Phase 1 LEISH-F3 + SLA-SE Vaccine Trial in Healthy Adult Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Infectious Disease Research Institute
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Infectious Disease Research Institute
ClinicalTrials.gov Identifier:
NCT02071758
First received: February 24, 2014
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Visceral Leishmaniasis
Biological: LEISH-F3 + SLA-SE
Biological: LEISH-F3 + GLA-SE
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Infectious Disease Research Institute:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 421 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Days 0, 7, 35, 63, 84, and 168 ] [ Designated as safety issue: No ]
    Immunogenicity will be evaluated by measuring humoral and cellular responses to LEISH-F3 + SLA-SE or LEISH-F3 + GLA-SE at specified timepoints.


Estimated Enrollment: 36
Study Start Date: April 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: LEISH-F3 + SLA-SE
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.
Biological: LEISH-F3 + GLA-SE
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.
Biological: LEISH-F3 + GLA-SE
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.
Biological: LEISH-F3 + SLA-SE

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02071758

Contacts
Contact: H. Frank Farmer, PhD, MD, CPI 386-366-6400 frank.farmer@covance.com

Locations
United States, Florida
Covance, Inc. Recruiting
Daytona Beach, Florida, United States, 32117
Principal Investigator: H. Frank Farmer, PhD, MD, CPI         
Sponsors and Collaborators
Infectious Disease Research Institute
Bill and Melinda Gates Foundation
Investigators
Study Director: Anna Marie Beckmann, PhD IDRI
  More Information

No publications provided

Responsible Party: Infectious Disease Research Institute
ClinicalTrials.gov Identifier: NCT02071758     History of Changes
Other Study ID Numbers: IDRI-LVVPX-117
Study First Received: February 24, 2014
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Infectious Disease Research Institute:
Leishmaniasis
Visceral leishmaniasis
Vaccine
Adjuvant
GLA
SLA

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic

ClinicalTrials.gov processed this record on October 20, 2014