Status:
COMPLETED
A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
GlaxoSmithKline
United States Agency for International Development (USAID)
Conditions:
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.
Detailed Description
The study begins with the US phase in which 26 volunteers aged 18 to 50 years will be enrolled to receive an investigational malaria vaccine. The vaccine is made of a malaria protein FMP010 mixed in t...
Eligibility Criteria
Inclusion
- A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of screening
- Free of significant health problems as established by medical history and clinical examination before entering into the study
- Available to participate for duration of study (approximately seven months)
- If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be capable of preventing pregnancy, have a negative pregnancy test at the time of each vaccination, and must agree to continue such precautions for two months after completion of the vaccination series.
- If the volunteer indicates he/she is active duty military (on the DCT sign-in page and intake form), approval from their supervisor through the Division Director using the Statement of Supervisor's Approval Form must be signed and on file prior to receipt of any test product
- Written informed consent must be obtained from the subject before screening procedures.
- Test of Understanding
- Prior to entry into this study, subjects must score at least 80% correct on a 10- question multiple-choice quiz that assesses their understanding of this study. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them to ensure comprehension, and they will have the opportunity to retest. If a volunteer fails to correctly answer 8 of 10 questions after two attempts they will be excluded from the study.
Exclusion
- Prior receipt of any investigational malaria vaccine
- Prior receipt of a vaccine containing either QS-21, MPL or AS02 or AS01
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. For corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the study vaccine
- Any past history of malaria
- Planned travel to malarious areas during the study period
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- A family history of congenital or hereditary immunodeficiency
- Chronic or active neurologic disease including seizure disorder
- History of splenectomy
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or abnormal baseline laboratory screening tests
- ALT above normal range
- Creatinine above normal range
- Hemoglobin below normal range
- Platelet count below normal range
- Total white cell count below normal range
- Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory infection without fever, i.e., Oral temperature \< 37.5°C.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness
- Seropositive for HIV, Hepatitis C virus (antibodies to HCV) and/or HBsAg
- 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/drug abuse as obtained by history and physical examination
- Female who is willing or intends to become pregnant during the study
- Any history of allergic reaction or anaphylaxis to previous vaccination
- Inability to make follow-up visits or complete diary cards
- Allergy to kanamycin, nickel, or imidazole
- 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 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00666380
Start Date
April 1 2008
End Date
June 1 2009
Last Update
May 29 2015
Active Locations (2)
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1
Department of Clinical Trials, WRAIR
Silver Spring, Maryland, United States, 20910
2
USAMRU-K/ KEMRI. Walter Reed Project
Kombewa, Kisumu, Nyanza Province, Kenya