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MalariaPhase 1NCT01086917

Experimental Human Malaria Infection by PfSPZ

A Phase 1 study testing PfSPZ Challenge in people with Malaria, run by Sanaria Inc. at 1 site in Netherlands.

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

The study is a single center, varied dose, open label study. A maximum of eighteen volunteers will be exposed to live NF54 P. falciparum sporozoites (PfSPZ Challenge) by intradermal injection. Read more about this study

Who is it for?
Ages 19 to 34 yearsHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
PfSPZ Challenge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteNetherlands
Study dates
Aug 2010to Jul 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 19 to 34 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age > 18 and < 35 years healthy volunteers (males or females)
  • Good health based on history and clinical examination
  • Negative pregnancy test
  • Use of adequate contraception for females
  • All volunteers must sign the informed consent form demonstrating their understanding of the meaning and procedures of the study
  • Volunteer agrees to inform the general practitioner and agrees to sign a request to release medical information concerning contra-indications for participation in the study
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  • Willingness to undergo a Pf sporozoite challenge
  • For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 till 3 days after treatment)
  • Reachable (24/7) by mobile phone during the whole study period
  • Living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 till 3 days after treatment)
  • Available to attend all study visits
  • Agreement to refrain from blood donation to Sanquin or for other purposes, during the study period until day 140.
  • Willingness to undergo HIV, hepatitis B and hepatitis C tests
  • Negative urine toxicology screening test at screening visit and day before challenge
  • Willingness to take a curative regimen of Malarone®

Who cannot join

  • History of malaria
  • Plans to travel to malaria endemic areas during the 140 day study period
  • Plans to travel outside of the Netherlands during day 0-28 of the study
  • Previous participation in any malaria vaccine study and/or positive serology for Pf
  • Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers
  • History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
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  • History of arrhythmias or prolonged QT-interval
  • Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old
  • An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system
  • Clinically significant abnormalities in electrocardiogram (ECG) at screening
  • Body Mass Index (BMI) below 18 or above 30 kg/m2
  • Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis
  • Positive HIV, HBV or HCV tests
  • Participation in any other clinical study within 30 days prior to the onset of the study
  • Enrollment in any other clinical study during the study period
  • Pregnant or lactating women
  • Volunteers unable to give written informed consent
  • Volunteers unable to be closely followed for social, geographic or psychological reasons
  • Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
  • A history of psychiatric disease
  • Known hypersensitivity to anti-malaria drugs
  • The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs within three months of study onset (inhaled and topical corticosteroids are allowed) and during the study period
  • Contra-indications to Malarone® including treatment taken by the volunteer that interferes with Malarone®
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including asplenia
  • Co-workers of the departments of Medical Microbiology or Internal Medicine of the Radboud University Nijmegen Medical Centre or Sanaria Inc.
  • A history of sickle cell anemia, sickle cell trait, thalassemia , thalassemia trait or G6PD deficiency

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Nijmegen Medical Center

    Nijmegen, 6500 HB

Other trials in Netherlands

About this study

Official title: Experimental Human Malaria Infection by Intradermal Injection of Plasmodium Falciparum Sporozoites (PfSPZ Challenge)

The study is a single center, varied dose, open label study. A maximum of eighteen volunteers will be exposed to live NF54 P. falciparum sporozoites (PfSPZ Challenge) by intradermal injection. Volunteers will be divided into three groups of 6 volunteers, each group spaced 25 days apart (21 days after the last challenge of the last volunteer from the previous dose group).

Read the detailed description

In every group on day 1, two volunteers will be injected. On day 3 the remaining four volunteers of the group will be injected. Injections in subsequent volunteers are always spaced at least one hour apart in any group. Injection of subsequent (groups of) volunteers will only commence if the previous injection was shown to be safe. Three different doses of PfSPZ will be administered: a dose of 2,500 PfSPZ Challenge (Group 1); a dose of 10,000 PfSPZ Challenge (Group 2) if not all volunteers become thick smear positive (TS+) in Group 1; and a dose of 25,000 PfSPZ Challenge (Group 3) if there is not 100% TS+ in Group 2. If all volunteers in Group 1 (2,500 PfSPZ Challenge) become thick smear positive, then Group 2a will receive 1,000 PfSPZ Challenge. If all volunteers in Group 2a become TS+, the volunteers in Group 3a will receive 500 PfSPZ Challenge. If all volunteers in Group 2 (10,000 PfSPZ Challenge) become TS+, Group 3b will receive 5,000 PfSPZ. If less than 100% of volunteers in Group 2a (1,000 PfSPZ Challenge) become TS+ then Group 3c will receive 1,750 PfSPZ Challenge.

