LeprosyPhase 1NCT06627257
Trial LEP-F1 + GLA-SE in Healthy Adult in Areas Endemic for Leprosy
A Phase 1 study testing LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low dose and LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High dose 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, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of LEP-F1 + GLA-SE compared to placebo administered as three intramuscular (IM) injections in adult participants aged 18 to 55. 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?
- LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low dose and LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2025to Aug 2026
- Phase
- Phase 1
- 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 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.
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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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Cassio P Ferreira, PhD, Principal investigator contact
Brazil1 site
Oswaldo Cruz Institue
Rio de Janeiro, Rio de Janeiro, 21040-360
Cassio P Ferreira, PhD
Veronica S Perreira, PhD
About this study
Official title: A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Antigen Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of LEP-F1 + GLA-SE in Healthy Adult Participants in Areas Endemic for Leprosy
This is a phase 1b, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of LEP-F1 + GLA-SE compared to placebo administered as three intramuscular (IM) injections in adult participants aged 18 to 55.
Read the detailed description
The LepVax Clinical Development Plan includes two indications for use. The first would be the prophylactic indication, where individuals at greater risk, such as contacts of patients affected by leprosy and who may be subclinically infected with M. leprae, would be vaccinated. This concept is not unique and many countries, such as Brazil, re-immunize leprosy patients and their close contacts with BCG (5, 12, 13). The proposed clinical trial, however, is to establish an initial safety profile in a leprosy endemic region where healthy adults will be included. The second use indication is for therapeutic indication of the vaccine that would be an adjuvant to the current treatment for leprosy. After vaccine safety is established, phase 2 protocols in leprosy patients will be proposed to assess vaccine dose and safety in this population, and then move on to phase 3, where vaccine efficacy will be evaluated.
This phase 1b, double-blind, randomized, placebo-controlled clinical trial will evaluate the safety, tolerability, and immunogenicity of LEP-F1 + GLA-SE in healthy adults. Two dose levels of LEP-F1 will be tested (2 and 10 µg of LEP-F1) and a fixed dose of 5 µg of GLA-SE in adults. These doses were selected because they demonstrated an acceptable safety and immunogenicity profile in the LEPVPX-118 study, the first clinical trial in humans. This study will establish a safety and immunogenicity profile in an endemic population that will allow the vaccine to advance in clinical development.
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, including safety laboratory analyses 7 days following each study injection. Blood samples will be obtained for immunological assays at Days 0, 35, 63, and 168.
- Conditions
- Leprosy
- Being tested
- LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low dose, LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High dose, Placebo Comparator: Placebo
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low doseDrug
Also called LepVax
2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0,28, and 56 in healthy participants.
LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High doseDrug
Also called LepVax
10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0,28, and 56 in healthy participants.
Placebo Comparator: PlaceboOther
Also called Sterile normal saline for injection.
Sterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients.
| Study group | Role | What they receive |
|---|---|---|
| LepVax | Experimental | Participants will be randomized within each Group to receive three doses of vaccine administered IM on Days 0, 28, and 56. Participants will be monitored for one year following the last study injection, including safety laboratory analyses 7 days following each study injection. Blood samples will be obtained for immunological assays at Days 0, 35, 63, and 168. Receives: Drug: LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low dose; Drug: LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High dose |
| Placebo groups | Placebo comparator | Participants will be randomized within each Group to receive three doses of placebo administered IM on Days 0, 28, and 56. Participants will be monitored for one year following the last study injection, including safety laboratory analyses 7 days following each study injection. Blood samples will be obtained for immunological assays at Days 0, 35, 63, and 168. Receives: Other: Placebo Comparator: 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: Day 0 to Day 84 following each injection
Phase 1b_The number of physician-attended adverse events
The number of physician-attended adverse events considered to be related to any of the study injections reported at any time during the study period.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
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, 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.
Measured: Days 0, 35, 63 and 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start2 Jan 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627257
- Sponsor's protocol ID
- ASCLIN 001/2023
- Status last verified
- Jan 2024
- First submitted
- 21 Aug 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duthie MS, Frevol A, Day T, Coler RN, Vergara J, Rolf T, Sagawa ZK, Marie Beckmann A, Casper C, Reed SG. A phase 1 antigen dose escalation trial to evaluate safety, tolerability and immunogenicity of the leprosy vaccine candidate LepVax (LEP-F1 + GLA-SE) in healthy adults. Vaccine. 2020 Feb 11;38(7):1700-1707. doi: 10.1016/j.vaccine.2019.12.050. Epub 2019 Dec 30.
