AzTrials
AzTrials

Plasmodium Falciparum MalariaPhase 1/2NCT02044198

A Phase I/IIa Study of the Safety, Immunogenicity and Efficacy of FMP2.1/AS01B, an Asexual Blood-Stage Vaccine for Plasmodium Falciparum Malaria

A Phase 1/2 study testing FMP2.1/AS01B 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
Search all trials

Trial summary

The purpose of this study is to evaluate an experimental malaria vaccine for its ability to prevent malaria infection or disease in a blood-stage challenge model (when volunteers are infected with malaria parasites using malaria-infected red blood cells). 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?
FMP2.1/AS01B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited Kingdom
Study dates
Mar 2014to Dec 2014
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, male or non-pregnant female adults aged 18 - 45 years
  • Subject is willing and able to give written informed consent for participation in the study
  • Resident in or near Oxford for the duration of the challenge part of the study. Or for volunteers not living in Oxford: agreement to stay in arranged accommodation close to the trial centre during a part of the study (from the day before challenge until anti-malarial treatment is completed).
  • Female subjects of child bearing potential must be willing to ensure that they practice continuous effective contraception for the duration of the study
  • Able (in the Investigator's opinion) and willing to comply with all study requirements
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
Show all 10Show fewer
  • Agreement to permanently refrain from blood donation, as per current UK Blood Transfusion and Tissue Transplantation Services guidelines (73).
  • Reachable (24 hours a day) by mobile phone during the period between CHMI and completion of antimalarial treatment.
  • Willingness to take a curative anti-malaria regimen following CHMI.
  • Answer all questions on the informed consent questionnaire 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).
  • Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
  • Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
  • History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait or any haematological condition that could affect susceptibility to malaria infection.
Show all 29Show fewer
  • 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).
  • Use of immunoglobulins or blood products within 3 months prior to enrolment or previous severe adverse reaction to a blood transfusion.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (or malaria infection).
  • Any history of anaphylaxis post vaccination.
  • Pregnancy, lactation or intention to become pregnant during the study.
  • Use of medications known to cause prolongation of the QT interval and existing contraindication to the use of Malarone.
  • Use of medications known to have a potentially clinically significant interaction with Riamet and Malarone.
  • Contraindications to the use of all three proposed anti-malarial medications; Riamet, Malarone and Chloroquine.
  • Any clinical condition known to prolong the QT interval.
  • Family history of congenital QT prolongation or sudden death.
  • Positive family history in 1st and 2nd degree relatives < 50 years old for cardiac disease.
  • History of cardiac arrhythmia, including clinically relevant bradycardia.
  • An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system.
  • Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests may be requested at the discretion of the Investigator. Absolute values for exclusion for confirmed abnormal results are shown in Appendix A.
  • 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 standard UK 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) at screening.
  • 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.
  • Volunteers unable to be closely followed for social, geographic or psychological reasons.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

  • NIHR Wellcome Trust Clinical Research Facility (NIHR WTCRF), Hammersmith Hospital

    London, London, W2 1NY

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

    Oxford, Oxfordshire, OX3 7LE

  • NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

The purpose of this study is to evaluate an experimental malaria vaccine for its ability to prevent malaria infection or disease in a blood-stage challenge model (when volunteers are infected with malaria parasites using malaria-infected red blood cells). The vaccine being testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve the body's response to a vaccination) called AS01B.

The aim is to use this protein and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will enable assessment of:

Read more
  1. The ability of the vaccine to prevent malaria infection.
  2. The safety of the vaccine in healthy participants.
  3. The response of the human immune system to the vaccine.

This will be done by giving participants three vaccinations and then exposing them to malaria infection by transfusing a small number of red blood cells infected with malaria under carefully regulated conditions. Participants will be followed closely to observe if and when they develop malaria. If the vaccine provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all.

The study will enrol 15 participants to be vaccinated and then challenged with malaria in addition to recruit 15 individuals to be control subjects.

Being tested
FMP2.1/AS01B
Keywords
Plasmodium Falciparum, 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.

  • FMP2.1/AS01BBiological

    Also called FMP2.1, AS01B

    50 µg FMP2.1 in 0.5 mL of the adjuvant AS01B (containing 50 mcg MPL + 50 mcg QS21) is administered via intramuscular (IM) injection in the deltoid region of the non-dominant arm

Study groups in NCT02044198
Study groupRoleWhat they receive
Group 1 - FMP2.1/AS01B vaccineActive comparatorFMP2.1/AS01B vaccine administered at days 0, 28 and 56. Blood-stage controlled human malaria infection (CHMI) at day 70.
Receives: Biological: FMP2.1/AS01B
Group 2 - controlNo interventionGroup 2 is an infectivity-control group for the malaria infection challenge procedures; these volunteers will not be vaccinated. Blood-stage controlled human malaria infection (CHMI) at day 70.

What is being measured

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

  1. PCR-derived parasite multiplication rate (PMR)

    PCR-derived parasite multiplication rate (PMR) will be the primary study endpoint, and comparison of the endpoint between the two study groups will constitute the primary analysis for efficacy.

    Measured: From the day before CHMI until 23 days after the challenge

Timeline

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

  1. First posted23 Jan 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2014
  4. Study completionDec 2014

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02044198
Sponsor's protocol ID
VAC054
Other IDs
2013-004098-28
Status last verified
Jan 2015
First submitted
21 Jan 2014
Last updated
9 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Payne RO, Milne KH, Elias SC, Edwards NJ, Douglas AD, Brown RE, Silk SE, Biswas S, Miura K, Roberts R, Rampling TW, Venkatraman N, Hodgson SH, Labbe GM, Halstead FD, Poulton ID, Nugent FL, de Graaf H, Sukhtankar P, Williams NC, Ockenhouse CF, Kathcart AK, Qabar AN, Waters NC, Soisson LA, Birkett AJ, Cooke GS, Faust SN, Woods C, Ivinson K, McCarthy JS, Diggs CL, Vekemans J, Long CA, Hill AV, Lawrie AM, Dutta S, Draper SJ. Demonstration of the Blood-Stage Plasmodium falciparum Controlled Human Malaria Infection Model to Assess Efficacy of the P. falciparum Apical Membrane Antigen 1 Vaccine, FMP2.1/AS01. J Infect Dis. 2016 Jun 1;213(11):1743-51. doi: 10.1093/infdis/jiw039. Epub 2016 Feb 4.

    PubMed 26908756

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FMP2.1/AS01B 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 29 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 9 Jan 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?

PCR-derived parasite multiplication rate (PMR) (time frame: From the day before CHMI until 23 days after the 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 NCT02044198, 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 9 Jan 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in