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Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis

PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STEP-LAGED DOSE TO ASSESS THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF THE LEISH-111F + MPL-SE VACCINE (RECOMBINANT THREADED ANTIGENS OF LEISHMANIA WITH MPL-SE ADJUVANT) IN COMBINATION WITH ANTIMONIAL PENTAVALENTE IN THE TREATMENT OF ADULT PATIENTS WITH MUCOSA LEISHMANIASIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-013-04
Enrollment
48
Registered
2004-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

5 mg Leish-111f + MPL-SE vaccine Type of group
5 pg Leishl 11 -f + 25 pg MPL-SE adjuvant, administered at 4-week intervals, as an adjunct to conventional pentavalent antimonial chemotherapy (20 mg / Kg / day for 28 days) in patients with leshmaniasis. Group name:20 mg vaccine Leish-111 f + MPL-SE Type of group
20 pg Leishl 11 -f + 25 pg MPL-SE adjuvant, administered at 4-week intervals, as an adjunct to conventional pentavalent antimonial chemotherapy (20 mg / Kg / day for 28 days) in patients with leshmaniasis.

Sponsors

INFECTIOUS DISEASES RESEARCH INSTITUTE,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with mucosal leishmaniasis confirmed by a positive smear, in vitro culture or PCR test

Exclusion criteria

Exclusion criteria: Mucosal leishmaniasis must not involve the vocal cords or cause respiratory distress, and there must be no evidence of other disease.

Design outcomes

Primary

MeasureTime frame
Outcome name:Occurrence of dose-limiting toxicity Measure:Occurrence of dose-limiting toxicity Timepoints:throughout the study—

Secondary

MeasureTime frame
Outcome name:Response of IgG and T cells to the Leish-111f vaccine Measure:Response of IgG and T cells to the Leish-111f vaccine Timepoints:throughout the study—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)