Malaria Challenge in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Malaria

In brief

The purpose of this study is to determine if sterile, protective immunity to malaria can be induced by malaria parasite exposure limited to the early liver stage of the parasite lifecycle.

Key facts

Study ID

NCT01500980

Run by

Seattle Children's Hospital

People needed

36

Starts

2011-12-01

Expected to finish

2012-11-01

Last updated by the study team

2012-12-13

Who can join

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

You may qualify if…

• Male and non-pregnant females age 18 to 50 years
• Good general health status as demonstrated by medical history, physical exam, and screening laboratory test performed within 90 days of enrollment
• Ability and willingness to provide informed consent
• No laboratory evidence of hematologic, hepatic, or renal disease
• Assessment of Understanding questionnaire completed and passed prior to enrollment
• Reliable access to the clinical trials centers and availability to participate for duration of study
• If the subject is biologically female and of reproductive potential she must agree to consistent pregnancy prevention

You may not qualify if…

• Recent travel to a malaria endemic area within 6 months of enrollment
• Planned travel to a malaria endemic area during the study period
• History of confirmed malaria diagnosis on peripheral blood smear
• Anticipated use during the study period, or use within the following periods prior to enrollment:
• Investigational malaria vaccine at any time
• Malaria chemoprophylaxis within 6 months
• Chronic systemic immunosuppressive medications within 6 months
• Blood products or immunoglobulins within 120 days
• Investigational product or vaccine within 30 days
• Systemic antibiotics with antimalarial effects within 30 days
• Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to each ITV infection and challenge
• Medications known to interact with primaquine, chloroquine or atovaquone/proguanil (only during the study period)
• History of:
• Sickle cell disease, sickle cell trait, or other hemoglobinopathies
• Splenectomy or functional asplenia
• Systemic anaphylaxis
• Gelatin allergy
• Severe allergic reactions to mosquito bites of study drugs
• Documented history of chronic or active neurologic disease
• Psoriasis or porphyria
• Ocular diseases including retinopathy or visual field defects
• Glucose 6 phosphate dehydrogenase (G6PD) deficiency
• 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 in the opinion of the Investigator.
• Weight <55 kg or >90 kg; body mass index (BMI) <18.5% or >31%
• History of known active cardiac disease or stroke

Where it is running

• Seattle Biomedical Research Institute's Malaria Clinical Trials Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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