None listed
Conditions
Interventions
active leishmaniasis Type of group
Intradermal injections of MFL-LSTA in saline and a dilution of 1: 100 of the diluent in patients with active leishmaniasis diagnosed by visualization of the parasite will be applied.
Group name:cured leishmaniasis Type of group
Intradermal injections of MFL-LSTA in saline and a dilution of 1: 100 of the diluent in patients with cured leishmaniasis will be applied.
Sponsors
INSTITUTO DE INVESTIGACION DE ENFERMEDADES TROPICALES DE LA MARINA DE LOS E.E.U.U (NMRCD),
Eligibility
Inclusion criteria
Inclusion criteria: • Man or Woman in good health • Age between 18 and 65 • No occupational exposure or other history of exposure to Leishmania (only Healthy Volunteers group) • Present and past confirmed history of Leishmaniasis by visualization of the parasite (group of Cured Leishmaniasis and group of Active Leishmaniasis) • Use of leishmanin (only Sensitization group)
Exclusion criteria
Exclusion criteria: • History of adult atopic dermatitis, contact dermatitis with multiple agents, unexplained urticaria or asthma • Rhinitis or active allergic conjunctivitis • Allergy to phenol, pharmaceutical detergents, Tween 80 or glycerol • Drugs: Steroids, Antihistamines, Cimetidine, Immunosuppressants in the last 3 months • Splenectomy • Pregnancy or breast-feeding • Active cutaneous leishmaniasis with scar (ees), for example, possible re-infections and cases of residual leishmaniasis. • Immunization in the last 4 weeks • Anergy of the DTH test (less than 5 mm induration) • Abnormal laboratory screening results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The record of adverse events Measure:SECURITY PARAMETERS / ADVERSE EVENTS Timepoints:throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:a) size of the induration that accompanies the DTH (power) response in the three different doses; b) the percentage of people with active leishmaniasis in whom the antigen induced a positive DTH reaction (> 5 mm) (sensitivity). c) the percentage of healthy volunteers in whom the antigen did not induce a positive DTH reaction (specificity). Measure:EVALUATION OF EFFECTIVENESS Timepoints:throughout the study | — |
Countries
Peru, United States
Outcome results
None listed