drugset / Trial / NCT00347555

Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly

NCT00347555

RandomizedParallel-groupTriple-blindPrevention

Summary

Malaria is an illness caused by a parasite (an animal or plant that lives in or on a host) that enters the human body through the bite of an infected mosquito. The purpose of this study is to find out about the safety of an experimental malaria vaccine and whether the vaccine causes humans to produce antibodies (proteins made by the body's immune system to help control or prevent infection). Four strengths of the vaccine will be tested. The lowest strength of the vaccine will be tested before the next higher strength is tested. Each dosage (shot) of vaccine will be given to 18 people in 4 dosage groups on Day 0, at 1 month and at 6 months. Two people in each dosage group will receive injections of a placebo (contains no medication). Participants will include 80 healthy adults between 18 and 40 years of age. Multiple blood draws will occur over the duration of the study. Participants will be involved in study related procedures for approximately 13 months.

Timeline

Start
2006-05
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject EBA-175 RII-NG Vaccine 5 ug Intramuscular
Subject EBA-175 RII-NG Vaccine 20 ug Intramuscular
Subject EBA-175 RII-NG Vaccine 80 ug Intramuscular
Subject EBA-175 RII-NG Vaccine 160 ug Intramuscular
Background Aluminum Phosphate Unknown 500 ug