Experimental Vaccine for Malaria in Adults in Mali
Plasmodium Falciparum Malaria
About this trial
This is an interventional treatment trial for Plasmodium Falciparum Malaria focused on measuring Blood-Stage, Investigational, Endemic, Malaria, Vaccine
Eligibility Criteria
INCLUSION CRITERIA: Males or females between 18 and 45 years, inclusive. Known residents of the village of Doneguebougou, Mali. Good general health as determined by means of the screening procedure. Available for the duration of the trial (78 weeks). Willingness to participate in the study as evidenced by signing the informed consent document. EXCLUSION CRITERIA: Pregnancy as determined by a positive urine beta-hCG (if female). Participant and her spouse are unwilling to use reliable contraception methods up until one month following the third immunization (if female). Currently lactating and breast-feeding (if female). Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, chronic infectious or renal disease by history, physical examination, and/or laboratory studies including urinalysis. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol. Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than 1.25 times the upper limit of normal of the testing laboratory). Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing). Laboratory evidence of hematologic disease (absolute leukocyte count less than 3000/mm(3) or greater than 13.5 x 10(3)/mm(3); hemoglobin less than 0.9 times the lower limit of normal of the testing laboratory, by sex; absolute lymphocyte count less than 1000/mm(3); or platelet count less than 120,000/mm(3)). Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing. Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. History of a severe allergic reaction or anaphylaxis. Severe asthma (emergency room visit or hospitalization within the last 6 months). Positive ELISA for HCV. Positive HBsAg by ELISA. Known immunodeficiency syndrome. Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study or while the study is ongoing. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study. History of a surgical splenectomy. Receipt of blood products within the past 6 months. Previous receipt of an investigational malaria vaccine. History of a known allergy to nickel. Previous receipt of a primary series of any Hepatitis B vaccine. History of known allergy to yeast.
Sites / Locations
- Malaria Research and Training Center (MRTC)