Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

Completed · Phase 1/Phase 2

Conditions studied: Malaria, Plasmodium Falciparum Malaria

In brief

Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.

Key facts

Study ID

NCT00312702

Run by

U.S. Army Medical Research and Development Command

People needed

18

Starts

2006-04-01

Expected to finish

2007-04-01

Last updated by the study team

2018-11-26

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A male or non-pregnant female 18 to 50 years of age (inclusive) at the time of screening.
• Written informed consent obtained from the subject before screening procedures.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.*
• Available to participate for duration of study (approximately 15 months).
• If the subject is female, she must be currently using birth control, must be surgically sterilized, or must be at least 1-year post menopausal.
• Pass a comprehension assessment test.

You may not qualify if…

• Prior receipt of an investigational malaria vaccine.
• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 28 days preceding the first dose of study vaccine, or planned use during the study period.
• Administration of chronic immunosuppressants or other immune modifying drugs within six months of vaccination.
• Chronic use of antibiotics with anti-malarial effects.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
• History of use of anti-malarial medication within 60 days prior to vaccination.
• Any history of malaria.
• Known exposure to malaria within the previous 12 months.
• Planned travel to malarious areas during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Chronic or active neurologic disease including seizures, but not including a single febrile seizure as a child.
• History of splenectomy.
• Acute disease at the time of enrollment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease.
• Seropositive for hepatitis B surface antigen.
• Seropositive for Hepatitis C virus (antibodies to HCV).
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV.
• Chronic or active intravenous drug use.
• History of severe reactions to mosquito bites as defined as anaphylaxis.
• Female who intends to become pregnant during the study.

Where it is running

• Walter Reed Army Institute of Research — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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