Status:
UNKNOWN
Safety and Immunogenicity of Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545])
Lead Sponsor:
African Malaria Network Trust
Conditions:
Malaria
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO\[25-545\]) will be tested in malaria endemic populations. The phase Ib study will include ad...
Detailed Description
This will be a randomized controlled trial to evaluate the Safety and Immunogenicity of recombinant pichia pastoris blood stage malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO\[25-545\]) versus...
Eligibility Criteria
Inclusion
- Age 18-55 years inclusive at the time of screening
- Residing in Bandiagara for the duration of the study
- Separate written informed consent obtained before screening and study start, respectively
- Available to participate in follow-up for the duration of study (14 months)
- General good health based on history and clinical examination
- Willingness not to become pregnant during the first five months of the study for female participants
Exclusion
- Previous vaccination with a investigational vaccine or a rabies vaccine
- Use of a 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 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 vaccines components
- History of splenectomy
- 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 \<4000/mm3 or \>14,500/mm3, absolute lymphocyte count \<1500/mm3, platelet count \<120,000/mm3, or hemoglobin \<10.0 g/dL).
- 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, renal or neurological condition, 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 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 :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00431808
Start Date
May 1 2007
End Date
June 1 2008
Last Update
April 3 2008
Active Locations (1)
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1
Malaria Research and Training Center
Bandiagara, Mali