The clinical, biological, parasitological and immunological data of these groups' volunteers will be compared. Volunteers and the investigator will not be blinded, but the laboratory personnel will be blinded.

Conditions
Malaria
Being tested
PfSPZ Challenge
Keywords
Malaria Challenge, Plasmodium falciparum, Controlled human malaria infection, PfSPZ Challenge
Medical subject headings
Malaria, Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PfSPZ ChallengeBiological

    Also called aseptic, purified, cryopreserved Plasmodium falciparum sporozoites

    each volunteer to receive a single dose

Study groups in NCT01086917
Study groupRoleWhat they receive
Group 1Experimentalto receive a dose of 2,500 PfSPZ Challenge
Receives: Biological: PfSPZ Challenge
Group 2Experimentalto receive a dose of 10,000 PfSPZ Challenge
Receives: Biological: PfSPZ Challenge
Group 3Experimentalto receive a dose of 25,000 PfSPZ Challenge
Receives: Biological: PfSPZ Challenge

What is being measured

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

  1. Number of volunteers with Plasmodium falciparum Infection

    To achieve a 100% infection rate of human volunteers by intradermal injection of aseptic, purified, cryopreserved Pf sporozoites (PfSPZ Challenge)as measured by 100% thick smear positivity (thick blood smears) of all volunteers from one group

    Measured: Upto 7 months

Secondary outcomes (1)

  1. Kinetics of infection

    To compare parasite kinetics between different doses of intradermal injection of PfSPZ Challenge as measured by:

    • A significant difference in time of thick smear positivity between the groups of volunteers
    • A significant quantitative difference in parasitemia as measured by retrospective PCR between the groups of volunteers
    • A significant difference in kinetics of parasitemia between the groups of volunteers as measured by retrospective PCR
    • A difference in occurrence or intensity of signs or symptoms between the groups of volunteers

    Measured: Upto 7 months

Timeline

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

  1. First posted15 Mar 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionFeb 2011
  4. Study completionJul 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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01086917
Sponsor's protocol ID
TIP2
Status last verified
Apr 2015
First submitted
11 Mar 2010
Last updated
21 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Roestenberg M, Bijker EM, Sim BKL, Billingsley PF, James ER, Bastiaens GJH, Teirlinck AC, Scholzen A, Teelen K, Arens T, van der Ven AJAM, Gunasekera A, Chakravarty S, Velmurugan S, Hermsen CC, Sauerwein RW, Hoffman SL. Controlled human malaria infections by intradermal injection of cryopreserved Plasmodium falciparum sporozoites. Am J Trop Med Hyg. 2013 Jan;88(1):5-13. doi: 10.4269/ajtmh.2012.12-0613. Epub 2012 Nov 13.

    PubMed 23149582

  • Teirlinck AC, Roestenberg M, Bijker EM, Hoffman SL, Sauerwein RW, Scholzen A. Plasmodium falciparum Infection of Human Volunteers Activates Monocytes and CD16+ Dendritic Cells and Induces Upregulation of CD16 and CD1c Expression. Infect Immun. 2015 Sep;83(9):3732-9. doi: 10.1128/IAI.00473-15. Epub 2015 Jul 13.

    PubMed 26169270

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PfSPZ Challenge in people with Malaria, run by Sanaria Inc. at 1 site in Netherlands.

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 15 inclusion and 26 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 21 Apr 2015. 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 Netherlands. 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?

Number of volunteers with Plasmodium falciparum Infection (time frame: Upto 7 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 NCT01086917, which also lists 2 linked publications.

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 21 Apr 2015.

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