Cutaneous LeishmaniasisPhase 2NCT01011309
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
A Phase 2 study testing LEISH-F2 + MPL-SE and Sodium stibogluconate in people with Cutaneous Leishmaniasis, run by Access to Advanced Health Institute (AAHI) at 1 site in Peru.
Trial summary
The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- LEISH-F2 + MPL-SE and Sodium stibogluconate
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePeru
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 12 years and < 70 years of age. In the first stage of the study, only patients aged ≥ 18 years and < 70 years will be enrolled. In the second stage, enrollment will also include adolescent patients aged ≥ 12 - < 18 years.
- Must have a clinical diagnosis of cutaneous leishmaniasis confirmed by positive identification of Leishmania parasite and identification of L. peruviana by PCR.
- Lesions must be clear of any superinfection prior to enrollment.
- Female patients of childbearing age must have a negative serum pregnancy test at screening, a negative urine pregnancy test within 24 hours before the first vaccination or initiation of chemotherapy, must not be breast-feeding, and are required to use adequate contraception through Day 84 of the study. These precautions are necessary due to unknown effects that LEISH-F2 + MPL SE, sodium stibogluconate might have in a fetus or newborn infant.
- The following laboratory blood tests must have values within the normal ranges at screening: sodium, potassium, urea, total bilirubin, ALT, AST, glucose, creatinine, alkaline phosphatase, total WBC count and platelet count. Hemoglobin may exceed the ULN since patients reside in the Andes at very high altitude (up to 20 g/dL)
- The following serology tests must be negative at screening: HIV-1/2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. All patients (or their parents) will receive HIV-related counseling prior to testing. Patients with positive HIV test results will be referred for counseling and treatment as appropriate.
- Potential study patients (or their guardians) must give written informed consent, be willing to be housed in Lima for a minimum of 20 days and up to 63 days, able to attend all required follow-up visits, have a permanent address, and be reachable by study site personnel.
Who cannot join
- Infection with species other than L.peruviana as confirmed by PCR.
- Presence of eleven or more active cutaneous leishmaniasis lesions.
- The diameter of the ulcerated area of any single lesion is >60 mm.
- Presence of lesions with superinfection at time of enrollment.
- History of mucocutaneous leishmaniasis or diagnosis of mucocutaneous leishmaniasis at screening.
- History of previous exposure to Leishmania vaccines.
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- Known use of injected or oral corticosteroids within 6 weeks prior to the first vaccination or initiation of chemotherapy.
- Participation in another experimental protocol or receipt of any investigational products within 30 days prior to the first vaccination or initiation of chemotherapy.
- History of autoimmune disease or other causes of immunosuppressive states.
- History or evidence of any acute or chronic illness that, in the opinion of the study clinician, may interfere with the evaluation of the safety or the immunogenicity of the vaccine. (Patients presenting with concomitant illness will be referred for standard clinical care).
- History of use of any medication that, in the opinion of the study clinician, may interfere with the evaluation of the safety or the immunogenicity of the vaccine.
- History of significant psychiatric illness.
- Drug addiction including alcohol abuse.
- Patients with a history of previous anaphylaxis, severe allergic reaction to vaccines or unknown allergens, or allergic reaction to eggs.
- Patients who are unlikely to cooperate with the requirements of the study protocol.
- ECG with evidence of ventricular arrythmias ≥ 4 extra systoles per minute.
- Known allergy or contraindication to chemotherapy (e.g., known reaction to pentavalent antimonials, cardiopathy, myocarditis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in the Treatment of Patients With Cutaneous Leishmaniasis
The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.
Read the detailed description
A phase 2, randomized, open-label, controlled study to evaluate the efficacy, safety, and immunogenicity of the vaccine administered three times (10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56) in the treatment of adults and adolescents with CL compared to treatment with standard chemotherapy (20 mg/kg/day sodium stibogluconate for 20 days). The proportion cured in each group will be determined using clinical criteria.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- LEISH-F2 + MPL-SE, Sodium stibogluconate
- Keywords
- Leishmaniasis, vaccine, immunotherapy
- Medical subject headings
- Leishmaniasis, Cutaneous, Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEISH-F2 + MPL-SEBiological
Also called There are no other names for the vaccine.
