drugset / Trial / NCT00587249
ICC-1132 - Candidate Vaccine Against P Falciparum Malaria
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |