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Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers

A Phase 1, Randomized, Dose-escalation Study to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine at Two Dose Levels of the ID93 Antigen and the GLA-SE Adjuvant in Healthy Adults

NCT01599897•Access to Advanced Health Institute (AAHI)

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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
+21 more criteria

Locations (1)

Johnson County Clin-Trials

Lenexa, Kansas, United States

Key Dates

Start Date

August 1, 2012

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

September 15, 2017

Enrollment

ACTUAL participants

Conditions

Pulmonary Tuberculosis

Interventions

ID93 + GLA-SE

BIOLOGICAL

ID93 alone

BIOLOGICAL

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

NCT06192160

Pulmonary Tuberculosis

View study

RECRUITINGPHASE3

Novel Triple-dose Tuberculosis Retreatment Regimen

NCT04260477

Multidrug-resistant TuberculosisPulmonary Tuberculosis+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers

Inclusion Criteria

Exclusion Criteria

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

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