Safety and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine With SSG for Patients With PKDL

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00982774
• Date of registration: 21/09/2009
• Primary sponsor: Infectious Disease Research Institute
• Public title: Safety and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine With SSG for Patients With PKDL
• Scientific title: Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in Combination With SSG in the Treatment of Patients With PKDL
• Date of first enrolment: April 2009
• Target sample size: 42
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00982774
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Sudan

Contacts

• Name: Franco Piazza, MD, MPH
• Affiliation: IDRI

• Name: Eltahir AG Khalil, MBBS
• Affiliation: IEND

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and females = 7 years and < 40 years of age.

- Must have a skin rash of > 6 months duration compatible with a diagnosis of PKDL
following a history of successful treatment of VL, and histopathology consistent with
PKDL (Section 6.1).

- Female patients of child bearing age must have a negative serum pregnancy test at
screening, a negative urine pregnancy test within 24 hours before study injection,
must not be breast-feeding, and are required to use adequate contraception through
Day 59 of the study. These precautions are necessary due to unknown effects that
LEISH-F2 + MPL-SE might have in a fetus or newborn infant.

- The following laboratory blood tests must have values within the normal ranges at
screening (Appendix 3): sodium, potassium, urea, total bilirubin, glucose,
creatinine, hemoglobin and platelet count. ALT, AST, alkaline phosphatase, and total
WBC count values (commonly elevated in PKDL patients) must be below grade 2 at
screening (Appendix 3).

- The following serology tests must be negative at screening: HIV 1/2 (in patients >14
years of age), 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 receive counseling at the
University and will be referred to the national AIDS control program for treatment if
appropriate.

- Normal ECG.

- Potential study patients (or their guardians) must give written informed consent, be
willing to be admitted to hospital for a minimum of 40 days and up to 60 days, able
to attend all required follow-up visits, have a permanent address, and be reachable
by study site personnel.

Exclusion Criteria:

- Presence of other skin conditions.

- Anti-leishmanial treatment within the past 30 days.

- History of previous exposure to Leishmania vaccines.

- Known use of injected or oral corticosteroids within 6 weeks prior to the first
administration of study injection.

- Participation in another experimental protocol or receipt of any investigational
products within 30 days prior to the first administration of study injection.

- 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
Principal Investigator, 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 Principal Investigator,
may interfere with the evaluation of the safety or the immunogenicity of the vaccine.

- History of significant psychiatric illness.

- Known to be a current drug or alcohol abuser.

- 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.

- Known allergy or contraindication to SSG.

- Regardless of eligibility, standard clinical care will be provided (at no cost to the
patient) to all PKDL patients screened for participation in the study.



Age minimum: 7 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Post Kala Azar Dermal Leishmaniasis

Intervention(s)

Biological: LEISH-F2 + MPL-SE vaccine

Primary Outcome(s)

Evaluate the safety of the vaccine given as 3 sc injections every 14 days in combination with standard SSG therapy in patients with persistent PKDL. [Time Frame: one year]

Secondary Outcome(s)

Assess the effect of the vaccine on the clinical course of PKDL. [Time Frame: one year]

To evaluate the immunogenicity of the vaccine by evaluating antibody and T-cell responses to the LEISH-F2 protein and Soluble Leishmania Antigen (SLA). [Time Frame: one year]

Secondary ID(s)

IDRI-LVPTC-107

Source(s) of Monetary Support

Please refer to primary and secondary sponsors