NCT01026246

EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly in Semi-immune Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Malaria accounts for 500 million febrile illnesses and more than a million deaths annually. The disease burden is heaviest in economically developing countries where it is estimated that up to 5 percent of the gross domestic product of sub-Saharan countries is consumed by the direct and indirect health costs of malaria. Researchers propose to conduct a Phase I dosage-escalating study to assess the safety and immunogenicity of 3 different dosages of erythrocyte-binding antigen 175 kDA region II-nonglycosylated (EBA-175 RII-NG) recombinant Plasmodium falciparum (Pf) vaccine adjuvanted with Adju-Phos (aluminum phosphate adjuvant): 5, 20, and 80 micrograms (mcg), given in 3 doses at 0, 1, and 6 months by intramuscular (IM) injection to healthy young adults in a malaria endemic area (semi-immune adults). One dose of vaccine will be given at each time point. The primary objective is to assess the safety and reactogenicity (tolerability) of ascending dosages of EBA-175 RII-NG vaccine among healthy subjects given in 3 IM doses at 0, 1 and 6 months. The secondary objective is to evaluate the immunogenicity of the EBA-175 RII-NG vaccine by measuring anti-EBA-175 RII-NG antibodies using enzyme-linked immunosorbent assay (ELISA), inhibition of Plasmodium falciparum growth in vitro, and inhibition of binding of EBA-175 RII-NG to red blood cells (RBCs). Participants will include 60 malaria semi-immune healthy subjects between the ages of 18 and 40 years, males and females, recruited from Accra, Ghana. Subjects will be randomized to receive 3 doses of the vaccine or saline placebo by the intramuscular route in a 9:1 ratio at 0, 1 and 6 months. The safety and immunogenicity of ascending dosages of the vaccine will be assessed. Eighteen subjects will receive vaccine at each of the following dosage levels: 5, 20, and 80 mcg. Two subjects will receive placebo for each dosage level. Dosage escalation will proceed only after review of the 2-week safety data of the 2 initial doses of the prior dosage level.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Placebo	The placebo used will be normal saline (0.9 percent NaCl).
BIOLOGICAL	EBA-175 RII-NG Malaria Vaccine	EBA-175 RII-NG malaria vaccine is supplied as a white, translucent, cloudy, nonparticulate liquid suspension in single-dose clear glass vials pre-mixed with Adju-Phos aluminum phosphate adjuvant. Each 2-mL vial of EBA-175 RII-NG vaccine contains: 0.7 mL (0.5 mL per dose) EBA-175 RII-NG, at the required dose concentration, 5 percent sucrose, 1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant, sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride), and no preservative.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-12-04
• Last updated: 2013-03-29

Locations

1 site across 1 country: Ghana