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Safety, Tolerability, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in Combination With Sodium Stibogluconate (SSG) in the Treatment of Patients With Post Kala-Azar Dermal Leishmaniasis (PKDL)
This study is currently recruiting participants.
Verified by Infectious Disease Research Institute, September 2009
First Received: September 21, 2009   Last Updated: September 22, 2009   History of Changes
Sponsor: Infectious Disease Research Institute
Information provided by: Infectious Disease Research Institute
ClinicalTrials.gov Identifier: NCT00982774
  Purpose

A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given at 14-day intervals as an adjunct to standard chemotherapy with sodium stibogluconate (20 mg/kg/day for 40 days) in patients with PKDL.


Condition Intervention Phase
Post Kala Azar Dermal Leishmaniasis
Biological: LEISH-F2 + MPL-SE vaccine
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine (Recombinant Three-antigen Leishmania Polyprotein LEISH-F2 With Adjuvant MPL-SE in Combination With Sodium Stibogluconate in the Treatment of Patients With Post Kala-Azar Dermal Leishmaniasis

Resource links provided by NLM:


Further study details as provided by Infectious Disease Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the effect of the vaccine on the clinical course of PKDL. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: April 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: LEISH-F2 + MPL-SE vaccine
    LEISH-F2 protein (10 ug) + MPL-SE (25ug) Three injections, 14 days apart
  Eligibility

Ages Eligible for Study:   7 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982774

Contacts
Contact: Eltahir A.G. Khalil, MBBS, MRCS +24911793267 eltahirk@iend.org

Locations
Sudan
IEND Recruiting
Khartoum, Sudan
Sponsors and Collaborators
Infectious Disease Research Institute
Investigators
Principal Investigator: Eltahir AG Khalil, MBBS IEND
Study Director: Franco Piazza, MD, MPH IDRI
  More Information

No publications provided

Responsible Party: Institute of Endemic Diseases and Infectious Disease Research Institute ( Professor Eltahir Khalil/PI and Franco Piazza/IDRI Study Director )
Study ID Numbers: IDRI-LVPTC-107, BMGF #39129
Study First Received: September 21, 2009
Last Updated: September 22, 2009
ClinicalTrials.gov Identifier: NCT00982774     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Infectious Disease Research Institute:
PKDL

Additional relevant MeSH terms:
Leishmaniasis
Anti-Infective Agents
Protozoan Infections
Antiprotozoal Agents
Skin Diseases, Parasitic
Skin Diseases
Antiplatyhelmintic Agents
Mastigophora Infections
Anthelmintics
Schistosomicides
Pharmacologic Actions
Antiparasitic Agents
Skin Diseases, Infectious
Antimony Sodium Gluconate
Therapeutic Uses
Leishmaniasis, Visceral
Sarcomastigophora Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on February 08, 2010