Leprosy
Conditions
Interventions
The study will include 30 healthy participants in phase 1b and 24 participants diagnosed with paucibacillary leprosy undergoing multidrug therapy (MDT-PB) in phase 2a. Safety at the lowest vaccine dos
Sponsors
Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos / Fiocruz
Fundação Oswaldo Cruz
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Men and women between 18 years and 55 years of age;For phase 1b, they must be in good general health, confirmed by medical history and physical examination, with negative clinical assessment for leprosy. For phase 2a, the diagnosis of paucibacillary leprosy must be confirmed;Female participants of childbearing potential must test negative on a serum pregnancy test at screening and a 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) until 30 days after the last injection if they have sex with men;Screening laboratory tests with normal or non-clinically significant values ??for: sodium, potassium, AST, ALT, total bilirubin, alkaline phosphatase, creatinine, glucose, total white blood cell count, hemoglobin, and platelet count. Abnormal results may be repeated at the discretion of the Responsible Researcher and/or sub-researchers, and may share doubts with the sponsor's Scientific Leader and, if necessary, with the DSMB;Negative serological tests for: Anti-HIV 1/2 antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV);Normal or non-clinically significant urinalysis as determined by the study physician or designee. Abnormal results may be repeated at the discretion of the Lead Investigator;Must be able to complete the study adverse event diary; Must consent to participate in the study, be able and willing to attend all assessment visits, be accessible by telephone or home visits, and live in the region until the study follow-up is completed
Exclusion criteria
Exclusion criteria: In phase 1b, history of Mycobacterium leprae infection.History of exposure to experimental products containing GLA-SE.History of active tuberculosis or with documented recurrence.History of previous infection with other non-tuberculous mycobacteria;Participation in another study protocol and/or administration of any study product in the last three 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 of screening.Received blood transfusion in the last three months prior to screening. 8. Donated blood products (platelets, whole blood, plasma, etc.) in the last month before screening.Received any vaccine one month prior to screening or planned immunizations during follow-up from D0 to D63 and D154 to D168.History of autoimmune disease or other immunosuppressive causes.History of any other decompensated acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disease, uncontrolled hypertension) or use of medications that, in the opinion of the Responsible Investigator, may interfere with safety or immunogenicity of the vaccine.Skin rash, tattoos, or any other dermatological condition that may adversely affect the vaccine injection site 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. 16. Alcohol or drug abuse in the last six months prior to screening.Chronic smoker (one pack or more per day).History of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens.Individuals who do not wish to cooperate with all procedures recommended in the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the safety and tolerability of 2 or 10 µg of LEP-F1 + GLA-SE after intramuscular administration on Days 0, 28 and 56. It will be verified by the number of participants who receive the injection and present local and systemic reactions within 7 days after each study injection by the number of participants spontaneously reporting adverse events from Day 0 to Day 84, by the number of adverse events seen by physicians considered related to any of the study injections reported at any time during the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the immunogenicity of 2 or 10 µg of LEP-F1 + GLA-SE after intramuscular administration on Days 0, 28 and 56 by quantifying cytokine production and IgG antibody responses to LEP-F1 at specific times through the response methods of the IgG antibodies to LEP-F1 evaluated by ELISA on Days 0, 35, 63 and 168 and through T cell responses measured by the production of selected cytokines to LEP-F1 in an assay with peripheral blood mononuclear cells (PBMCs) by ELISA or assay multiplex on Days 0, 35, 63 and 168.;Evaluate the immunogenicity of 2 or 10 µg of LEP-F1 + GLA-SE after intramuscular administration on Days 0, 28 and 56 by quantifying antigen-specific T cell responses at specific time points. The evaluation will be done through T cell responses measured by intracellular cytokine staining (ICS) in PBMCs on Days 0, 35, 63 and 168. Evaluate candidate biomarkers indicative of disease status to allow future studies to assess the impact of LEP-F1 + GLA-SE vaccination on disease status. It will be evaluated through assays with candidate biomarkers measured on Day 0 and 63 including gene expression signatures and multiplex serum protein assay Evaluate the impact of LEP-F1 + GLA-SE vaccination on neurological function (Phase 2a) through clinical and neurophysiological tests (Phase 2a). | — |
Countries
Brazil
Contacts
Public ContactCristiane Domingues
Outcome results
None listed