Cutaneous LeishmaniasisPhase 2NCT00121862
Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite
A Phase 2 study testing Leish-111f + MPL-SE vaccine in people with Cutaneous Leishmaniasis, run by Access to Advanced Health Institute (AAHI) at 1 site in Colombia.
Trial summary
This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in adult subjects who have no evidence of previous exposure to the Leishmania parasite. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Leish-111f + MPL-SE vaccine
- Type of treatment
- Vaccines
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2005to Mar 2006
- Phase
- Phase 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have negative Montenegro skin test (0 mm)
- Must be in good general health with normal lab values
- Negative for HIV, hepatitis B and C
Who cannot join
- History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE
- Nursing or pregnant female
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Programa de Estudio y Control de Enfermedades Tropicales (PECET)
Medellín
About this study
Official title: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Leish-111f + MPL-SE Vaccine Compared to the Leish-111f Protein Alone in Montenegro Skin Test-Negative Healthy Adults
This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in adult subjects who have no evidence of previous exposure to the Leishmania parasite.
Read the detailed description
Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of Leishmania disease. All available medical therapies require weeks of treatment and cause significant toxicity.
It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune responses. These findings argue that a vaccine that generates a T helper 1 response against the parasite will prevent the infection and disease. This is a phase 2, randomized, double blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-negative healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). In addition, the safety and immunogenicity of the vaccine will be compared to that of the Leish-111f protein (10 μg) given alone. The vaccine, Leish-111f protein alone or placebo will be given to each study subject three times at 4 week intervals.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Leish-111f + MPL-SE vaccine
- Keywords
- Leishmaniasis, Subunit Vaccine, Prevention, T cell
- 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-111f + MPL-SE vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Dose-limiting toxicities: hematology and serum chemistry evaluations at Screening, Days 7, 35, 63, 84
T-cell IFN-γ response to the Leish-111f protein: immunology evaluations at Days 0, 84, 168
Secondary outcomes (3)
T-cell IL-5 response to the Leish-111f protein
Antibody responses to the Leish-111f protein
Skin test reactivity to the Leish-111f protein at Days 84, 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startAug 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Investigators
- Franco M Piazza, MD, MPH, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121862
- Sponsor's protocol ID
- IDRI-LCVPX-201
- Status last verified
- May 2006
- First submitted
- 18 Jul 2005
- Last updated
- 5 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Leish-111f + MPL-SE Vaccine Compared to the Leish-111f Protein Alone in Montenegro Skin Test-Negative Healthy Adults
- ClinicalTrials.gov ID
- NCT00121862
- Acronym / sponsor ID
- IDRI-LCVPX-201
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Leishmaniasis, Subunit Vaccine, Prevention, T cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Aug 2005
- Study completion
- Mar 2006
- First posted
- 21 Jul 2005 (estimated)
- 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 study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in adult subjects who have no evidence of previous exposure to the Leishmania parasite.
Detailed description
Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of Leishmania disease. All available medical therapies require weeks of treatment and cause significant toxicity.
It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune responses. These findings argue that a vaccine that generates a T helper 1 response against the parasite will prevent the infection and disease. This is a phase 2, randomized, double blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-negative healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). In addition, the safety and immunogenicity of the vaccine will be compared to that of the Leish-111f protein (10 μg) given alone. The vaccine, Leish-111f protein alone or placebo will be given to each study subject three times at 4 week intervals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must have negative Montenegro skin test (0 mm)
- Must be in good general health with normal lab values
- Negative for HIV, hepatitis B and C
Key exclusion criteria (2 listed)
- History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE
- Nursing or pregnant female
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-111f + MPL-SE vaccine | Biological | – |
Primary outcome
Adverse events
Dose-limiting toxicities: hematology and serum chemistry evaluations at Screening, Days 7, 35, 63, 84
T-cell IFN-γ response to the Leish-111f protein: immunology evaluations at Days 0, 84, 168
3 secondary outcomes
T-cell IL-5 response to the Leish-111f protein
Antibody responses to the Leish-111f protein
Skin test reactivity to the Leish-111f protein at Days 84, 168
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2006.
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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 M 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-111f + MPL-SE vaccine in people with Cutaneous Leishmaniasis, run by Access to Advanced Health Institute (AAHI) at 1 site in Colombia.
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 3 inclusion and 2 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 5 May 2006. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events. 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?
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 5 May 2006.