PubMed 31899025Cunha SS, Alexander N, Barreto ML, Pereira ES, Dourado I, Maroja Mde F, Ichihara Y, Brito S, Pereira S, Rodrigues LC. BCG revaccination does not protect against leprosy in the Brazilian Amazon: a cluster randomised trial. PLoS Negl Trop Dis. 2008 Feb 13;2(2):e167. doi: 10.1371/journal.pntd.0000167.
PubMed 18270542Duppre NC, Camacho LA, da Cunha SS, Struchiner CJ, Sales AM, Nery JA, Sarno EN. Effectiveness of BCG vaccination among leprosy contacts: a cohort study. Trans R Soc Trop Med Hyg. 2008 Jul;102(7):631-8. doi: 10.1016/j.trstmh.2008.04.015. Epub 2008 Jun 2.
PubMed 18514242Bertholet S, Goto Y, Carter L, Bhatia A, Howard RF, Carter D, Coler RN, Vedvick TS, Reed SG. Optimized subunit vaccine protects against experimental leishmaniasis. Vaccine. 2009 Nov 23;27(50):7036-45. doi: 10.1016/j.vaccine.2009.09.066. Epub 2009 Sep 26.
PubMed 19786136Baldwin SL, Bertholet S, Kahn M, Zharkikh I, Ireton GC, Vedvick TS, Reed SG, Coler RN. Intradermal immunization improves protective efficacy of a novel TB vaccine candidate. Vaccine. 2009 May 18;27(23):3063-71. doi: 10.1016/j.vaccine.2009.03.018. Epub 2009 Mar 26.
PubMed 19428920Olugbile S, Kulangara C, Bang G, Bertholet S, Suzarte E, Villard V, Frank G, Audran R, Razaname A, Nebie I, Awobusuyi O, Spertini F, Kajava AV, Felger I, Druilhe P, Corradin G. Vaccine potentials of an intrinsically unstructured fragment derived from the blood stage-associated Plasmodium falciparum protein PFF0165c. Infect Immun. 2009 Dec;77(12):5701-9. doi: 10.1128/IAI.00652-09. Epub 2009 Sep 28.
PubMed 19786562Baldwin SL, Shaverdian N, Goto Y, Duthie MS, Raman VS, Evers T, Mompoint F, Vedvick TS, Bertholet S, Coler RN, Reed SG. Enhanced humoral and Type 1 cellular immune responses with Fluzone adjuvanted with a synthetic TLR4 agonist formulated in an emulsion. Vaccine. 2009 Oct 9;27(43):5956-63. doi: 10.1016/j.vaccine.2009.07.081. Epub 2009 Aug 11.
PubMed 19679214Global leprosy update, 2014: need for early case detection. Wkly Epidemiol Rec. 2015 Sep 4;90(36):461-74. No abstract available. English, French.
PubMed 26343055Scollard DM. The biology of nerve injury in leprosy. Lepr Rev. 2008 Sep;79(3):242-53.
PubMed 19009974Coler RN, Bertholet S, Moutaftsi M, Guderian JA, Windish HP, Baldwin SL, Laughlin EM, Duthie MS, Fox CB, Carter D, Friede M, Vedvick TS, Reed SG. Development and characterization of synthetic glucopyranosyl lipid adjuvant system as a vaccine adjuvant. PLoS One. 2011 Jan 26;6(1):e16333. doi: 10.1371/journal.pone.0016333.
PubMed 21298114Merle CS, Cunha SS, Rodrigues LC. BCG vaccination and leprosy protection: review of current evidence and status of BCG in leprosy control. Expert Rev Vaccines. 2010 Feb;9(2):209-22. doi: 10.1586/erv.09.161.
PubMed 20109030Setia MS, Steinmaus C, Ho CS, Rutherford GW. The role of BCG in prevention of leprosy: a meta-analysis. Lancet Infect Dis. 2006 Mar;6(3):162-70. doi: 10.1016/S1473-3099(06)70412-1.
PubMed 16500597Wilder-Smith EP, Van Brakel WH. Nerve damage in leprosy and its management. Nat Clin Pract Neurol. 2008 Dec;4(12):656-63. doi: 10.1038/ncpneuro0941. Epub 2008 Nov 11.
PubMed 19002133
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Antigen Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of LEP-F1 + GLA-SE in Healthy Adult Participants in Areas Endemic for Leprosy
- ClinicalTrials.gov ID
- NCT06627257
- Acronym / sponsor ID
- ASCLIN 001/2023
- Conditions
- Leprosy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 4 Oct 2024 (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, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of LEP-F1 + GLA-SE compared to placebo administered as three intramuscular (IM) injections in adult participants aged 18 to 55.
