• Type: Subunit vaccine
• Status: Clinical trial
• Host Species for Licensed Use: Human
• Host Species as Laboratory Animal Model: human
• Antigen: LEISH-F1: a polyprotein composed of these three priority candidate antigens (LmSTI1, TSA, LeIF) fused in tandem, Leish-111f(Coler et al., 2002)
• LeIF gene engineering:
  • Type: Recombinant protein preparation
  • Detailed Gene Information: Click Here.
• TSA gene engineering:
  • Type: Recombinant protein preparation
  • Detailed Gene Information: Click Here.
• LmSTI1 gene engineering:
  • Type: Recombinant protein preparation
  • Detailed Gene Information: Click Here.
• Adjuvant:
  • VO ID: VO_0001345
• Immunization Route: subcutaneous injection
• Description: A Leishmaniasis subunit vaccine made of LEISH-F1+MPL-SE (Nascimento et al., 2010)

Human Response

• Vaccination Protocol: a randomized, double-blind, controlled, dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1+MPL-SE vaccine (consisting of 5, 10, or 20 μg recombinant Leishmania polyprotein LEISH-F1 antigen+25 μg MPL-SE adjuvant) (n=27), adjuvant alone (n=8), or saline placebo (n=9). The study injections were given subcutaneously on Days 0, 28, and 56, and the patients were followed through Day 336 for safety, immunological, and clinical evolution endpoints. (Nascimento et al., 2010)
• Immune Response: IgG antibody response to LEISH-F1 in all vaccine recipients, no significant differences in titer among vaccine recipients who received 5, 10, or 20 μg of LEISH-F1 + 25 μg MPL-SE(Nascimento et al., 2010)
• Side Effects: does not induce many AE's (mild or moderate headache and fever in few recipients)(Nascimento et al., 2010)