Status:
COMPLETED
Malaria Challenge in Healthy Volunteers
Lead Sponsor:
Seattle Children's Hospital
Conditions:
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
This randomized, partial double-blind, placebo-controlled phase 1 study is designed to evaluate whether sterile protective immunity to P. falciparum can be induced by wild-type (non-attenuated) sporoz...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Clinically significant abnormal screening electrocardiogram (ECG)
- Moderate or high risk for coronary heart disease (CHD) based on NHANES I cardiovascular risk assessment
- Acute illness at the time of enrollment
- Pregnant or nursing female
- Infection with HIV, Hepatitis B, Hepatitis C
- Psychiatric condition that precludes compliance with the protocol
- Suspected or known current alcohol or drug abuse
- Any other finding that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a subject's ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study
- Clinical trial staff with direct involvement in the conduct of the trial
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01500980
Start Date
December 1 2011
End Date
November 1 2012
Last Update
December 13 2012
Active Locations (1)
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1
Seattle Biomedical Research Institute's Malaria Clinical Trials Center
Seattle, Washington, United States, 98109