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

COMPLETEDPHASE1

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

A Phase 1b, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in BCG-Vaccinated Healthy Adults

NCT01927159•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 BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Has completed the written informed consent process prior to start of screening evaluations
•2. Male or female who is ≥18 years and ≤50 years of age at the time of randomization
•3. 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
•4. Agrees to avoid elective surgery for the full duration of the study
•5. For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 and for the full duration of the study. 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), or the combination of a condom or diaphragm with spermicide gel
•6. Has general good health, confirmed by medical history and physical examination
•7. Has body mass index (BMI) between 19 and 33 (weight/height2) by nomogram
•8. Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar

Exclusion Criteria

•1. Acute illness at the time of randomization
•2. Oral temperature ≥37.5°C at the time of randomization
•3. Clinically significant abnormal laboratory values for any of the following screening laboratory parameters, per local laboratory normal ranges from blood collected within 30 days prior to Study Day 0 randomization as follows:
•* hemoglobin, hematocrit, absolute neutrophil count, absolute lymphocyte count, or platelet count below lower limit of normal (LLN)
•* white blood cell count above upper limit of normal (ULN) or below LLN (i.e., must be within normal limits)
•* ALT, AST, total bilirubin, alkaline phosphatase, creatinine, or blood urea nitrogen (BUN) above ULN
•4. Evidence of systemic or local disease process on screening urinalysis
•5. Evidence of significant active infection
•6. History of treatment for active or latent tuberculosis or evidence of active tuberculosis
•7. Shared a residence within the last year prior to randomization with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis
+18 more criteria

Locations (1)

SATVI

Worcester, Western Cape, South Africa

Key Dates

Start Date

September 1, 2013

Primary Completion Date

July 1, 2015

Completion Date

July 1, 2015

Last Updated

February 1, 2018

Enrollment

ACTUAL participants

Conditions

Pulmonary Tuberculosis

Interventions

ID93 + GLA-SE

BIOLOGICAL

Placebo

OTHER

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

NCT06192160

Pulmonary Tuberculosis

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RECRUITINGPHASE3

Novel Triple-dose Tuberculosis Retreatment Regimen

NCT04260477

Multidrug-resistant TuberculosisPulmonary Tuberculosis+2 more

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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: February 1, 2018Data 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 BCG-Vaccinated Healthy Adult Volunteers

Inclusion Criteria

Exclusion Criteria

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