Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
Leprosy
About this trial
This is an interventional treatment trial for Leprosy
Eligibility Criteria
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.
Sites / Locations
- Veronica Schmitz Pereira
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Low dose
High dose
TBD dose in patients
Placebo
2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants.
10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants.
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.
Sterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients.