- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00486382
Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Uttar Pradesh
-
Varanasi, Uttar Pradesh, India, 221 005
- Banaras Hindu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose
Biological/Vaccine: Leish-111f + MPL-SE Adjuvant
|
|
Experimental: Medium dose
Biological/Vaccine: Leish-111f + MPL-SE Adjuvant
|
|
Experimental: High dose
Biological/Vaccine: Leish-111f + MPL-SE Adjuvant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Injection site reactions
Time Frame: For 7 days following each injection.
|
For 7 days following each injection.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shyam Sundar, MD, Banaras Hindu University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDRI-LVVPX-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Visceral Leishmaniasis
-
Drugs for Neglected DiseasesNovartis PharmaceuticalsRecruitingPrimary Visceral LeishmaniasisEthiopia
-
Drugs for Neglected DiseasesNovartis PharmaceuticalsRecruiting
-
Drugs for Neglected DiseasesGilead Sciences; Paladin Labs Inc.Completed
-
Drugs for Neglected DiseasesWellcome Trust grant 212346/Z/18/Z - 21st Century Treatments for Sustainable...CompletedVisceral Leishmaniasis | Cutaneous LeishmaniasesUnited Kingdom
-
Centre Hospitalier Universitaire de NiceCompleted
-
Centre Hospitalier Universitaire de NiceRecruiting
-
International Centre for Diarrhoeal Disease Research...CompletedVisceral LeishmaniasisBangladesh
-
Aurobindo Pharma LtdAxis Clinicals LimitedCompletedVisceral LeishmaniasisBangladesh, India
-
Drugs for Neglected DiseasesCompletedVisceral LeishmaniasisUganda, Kenya
-
Banaras Hindu UniversityCompletedVisceral LeishmaniasisIndia
Clinical Trials on Leish-111f + MPL-SE Adjuvant
-
IDRIBill and Melinda Gates FoundationCompleted
-
IDRIBill and Melinda Gates FoundationCompletedLeishmaniasis, MucocutaneousPeru
-
IDRIBill and Melinda Gates FoundationCompletedCutaneous LeishmaniasisColombia
-
IDRIBill and Melinda Gates FoundationCompletedLeishmaniasis, CutaneousBrazil
-
National Institute of Allergy and Infectious Diseases...Completed
-
IDRICompletedPost Kala Azar Dermal LeishmaniasisSudan
-
IDRIBill and Melinda Gates FoundationCompletedVisceral LeishmaniasisUnited States
-
IDRICompleted
-
IDRICompletedCutaneous LeishmaniasisPeru
-
Butantan InstituteCompletedInfluenza | H7N9 InfluenzaBrazil