Visceral LeishmaniasisPhase 1NCT00486382
Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India
A Phase 1 study testing Leish-111f + MPL-SE Adjuvant in people with Visceral Leishmaniasis and Post-kala-azar Dermal Leishmaniasis, run by Access to Advanced Health Institute (AAHI) at 1 site in India.
Trial summary
The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Leishmaniasis, Post-kala-azar Dermal Leishmaniasis
- What is being tested?
- Leish-111f + MPL-SE Adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2007to Nov 2008
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females ≥ 18 years and < 55 years of age.
- Must be in good general health as confirmed by a medical history and physical exam.
- DAT titer must be <1:400 and rK39 serology negative (for inclusion in the DAT-negative group) or DAT titer ≥1:1600 (for inclusion in the DAT-positive group).
- The following laboratory blood tests must have values within the normal ranges at screening (Appendix 4): sodium, potassium, urea, ALT, AST, total bilirubin, creatinine, alkaline phosphatase, glucose, hemoglobin, total WBC count and platelet count.
- The following serology tests must be negative at screening: HIV 1/2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. All subjects will receive HIV related counseling prior to testing. Subjects 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.
- Subjects must give written informed consent, be willing and able to attend all required visits, have a permanent address, and be reachable by study site personnel.
- Female subjects of childbearing potential must have a negative urine 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 84 of the study. These precautions are necessary due to unknown effects that Leish-111f + MPL-SE might have in a fetus or newborn infant.
Who cannot join
- Previous exposure to Leishmania vaccines or experimental products containing MPL-SE.
- Participation in another experimental protocol or receipt of any investigational products within 30 days prior to the first administration of study injection.
- Known use of injected or oral corticosteroids within 6 weeks prior to the first administration of study injection.
- 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 Principal Investigator, may interfere with the evaluation of the safety or the immunogenicity of the vaccine. (Potential subjects presenting with concomitant illness will be referred for 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.
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- History of significant psychiatric illness.
- Known to be a current drug or alcohol abuser.
- Subjects with a history of previous anaphylaxis, severe allergic reaction to vaccines or unknown allergens, or allergic reaction to eggs.
- History of chronic headaches or migraine.
- Subjects who are unlikely to cooperate with the requirements of the study protocol.
- Subjects who are not permanent residents or who are planning to move to another town/city.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-111F + MPL-SE Vaccine (Recombinant Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE) in Healthy Adults In India
The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects.
Read the detailed description
The purpose of this study is to determine the safety, tolerability, and immunogenicity of an investigational vaccine being developed for immunotherapy of visceral leishmaniasis (VL) and post kala-azar dermal leishmaniasis (PKDL). The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f) together with adjuvant MPL-SE.
The primary objective is to evaluate the safety and tolerability of the Leish-111f + MPL-SE vaccine given as three subcutaneous injections every 28 days at each of three dose levels of the Leish-111f protein (5 μg, 10 μg, or 20 μg) together with MPL-SE adjuvant (25 μg) in healthy adults.
The secondary objective is to assess the immunogenicity of the vaccine by evaluating T-cell and antibody response to the Leish-111f protein of the vaccine.
- Being tested
- Leish-111f + MPL-SE Adjuvant
- Keywords
- visceral leishmaniasis, vaccine
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leish-111f + MPL-SE AdjuvantBiological
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Biological/Vaccine: Leish-111f + MPL-SE Adjuvant Receives: Biological: Leish-111f + MPL-SE Adjuvant |
| Medium dose | Experimental | Biological/Vaccine: Leish-111f + MPL-SE Adjuvant Receives: Biological: Leish-111f + MPL-SE Adjuvant |
| High dose | Experimental | Biological/Vaccine: Leish-111f + MPL-SE Adjuvant Receives: Biological: Leish-111f + MPL-SE Adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection site reactions
Measured: For 7 days following each injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Shyam Sundar, MD, Principal investigator, Banaras Hindu UniversityFranco M Piazza, MD, MPh, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486382
- Sponsor's protocol ID
- IDRI-LVVPX-104
- Status last verified
- Apr 2015
- First submitted
- 12 Jun 2007
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-111F + MPL-SE Vaccine (Recombinant Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE) in Healthy Adults In India
- ClinicalTrials.gov ID
- NCT00486382
- Acronym / sponsor ID
- IDRI-LVVPX-104
- Keywords
- visceral leishmaniasis, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Apr 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 14 Jun 2007 (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.
The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects.
Detailed description
The purpose of this study is to determine the safety, tolerability, and immunogenicity of an investigational vaccine being developed for immunotherapy of visceral leishmaniasis (VL) and post kala-azar dermal leishmaniasis (PKDL). The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f) together with adjuvant MPL-SE.
The primary objective is to evaluate the safety and tolerability of the Leish-111f + MPL-SE vaccine given as three subcutaneous injections every 28 days at each of three dose levels of the Leish-111f protein (5 μg, 10 μg, or 20 μg) together with MPL-SE adjuvant (25 μg) in healthy adults.
The secondary objective is to assess the immunogenicity of the vaccine by evaluating T-cell and antibody response to the Leish-111f protein of the vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Biological: Leish-111f + MPL-SE AdjuvantBiological/Vaccine: Leish-111f + MPL-SE Adjuvant |
| Medium dose | Experimental | Biological: Leish-111f + MPL-SE AdjuvantBiological/Vaccine: Leish-111f + MPL-SE Adjuvant |
| High dose | Experimental | Biological: Leish-111f + MPL-SE AdjuvantBiological/Vaccine: Leish-111f + MPL-SE Adjuvant |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and females ≥ 18 years and < 55 years of age.
- Must be in good general health as confirmed by a medical history and physical exam.
- DAT titer must be <1:400 and rK39 serology negative (for inclusion in the DAT-negative group) or DAT titer ≥1:1600 (for inclusion in the DAT-positive group).
- The following laboratory blood tests must have values within the normal ranges at screening (Appendix 4): sodium, potassium, urea, ALT, AST, total bilirubin, creatinine, alkaline phosphatase, glucose, hemoglobin, total WBC count and platelet count.
- The following serology tests must be negative at screening: HIV 1/2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. All subjects will receive HIV related counseling prior to testing. Subjects 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 (12 listed)
- Previous exposure to Leishmania vaccines or experimental products containing MPL-SE.
- Participation in another experimental protocol or receipt of any investigational products within 30 days prior to the first administration of study injection.
- Known use of injected or oral corticosteroids within 6 weeks prior to the first administration of study injection.
- 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 Principal Investigator, may interfere with the evaluation of the safety or the immunogenicity of the vaccine. (Potential subjects presenting with concomitant illness will be referred for clinical care.)
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 Adjuvant | Biological | High dose, Low dose, Medium dose |
Primary outcome
Injection site reactions
Time frame: For 7 days following each injection.
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 3 Apr 2015.
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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.
Shyam Sundar, MD principal investigator
Banaras Hindu University
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 1 study testing Leish-111f + MPL-SE Adjuvant in people with Visceral Leishmaniasis and Post-kala-azar Dermal Leishmaniasis, run by Access to Advanced Health Institute (AAHI) at 1 site in India.
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 12 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 3 Apr 2015. 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 India. 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?
Injection site reactions (time frame: For 7 days following each injection.). 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 3 Apr 2015.