Visceral Leishmaniasis Clinical Trial
Official title:
A Phase 1, Open-Label, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-111F + MPL-SE Vaccine (Recombinant Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE) in Healthy Adults In India
The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects.
The purpose of this study is to determine the safety, tolerability, and immunogenicity of an
investigational vaccine being developed for immunotherapy of visceral leishmaniasis (VL) and
post kala-azar dermal leishmaniasis (PKDL). The vaccine, identified as Leish-111f + MPL-SE,
consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f) together with
adjuvant MPL-SE.
The primary objective is to evaluate the safety and tolerability of the Leish-111f + MPL-SE
vaccine given as three subcutaneous injections every 28 days at each of three dose levels of
the Leish-111f protein (5 μg, 10 μg, or 20 μg) together with MPL-SE adjuvant (25 μg) in
healthy adults.
The secondary objective is to assess the immunogenicity of the vaccine by evaluating T-cell
and antibody response to the Leish-111f protein of the vaccine.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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