Phase I, Double-Blinded, Placebo-Controlled Dosage-Escalation Study of the Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly in Semi-immune Adults

NCT01026246 Phase 1 COMPLETED

Malaria is caused by a germ that people get from the bites of some mosquitoes. It kills over 2 million people each year. Many of the drugs used to treat malaria do not work as well as they used to and researchers are exploring other vaccines to prevent malaria. The purpose of this study is to learn if the vaccine, called EBA-175 RII-NG, is safe and if it strengthens the body's defenses against malaria. Participants will include 60 healthy adults, ages 18-40, recruited from Accra, Ghana. Several dosages of the vaccine will be tested for safety. The lowest dosages of the vaccine will be tested before the next higher dose is tested. There will be two groups for each dose, one group will receive the vaccine and the other group will receive a placebo (salt water solution). Participants may be involved in study related procedures for up to 398 days.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	COMPLETED
Enrolment	60
Start date	2010-06
Completion	2012-03

Conditions

• Plasmodium Falciparum Malaria

Interventions

• Placebo
• EBA-175 RII-NG Malaria Vaccine

Primary outcomes

• Number of subjects experiencing severe (Grade 3) solicited injection site reactions. — Within 14 days following vaccination.
• Number of subjects experiencing severe solicited systemic reactions (Grade 3). — Within 14 days following vaccination.
• Number of subjects experiencing severe (Grade 3) clinical laboratory values. — Within 14 days following vaccination.
• Number of subjects spontaneously reporting adverse events considered associated with the vaccination that are severe (Grade 3). — Duration of study.
• Serious adverse events considered associated with the vaccination. — Duration of study.

Countries

Ghana