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

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

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

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.
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.