Status:
COMPLETED
Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
1-6 years
Phase:
PHASE2
Brief Summary
Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by mosquito bites. The purpose of this study is to compare the number of children who get malaria after recei...
Detailed Description
This is a randomized, controlled, phase II clinical trial to evaluate the efficacy, safety and immunogenicity of the apical membrane antigen-1 of Plasmodium (P.) falciparum (AMA-1) malaria vaccine FMP...
Eligibility Criteria
Inclusion
- Age 1-6 years inclusive at the time of screening
- Residing in Bandiagara town
- Appear to be in generally good health based on clinical and laboratory investigation
- Separate written informed consent obtained from the parent/guardian before screening and study start, respectively
- Available to participate in follow-up for the duration of study (26 months)
Exclusion
- Previous vaccination with an investigational vaccine or a rabies vaccine
- Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This exclusion includes any dose level of oral steroids or inhaled steroids, but not topical steroids.
- Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Confirmed or suspected autoimmune disease
- History of allergic reactions or anaphylaxis to immunizations or to any vaccine component
- History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care
- History of allergy to tetracycline, doxycycline, nickel, Imidazole, eggs, neomycin, chlortetracycline or amphotericin B
- History of splenectomy
- Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than the upper limit of normal of the testing laboratory = 49.6 U/L)
- Laboratory evidence of renal disease (serum or plasma creatinine greater than 62 micro mol/L), or more than trace protein or blood on urine dipstick testing)
- Laboratory evidence of hematologic disease (absolute leukocyte count \<5,300/mm\^3 or \>15,300/mm\^3, absolute lymphocyte count \<2,300 mm\^3, platelet count \<133,000/mm\^3, or hemoglobin \<9.0 g/dL)
- Hepatitis B surface antigen positive
- Chronic skin condition that could interfere with vaccine site reactogenicity assessment
- Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period
- Simultaneous participation in any other interventional clinical trial
- Acute or chronic pulmonary, cardiovascular, hepatic (including hepatomegaly), renal or neurological condition, severe malnutrition, or any other clinical findings that in the opinion of the PI may increase the risk of participating in the study
- Other condition that in the opinion of the Principal Investigator (PI) would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00460525
Start Date
May 1 2007
End Date
July 1 2009
Last Update
November 9 2018
Active Locations (1)
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1
University of Bamako, Malaria Research and Training Center
Bamako, Mali