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Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients

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. Identifier: NCT03947437
Recruitment Status : Withdrawn (Finances)
First Posted : May 13, 2019
Last Update Posted : July 29, 2020
Oswaldo Cruz Institute
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date July 29, 2020
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Number of participants experiencing solicited AEs [ Time Frame: 7 days following each injection ]
  • Number of participants experiencing unsolicited AEs [ Time Frame: Days 0 to 84 ]
  • Number of participants experiencing medically-attended adverse events considered related to any of the study injections [ Time Frame: Days 0 to 421 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • IgG antibody responses to LEP-F1 by ELISA [ Time Frame: Days 0, 35, and 63 ]
  • T cell responses measured by selected cytokine production to LEP-F1 by whole blood assay [ Time Frame: Days 0, 35, and 63 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
Official Title  ICMJE A Phase 1b / 2a, Double-Blind, Randomized, Placebo-Controlled, Antigen Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of LEP-F1 + GLA-SE in Adult Participants in Areas Endemic for Leprosy
Brief Summary This is a phase 1b/2a, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of the LEP-F1 + GLA-SE investigational vaccine compared to placebo.
Detailed Description

The proposed clinical trial will establish an initial safety profile for the vaccine in a region endemic for leprosy. The trial will enroll both healthy participants and paucibacillary leprosy patients receiving standard-of-care therapy. Safety at the lower vaccine dose will be demonstrated in healthy participants prior to antigen dose-escalation. Further, safety in all healthy participants will be demonstrated prior to enrolling leprosy patients.

Participants will be randomized within each Group to receive three doses of vaccine or placebo administered IM on Days 0, 28, and 56. Participants will be monitored for one year following the last study injection.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants, investigators, outcomes assessors, and laboratory personnel performing immunology assays will be blinded to treatment assignment. However, the study product administrators will be unblinded due to a difference in product appearance. These personnel will not be involved in study-related assessments or have participant contact for data collection following study injection.
Primary Purpose: Treatment
Condition  ICMJE Leprosy
Intervention  ICMJE
  • Biological: LEP-F1 + GLA-SE
    Leprosy antigen formulated with an adjuvant.
    Other Name: LepVax
  • Biological: Placebo
    Sterile normal saline for injection.
Study Arms  ICMJE
  • Experimental: Low dose
    2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants.
    Intervention: Biological: LEP-F1 + GLA-SE
  • Experimental: High dose
    10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants.
    Intervention: Biological: LEP-F1 + GLA-SE
  • Experimental: TBD dose in patients
    TBD μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in paucibacillary leprosy patients. Dose will be determined by safety and immunogenicity data from healthy participants.
    Intervention: Biological: LEP-F1 + GLA-SE
  • Placebo Comparator: Placebo
    Sterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 27, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females ≥ 18 years and ≤ 55 years of age.
  2. For Cohort 1, participants must be in good general health as confirmed by a medical history and physical exam. For Cohort 2, patients must have confirmed diagnosis of paucibacillary leprosy.
  3. Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study vaccination, must not be breast-feeding, and are required to use one of the following methods of contraception from enrollment in study until 30 days after last injection (only if in sexual relationships with men): hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy. These precautions are necessary due to unknown effects that LEP-F1 + GLA-SE might cause in a fetus or newborn infant. Women are considered non-child-bearing potential if they are post-menopausal (menopause defined as at least 12 months spontaneous amenorrhea) or have had documented hysterectomy and/or oophorectomy.
  4. Screening laboratory values within the normal ranges or not clinically significant as determined by the Investigator and approved by the Medical Monitor: sodium, potassium, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobin, and platelet count. Abnormal results may be repeated once for confirmation at Investigator discretion.
  5. Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and QuantiFERON®-TB Gold (QFT).
  6. Normal or not clinically significant urinalysis as determined by the study clinician or designee. Abnormal results may be repeated at Investigator discretion.
  7. Subject is capable of completing a study memory aid.
  8. Subject gave informed consent, is able and willing to make all evaluation visits, is reachable by telephone or personal contact by the study site personnel, and is willing to remain in the study area for the duration of the trial.

Exclusion Criteria:

  1. For Cohort 1, history of infection with M. leprae.
  2. Previous exposure to M. leprae vaccines or experimental products containing GLA-SE.
  3. History of active or documented latent TB.
  4. History of previous infection with other non-tuberculous mycobacteria.
  5. Participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to Enrollment.
  6. Received any vaccine within 30 days prior to Enrollment or plan to have any immunizations between Days 0-63 due to the washout period prior to immunology blood draws.
  7. Received a blood transfusion within 3 months prior to Enrollment.
  8. Donated blood products (platelets, whole blood, plasma, etc.) within 30 days prior to Enrollment.
  9. Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to Enrollment.
  10. History of autoimmune disease or other causes of immunosuppressive states.
  11. History of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension), or use of medication that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
  12. Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
  13. BMI ≥ 32.
  14. Hypertension (systolic > 150 or diastolic > 95).
  15. History of significant psychiatric illness with current use of medication.
  16. Known or suspected alcohol or drug abuse within the past 6 months prior to Screening.
  17. Smokes 1 pack or more of cigarettes per day.
  18. History of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
  19. Participants who are unlikely to cooperate with the requirements of the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03947437
Other Study ID Numbers  ICMJE IDRI-LEPVPX-119
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party IDRI
Study Sponsor  ICMJE IDRI
Collaborators  ICMJE Oswaldo Cruz Institute
Investigators  ICMJE
Study Chair: Corey Casper, MD, MPH IDRI
PRS Account IDRI
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP