Status:
COMPLETED
Experimental Vaccine for Malaria in Adults in Mali
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study will determine the highest dose of an experimental vaccine called AMA1-C1 that can safely be given to adults exposed to malaria. Malaria affects about 300 million to 500 million people worl...
Detailed Description
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. Be...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 23 2004
Trial Type :
INTERVENTIONAL
End Date :
January 22 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00343005
Start Date
April 23 2004
End Date
January 22 2008
Last Update
July 2 2017
Active Locations (1)
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1
Malaria Research and Training Center (MRTC)
Bamako, Mali