LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
Investigational products: LEISH-F3 (recombinant protein antigen) + GLA-SE (adjuvant)
leishmaniasis vaccine and LEISH-F3 (recombinant protein antigen) + MPL-SE (adjuvant)
leishmaniasis vaccine. Stage of development: Phase 1 clinical development. Healthy adult
subjects, 18 to 49 will be recruited through a U.S. site. Primary objective: To evaluate the
safety and tolerability of the LEISH-F3 + GLA-SE vaccine and the LEISH-F3 + MPL-SE vaccine
following intramuscular (IM) administration of 20 µg of LEISH-F3 together with 2 or 5 µg of
GLA-SE or 10 µg of MPL-SE on Days 0, 28, and 168. Secondary objective: To assess the
immunogenicity of LEISH-F3 formulated with GLA-SE, MPL-SE, or SE by evaluating IgG antibody
responses to LEISH-F3 at Days 0, 28, 56, 168, 196, and 365, and T cell responses to LEISH-F3
at Days 0, 14, 42, 168, 182, and 365. Each subject's duration of participation will be about
18 months.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)