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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00982774
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
IDRI

Brief Summary:
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 or disease Intervention/treatment Phase
Post Kala Azar Dermal Leishmaniasis Biological: LEISH-F2 + MPL-SE vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: LEISH-F2 + MPL-SE vaccine
    LEISH-F2 protein (10 ug) + MPL-SE (25ug) Three injections, 14 days apart


Primary Outcome Measures :
  1. 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 Measures :
  1. Assess the effect of the vaccine on the clinical course of PKDL. [ Time Frame: one year ]
  2. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982774


Locations
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Sudan
IEND
Khartoum, Sudan
Sponsors and Collaborators
IDRI
Investigators
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Principal Investigator: Eltahir AG Khalil, MBBS IEND
Study Director: Franco Piazza, MD, MPH IDRI
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Responsible Party: Professor Eltahir Khalil/PI and Franco Piazza/IDRI Study Director, Institute of Endemic Diseases and Infectious Disease Research Institute
ClinicalTrials.gov Identifier: NCT00982774    
Other Study ID Numbers: IDRI-LVPTC-107
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
Keywords provided by IDRI:
PKDL
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases