Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion

February 21, 2019 updated by: IDRI

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in HIV Uninfected Adult TB Patients After Treatment Completion

The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful completion of TB treatment with confirmed bacteriologic cure, in preparation for a future Phase 2b prevention of TB recurrence trial in the same population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Cape Town, South Africa, 7530
        • TASK Applied Sciences
      • Cape Town, South Africa, 7750
        • Desmond Tutu HIV Centre (DTHC)
      • Worcester, South Africa, 6850
        • South African Tuberculosis Vaccine Initiative (SATVI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females 18 to 60 years of age.
  2. Subjects must have been successfully treated, i.e., completed the scheduled course of TB treatment as per the prevailing South African national guidelines, for MTB culture-confirmed, drug sensitive pulmonary TB, as evidenced by a record of positive liquid MTB culture with formal drug sensitivity testing (DST) and/or by Xpert MTB/RIF test at baseline.
  3. Must have two separate samples showing bacteriologic confirmation of cure - defined in the first instance as Xpert MTB/RIF test negative, or, if Xpert MTB/RIF positive, as MTB liquid culture negative - on two successive occasions at least 30 days apart. Subjects who are sputum unproductive will be deemed Xpert MTB/RIF and MTB liquid culture negative.
  4. 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 injection, must not be breast-feeding, and be willing to avoid pregnancy for 3 months following first study injection. 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.
  5. The following screening laboratory values must be within the laboratory reference range or, if abnormal, deemed not clinically significant and less than Grade 2 severity on the FDA Toxicity Scale, as determined by the PI and LMM or Sponsor Medical Advisor: ALT, AST, total bilirubin, creatinine, total WBC count, hemoglobin, and platelet count.
  6. The HIV 1/2 antibody serology tests must be negative.
  7. 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 be willing to remain in the study area for the duration of the trial.

Exclusion Criteria:

  1. TB treatment failure, as evidenced by clinical diagnosis or a positive MTB liquid culture at month 4 or 5 after starting treatment. A positive MTB liquid culture at, or after, end of treatment would exclude subjects from receiving further study injections.
  2. Previous course of TB treatment completed within 5 calendar years prior to obtaining baseline diagnostic sputum samples.
  3. Receipt of any investigational products or investigational drug in the past 6 months or investigational vaccine ever.
  4. Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) in the past 6 months. Topical steroids would be allowable.
  5. Received incomplete or investigational, or non-standard TB drug regimen, other than the prevailing current South African national guideline as reference standard, or poor adherence to TB treatment regimen.
  6. Diagnosed with rifampicin-resistant MTB strain (by Xpert MTB/RIF and/or culture and formal DST).
  7. History of autoimmune disease or other causes of immunosuppressive states.
  8. History or evidence of any acute or chronic illness (including diabetes mellitus, asthma), medical or surgical condition, or chronic heavy ethanol or drug use, 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.
  9. Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines, eggs, or unknown allergens.
  10. Subjects who are unlikely to cooperate with the requirements of the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 mcg ID93 + 2 mcg GLA-SE Vaccine
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.
Biological: ID93 + GLA-SE
ID93 + GLA-SE
Experimental: 10 mcg ID93 + 2 mcg GLA-SE Vaccine
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.
Biological: ID93 + GLA-SE
ID93 + GLA-SE
Experimental: 2 mcg ID93 + 5 mcg GLA-SE Vaccine
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.
Biological: ID93 + GLA-SE
ID93 + GLA-SE
Placebo Comparator: Placebo
Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.
Other: Placebo
Placebo
Experimental: 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 doses
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.
Biological: ID93 + GLA-SE
ID93 + GLA-SE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: 224 days
Safety outcomes will include solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; and serious adverse events after the first study injection until end of study follow-up.
224 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity Responder Rate
Time Frame: Day 70
Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at Day 70.
Day 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IDRI

Collaborators

Wellcome Trust
South African Tuberculosis Vaccine Initiative

Investigators

  • Principal Investigator: Mark Hatherill, MD, South African Tuberculosis Vaccine Initiative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDRI-TBVPX-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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