drugset / Trial / NCT00371189

Adenovirus Vaccine for Malaria

NCT00371189

RandomizedParallel-groupTriple-blindPrevention

Summary

Malaria is caused by a parasite carried by a mosquito. Currently, there is no vaccine licensed to prevent malaria. The purpose of this study is to find the most effective and safest dose of an experimental vaccine for the treatment of malaria. Participants will include 72 healthy adults, ages18 to 45, enrolled at Vanderbilt University Medical Center and Stanford University. Volunteers will receive 3 doses of either the malaria vaccine or placebo (contains no vaccine) by injection into a muscle at 0, 1 and 6 months. Investigators will evaluate how the body responds to increasing dosage strengths of the vaccine. Study procedures include physical exam, multiple blood draws, and completion of a memory aid (diary). Each participant will be actively involved in the study for about 12 months. Then, an annual phone call will be made to check for any serious illness events for a period of 5 years.

Timeline

Start
2007-01
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad35.CS.01 Vaccine 1e+08 unknown Intramuscular
Subject Ad35.CS.01 Vaccine 1e+09 unknown Intramuscular
Subject Ad35.CS.01 Vaccine 1e+10 unknown Intramuscular
Subject Ad35.CS.01 Vaccine 1e+11 unknown Intramuscular