Experimental Vaccine for Malaria in Adults in Mali

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jun 19, 2006

Keywords

ClinConnect Summary

The purpose of this Phase 1 clinical trial is to evaluate the safety and immunogenicity of the Plasmodium falciparum malaria vaccine AMA1-C1/Alhydrogel, in healthy malaria-exposed adult volunteers. Between 2-3 million deaths occur each year as a result of malaria. Most of these deaths are a result of P. falciparum malaria, in children under five years of age, in sub-Saharan Africa. A safe and effective vaccine that would reduce both morbidity and mortality secondary to P. falciparum would be a valuable resource in the fight against this disease. The apical membrane antigen 1 (AMA1) is a sur...

Gender

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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.