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HealthyPhase 1NCT01058226

Reproducibility of Malaria Challenge in Healthy Volunteers

A Phase 1 study testing Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites) in people with Healthy, run by Seattle Children's Hospital at 1 site in United States.

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 is a prospective, single arm, single intervention safety and immunogenicity study in 6 healthy, malaria-naive adults, conducted to demonstrate the successful implementation of the well-established malaria challenge model at the Seattle Biomedical Research Institute (Seattle BioMed). Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites)
How many people
6 participants
Where
1 siteUnited States
Study dates
Feb 2010to Sep 2010
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

  • Age 18 to 50 years
  • Male or non-pregnant female
  • Good general health
  • Hemoglobin, WBC, platelets and creatinine within normal ranges
  • ALT, AST, bilirubin, alkaline phosphatase <1.25 times upper limit of normal
  • Normal urine
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  • Negative HIV-1 and 2 blood test
  • Negative Hepatitis B surface antigen (HBsAg)
  • Negative anti-Hepatitis C virus antibodies (anti-HCV)
  • Low risk for coronary heart disease (CHD)
  • Ability and willingness to provide informed consent
  • Assessment of Understanding questionnaire completed
  • Reliable access to the trial center and availability for duration of study
  • If the participant is biologically female, she must:
  • Have negative serum or urine beta human chorionic gonadotropin pregnancy test performed within 3 days prior to challenge
  • Agree to consistently use effective contraception from 21 days prior to enrollment for the duration of the study
  • OR not be of reproductive potential
  • OR be sexually abstinent
  • Also agree not to seek pregnancy through alternative methods

Who cannot join

  • Planned travel to malaria endemic area during the study period
  • Recent travel to a malaria endemic area within 3 months of enrollment
  • Prior receipt of an investigational malaria vaccine
  • History of malaria diagnosis based on positive peripheral blood smear
  • Use of malaria chemoprophylaxis with chloroquine within 5 months of malaria challenge, with atovaquone/proguanil within 2 months of malaria challenge or with mefloquine within 30 days prior to malaria challenge
  • Recent or anticipated use of systemic antibiotics with anti-malarial effects during the study period
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  • Anticipated use of medications known to interact with chloroquine and/or atovaquone/proguanil during the study period
  • Use of investigational or non-registered drug or vaccine within 30 days preceding challenge or planned use during the study period
  • Immunosuppressive medications received within 6 months prior to challenge or planned use within 21 days after challenge
  • Any vaccination received or planned within 30 days prior to challenge
  • Blood products or immunoglobulins received within 120 days of challenge
  • Screening laboratory abnormalities
  • Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status
  • History of anaphylaxis
  • History of severe allergic reactions to mosquito bites
  • History of, or known active cardiac disease
  • Elevated risk of coronary heart disease
  • Clinically significant ECG findings
  • Chronic or active neurologic disease
  • History of splenectomy or functional asplenia
  • History of psoriasis or porphyria
  • History of ocular disease diagnosed by an ophthalmologist as retinopathy or visual field defects
  • Acute illness at the time of enrollment
  • Serologic positivity for HIV, hepatitis C and/or hepatitis b
  • Pregnant or lactating female or female who intends to become pregnant during the study period
  • Psychiatric condition that precludes compliance with the protocol including but not limited to: psychosis within the past 3 years OR ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years
  • Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV
  • Recreational intravenous drug use in the last 12 months
  • Any other finding that, in the judgement of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent or increase the risk of having an adverse outcome from participating in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Seattle Biomedical Research Institue's Malaria Clinical Trial Center

    Seattle, Washington, 98109

Other trials in United States

About this study

This is a prospective, single arm, single intervention safety and immunogenicity study in 6 healthy, malaria-naive adults, conducted to demonstrate the successful implementation of the well-established malaria challenge model at the Seattle Biomedical Research Institute (Seattle BioMed).

Read the detailed description

This study is designed to demonstrate the ability to inoculate malaria naive human volunteers with the Plasmodium falciparum strain of malaria sporozoites by the bite of infected mosquitoes under controlled conditions. Subjects are monitored closely for development of malaria and treated with standard doses of anti-malarial medications which the Plasmodium falciparum strain of malaria is known to be sensitive.

Study participants will undergo malaria sporozoite challenge with wild-type NF54 strain of Plasmodium falciparum sporozoites administered via the bite of five infected Anopheles stephensi mosquitoes under controlled containment conditions.

Participants will be closely monitored for acute reactogenicity and signs and/or symptoms of malaria infection, and from day five post-challenge, will have daily blood films examined for the presence of malaria parasites. Participants who develop malaria infection will be treated with a standard oral regimen of chloroquine, or other FDA-approved anti-malarial drugs, under direct observation. Participants will be treated upon first evidence of microscopic parasitemia or at day 18 if they remain negative. Participants will be housed with study staff in a local hotel for close observation from day 9 post-challenge, until three consecutive blood smears are negative and all symptoms have resolved, then followed weekly for a total of 8 weeks.

Follow-up for safety will be conducted at 4- and 6- months post-challenge.

Conditions
Healthy
Being tested
Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites)
Keywords
Experimental malaria challenge

What participants receive

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

  • Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites)Biological

    Malaria sporozoite challenge with the wild-type NF54 strain of Plasmodium falciparum delivered by the bite of five infected Anopheles stephensi mosquitoes.

What is being measured

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

  1. Development of malaria parasitemia and time to parasitemia demonstrated on peripheral blood smear

    Measured: Day 5 through Day 28 post challenge

Secondary outcomes (5)

  1. Occurrence of unsolicited AEs

    Measured: Day 0 through Day 56 post challenge

  2. Local and systemic solicited adverse events (AEs)

    Measured: Day 5 through Day 28 post challenge

  3. Occurrence of serious AEs

    Measured: Day 0 through Day 56 post challenge

  4. Cell-mediated immune response to experimental malaria infection

    Measured: Day 0 through Day 56 post challenge

  5. Humoral immune responses to experimental malaria infection

    Measured: Day 0 through Day 56 post challenge

Timeline

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

  1. First posted28 Jan 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionMay 2010
  4. Study completionSep 2010

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
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01058226
Sponsor's protocol ID
MC-001
Status last verified
Mar 2011
First submitted
26 Jan 2010
Last updated
31 Mar 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Talley AK, Healy SA, Finney OC, Murphy SC, Kublin J, Salas CJ, Lundebjerg S, Gilbert P, Van Voorhis WC, Whisler J, Wang R, Ockenhouse CF, Heppner DG, Kappe SH, Duffy PE. Safety and comparability of controlled human Plasmodium falciparum infection by mosquito bite in malaria-naive subjects at a new facility for sporozoite challenge. PLoS One. 2014 Nov 18;9(11):e109654. doi: 10.1371/journal.pone.0109654. eCollection 2014.

    PubMed 25405724

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites) in people with Healthy, run by Seattle Children's Hospital at 1 site in United States.

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 19 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 31 Mar 2011. 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 States. 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?

Development of malaria parasitemia and time to parasitemia demonstrated on peripheral blood smear (time frame: Day 5 through Day 28 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 NCT01058226, 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 31 Mar 2011.

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