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

Access to Advanced Health Institute (AAHI)1 site in 1 country60 target enrollmentAugust 2012

ConditionsPulmonary Tuberculosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pulmonary Tuberculosis
Sponsor: Access to Advanced Health Institute (AAHI)
Enrollment: 60
Locations: 1
Primary Endpoint: Number of patients experiencing adverse events.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

May 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Access to Advanced Health Institute (AAHI)

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

Number of patients experiencing adverse events.

Time Frame: 420 days

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.