Cutaneous Leishmaniasis
Conditions
Keywords
Leishmaniasis, vaccine, immunotherapy
Brief summary
The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.
Detailed description
A phase 2, randomized, open-label, controlled study to evaluate the efficacy, safety, and immunogenicity of the vaccine administered three times (10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56) in the treatment of adults and adolescents with CL compared to treatment with standard chemotherapy (20 mg/kg/day sodium stibogluconate for 20 days). The proportion cured in each group will be determined using clinical criteria.
Interventions
BIOLOGICALLEISH-F2 + MPL-SE
10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56
20 mg/kg/day IV daily for 20 days
Sponsors
Access to Advanced Health Institute (AAHI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males and females ≥ 12 years and \< 70 years of age. In the first stage of the study, only patients aged ≥ 18 years and \< 70 years will be enrolled. In the second stage, enrollment will also include adolescent patients aged ≥ 12 - \< 18 years. * Must have a clinical diagnosis of cutaneous leishmaniasis confirmed by positive identification of Leishmania parasite and identification of L. peruviana by PCR. * Lesions must be clear of any superinfection prior to enrollment. * Female patients of childbearing age must have a negative serum pregnancy test at screening, a negative urine pregnancy test within 24 hours before the first vaccination or initiation of chemotherapy, must not be breast-feeding, and are required to use adequate contraception through Day 84 of the study. These precautions are necessary due to unknown effects that LEISH-F2 + MPL SE, sodium stibogluconate might have in a fetus or newborn infant. * The following laboratory blood tests must have values within the normal ranges at screening: sodium, potassium, urea, total bilirubin, ALT, AST, glucose, creatinine, alkaline phosphatase, total WBC count and platelet count. Hemoglobin may exceed the ULN since patients reside in the Andes at very high altitude (up to 20 g/dL) * The following serology tests must be negative at screening: HIV-1/2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. All patients (or their parents) will receive HIV-related counseling prior to testing. Patients with positive HIV test results will be referred for counseling and treatment as appropriate. * Potential study patients (or their guardians) must give written informed consent, be willing to be housed in Lima for a minimum of 20 days and up to 63 days, able to attend all required follow-up visits, have a permanent address, and be reachable by study site personnel.
Exclusion criteria
* Infection with species other than L.peruviana as confirmed by PCR. * Presence of eleven or more active cutaneous leishmaniasis lesions. * The diameter of the ulcerated area of any single lesion is \>60 mm. * Presence of lesions with superinfection at time of enrollment. * History of mucocutaneous leishmaniasis or diagnosis of mucocutaneous leishmaniasis at screening. * History of previous exposure to Leishmania vaccines. * Known use of injected or oral corticosteroids within 6 weeks prior to the first vaccination or initiation of chemotherapy. * Participation in another experimental protocol or receipt of any investigational products within 30 days prior to the first vaccination or initiation of chemotherapy. * History of autoimmune disease or other causes of immunosuppressive states. * History or evidence of any acute or chronic illness that, in the opinion of the study clinician, may interfere with the evaluation of the safety or the immunogenicity of the vaccine. (Patients presenting with concomitant illness will be referred for standard clinical care). * History of use of any medication that, in the opinion of the study clinician, may interfere with the evaluation of the safety or the immunogenicity of the vaccine. * History of significant psychiatric illness. * Drug addiction including alcohol abuse. * Patients with a history of previous anaphylaxis, severe allergic reaction to vaccines or unknown allergens, or allergic reaction to eggs. * Patients who are unlikely to cooperate with the requirements of the study protocol. * ECG with evidence of ventricular arrythmias ≥ 4 extra systoles per minute. * Known allergy or contraindication to chemotherapy (e.g., known reaction to pentavalent antimonials, cardiopathy, myocarditis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Date of Clinical Cure | Day 84 | Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure. |
| Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Day 0 through Day 84 | Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | Days 0, 56 or 84, and 168 | Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0. |
Countries
Peru
Participant flow
Recruitment details
Patients with CL were actively recruited from Andean mountain regions endemic for transmission of Leishmania peruviana. Patients were treated in a medical clinic at the Instituto de Medicina Tropical 'Alexander von Humboldt', Universidad Peruana Cayetano Heredia, Lima, Peru.
Pre-assignment details
All eligible patients were randomized to treatment groups. One patient was mistakenly randomized (ineligible) and was not treated.
Participants by arm
| Arm | Count |
|---|---|
| Immunotherapy v1.4/1.5 10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56. | 14 |
| Immunotherapy v1.6 10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28. | 10 |
| Chemotherapy Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days. | 21 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Immunotherapy v1.6 | Chemotherapy | Immunotherapy v1.4/1.5 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 14 Participants | 44 Participants |
| Age Continuous | 32.7 years STANDARD_DEVIATION 6.8 | 40.2 years STANDARD_DEVIATION 16 | 38.3 years STANDARD_DEVIATION 14.2 | 38.0 years STANDARD_DEVIATION 14 |
| Region of Enrollment Peru | 10 participants | 21 participants | 14 participants | 45 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 5 Participants | 18 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 9 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 14 | 10 / 10 | 21 / 21 |
| serious Total, serious adverse events | 1 / 14 | 0 / 10 | 1 / 21 |
Outcome results
Primary
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.
