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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02465216
First Posted: June 8, 2015
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Wellcome Trust
South African Tuberculosis Vaccine Initiative
Information provided by (Responsible Party):
IDRI
  Purpose
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.

Condition Intervention Phase
Pulmonary Tuberculosis Other: Placebo Biological: ID93 + GLA-SE Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by IDRI:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Days 0, 14, 28, 56, 70, 84, and 224 ]
    Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at specified timepoints.


Enrollment: 60
Study Start Date: June 2015
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 10 mcg ID93 + 5 mcg GLA-SE Vaccine
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and high dose of adjuvant.
Biological: ID93 + GLA-SE
ID93 + GLA-SE
Placebo Comparator: Placebo
Two intramuscular injections of normal saline at Days 0 and 56.
Other: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465216


Locations
South Africa
TASK Applied Sciences
Cape Town, South Africa, 7530
Desmond Tutu HIV Centre (DTHC)
Cape Town, South Africa, 7750
South African Tuberculosis Vaccine Initiative (SATVI)
Worcester, South Africa, 6850
Sponsors and Collaborators
IDRI
Wellcome Trust
South African Tuberculosis Vaccine Initiative
Investigators
Principal Investigator: Mark Hatherill, MD South African Tuberculosis Vaccine Initiative
  More Information

Responsible Party: IDRI
ClinicalTrials.gov Identifier: NCT02465216     History of Changes
Other Study ID Numbers: IDRI-TBVPX-203
First Submitted: June 3, 2015
First Posted: June 8, 2015
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by IDRI:
Tuberculosis
TB
Pulmonary
Vaccine
Adjuvant

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs