Post Kala Azar Dermal LeishmaniasisPhase 1NCT00982774
Safety and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine With SSG for Patients With PKDL
A Phase 1 study testing LEISH-F2 + MPL-SE vaccine in people with Post Kala Azar Dermal Leishmaniasis, run by Access to Advanced Health Institute (AAHI) at 1 site in Sudan.
Trial summary
A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given at 14-day intervals as an adjunct to standard chemotherapy with sodium stibogluconate (20 mg/kg/day for 40 days) in patients with PKDL. Read more about this study
- Who is it for?
- Ages 7 to 40 years
- Conditions the study is for
- Post Kala Azar Dermal Leishmaniasis
- What is being tested?
- LEISH-F2 + MPL-SE vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 42 participants
- Where
- 1 siteSudan
- Study dates
- Apr 2009to Apr 2011
- 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 7 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females = 7 years and < 40 years of age.
- Must have a skin rash of > 6 months duration compatible with a diagnosis of PKDL following a history of successful treatment of VL, and histopathology consistent with PKDL (Section 6.1).
- Female patients of child bearing age must have a negative serum pregnancy test at screening, a negative urine pregnancy test within 24 hours before study injection, must not be breast-feeding, and are required to use adequate contraception through Day 59 of the study. These precautions are necessary due to unknown effects that LEISH-F2 + MPL-SE might have in a fetus or newborn infant.
- The following laboratory blood tests must have values within the normal ranges at screening (Appendix 3): sodium, potassium, urea, total bilirubin, glucose, creatinine, hemoglobin and platelet count. ALT, AST, alkaline phosphatase, and total WBC count values (commonly elevated in PKDL patients) must be below grade 2 at screening (Appendix 3).
- The following serology tests must be negative at screening: HIV 1/2 (in patients >14 years of age), 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 receive counseling at the University and will be referred to the national AIDS control program for treatment if appropriate.
- Normal ECG.
- Potential study patients (or their guardians) must give written informed consent, be willing to be admitted to hospital for a minimum of 40 days and up to 60 days, able to attend all required follow-up visits, have a permanent address, and be reachable by study site personnel.
Who cannot join
- Presence of other skin conditions.
- Anti-leishmanial treatment within the past 30 days.
- History of previous exposure to Leishmania vaccines.
- Known use of injected or oral corticosteroids within 6 weeks prior to the first administration of study injection.
- Participation in another experimental protocol or receipt of any investigational products within 30 days prior to the first administration of study injection.
- History of autoimmune disease or other causes of immunosuppressive states.
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- History or evidence of any acute or chronic illness that, in the opinion of the Principal Investigator, 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 Principal Investigator, may interfere with the evaluation of the safety or the immunogenicity of the vaccine.
- History of significant psychiatric illness.
- Known to be a current drug or alcohol abuser.
- 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.
- Known allergy or contraindication to SSG.
- Regardless of eligibility, standard clinical care will be provided (at no cost to the patient) to all PKDL patients screened for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in Combination With SSG in the Treatment of Patients With PKDL
A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given at 14-day intervals as an adjunct to standard chemotherapy with sodium stibogluconate (20 mg/kg/day for 40 days) in patients with PKDL.
- Conditions
- Post Kala Azar Dermal Leishmaniasis
- Being tested
- LEISH-F2 + MPL-SE vaccine
- Keywords
- PKDL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEISH-F2 + MPL-SE vaccineBiological
LEISH-F2 protein (10 ug) + MPL-SE (25ug) Three injections, 14 days apart
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of the vaccine given as 3 sc injections every 14 days in combination with standard SSG therapy in patients with persistent PKDL.
Measured: one year
Secondary outcomes (2)
Assess the effect of the vaccine on the clinical course of PKDL.
Measured: one year
To evaluate the immunogenicity of the vaccine by evaluating antibody and T-cell responses to the LEISH-F2 protein and Soluble Leishmania Antigen (SLA).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Kala Azar Dermal 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Investigators
- Eltahir AG Khalil, MBBS, Principal investigator, IENDFranco Piazza, MD, MPH, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982774
- Sponsor's protocol ID
- IDRI-LVPTC-107
- Status last verified
- Jun 2011
- First submitted
- 21 Sep 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in Combination With SSG in the Treatment of Patients With PKDL
- ClinicalTrials.gov ID
- NCT00982774
- Acronym / sponsor ID
- IDRI-LVPTC-107
- Conditions
- Post Kala Azar Dermal Leishmaniasis
- Keywords
- PKDL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Sep 2009 (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.
A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given at 14-day intervals as an adjunct to standard chemotherapy with sodium stibogluconate (20 mg/kg/day for 40 days) in patients with PKDL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 7 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Males and females = 7 years and < 40 years of age.
- Must have a skin rash of > 6 months duration compatible with a diagnosis of PKDL following a history of successful treatment of VL, and histopathology consistent with PKDL (Section 6.1).
- Female patients of child bearing age must have a negative serum pregnancy test at screening, a negative urine pregnancy test within 24 hours before study injection, must not be breast-feeding, and are required to use adequate contraception through Day 59 of the study. These precautions are necessary due to unknown effects that LEISH-F2 + MPL-SE might have in a fetus or newborn infant.
- The following laboratory blood tests must have values within the normal ranges at screening (Appendix 3): sodium, potassium, urea, total bilirubin, glucose, creatinine, hemoglobin and platelet count. ALT, AST, alkaline phosphatase, and total WBC count values (commonly elevated in PKDL patients) must be below grade 2 at screening (Appendix 3).
- The following serology tests must be negative at screening: HIV 1/2 (in patients >14 years of age), 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 receive counseling at the University and will be referred to the national AIDS control program for treatment if appropriate.
Key exclusion criteria (14 listed)
- Presence of other skin conditions.
- Anti-leishmanial treatment within the past 30 days.
- History of previous exposure to Leishmania vaccines.
- Known use of injected or oral corticosteroids within 6 weeks prior to the first administration of study injection.
- Participation in another experimental protocol or receipt of any investigational products within 30 days prior to the first administration of study injection.
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-SE vaccineLEISH-F2 protein (10 ug) + MPL-SE (25ug) Three injections, 14 days apart | Biological | – |
Primary outcome
Evaluate the safety of the vaccine given as 3 sc injections every 14 days in combination with standard SSG therapy in patients with persistent PKDL.
Time frame: one year
2 secondary outcomes
Assess the effect of the vaccine on the clinical course of PKDL.
Time frame: one year
To evaluate the immunogenicity of the vaccine by evaluating antibody and T-cell responses to the LEISH-F2 protein and Soluble Leishmania Antigen (SLA).
Time frame: one year
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 27 Jun 2011.
Related trials for Post Kala Azar Dermal Leishmaniasis
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Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
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.
Eltahir AG Khalil, MBBS principal investigator
IEND
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 1 study testing LEISH-F2 + MPL-SE vaccine in people with Post Kala Azar Dermal Leishmaniasis, run by Access to Advanced Health Institute (AAHI) at 1 site in Sudan.
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 14 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 27 Jun 2011. 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 Sudan. 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 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?
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?
Evaluate the safety of the vaccine given as 3 sc injections every 14 days in combination with standard SSG therapy in patients with persistent PKDL. (time frame: one year). 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 27 Jun 2011.