drugset / Trial / NCT00587249

ICC-1132 - Candidate Vaccine Against P Falciparum Malaria

NCT00587249

Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purposes of this study are to evaluate the safety and immune responses (the body's defense system) to an investigational malaria vaccine called ICC-1132. Three different doses of the vaccine will be studied in 3 groups of people, and the results will be compared. The study will involve about 80 healthy volunteers, 18-45 years of age, who will receive an injection of a specific dose of the vaccine in their arm on 2 or 3 different days. Blood samples will be collected approximately 15 times for laboratory studies. Volunteers will record their temperature twice per day. Volunteers will complete a daily symptom diary for 7 days after each vaccination. Volunteers will participate in the study for up to 13 months.

Timeline

Start
2002-07
Primary completion
2005-07
Completion
2005-07

Drugs

EvaluationDrugModalityDoseRoute
Subject ICC-1132 Vaccine 10 ug Intramuscular
Subject ICC-1132 Vaccine 20 ug Intramuscular
Subject ICC-1132 Vaccine 50 ug Intramuscular
Background Aluminum hydroxide Unknown Intramuscular