• Vaccine Ontology ID: VO_0004266
• Type: Subunit vaccine
• Status: Clinical trial
• Antigen: Recombinant Leishmania polyprotein LEISH-F1 (formerly known as Leish-111f) antigen. The antigen component of the vaccine includes three proteins derived from L. major and conserved across various Leishmania species, including L. donovani; L. chagasi, which causes New World VL; and L. braziliensis, which causes both CL and mucosal leishmaniasis (ML) in the New World. The three proteins are: Leishmania elongation initiation factor (LeIF), thiol-specific antioxidant (TSA), and Leishmania major stress-inducible protein 1 (LmSTI1) (Chakravarty et al., 2011).
• Adjuvant: MPL-SE vaccine adjuvant
  • VO ID: VO_0001345
  • Description: 25μg MPL(®)-SE adjuvant (Chakravarty et al., 2011)
• Immunization Route: subcutaneous injection

Human Response

• Vaccination Protocol: The subjects in this trial were healthy male and female adults ≥18 years and <55 years of age from the village near Varanasi that had experienced an outbreak of VL approximately 15 years prior to the start of the trial. Eligible subjects were enrolled into the trial in three sequential cohorts (Fig. 1a). The vaccine consisted of LEISH-F1 antigen (5 μg in Cohort 1, 10 μg in Cohort 2, and 20 μg in Cohort 3) + MPL-SE adjuvant (25 μg), and was administered subcutaneously in the upper arm in a volume of 0.5 mL on days 0, 28, and 56. Subjects were followed through day 168 (Chakravarty et al., 2011).
• Immune Response: There were statistically significant increases in median cytokine concentrations at day 84 compared to day 0 for all measured cytokines except IL-4 in the DAT-positives and IL-10 in both DAT-negatives and DAT-positives, although in some cases the differences were quite small (Chakravarty et al., 2011).
• Side Effects: Malaise was the predominant solicited systemic reaction, followed by myalgia, pyrexia, and headache. All local injection-site and systemic reactions were of mild or moderate severity (Chakravarty et al., 2011).
• Description: The LEISH-F1 + MPL-SE vaccine was safe and well-tolerated in this population of DAT-negative and DAT-positive subjects (Chakravarty et al., 2011).

Human Response

• Vaccination Protocol: The subjects in this trial were healthy male and female adults ≥18 years and <55 years of age from the village near Varanasi that had experienced an outbreak of VL approximately 15 years prior to the start of the trial. Eligible subjects were enrolled into the trial in three sequential cohorts (Fig. 1a). The vaccine consisted of LEISH-F1 antigen (5 μg in Cohort 1, 10 μg in Cohort 2, and 20 μg in Cohort 3) + MPL-SE adjuvant (25 μg), and was administered subcutaneously in the upper arm in a volume of 0.5 mL on days 0, 28, and 56. Subjects were followed through day 168 (Chakravarty et al., 2011).
• Immune Response: There were statistically significant increases in median cytokine concentrations at day 84 compared to day 0 for all measured cytokines except IL-4 in the DAT-positives and IL-10 in both DAT-negatives and DAT-positives, although in some cases the differences were quite small (Chakravarty et al., 2011).
• Side Effects: Malaise was the predominant solicited systemic reaction, followed by myalgia, pyrexia, and headache. All local injection-site and systemic reactions were of mild or moderate severity (Chakravarty et al., 2011).
• Description: The LEISH-F1 + MPL-SE vaccine was safe and well-tolerated in this population of DAT-negative and DAT-positive subjects (Chakravarty et al., 2011).