- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02071758
Phase 1 LEISH-F3 + SLA-SE Vaccine Trial in Healthy Adult Volunteers
February 22, 2016 updated by: IDRI
A Phase 1, Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F3 + SLA-SE Vaccine Compared to LEISH-F3 + GLA-SE Vaccine in Healthy Adult Subjects
The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of visceral leishmaniasis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Daytona Beach, Florida, United States, 32117
- Covance, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females 18 to 49 years of age.
- Must be in good general health as confirmed by a medical history and physical exam.
- Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study vaccination, must not be breast-feeding, and are required to use one of the following methods of contraception during the first 3 months of the study: hormonal (e.g., oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); abstinence; or bilateral tubal ligation (if no conception post-procedure). These precautions are necessary due to unknown effects that LEISH-F3 + SLA-SE or LEISH-F3 + GLA-SE might cause in a fetus or newborn infant.
- The following screening laboratory values must be within the normal ranges or not clinically significant as determined by the PI and Medical Monitor (MM): sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobin, and platelet count.
- The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
- Negative urine test for recreational drugs and alcohol per Clinical Research Unit standards.
- Urinalysis not clinically significant as determined by the study clinician.
- Must be capable of completing a study memory aid in English.
- Must give informed consent, be able and willing to make all evaluation visits, be reachable by telephone or personal contact by the study site personnel, and have a permanent address.
Exclusion Criteria:
- History of possible infection with Leishmania or previous exposure to Leishmania vaccines or experimental products containing SLA or GLA.
- Veterans who served in the military in the Middle East (Iran, Iraq), Afghanistan, or any other areas endemic to Leishmania.
- Travelers to, or immigrants from, areas endemic to Leishmania.
- Participation in another experimental protocol or receipt of any investigational products within the past 3 months.
- Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) within the past 6 months.
- Received a blood transfusion within the past 3 months.
- Donated blood products (platelets, whole blood, plasma, etc.) within past one month.
- Received any vaccine within past 1 month and no planned immunizations while on study with the exception of seasonal influenza vaccine which should not be given between Day 0-84 or Day 138-168 due to 30-day washout period prior to immunology blood draws.
- History of autoimmune disease or other causes of immunosuppressive states.
- History or evidence of any acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic, or renal disorders, controlled hypertension), or use of medication that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
- BMI, that in the opinion of the Investigator, poses a health risk.
- Hypertension (systolic >150 or diastolic >95).
- History of significant psychiatric illness with current use of medication.
- Known or suspected alcohol or drug abuse within the past 6 months.
- Chronic smoker (> 20 pack years).
- Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines, eggs, or unknown allergens.
- Subjects who are unlikely to cooperate with the requirements of the study protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 20 mcg LEISH-F3 + 5 mcg SLA-SE Vaccine
Three intramuscular injections of LEISH-F3 + SLA-SE at Days 0, 28, and 56.
High dose of antigen and low dose of SLA-SE adjuvant.
|
|
Experimental: 20 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine
Three intramuscular injections of LEISH-F3 + GLA-SE at Days 0, 28, and 56.
High dose of antigen and high dose of GLA-SE adjuvant.
|
|
Experimental: 5 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine
Three intramuscular injections of LEISH-F3 + GLA-SE at Days 0, 28, and 56.
Low dose of antigen and high dose of GLA-SE adjuvant.
|
|
Experimental: 20 mcg LEISH-F3 + 10 mcg SLA-SE Vaccine
Three intramuscular injections of LEISH-F3 + SLA-SE at Days 0, 28, and 56.
High dose of antigen and high dose of SLA-SE adjuvant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Events
Time Frame: 421 days
|
Solicited and unsolicited adverse events will be recorded for 28 days following each study injection; serious adverse events and adverse events of special interest will be recorded for the duration of the study.
|
421 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity
Time Frame: Days 0, 7, 35, 63, 84, and 168
|
Immunogenicity will be evaluated by measuring humoral and cellular responses to LEISH-F3 + SLA-SE or LEISH-F3 + GLA-SE at specified timepoints.
|
Days 0, 7, 35, 63, 84, and 168
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
February 24, 2014
First Submitted That Met QC Criteria
February 24, 2014
First Posted (Estimate)
February 26, 2014
Study Record Updates
Last Update Posted (Estimate)
February 23, 2016
Last Update Submitted That Met QC Criteria
February 22, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDRI-LVVPX-117
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.
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IDRICompletedCutaneous LeishmaniasisPeru