LeprosyPhase 1/2NCT03947437
Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
A Phase 1/2 study testing LEP-F1 + GLA-SE in people with Leprosy, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Leprosy
- What is being tested?
- LEP-F1 + GLA-SE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2024to Apr 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 participants of childbearing age should 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 breast-feeding and are required to use at least one contraceptive method from the time of study inclusion (Day 0) until 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 leukocyte 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.
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- 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
- Participants must meet ALL of the following criteria listed below to be included in the study:
- Men and women between 18 and 55 years old.
- Diagnosis of PB leprosy (BI=0) before MDT treatment
- Female participants of childbearing age should 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 breast-feeding and are required to use at least one contraceptive method from the time of study inclusion (Day 0) until 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 leukocyte 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
Who cannot join
- Individuals who meet ANY of the following criteria will be considered ineligible:
- History of infection with Mycobacterium leprae.
- History of exposure to experimental products containing GLA-SE.
- History of active or documented latent tuberculosis.
- 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.
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- Treatment with immunosuppressive drugs (eg oral or injected steroids, such as prednisone; high doses of inhaled steroids) or cytotoxic therapies (eg chemotherapy or radiation) within 6 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 acute or chronic decompensated disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, haematological, metabolic or renal disease, uncontrolled hypertension) or use of medication 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.
- Individuals who meet ANY of the following criteria will be considered ineligible:
- Previous treatment for leprosy.
- History of exposure to experimental products containing GLA-SE.
- History of active or documented latent tuberculosis.
- 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 injected steroids, such as prednisone; high doses of inhaled steroids) or cytotoxic therapies (eg chemotherapy or radiation) within 6 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 acute or chronic decompensated disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, haematological, metabolic or renal disease, uncontrolled hypertension) or use of medication 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.
- Vital signs are performed after participants have sat for five minutes without hot or cold drinks or smoking for the past five minutes. Vital signs can be performed up to three times to allow resolution of transient conditions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Veronica Schmitz Pereira
Rio de Janeiro, FIOCRUZ - 33.781.055/0001
Veronica S Pereira, PHD, +55 (21) 2562-1579 ext. 1579, veronicaschmitz@ioc.fiocruz.br
Cassio P Ferreira, PHD, cassio.ferreira@ioc.fiocruz.br
About this study
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
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.
Read the 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.
- Conditions
- Leprosy
- Being tested
- LEP-F1 + GLA-SE, Placebo
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEP-F1 + GLA-SEBiological
Also called LepVax
Leprosy antigen formulated with an adjuvant.
PlaceboBiological
Sterile normal saline for injection.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants. Receives: Biological: LEP-F1 + GLA-SE |
| High dose | Experimental | 10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants. Receives: Biological: LEP-F1 + GLA-SE |
| TBD dose in patients | Experimental | 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. Receives: Biological: LEP-F1 + GLA-SE |
| Placebo | Placebo comparator | Sterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Measured: 7 days following each injection
Phase 1b_Number of participants experiencing unsolicited AEs
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Measured: Days 0 to 84
Phase 1b_The number of adverse events attended by physicians considered related to any of the study injections reported at any time during the study period.
The number of adverse events attended by physicians considered related to any of the study injections reported at any time during the study period.
Measured: Days 0 to 421
Phase 1b_The LEP-F1 specific T cell IFN--γ production responses in assay with PBMCs evaluated by ELISA on Days 0, 35 and 63.
The LEP-F1 specific T cell IFN-γ production responses in assay with PBMCs evaluated by ELISA on Days 0, 35 and 63.
Measured: Days 0, 35 and 63.
Phase 2a_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Measured: 7 days following each injection
Phase 2a_The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Measured: Day 0 to Day 84.
Phase 2a_The number of physician-assisted adverse events considered related to any of the study injections reported at any time during the study period
The number of physician-assisted adverse events considered related to any of the study injections reported at any time during the study period
Measured: Day 0 to Day 421
Phase 2a_The frequency and intensity of solicited adverse events within 7 days of each study injection.
The frequency and intensity of solicited adverse events within 7 days of each study injection.
Measured: 7 days following each injection
Phase 2a_The frequency and intensity of unsolicited adverse events during study participation (D0 to D421).
The frequency and intensity of unsolicited adverse events during study participation (D0 to D421).
Measured: Day 0 to Day 421
Phase 2a_The frequency and causality of serious adverse events occurring during study participation (D0 to D421).
The frequency and causality of serious adverse events occurring during study participation (D0 to D421).
Measured: Day 0 to Day 421
Secondary outcomes (7)
Phase 1b_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168
Measured: Days 0, 35, and 63
Phase 1b_ The T cell responses measured by LEP-F1-specific cytokine production in PBMC assay by ELISA or multiplex assay on Days 0, 35, 63, and 168.whole blood assay
The T cell responses measured by LEP-F1-specific cytokine production in PBMC assay by ELISA or multiplex assay on Days 0, 35, 63, and 168.
Measured: Days 0, 35, 63 and 168
Phase 2a_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
Measured: Days 0, 35, 63, and 168.
