Status:
COMPLETED
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
GlaxoSmithKline
The PATH Malaria Vaccine Initiative (MVI)
Conditions:
Malaria
Plasmodium Falciparum Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.
Detailed Description
* Controlled challenge, Phase I/IIa WRAIR study. * Healthy, malaria-naive adults aged 18 - 50 years. * 2 groups, 5 subjects in group A (10µg dose) and 15 subjects in group B (50µg dose). * Control: no...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Any history of anaphylaxis in reaction to vaccination.
- A clinical history of sickle cell disease or sickle cell trait.
- Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00312702
Start Date
April 1 2006
End Date
April 1 2007
Last Update
November 26 2018
Active Locations (1)
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1
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910