NCT02508376View on ClinicalTrials.gov

Safety, Tolerability, and Immunogenicity of the Vaccine Candidates ID93 + AP10-602 and ID93 + GLA-SE Administered Intramuscularly in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

October 22, 2015

Primary Completion Date

August 31, 2017

Study Completion Date

August 31, 2017

Conditions
Tuberculosis
Interventions
OTHER

AP10-602

AP10-602 contains GLA formulated with liposomes and an additional immunological adjuvant. The ID93 (10 mcg) + AP10-602 (5 mcg) arm will receive intervention on days 1, 29 and 57. The ID93 (10 mcg) + AP10-602 (10 mcg) arm will receive intervention on days 1, 29 and 57.

BIOLOGICAL

GLA-SE

Glucopyranosyl Lipid A- Stable oil-in-water emulsion (GLA-SE). The ID93 (10 mcg) + GLA-SE (5 mcg) arm will receive intervention on days 1, 29 and 57

BIOLOGICAL

ID93

ID93 is a fusion polyprotein comprising four Mtb antigens (Rv2608, Rv3619, Rv3620, Rv1813). All arms will receive 10 mcg ID93 IM on days 1, 29 and 57

Trial Locations (1)

52242-2600

University of Iowa - Vaccine Research and Education Unit, Iowa City

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02508376 - Safety, Tolerability, and Immunogenicity of the Vaccine Candidates ID93 + AP10-602 and ID93 + GLA-SE Administered Intramuscularly in Healthy Adult Subjects | Biotech Hunter | Biotech Hunter