Reproducibility of Malaria Challenge in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT01058226

Run by

Seattle Children's Hospital

People needed

6

Starts

2010-02-01

Expected to finish

2010-09-01

Last updated by the study team

2011-03-31

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Seattle Biomedical Research Institue's Malaria Clinical Trial Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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