Detailed description
The LepVax Clinical Development Plan includes two indications for use. The first would be the prophylactic indication, where individuals at greater risk, such as contacts of patients affected by leprosy and who may be subclinically infected with M. leprae, would be vaccinated. This concept is not unique and many countries, such as Brazil, re-immunize leprosy patients and their close contacts with BCG (5, 12, 13). The proposed clinical trial, however, is to establish an initial safety profile in a leprosy endemic region where healthy adults will be included. The second use indication is for therapeutic indication of the vaccine that would be an adjuvant to the current treatment for leprosy. After vaccine safety is established, phase 2 protocols in leprosy patients will be proposed to assess vaccine dose and safety in this population, and then move on to phase 3, where vaccine efficacy will be evaluated.
This phase 1b, double-blind, randomized, placebo-controlled clinical trial will evaluate the safety, tolerability, and immunogenicity of LEP-F1 + GLA-SE in healthy adults. Two dose levels of LEP-F1 will be tested (2 and 10 µg of LEP-F1) and a fixed dose of 5 µg of GLA-SE in adults. These doses were selected because they demonstrated an acceptable safety and immunogenicity profile in the LEPVPX-118 study, the first clinical trial in humans. This study will establish a safety and immunogenicity profile in an endemic population that will allow the vaccine to advance in clinical development.
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, including safety laboratory analyses 7 days following each study injection. Blood samples will be obtained for immunological assays at Days 0, 35, 63, and 168.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LepVax | Experimental | Drug: LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low dose, Drug: LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High doseParticipants will be randomized within each Group to receive three doses of vaccine administered IM on Days 0, 28, and 56. Participants will be monitored for one year following the last study injection, including safety laboratory analyses 7 days following each study injection. Blood samples will be obtained for immunological assays at Days 0, 35, 63, and 168. |
| Placebo groups | Placebo comparator | Other: Placebo Comparator: PlaceboParticipants will be randomized within each Group to receive three doses of placebo administered IM on Days 0, 28, and 56. Participants will be monitored for one year following the last study injection, including safety laboratory analyses 7 days following each study injection. Blood samples will be obtained for immunological assays at Days 0, 35, 63, and 168. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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 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.
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low doseAlso: LepVax2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0,28, and 56 in healthy participants. | Drug | LepVax |
| LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High doseAlso: LepVax10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0,28, and 56 in healthy participants. | Drug | LepVax |
| Placebo Comparator: PlaceboAlso: Sterile normal saline for injection.Sterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients. | Other | Placebo groups |
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: Day 0 to Day 84 following each injection
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Phase 1b_The number of physician-attended adverse events
Time frame: Through study completion, an average of 1 year
The number of physician-attended adverse events considered to be related to any of the study injections reported at any time during the study period.
2 secondary outcomes
Phase 1b_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63,and 168.
Time frame: 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
Time frame: Days 0, 35, 63 and 168
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 31899025Duthie MS, Frevol A, Day T, Coler RN, Vergara J, Rolf T, Sagawa ZK, Marie Beckmann A, Casper C, Reed SG. A phase 1 antigen dose escalation trial to evaluate safety, tolerability and immunogenicity of the leprosy vaccine candidate LepVax (LEP-F1 + GLA-SE) in healthy adults. Vaccine. 2020 Feb 11;38(7):1700-1707. doi: 10.1016/j.vaccine.2019.12.050. Epub 2019 Dec 30.
- Background: PubMed 18270542Cunha SS, Alexander N, Barreto ML, Pereira ES, Dourado I, Maroja Mde F, Ichihara Y, Brito S, Pereira S, Rodrigues LC. BCG revaccination does not protect against leprosy in the Brazilian Amazon: a cluster randomised trial. PLoS Negl Trop Dis. 2008 Feb 13;2(2):e167. doi: 10.1371/journal.pntd.0000167.
- Background: PubMed 18514242Duppre NC, Camacho LA, da Cunha SS, Struchiner CJ, Sales AM, Nery JA, Sarno EN. Effectiveness of BCG vaccination among leprosy contacts: a cohort study. Trans R Soc Trop Med Hyg. 2008 Jul;102(7):631-8. doi: 10.1016/j.trstmh.2008.04.015. Epub 2008 Jun 2.
- Background: PubMed 19786136Bertholet S, Goto Y, Carter L, Bhatia A, Howard RF, Carter D, Coler RN, Vedvick TS, Reed SG. Optimized subunit vaccine protects against experimental leishmaniasis. Vaccine. 2009 Nov 23;27(50):7036-45. doi: 10.1016/j.vaccine.2009.09.066. Epub 2009 Sep 26.
