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Table 2 Treatment Groups in Patients with Cutaneous Leishmaniasis (Brazil)

From: Consultation meeting on the development of therapeutic vaccines for post kala azar dermal leishmaniasis

Cohort N Treatment Timing of Treatment
    Study Injections Pentavalent Antimony (Sb5+)
# 1 9
3
3
5 μg Leish-111f in 25 μg MPL-SE + Sb5+
25 μg MPL-SE + Sb5+
Placebo (saline) + Sb5+
Day 0, Day 28 and Day 56 SMC1
# 2* 9
3
3
10 μg Leish-111f in 25 μg MPL-SE + Sb5+
25 μg MPL-SE + Sb5+
Placebo (saline) + Sb5+
Day 0, Day 28 and Day 56 SMC1
# 3** 9
32
3
20 μg Leish-111f in 25 μg MPL-SE + Sb5+
25 μg MPL-SE + Sb5+
Placebo (saline) + Sb5+
Day 0, Day 28 and Day 56 SMC1
  1. 1SMC = Standard multiple cycles: 10 days of pentavalent antimony (10 mg/kg IM or IV once daily) starting on Day 0, followed by 11 days of no antimony. Cycles are repeated until cure is achieved.
  2. 2Only 2 patients were randomized to adjuvant in the third cohort (inability to recruit 15 patients). Sequential enrollment of cohorts: * = after Day 84 of cohort 1; ** = after Day 84 of cohort 2.