NCT02071758

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

February 24, 2014

Last Update Submit

February 22, 2016

Conditions

Visceral Leishmaniasis

Keywords

LeishmaniasisVisceral leishmaniasisVaccineAdjuvantGLASLA

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    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 Outcomes (1)

  • Immunogenicity

    Days 0, 7, 35, 63, 84, and 168

Study Arms (4)

20 mcg LEISH-F3 + 5 mcg SLA-SE Vaccine

EXPERIMENTAL

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

20 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine

EXPERIMENTAL

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

5 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine

EXPERIMENTAL

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

20 mcg LEISH-F3 + 10 mcg SLA-SE Vaccine

EXPERIMENTAL

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

Interventions

LEISH-F3 + SLA-SEBIOLOGICAL
20 mcg LEISH-F3 + 10 mcg SLA-SE Vaccine20 mcg LEISH-F3 + 5 mcg SLA-SE Vaccine
LEISH-F3 + GLA-SEBIOLOGICAL
20 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine5 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance, Inc.

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Leishmaniasis, VisceralLeishmaniasis

Condition Hierarchy (Ancestors)

Euglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne DiseasesSkin Diseases, ParasiticSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anna Marie Beckmann, PhD

    Access to Advanced Health Institute (AAHI)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

US(1)