Phase 2
N=45
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
Cutaneous Leishmaniasis
Bottom Line
View on ClinicalTrials.gov: NCT01011309 ↗Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Nov 2013
Primary outcome: Primary: Date of Clinical Cure — 2; 2; 15; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LEISH-F2 + MPL-SE (Biological); Sodium stibogluconate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Access to Advanced Health Institute (AAHI)
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Date of Clinical Cure |
2; 2; 15; 10; 5; 1 | — |
| PRIMARY Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study. |
10; 9; 0; 8; 10; 0 | — |
| SECONDARY IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10) |
NA; 84.56; 2.004; 76.72; NA; 0.662 | — |
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). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.
Eligibility Criteria
Inclusion Criteria
- Males and females ≥ 12 years and 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.
- 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).
Data sourced from ClinicalTrials.gov (NCT01011309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.