

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01623557
Sponsor's protocol ID
VAC045
Acronym
VAC045
Status last verified
Feb 2015
First submitted
16 May 2012
Last updated
16 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Hodgson SH, Ewer KJ, Bliss CM, Edwards NJ, Rampling T, Anagnostou NA, de Barra E, Havelock T, Bowyer G, Poulton ID, de Cassan S, Longley R, Illingworth JJ, Douglas AD, Mange PB, Collins KA, Roberts R, Gerry S, Berrie E, Moyle S, Colloca S, Cortese R, Sinden RE, Gilbert SC, Bejon P, Lawrie AM, Nicosia A, Faust SN, Hill AV. Evaluation of the efficacy of ChAd63-MVA vectored vaccines expressing circumsporozoite protein and ME-TRAP against controlled human malaria infection in malaria-naive individuals. J Infect Dis. 2015 Apr 1;211(7):1076-86. doi: 10.1093/infdis/jiu579. Epub 2014 Oct 21.

    PubMed 25336730

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ChAd63-MVA CS and ChAd63-MVA ME-TRAP in people with Plasmodium Falciparum 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 10 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 16 Feb 2015. 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?

The effectiveness of ChAd63-MVA CS and ChAd63-MVA ME-TRAP at preventing malaria infection (time frame: Up to 30 days post challenge). 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 NCT01623557, 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 16 Feb 2015.

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