Status:
COMPLETED
Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
The PATH Malaria Vaccine Initiative (MVI)
United States Agency for International Development (USAID)
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
12-47 years
Phase:
PHASE2
Brief Summary
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-e...
Detailed Description
Field trial of a candidate antigen/adjuvant conducted at one study center with 12 outlying (satellite) field stations. Subjects were screened no more than 45 days prior to the first inoculation and we...
Eligibility Criteria
Inclusion
- All subjects must satisfy the following criteria at study entry:
- A healthy male or female child, 12 to 47 months of age on the day of screening
- Written informed consent obtained from at least one parent/guardian before study start
- Available to participate for the study duration (about 14 months)
Exclusion
- Acute disease at the time of entry into the study that in the opinion of the investigator may pose a threat to the subject
- Prior receipt of a rabies vaccine or any investigational vaccine
- Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed)
- Administration or anticipated administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid
- Previous vaccination with a vaccine containing MPL or QS21 (e.g., RTS,S/AS02A)
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV test will be performed as part of this study.)
- History of allergic reactions or anaphylaxis to immunizations or to any vaccine components, such as eggs
- History of surgical splenectomy
- Administration of immunoglobulins, blood transfusions, or any other blood products within the six months preceding the first dose of study vaccine or planned administration during the study period
- Simultaneous participation in any other clinical trial
- Acute or chronic cardiovascular, pulmonary, hepatic, or renal condition that in the opinion of the PI, may increase the risk to the subject from participating in the study
- Any other condition or circumstance that in the opinion of the investigator may pose a threat to the subject
Key Trial Info
Start Date :
April 8 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00223990
Start Date
April 8 2005
End Date
June 1 2007
Last Update
February 12 2021
Active Locations (1)
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1
Walter Reed Project, Kombewa Clinic
Kisumu, Nyanza Province, Kenya