Time frame: Day 0 through Day 84
Population: Safety population: All patients who received at least one study injection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Injection site erythema | 10 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Headache | 3 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Hemoglobin decreased | 3 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Total bilirubin increased | 4 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Alkaline phosphatase increased | 5 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Injection site pain | 8 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Superinfection bacterial | 4 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Injection site induration | 8 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | WBC decreased | 4 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | ALT increased | 8 participants |
| Immunotherapy v1.4/1.5 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Nausea | 0 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Injection site erythema | 9 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Injection site induration | 10 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Superinfection bacterial | 0 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | ALT increased | 4 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Injection site pain | 10 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Alkaline phosphatase increased | 1 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Total bilirubin increased | 1 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Hemoglobin decreased | 0 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | WBC decreased | 1 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Headache | 3 participants |
| Immunotherapy v1.6 | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Nausea | 0 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Headache | 5 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Hemoglobin decreased | 7 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Superinfection bacterial | 0 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Injection site erythema | 0 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | WBC decreased | 10 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Injection site induration | 0 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Alkaline phosphatase increased | 1 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | ALT increased | 10 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Nausea | 3 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Total bilirubin increased | 3 participants |
| Chemotherapy | Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. | Injection site pain | 0 participants |
Primary
Date of Clinical Cure
Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.
Time frame: Day 84
Population: Per-protocol population: All patients who received all three study injections if in the immunotherapy groups or at least 15 injections of SSG if in the chemotherapy group, and completed the Day 56 visit (Immunotherapy v1.6), the Day 84 visit (Immunotherapy v1.4/1.5), or the Day 56 or Day 84 visit (Chemotherapy group).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immunotherapy v1.4/1.5 | Date of Clinical Cure | Clinical cure by Day 84 without rescue treatment | 2 participants |
| Immunotherapy v1.4/1.5 | Date of Clinical Cure | Clinical cure by Day 84 with rescue treatment | 10 participants |
| Immunotherapy v1.6 | Date of Clinical Cure | Clinical cure by Day 84 without rescue treatment | 2 participants |
| Immunotherapy v1.6 | Date of Clinical Cure | Clinical cure by Day 84 with rescue treatment | 5 participants |
| Chemotherapy | Date of Clinical Cure | Clinical cure by Day 84 without rescue treatment | 15 participants |
| Chemotherapy | Date of Clinical Cure | Clinical cure by Day 84 with rescue treatment | 1 participants |
Secondary
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0.
Time frame: Days 0, 56 or 84, and 168
Population: Per-protocol population: patients who received all three study injections (immunotherapy groups) or at least 15 SSG injections (chemotherapy group) and completed the Day 84 or Day 56 visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to LEISH-F2 - Day 56 | NA Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to SLA - Day 168 | 0.2 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to LEISH-F2 - Day 56 | NA Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to SLA - Day 56 | NA Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to SLA - Day 84 | 0.27 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to LEISH-F2 - Day 84 | 0.92 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to LEISH-F2 - Day 168 | 23.93 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to SLA - Day 56 | NA Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to LEISH-F2 - Day 168 | 1.00 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to SLA - Day 168 | 0.952 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to LEISH-F2 - Day 168 | 2.19 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to SLA - Day 56 | NA Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to SLA - Day 84 | 0.63 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to LEISH-F2 - Day 84 | 1.44 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to SLA - Day 84 | 1.6 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to LEISH-F2 - Day 84 | 76.72 Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to LEISH-F2 - Day 56 | NA Relative ELISA Units |
| Immunotherapy v1.4/1.5 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to SLA - Day 168 | 0.63 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to LEISH-F2 - Day 84 | NA Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to LEISH-F2 - Day 56 | 84.56 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to LEISH-F2 - Day 84 | NA Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to LEISH-F2 - Day 168 | 10.26 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to SLA - Day 56 | 1.36 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to SLA - Day 84 | NA Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to SLA - Day 168 | 0.95 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to LEISH-F2 - Day 56 | 4.97 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to LEISH-F2 - Day 84 | NA Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to LEISH-F2 - Day 168 | 2.06 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to SLA - Day 56 | 0.87 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to SLA - Day 84 | NA Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to SLA - Day 168 | 0.31 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to LEISH-F2 - Day 56 | 3.16 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to LEISH-F2 - Day 168 | 0.9 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to SLA - Day 56 | 1.02 Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to SLA - Day 84 | NA Relative ELISA Units |
| Immunotherapy v1.6 | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to SLA - Day 168 | 0.565 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to SLA - Day 56 | 0.69 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to SLA - Day 168 | 0.69 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to SLA - Day 84 | 0.54 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to LEISH-F2 - Day 56 | 2.004 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to SLA - Day 56 | 0.59 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to LEISH-F2 - Day 56 | 1.22 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to LEISH-F2 - Day 84 | 1.17 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to LEISH-F2 - Day 168 | 0.74 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to SLA - Day 168 | 0.763 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to LEISH-F2 - Day 168 | 1.03 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to LEISH-F2 - Day 168 | 0.82 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to LEISH-F2 - Day 84 | 1.333 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to LEISH-F2 - Day 84 | 0.662 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to SLA - Day 56 | 0.84 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to LEISH-F2 - Day 56 | 1.09 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IL-10 response to SLA - Day 84 | 0.92 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IFN-g response to SLA - Day 84 | 0.89 Relative ELISA Units |
| Chemotherapy | IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) | IgG antibody to SLA - Day 168 | 0.33 Relative ELISA Units |