Status:
COMPLETED
Experimental Vaccine for Malaria
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study will examine the safety and immune response of healthy adult volunteers to AMA1-C1, an experimental malaria vaccine developed by the NIAID. Malaria affects about 300 million to 500 million ...
Detailed Description
The study is a randomized, single-blinded (blinded to volunteers) placebo-controlled Phase 1 clinical trial in healthy adult volunteers designed to evaluate the safety and reactogenicity of a new mala...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males or females between 18 and 50 years, inclusive.
- Available for the duration of the trial (34 weeks)
- Willingness to participate in the study as evidenced by signing the informed consent document.
- Weighing at least 110 pounds.
- EXCLUSION CRITERIA:
- Age less than 18 years because insufficient data are available in adults to judge potential risk in children.
- Pregnancy as determined by a positive urine Beta-hCG (if female).
- Participant unwilling to use reliable contraception methods (condoms or oral contraceptives) for the duration of the trial (if female).
- Currently lactating and breast-feeding (if female).
- Participant unwilling to undergo apheresis.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, 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 (aspartate aminotransferase AST greater than the upper limit of normal of the testing laboratory and/or total bilirubin levels greater than the upper limits of normal of the testing laboratory).
- Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory).
- Laboratory evidence of hematologic disease (absolute neutrophil count less than 1,500/mm(3); hemoglobin less than the lower limit of normal of the testing laboratory, by sex; or platelet count less than 140,000/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 enrolling in 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 to drugs or foods.
- Asthma that has resulted in an emergency room visit or hospitalization within the last 6 months.
- Positive ELISA and confirmatory Western blot tests for HIV-1.
- Positive ELISA and standard confirmatory tests for HCV.
- Positive HBsAg by ELISA.
- Known immunodeficiency syndrome.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of enrolling in 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.
- Receipt of antimalarial prophylaxis during the past 12 months.
- Prior malaria infection.
- Travel to a malaria-endemic country during the past 12 months or planned travel to a malaria-endemic country during the course of the study.
- History of a known allergy to nickel.
- History of known allergy to yeast.
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2006
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00114010
Start Date
April 1 2005
End Date
December 22 2006
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892