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Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients

Primary Purpose

Leprosy

Status
Not yet recruiting
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
LEP-F1 + GLA-SE
Placebo
Sponsored by
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leprosy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Males and females ≥ 18 years and ≤ 55 years of age.
  2. 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.
  3. 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.
  4. 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.
  5. Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and QuantiFERON®-TB Gold (QFT).
  6. Normal or not clinically significant urinalysis as determined by the study clinician or designee. Abnormal results may be repeated at Investigator discretion.
  7. Subject is capable of completing a study memory aid.
  8. 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:

  1. For Cohort 1, history of infection with M. leprae.
  2. Previous exposure to M. leprae vaccines or experimental products containing GLA-SE.
  3. History of active or documented latent TB.
  4. History of previous infection with other non-tuberculous mycobacteria.
  5. Participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to Enrollment.
  6. 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.
  7. Received a blood transfusion within 3 months prior to Enrollment.
  8. Donated blood products (platelets, whole blood, plasma, etc.) within 30 days prior to Enrollment.
  9. 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.
  10. History of autoimmune disease or other causes of immunosuppressive states.
  11. 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.
  12. Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
  13. BMI ≥ 32.
  14. Hypertension (systolic > 150 or diastolic > 95).
  15. History of significant psychiatric illness with current use of medication.
  16. Known or suspected alcohol or drug abuse within the past 6 months prior to Screening.
  17. Smokes 1 pack or more of cigarettes per day.
  18. History of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
  19. 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

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose

High dose

TBD dose in patients

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Phase 1b_Number of participants experiencing unsolicited AEs
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.
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.
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.
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.
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
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.
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).
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).
The frequency and causality of serious adverse events occurring during study participation (D0 to D421).

Secondary Outcome Measures

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
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.
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.
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.
Phase 2a_The neurological nerve function as measured by clinical and neurophysiological tests
The neurological nerve function as measured by clinical and neurophysiological tests
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.
Phase 2a_The number of M. leprae genome copies (bacillus quantification).
The number of M. leprae genome copies (bacillus quantification).

Full Information

First Posted
May 9, 2019
Last Updated
June 12, 2023
Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators
Oswaldo Cruz Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03947437
Brief Title
Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators
Oswaldo Cruz Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leprosy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
This is a double-blind study. Participants, investigators, study personnel performing any study-related assessments following study injection, and laboratory personnel performing immunology assays will be blinded to treatment assignment.
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Description
2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants.
Arm Title
High dose
Arm Type
Experimental
Arm Description
10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants.
Arm Title
TBD dose in patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients.
Intervention Type
Biological
Intervention Name(s)
LEP-F1 + GLA-SE
Other Intervention Name(s)
LepVax
Intervention Description
Leprosy antigen formulated with an adjuvant.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Sterile normal saline for injection.
Primary Outcome Measure Information:
Title
Phase 1b_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Description
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
Title
Phase 1b_Number of participants experiencing unsolicited AEs
Description
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Time Frame
Days 0 to 84
Title
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.
Description
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
Title
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.
Description
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.
Title
Phase 2a_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Description
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
Title
Phase 2a_The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Description
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Time Frame
Day 0 to Day 84.
Title
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
Description
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
Title
Phase 2a_The frequency and intensity of solicited adverse events within 7 days of each study injection.
Description
The frequency and intensity of solicited adverse events within 7 days of each study injection.
Time Frame
7 days following each injection
Title
Phase 2a_The frequency and intensity of unsolicited adverse events during study participation (D0 to D421).
Description
The frequency and intensity of unsolicited adverse events during study participation (D0 to D421).
Time Frame
Day 0 to Day 421
Title
Phase 2a_The frequency and causality of serious adverse events occurring during study participation (D0 to D421).
Description
The frequency and causality of serious adverse events occurring during study participation (D0 to D421).
Time Frame
Day 0 to Day 421
Secondary Outcome Measure Information:
Title
Phase 1b_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
Description
IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168
Time Frame
Days 0, 35, and 63
Title
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
Description
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.
Time Frame
Days 0, 35, 63 and 168
Title
Phase 2a_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
Description
IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
Time Frame
Days 0, 35, 63, and 168.
Title
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.
Description
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.
Title
Phase 2a_The neurological nerve function as measured by clinical and neurophysiological tests
Description
The neurological nerve function as measured by clinical and neurophysiological tests
Time Frame
Day 0 to Day 421
Title
Phase 2a_The number of participants who received LepVax and had episodes of RR after the start of the study.
Description
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
Title
Phase 2a_The number of M. leprae genome copies (bacillus quantification).
Description
The number of M. leprae genome copies (bacillus quantification).
Time Frame
Day 0 to Day 421
Other Pre-specified Outcome Measures:
Title
Phase 1b_The T cell responses measured by intracellular cytokine (ICS) staining in PBMCs on Days 0, 35, 63, and 168.
Description
The T cell responses measured by intracellular cytokine (ICS) staining in PBMCs on Days 0, 35, 63, and 168.
Time Frame
Days 0, 35, 63, and 168.
Title
Phase 1b_The assays of candidate biomarkers measured on Day 0 and 63 including gene expression signatures and serum protein multiplex assay.
Description
The assays of candidate biomarkers measured on Day 0 and 63 including gene expression signatures and serum protein multiplex assay.
Time Frame
Day 0 and 163
Title
Phase 2a_The T cell responses measured by intracellular cytokine staining of PBMCs on Days 0, 35, 63 and 168
Description
The T cell responses measured by intracellular cytokine staining of PBMCs on Days 0, 35, 63 and 168
Time Frame
Days 0, 35, 63 and 168
Title
Phase 2a_The Assays of candidate biomarkers measured on Day 0 and 63 including gene expression signatures and serum protein multiplex assay
Description
The Assays of candidate biomarkers measured on Day 0 and 63 including gene expression signatures and serum protein multiplex assay
Time Frame
Day 0 and 63

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Phase 1b 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 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 Exclusion Criteria (Phase 1b) 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. 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. Inclusion Criteria (Phase 2a) 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 Exclusion Criteria (Phase 2a) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassio Porto Ferreira, PhD
Phone
+552125621588
Ext
1588
Email
cassio.ferreira@fiocruz.br
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Schmitz Pereira, PhD
Phone
+55 (21) 2562-1579
Ext
1579
Email
veronicaschmitz@ioc.fiocruz.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Schmitz Pereira, PHD
Organizational Affiliation
Instituto Oswaldo Cruz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veronica Schmitz Pereira
City
Rio de Janeiro
ZIP/Postal Code
FIOCRUZ - 33.781.055/0001
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica S Pereira, PHD
Phone
+55 (21) 2562-1579
Ext
1579
Email
veronicaschmitz@ioc.fiocruz.br
First Name & Middle Initial & Last Name & Degree
Cassio P Ferreira, PHD
Email
cassio.ferreira@ioc.fiocruz.br
First Name & Middle Initial & Last Name & Degree
Cassio P Ferreira, PHD
First Name & Middle Initial & Last Name & Degree
Veronica S Pereira, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients

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