Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers

NCT03302897 | Completed Phase 1 FDA Drug

• 1 other identifier: IDRI-LEPVPX-118
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 leprosy. Two dose levels of the vaccine will be evaluated.

Conditions

Leprosy

Keywords

Leprosy, vaccine, adjuvant, GLA, GLA-SE

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 (IgG antibody and T cell responses to LEP-F1)

  Days 0, 35, and 63

Study Arms (2)

2 μg LEP-F1 + 5 μg GLA-SE

EXPERIMENTAL

Three intramuscular injections of LEP-F1 + GLA-SE at Days 0, 28, and 56. Low dose of antigen.

Biological: LEP-F1 + GLA-SE

10 μg LEP-F1 + 5 μg GLA-SE

EXPERIMENTAL

Three intramuscular injections of LEP-F1 + GLA-SE at Days 0, 28, and 56. Higher dose of antigen.

Biological: LEP-F1 + GLA-SE

Interventions

LEP-F1 + GLA-SE BIOLOGICAL

Investigational vaccine

10 μg LEP-F1 + 5 μg GLA-SE; 2 μg LEP-F1 + 5 μg GLA-SE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females 18 years to 55 years of age.
• Must be in good general health as confirmed by a medical history and physical exam.
• Female subjects of childbearing potential 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 from enrollment (Day 0) in study until 30 days after last injection (only if in sexual relationships with men): hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy. These precautions are necessary due to unknown effects that LEP-F1 + GLA-SE might cause in a fetus or newborn infant. Women are considered non-child-bearing potential if they are post-menopausal (defined as at least 12 months spontaneous amenorrhea and confirmed with FSH \> 40 mIU/ml) or have had documented hysterectomy and/or oophorectomy.
• The following screening laboratory values must be within the normal ranges or not clinically significant as determined by the Investigator and approved by the Medical Monitor: sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobin, and platelet count. Abnormal results may be repeated once for confirmation at Investigator discretion.
• The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), QuantiFERON®-TB Gold (QFT), and hepatitis C virus (HCV) antibody.
• Negative test for recreational drugs and alcohol per Clinical Research Unit standards.
• Normal or not clinically significant urinalysis as determined by the study clinician or designee. Abnormal results may be repeated at Investigator discretion.
• 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 infection with M. leprae or previous exposure to M. leprae vaccines or experimental products containing GLA-SE.
• History of BCG vaccination.
• History of active or documented latent TB.
• History of previous infection with other non-tuberculous mycobacteria.
• Travel to or residence in India, Brazil, or Indonesia for more than 6 months.
• Participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to Screening.
• 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) in the past 6 months prior to Screening.
• Received a blood transfusion within past 3 months prior to Screening.
• Donated blood products (platelets, whole blood, plasma, etc.) within past one month prior to Screening.
• Received any vaccine within past 1 month prior to Screening or have any planned immunizations while on study, with the exception of seasonal influenza vaccine which can be given after 1 month post the third study injection (Day 84).
• History of autoimmune disease or other causes of immunosuppressive states.
• History of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled 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 ≥ 32.
• Hypertension (systolic \> 150 or diastolic \> 95) at screening and Day 0.

Sponsors & Collaborators

• Access to Advanced Health Institute (AAHI): lead
• American Leprosy Missions: collaborator

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Leprosy

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Corey Casper, MD, MPH

  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: October 2, 2017
• First Posted: October 5, 2017
• Study Start: October 2, 2017
• Primary Completion: March 5, 2019
• Study Completion: March 5, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)