- Background: PubMed 19428920Baldwin SL, Bertholet S, Kahn M, Zharkikh I, Ireton GC, Vedvick TS, Reed SG, Coler RN. Intradermal immunization improves protective efficacy of a novel TB vaccine candidate. Vaccine. 2009 May 18;27(23):3063-71. doi: 10.1016/j.vaccine.2009.03.018. Epub 2009 Mar 26.
- Background: PubMed 19786562Olugbile S, Kulangara C, Bang G, Bertholet S, Suzarte E, Villard V, Frank G, Audran R, Razaname A, Nebie I, Awobusuyi O, Spertini F, Kajava AV, Felger I, Druilhe P, Corradin G. Vaccine potentials of an intrinsically unstructured fragment derived from the blood stage-associated Plasmodium falciparum protein PFF0165c. Infect Immun. 2009 Dec;77(12):5701-9. doi: 10.1128/IAI.00652-09. Epub 2009 Sep 28.
- Background: PubMed 19679214Baldwin SL, Shaverdian N, Goto Y, Duthie MS, Raman VS, Evers T, Mompoint F, Vedvick TS, Bertholet S, Coler RN, Reed SG. Enhanced humoral and Type 1 cellular immune responses with Fluzone adjuvanted with a synthetic TLR4 agonist formulated in an emulsion. Vaccine. 2009 Oct 9;27(43):5956-63. doi: 10.1016/j.vaccine.2009.07.081. Epub 2009 Aug 11.
- Background: PubMed 26343055Global leprosy update, 2014: need for early case detection. Wkly Epidemiol Rec. 2015 Sep 4;90(36):461-74. No abstract available. English, French.
- Background: PubMed 19009974Scollard DM. The biology of nerve injury in leprosy. Lepr Rev. 2008 Sep;79(3):242-53.
- Background: PubMed 21298114Coler RN, Bertholet S, Moutaftsi M, Guderian JA, Windish HP, Baldwin SL, Laughlin EM, Duthie MS, Fox CB, Carter D, Friede M, Vedvick TS, Reed SG. Development and characterization of synthetic glucopyranosyl lipid adjuvant system as a vaccine adjuvant. PLoS One. 2011 Jan 26;6(1):e16333. doi: 10.1371/journal.pone.0016333.
- Background: PubMed 20109030Merle CS, Cunha SS, Rodrigues LC. BCG vaccination and leprosy protection: review of current evidence and status of BCG in leprosy control. Expert Rev Vaccines. 2010 Feb;9(2):209-22. doi: 10.1586/erv.09.161.
- Background: PubMed 16500597Setia MS, Steinmaus C, Ho CS, Rutherford GW. The role of BCG in prevention of leprosy: a meta-analysis. Lancet Infect Dis. 2006 Mar;6(3):162-70. doi: 10.1016/S1473-3099(06)70412-1.
- Scollard DM. The biology of nerve injury in leprosy. Lepr Rev 2008; 79:242-53.Link provided by the sponsor.
- Wilder-Smith EP, Van Brakel WH. Nerve damage in leprosy and its management. Nature clinical practice. Neurology 2008; 4:656-63.Link provided by the sponsor.
- OMS. 2015. Global leprosy update, 2014: need for early case detection. Wkly Epidemiol Rec 2014; 90:461-74.Link provided by the sponsor.
- Setia MS, Steinmaus C, Ho CS, Rutherford GW. The role of BCG in prevention of leprosy: a meta-analysis. Lancet Infect Dis 2006; 6:162-70.Link provided by the sponsor.
- Merle CS, Cunha SS, Rodrigues LC. BCG vaccination and leprosy protection: review of current evidence and status of BCG in leprosy control. Expert review of vaccines 2010;9: 209-22Link provided by the sponsor.
- Coler RN, Bertholet S, Moutaftsi M, et al. Development and characterization of synthetic glucopyranosyl lipid adjuvant system as a vaccine adjuvant. PLoS One 2011; 6: e16333Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases
Atopic Dermatitis, Psoriasis
RecruitingPhase 3
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
Leprosy
Recruiting
Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
Leprosy, Leprosy Neuropathy
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.
Cassio P Ferreira, PhD, Principal investigator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low dose and LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High dose 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 9 inclusion and 19 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 4 Oct 2024. 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 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.
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 P Ferreira, PhD, Principal investigator (+ 55 (21) 2562-1527, cassio.ferreira@ioc.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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06627257, which also lists 13 linked publications.
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 4 Oct 2024.