Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults

Completed · Phase 1

Conditions studied: Malaria

In brief

Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for protecting troops against malaria are insecticidal nets, clothing, and antimalarial treatment. To be effective, these methods must be self-administered and be used consistently, often unattainable in field or combat situations. The United States Army Medical Research and Development Command (USAMRMC), through the United States Army Medical Materiel Development Activity (USAMMDA) and the Walter Reed Army Institute of Research (WRAIR) are actively pursuing the development of an effective vaccine against P. falciparum malaria; development of such a vaccine is a high priority for the US military and other individuals who travel to endemic regions, and is equally important to populations residing in those areas. A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS) vaccine will 1. assess the safety and reactogenicity of candidate P. falciparum malaria vaccine FMP012/GLA-SE Secondary: 2. measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent assay (ELISA) 3. assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite challenge.

Key facts

Study ID

NCT01540474

Run by

U.S. Army Medical Research and Development Command

People needed

36

Starts

2012-02-01

Expected to finish

2012-12-01

Last updated by the study team

2021-06-08

Who can join

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

You may not qualify if…

• History of malaria infection
• History of travel to P. falciparum endemic areas in the 3 months prior to day of first vaccination or day of challenge
• History of receiving a malaria vaccine
• Receipt of any licensed vaccine within 7 days prior to first vaccination
• History of receipt of malaria prophylaxis during the 2 months prior to day of first vaccination or day of challenge
• History of use of any drugs with significant antimalarial activity during the course of the study period
• Prior receipt of any vaccine containing either QS-21, MPL or GLA-SE in the previous 5 years (including Cervarix®, GSK)
• Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period.
• Any history of allergic reaction or anaphylaxis to previous vaccination
• Allergy to kanamycin, nickel, or imidazole Pregnant or lactating female at screening or plans to become pregnant or breastfeed from the time of enrollment until three months after challenge
• Allergy to antimalarial drugs or use of medications known to interact with both CQ and artemether/lumefantrine
• Significant (eg, systemic) hypersensitivity reactions to mosquito bites
• History of sickle cell disease
• History of psoriasis or porphyria
• History of splenectomy
• Any confirmed or suspected immunodeficiency, including HIV infection
• Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune-modifying drugs within six months of vaccination
• Inhaled and topical steroids are allowed
• A family history of congenital or hereditary immunodeficiency
• Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by history, physical examination, or laboratory evaluation
• Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or any planned administration during the study period
• Any abnormal baseline laboratory screening tests listed below (normal values are defined in the adverse event section of this protocol):
• Seropositive for HIV or Hepatitis C virus or HBsAg positive
• Hepatomegaly, right upper quadrant abdominal pain or tenderness

Where it is running

• Clinical Trials Center, WRAIR — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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