Phase 2a_T cell responses measured by LEP-F1-specific cytokine production in PBMC assay by ELISA or multiplex assay on Days 0, 35, 63, and 168.
T cell responses measured by LEP-F1-specific cytokine production in PBMC assay by ELISA or multiplex assay on Days 0, 35, 63, and 168.
Measured: on Days 0, 35, 63, and 168.
Phase 2a_The neurological nerve function as measured by clinical and neurophysiological tests
The neurological nerve function as measured by clinical and neurophysiological tests
Measured: Day 0 to Day 421
Phase 2a_The number of participants who received LepVax and had episodes of RR after the start of the study.
The number of participants who received LepVax and had episodes of RR after the start of the study.
Measured: Day 0 to Day 421
Phase 2a_The number of M. leprae genome copies (bacillus quantification).
The number of M. leprae genome copies (bacillus quantification).
Measured: Day 0 to Day 421
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study startFeb 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Responsible party
- Sponsor
- Investigators
- Veronica Schmitz Pereira, PHD, Principal investigator, Oswaldo Cruz Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947437
- Sponsor's protocol ID
- ASCLIN 002/2020
- Status last verified
- Jun 2023
- First submitted
- 9 May 2019
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03947437
- Acronym / sponsor ID
- ASCLIN 002/2020
- Conditions
- Leprosy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Study start
- Feb 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Biological: LEP-F1 + GLA-SE2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants. |
| High dose | Experimental | Biological: LEP-F1 + GLA-SE10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants. |
| TBD dose in patients | Experimental | Biological: LEP-F1 + GLA-SETBD 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. |
| Placebo | Placebo comparator | Biological: PlaceboSterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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 participants of childbearing age should 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 breast-feeding and are required to use at least one contraceptive method from the time of study inclusion (Day 0) until 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 leukocyte 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.
Key exclusion criteria (41 listed)
- History of infection with Mycobacterium leprae.
- History of exposure to experimental products containing GLA-SE.
- History of active or documented latent tuberculosis.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEP-F1 + GLA-SEAlso: LepVaxLeprosy antigen formulated with an adjuvant. | Biological | High dose, Low dose, TBD dose in patients |
| PlaceboSterile normal saline for injection. | Biological | Placebo |
Primary outcome
Phase 1b_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Time frame: 7 days following each injection
The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Phase 1b_Number of participants experiencing unsolicited AEs
Time frame: Days 0 to 84
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Phase 1b_The number of adverse events attended by physicians considered related to any of the study injections reported at any time during the study period.
Time frame: Days 0 to 421
The number of adverse events attended by physicians considered related to any of the study injections reported at any time during the study period.
Phase 1b_The LEP-F1 specific T cell IFN--γ production responses in assay with PBMCs evaluated by ELISA on Days 0, 35 and 63.
Time frame: Days 0, 35 and 63.
The LEP-F1 specific T cell IFN-γ production responses in assay with PBMCs evaluated by ELISA on Days 0, 35 and 63.
Phase 2a_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Time frame: 7 days following each injection
The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Phase 2a_The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Time frame: Day 0 to Day 84.
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Phase 2a_The number of physician-assisted adverse events considered related to any of the study injections reported at any time during the study period
Time frame: Day 0 to Day 421
The number of physician-assisted adverse events considered related to any of the study injections reported at any time during the study period
Phase 2a_The frequency and intensity of solicited adverse events within 7 days of each study injection.
Time frame: 7 days following each injection
The frequency and intensity of solicited adverse events within 7 days of each study injection.
Phase 2a_The frequency and intensity of unsolicited adverse events during study participation (D0 to D421).
Time frame: Day 0 to Day 421
The frequency and intensity of unsolicited adverse events during study participation (D0 to D421).
Phase 2a_The frequency and causality of serious adverse events occurring during study participation (D0 to D421).
Time frame: Day 0 to Day 421
The frequency and causality of serious adverse events occurring during study participation (D0 to D421).
7 secondary outcomes
Phase 1b_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
Time frame: Days 0, 35, and 63
Phase 1b_ The T cell responses measured by LEP-F1-specific cytokine production in PBMC assay by ELISA or multiplex assay on Days 0, 35, 63, and 168.whole blood assay
Time frame: Days 0, 35, 63 and 168
Phase 2a_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
Time frame: Days 0, 35, 63, and 168.
Phase 2a_T cell responses measured by LEP-F1-specific cytokine production in PBMC assay by ELISA or multiplex assay on Days 0, 35, 63, and 168.
Time frame: on Days 0, 35, 63, and 168.
Phase 2a_The neurological nerve function as measured by clinical and neurophysiological tests
Time frame: Day 0 to Day 421
Phase 2a_The number of participants who received LepVax and had episodes of RR after the start of the study.
Time frame: Day 0 to Day 421
Phase 2a_The number of M. leprae genome copies (bacillus quantification).
Time frame: Day 0 to Day 421
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Schmitz Pereira, PHD principal investigator
Oswaldo Cruz Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LEP-F1 + GLA-SE in people with Leprosy, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cassio Porto Ferreira, PhD (+552125621588 ext. 1588, cassio.ferreira@fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection. (time frame: 7 days following each injection). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.