10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56
Sodium stibogluconateDrug
Also called Marfan SSG
20 mg/kg/day IV daily for 20 days
| Study group | Role | What they receive |
|---|---|---|
| LEISH-F2 + MPL-SE vaccine | Experimental | Recombinant three antigen Leishmania polyprotein + MPL-SE adjuvant Receives: Biological: LEISH-F2 + MPL-SE |
| Sodium stibogluconate (SSG) | Active comparator | 20 mg/kg/day IV for 20 days Receives: Drug: Sodium stibogluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Date of Clinical Cure
Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.
Measured: Day 84
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.
Measured: Day 0 through Day 84
Secondary outcomes (1)
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0.
Measured: Days 0, 56 or 84, and 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cutaneous LeishmaniasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franco Piazza, MD, MPH, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011309
- Sponsor's protocol ID
- IDRI-LCVTC-202
- Status last verified
- Nov 2013
- First submitted
- 9 Nov 2009
- Last updated
- 11 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in the Treatment of Patients With Cutaneous Leishmaniasis
- ClinicalTrials.gov ID
- NCT01011309
- Acronym / sponsor ID
- IDRI-LCVTC-202
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Leishmaniasis, vaccine, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 18 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.
Detailed description
A phase 2, randomized, open-label, controlled study to evaluate the efficacy, safety, and immunogenicity of the vaccine administered three times (10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56) in the treatment of adults and adolescents with CL compared to treatment with standard chemotherapy (20 mg/kg/day sodium stibogluconate for 20 days). The proportion cured in each group will be determined using clinical criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEISH-F2 + MPL-SE vaccine | Experimental | Biological: LEISH-F2 + MPL-SERecombinant three antigen Leishmania polyprotein + MPL-SE adjuvant |
| Sodium stibogluconate (SSG) | Active comparator | Drug: Sodium stibogluconate20 mg/kg/day IV for 20 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females ≥ 12 years and < 70 years of age. In the first stage of the study, only patients aged ≥ 18 years and < 70 years will be enrolled. In the second stage, enrollment will also include adolescent patients aged ≥ 12 - < 18 years.
- Must have a clinical diagnosis of cutaneous leishmaniasis confirmed by positive identification of Leishmania parasite and identification of L. peruviana by PCR.
- Lesions must be clear of any superinfection prior to enrollment.
- Female patients of childbearing age must have a negative serum pregnancy test at screening, a negative urine pregnancy test within 24 hours before the first vaccination or initiation of chemotherapy, must not be breast-feeding, and are required to use adequate contraception through Day 84 of the study. These precautions are necessary due to unknown effects that LEISH-F2 + MPL SE, sodium stibogluconate might have in a fetus or newborn infant.
- The following laboratory blood tests must have values within the normal ranges at screening: sodium, potassium, urea, total bilirubin, ALT, AST, glucose, creatinine, alkaline phosphatase, total WBC count and platelet count. Hemoglobin may exceed the ULN since patients reside in the Andes at very high altitude (up to 20 g/dL)
Key exclusion criteria (17 listed)
- Infection with species other than L.peruviana as confirmed by PCR.
- Presence of eleven or more active cutaneous leishmaniasis lesions.
- The diameter of the ulcerated area of any single lesion is >60 mm.
- Presence of lesions with superinfection at time of enrollment.
- History of mucocutaneous leishmaniasis or diagnosis of mucocutaneous leishmaniasis at 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 |
|---|---|---|
| LEISH-F2 + MPL-SEAlso: There are no other names for the vaccine.10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56 | Biological | LEISH-F2 + MPL-SE vaccine |
| Sodium stibogluconateAlso: Marfan SSG20 mg/kg/day IV daily for 20 days | Drug | Sodium stibogluconate (SSG) |
Primary outcome
Date of Clinical Cure
Time frame: Day 84
Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.
Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.
Time frame: Day 0 through Day 84
Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.
1 secondary outcome
IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)
Time frame: Days 0, 56 or 84, and 168
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Franco Piazza, MD, MPH study director
Access to Advanced Health Institute (AAHI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEISH-F2 + MPL-SE and Sodium stibogluconate in people with Cutaneous Leishmaniasis, run by Access to Advanced Health Institute (AAHI) at 1 site in Peru.
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 7 inclusion and 17 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: finished, as of the sponsor's last update on 11 Dec 2013. 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 Peru. 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. 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 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?
Yes. Results are posted in the registry (first posted 18 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Date of Clinical Cure (time frame: Day 84). The study lists 2 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 11 Dec 2013.