Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
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ClinicalTrials.gov Identifier: NCT03947437 |
Recruitment Status :
Withdrawn
(Finances)
First Posted : May 13, 2019
Last Update Posted : July 29, 2020
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Condition or disease | Intervention/treatment | Phase |
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Leprosy | Biological: LEP-F1 + GLA-SE Biological: Placebo | Phase 1 Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
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 |
Official Title: | 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 |
Estimated Study Start Date : | October 2019 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2021 |

Arm | Intervention/treatment |
---|---|
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.
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Biological: LEP-F1 + GLA-SE
Leprosy antigen formulated with an adjuvant.
Other Name: LepVax |
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.
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Biological: LEP-F1 + GLA-SE
Leprosy antigen formulated with an adjuvant.
Other Name: LepVax |
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.
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Biological: LEP-F1 + GLA-SE
Leprosy antigen formulated with an adjuvant.
Other Name: LepVax |
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.
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Biological: Placebo
Sterile normal saline for injection. |
- 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 ]
- 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 ]

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.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Males and females ≥ 18 years and ≤ 55 years of age.
- 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.
- 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.
- 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.
- Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and QuantiFERON®-TB Gold (QFT).
- Normal or not clinically significant urinalysis as determined by the study clinician or designee. Abnormal results may be repeated at Investigator discretion.
- Subject is capable of completing a study memory aid.
- 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:
- For Cohort 1, history of infection with M. leprae.
- Previous exposure to M. leprae vaccines or experimental products containing GLA-SE.
- History of active or documented latent TB.
- History of previous infection with other non-tuberculous mycobacteria.
- Participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to Enrollment.
- 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.
- Received a blood transfusion within 3 months prior to Enrollment.
- Donated blood products (platelets, whole blood, plasma, etc.) within 30 days prior to Enrollment.
- 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.
- History of autoimmune disease or other causes of immunosuppressive states.
- 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.
- Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
- BMI ≥ 32.
- Hypertension (systolic > 150 or diastolic > 95).
- History of significant psychiatric illness with current use of medication.
- Known or suspected alcohol or drug abuse within the past 6 months prior to Screening.
- Smokes 1 pack or more of cigarettes per day.
- History of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
- Participants who are unlikely to cooperate with the requirements of the study protocol.

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): NCT03947437
Brazil | |
Oswaldo Cruz Institute (Fiocruz) | |
Rio de Janeiro, Rj, Cep, Brazil, 21040-900 |
Study Chair: | Corey Casper, MD, MPH | IDRI |
Responsible Party: | IDRI |
ClinicalTrials.gov Identifier: | NCT03947437 |
Other Study ID Numbers: |
IDRI-LEPVPX-119 |
First Posted: | May 13, 2019 Key Record Dates |
Last Update Posted: | July 29, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Leprosy Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |