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

Study Summary

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.

Primary Outcome

Number of participants for each dose (1 through 3) that experienced any symptom, general solicited symptoms, and local solicited symptoms

Conditions Studied

Interventions

• BIOLOGICAL Group 1: 10 ug FMP012 with 2 ug GLA-SE
• BIOLOGICAL Group 2: 10 ug FMP012 with 5 ug GLA-SE
• BIOLOGICAL 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE
• OTHER Controlled group-Challenged Only: no vaccination

Study Locations (1)