Status:
COMPLETED
Malaria Vaccine in Children in Mali
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
2-3 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will test an experimental vaccine called AMA1-C1 in children to see if it is safe and if it reduces episodes of malaria parasitemia (parasites in the blood) in children exposed to malaria. ...
Detailed Description
Apical membrane antigen-1 (AMA1) is a surface protein expressed during the asexual blood stage of P. falciparum. It is produced as an 83-kDa polypeptide by mature schizonts in infected erythrocytes. I...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males or females aged 2 to less than 4 years old. Children must be born no earlier than September 1, 2002 and must have had their second birthday prior to first vaccination.
- Known residents of the village of Doneguebougou, Mali or Bancoumana.
- Good general health as determined by means of the screening procedures.
- Available for the duration of the trial (52 weeks).
- Willingness to participate in the study as evidenced by parents/legal guardians signing or fingerprinting the informed consent document.
- EXCLUSION CRITERIA:
- 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 or the parent/legal guardian 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 14,500/mm(3), absolute lymphocyte count less than 1000/mm(3), platelet count less 120,000/mm(3), or hemoglobin less than 8.5 g/dL).
- 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.
- 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.
- Receipt of a live vaccine within past 4 weeks (e.g. measles/mumps/rubella (MMR)) or a non-live vaccine (e.g. diphtheria/pertussis/tetanus (DPT)) within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy.
- Receipt of a blood transfusion within the past 6 months.
- Previous receipt of an investigational malaria vaccine.
- History of a known allergy to nickel.
- History of known allergy to yeast.
- Known hypersensitivity to any component of the Hib vaccine (tetanus toxoid, lactose).
- Previous administration of Hib vaccines.
- Known thrombocytopenia or bleeding disorders.
Exclusion
Key Trial Info
Start Date :
January 19 2006
Trial Type :
INTERVENTIONAL
End Date :
December 8 2006
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00341250
Start Date
January 19 2006
End Date
December 8 2006
Last Update
July 2 2017
Active Locations (2)
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1
Bancoumana Clinical Trial Center
Bankoumana, Mali
2
Doneguebougou Malaria Vaccine Center
Donéguébougou, Mali