Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability, and Immunogenicity of Leish-111f + MPL-SE Vaccine in Combination With Pentavalent Antimony in Treatment of Mucosal Leishmaniasis
Brief Summary: The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein, in combination with standard pentavalent antimony therapy in adult patients with mucosal leishmaniasis.


Options:
A: Inclusion Criteria:

* Gender: Male or female
* Age: \>12 yrs of age
* Presentation: 1-to-2 ulcerative lesions, each \< 30 mm in largest diameter and with a total lesion area \<900 mm2.
* Parasitology: Parasitological confirmation of the lesion will be made by visualization or culture of Leishmania from the biopsy or aspirate of the lesion.

Exclusion Criteria:

* Previous treatment for leishmaniasis with Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol in the last 3 months.
* Other diseases that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.
B: Inclusion Criteria:

* Subject with a confirmed infection due to L. braziliensis by polymerase chain reaction assay
* Subject has a lesion that satisfies the following criteria:
* ulcerative in character
* ulcer size equal or more than 0.5 cm and 3 cm (Longest diameter)
* not located on the ear, face, close to mucosal membranes, joints or on a location that in the opinion of the PI is difficult to maintain application of study drug topically.
* Subject with up to 3 lesions.
* Duration of lesion less than 3 months by patient history
* Subject able to give written informed consent and that the opinion of the investigator, the subject is capable of understanding and complying with the protocol

Exclusion Criteria:

* Female with a positive serum pregnancy test at screening or who is breast feeding, lactating or female at fertile age who does not agree to take appropriate contraception during treatment period up to Day 45.
* History of clinically significant medical problems or treatment that might interact, either negatively or positively, with topical treatment of leishmaniasis including any immunocompromising condition.
* Within 8 weeks (56 days) of starting study treatments, received treatment for leishmaniasis with any medication including antimonials likely, in the opinion of the PI, to modify the course of the Leishmania infection
* Has diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on physical exam.
* History of known or suspected hypersensitivity or idiosyncratic reactions to amphotericin
* Has laboratory values at screening as follow: Haemoglobin below 10 grams, Serum creatinine above normal level, alanine aminotransferase and or aspartate aminotransferase 3 times above normal range
C: Inclusion Criteria:

* Parasitologically proven cases of CL based on positive smear and/or culture.
* Patients belonging to the National Colombian Army.
* Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician)
* Age 18-40 years.
* Willing to participate in the study, sign the informed consent , to go to the scheduled visits and to the follow-up visits.
* Abstain to receive any other treatment for CL during the trial and follow-up periods.
* Non purulent lesions.
* Mentally sane volunteers.
* No Leishmaniasis treatment in the six months prior to the recruitment.
* Number of lesions no more than 5

Exclusion criteria:

* None of the lesions must be close to the anal, oral and nasal mucosa, or next to the urogenital and anal canal.
* Serious systemic illnesses (as judged by the physician)
* Patients with mucosal compromise.
* Patients with diffuse Leishmaniasis ( defined as 10 or more cutaneous lesions and negative Montenegro's test)
D: Inclusion Criteria:

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

Exclusion Criteria:

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

Answer: D