NCT01599897

Brief Summary

The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis. The vaccine, identified as ID93 + GLA-SE, consists of the recombinant four-antigen Mycobacterium tuberculosis recombinant protein ID93 together with the adjuvant GLA-SE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2012

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

May 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

May 14, 2012

Last Update Submit

September 14, 2017

Conditions

Pulmonary Tuberculosis

Keywords

TuberculosisTBPulmonaryVaccine

Outcome Measures

Primary Outcomes (1)

  • Number of patients experiencing adverse events.

    To evaluate the safety and tolerability of 2 or 10 μg of ID93 together with 2 or 5 μg of GLA-SE compared to 2 or 10 µg of ID93 alone following intramuscular administration on Days 0, 28, and 56. The safety assessments will be based on local and systemic reactions, including reported adverse events, changes in laboratory values, and changes in vital signs. The severity and relationship to treatment will be recorded for all adverse events.

    420 days

Secondary Outcomes (1)

  • Immunogenicity

    Days 0, 1, 3, 7, 14, 28, 42, 56, 70, 84, 238

Study Arms (6)

2 µg ID93 + 2 µg GLA-SE

EXPERIMENTAL

Low dose and antigen and low dose of adjuvant.

Biological: ID93 + GLA-SE

10 µg ID93 + 2 µg GLA-SE

EXPERIMENTAL

High dose of antigen and low dose of adjuvant.

Biological: ID93 + GLA-SE

2 µg ID93 + 5 µg GLA-SE

EXPERIMENTAL

Low dose of antigen and high dose of adjuvant.

Biological: ID93 + GLA-SE

10 µg ID93 + 5 µg GLA-SE

EXPERIMENTAL

High dose of antigen and high dose of adjuvant.

Biological: ID93 + GLA-SE

2 µg ID93 alone

ACTIVE COMPARATOR

Low dose of antigen alone.

Biological: ID93 alone

10 µg ID93 alone

ACTIVE COMPARATOR

High dose of antigen alone.

Biological: ID93 alone

Interventions

ID93 + GLA-SEBIOLOGICAL

ID93 antigen and GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.

10 µg ID93 + 2 µg GLA-SE10 µg ID93 + 5 µg GLA-SE2 µg ID93 + 2 µg GLA-SE2 µg ID93 + 5 µg GLA-SE
ID93 aloneBIOLOGICAL

ID93 antigen alone. 3 injections and Days 0, 28, and 56.

10 µg ID93 alone2 µg ID93 alone

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Has completed the written informed consent process prior to start of screening evaluations
  • Male or female who is 18 to 45 years of age at the time of randomization
  • Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
  • Agrees to avoid elective surgery for the full duration of the study
  • For female subjects: agrees to avoid pregnancy through Study Day 238. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), condoms or the combination of diaphragm with spermicide
  • Has body mass index (BMI) between 19 and 33 (weight/height2) by nomogram at the time of randomization

You may not qualify if:

  • Acute illness at the time of randomization
  • Oral temperature greater than 37.5C (99.5F) at the time of randomization
  • Values for any of the following screening laboratory parameters, from blood collected within 15 days prior to randomization, outside the normal ranges per local laboratory parameters: hemoglobin, hematocrit, absolute neutrophil count, absolute lymphocyte count, white blood cell count, electrolytes, ALT, AST, total bilirubin, alkaline phosphatase (ALP), creatinine, BUN, and lipid profile
  • Evidence of systemic or local disease process on screening urinalysis
  • Evidence of significant active infection
  • Positive laboratory test (e.g., QuantiFERON(R)-TB) evidence of Mtb infection at screening
  • History of treatment for active or latent tuberculosis infection
  • History or evidence of active tuberculosis
  • Has received vaccination or immunotherapy with a BCG product at any time prior to randomization
  • Shared a residence within the last year prior to randomization with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis
  • History of or evidence of current hypertension
  • History of autoimmune disease or immunosuppression
  • Used immunosuppressive medication within 42 days before randomization (inhaled and topical corticosteroids are permitted)
  • Received immunoglobulin or blood products within 42 days before randomization
  • Received any investigational drug therapy or investigational vaccine within 182 days before randomization, or planned participation in any other investigational study during the study period
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

  • Coler RN, Day TA, Ellis R, Piazza FM, Beckmann AM, Vergara J, Rolf T, Lu L, Alter G, Hokey D, Jayashankar L, Walker R, Snowden MA, Evans T, Ginsberg A, Reed SG; TBVPX-113 Study Team. The TLR-4 agonist adjuvant, GLA-SE, improves magnitude and quality of immune responses elicited by the ID93 tuberculosis vaccine: first-in-human trial. NPJ Vaccines. 2018 Sep 4;3:34. doi: 10.1038/s41541-018-0057-5. eCollection 2018.

    PMID: 30210819DERIVED

MeSH Terms

Conditions

Tuberculosis, PulmonaryTuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Franco Piazza, MD, MPH

    Access to Advanced Health Institute (AAHI)

    STUDY DIRECTOR

  • Anna Marie Beckmann, PhD

    Access to Advanced Health Institute (AAHI)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

US(1)