Trial LEP-F1 + GLA-SE in Healthy Adult in Areas Endemic for Leprosy

Launched by THE IMMUNOBIOLOGICAL TECHNOLOGY INSTITUTE (BIO-MANGUINHOS) / OSWALDO CRUZ FOUNDATION (FIOCRUZ) · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial, called LEP-F1 + GLA-SE, is studying a new vaccine aimed at preventing leprosy, a disease caused by bacteria. The trial is in its early phase and will involve healthy adults aged 18 to 55 who live in areas where leprosy is more common. Participants will receive three injections of either the vaccine or a placebo (a harmless substance that looks like the vaccine but has no effect) to see how safe the vaccine is, how well it is tolerated, and whether it stimulates an immune response.

To join the trial, participants must be in good health and not have a history of leprosy or any serious medical conditions. Women who can become pregnant must meet specific requirements regarding pregnancy tests and contraception. Participants will need to commit to attending all study visits and keeping a diary of any side effects they might experience. The trial is not yet recruiting, but if you're eligible and interested, it could be an opportunity to help researchers learn more about leprosy prevention.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women between 18 and 55 years old.
• • They should be in good general health, confirmed by a medical history and physical examination, with negative clinical evaluation for leprosy.
• • Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on study vaccination days (D0, D28, and D56). They must not be breastfeeding and must use at least one method of contraception from the time of study enrollment (Day 0) through 30 days after the last injection if they have sex with men.
• • Screening laboratory tests with normal, within laboratory reference limits for: sodium, potassium, AST, ALT, total bilirubin, alkaline phosphatase, creatinine, glucose, total WBC count, hemoglobin and platelet count. Abnormal results may be repeated at the discretion of the Principal Investigator and/or sub-investigators, who may share doubts with the sponsor's Scientific Leader and if necessary, with the DSMB.
• • Negative serological tests for: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
• • Normal or not clinically significant urinalysis as determined by the study doctor or designee. Abnormal results may be repeated at the discretion of the Principal Investigator.
• • Must be able to complete the study adverse events diary.
• • Must consent to participate in the study, be able and willing to make all evaluation visits, be accessible by telephone or home visits, and live in the region until study follow-up completion.
• • Having completed the primary vaccination course for Covid 19, at least 14 days before inclusion in the study. If 14 days have not been completed, the participant may be rescheduled for a new eligibility assessment
• Exclusion Criteria:
• • History of infection with Mycobacterium leprae.
• • History of exposure to experimental products containing GLA-SE.
• • History of active tuberculosis or documented recurrence.
• • History of previous infection with other non-tuberculous mycobacteria.
• • Participation in another trial protocol and/or receipt of any trial products in the last 3 months prior to screening.
• • Treatment with immunosuppressive drugs (eg, oral or injectable steroids such as prednisone; high-dose inhaled steroids) or cytotoxic therapies (eg, chemotherapy or radiotherapy) within six months prior to screening.
• • Have received blood transfusion within the last 3 months prior to screening.
• • Donated blood products (platelets, whole blood, plasma, etc.) within the last month prior to screening.
• • Received any vaccine 1 month prior to screening or planned immunizations during the follow-up from D0 to D63 and D154 to D168.
• • History of autoimmune disease or other immunosuppressive causes.
• • History of any other uncompensated acute or chronic disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disease, uncontrolled hypertension) or use of medications that, in the opinion of the Principal Investigator, may interfere with safety or immunogenicity of the vaccine.
• • Rash, tattoos, or any other dermatological condition that may adversely affect the injection site of the vaccine or interfere with its evaluation.
• • Body mass index (BMI) ≥ 32.
• • Systemic arterial hypertension (systolic \> 150 or diastolic \> 95).
• • History of psychiatric illness with current medication use.
• • Alcohol or drug abuse in the last 6 months prior to screening.
• • Chronic smoker (1 pack or more per day).
• • History of previous anaphylaxis or severe allergic reaction to unknown vaccines or allergens.
• • Individuals who do not wish to cooperate with all procedures recommended in the study protocol.