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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01927159
First Posted: August 22, 2013
Last Update Posted: September 15, 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:
Aeras
South African Tuberculosis Vaccine Initiative
Information provided by (Responsible Party):
IDRI
  Purpose
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.

Condition Intervention Phase
Pulmonary Tuberculosis Biological: ID93 + GLA-SE Other: Placebo Phase 1

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

Resource links provided by NLM:


Further study details as provided by IDRI:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 294 days ]
    Solicited and unsolicited adverse events will be recorded for 28 days following each study injection; serious adverse events and adverse events of special interest will be recorded for the duration of the study.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Days 0, 14, 42, 112, 126, 196, 294 ]
    Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at specified timepoints.


Enrollment: 66
Study Start Date: September 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mcg ID93 + 2 mcg GLA-SE Vaccine (QFT-)
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and low dose of adjuvant. This group limited to adults with negative Quantiferon Gold TB (QFT) test.
Biological: ID93 + GLA-SE
Experimental: 2 mcg ID93 + 2 mcg GLA-SE Vaccine
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. Low dose of antigen and low dose of adjuvant.
Biological: ID93 + GLA-SE
Experimental: 10 mcg ID93 + 2 mcg GLA-SE Vaccine
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and low dose of adjuvant.
Biological: ID93 + GLA-SE
Experimental: 10 mcg ID93 + 5 mcg GLA-SE Vaccine
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and high dose of adjuvant.
Biological: ID93 + GLA-SE
Placebo Comparator: Saline
Three intramuscular injections of saline at Days 0, 28, and 112.
Other: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  8. History of autoimmune disease or immunosuppression
  9. Used immunosuppressive medication within 42 days before randomization (inhaled and topical corticosteroids are permitted)
  10. Received immunoglobulin or blood products within 42 days before randomization
  11. Received any investigational drug therapy or investigational vaccine within 182 days before randomization, or planned participation in any other investigational study during the study period
  12. Received investigational Mtb vaccine at any time prior to randomization
  13. Received a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to randomization.
  14. Unable to discontinue current chronic prescription drug therapy that can be hepatotoxic or toxic to the bone marrow or kidneys.
  15. History or laboratory evidence of immunodeficiency state including but not limited to any laboratory indication of HIV-1 infection
  16. History of allergic disease or reactions (including allergy to kanamycin-related antibiotics, allergic reaction to eggs, and severe eczema), likely to be exacerbated by any component of the study vaccine
  17. Previous medical history that may compromise the safety of the participant in the study, including but not limited to: severe impairment of pulmonary function from pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; or uncontrolled epilepsy
  18. Evidence of chronic hepatitis (e.g., hepatitis B surface antigen or hepatitis C antibody)
  19. Chronic heavy ethanol intake which, in the opinion of the investigator, may compromise the safety of the participant or interfere with the evaluation of the safety of the vaccine
  20. Cannabis smoking 3 or more days per week
  21. Positive urine test for illicit drugs (opiates, cocaine, amphetamines)
  22. History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine
  23. All female participants: currently pregnant or lactating/nursing; or positive urine pregnancy test during screening or on the day of study injection
  24. Received a tuberculin skin test within 3 months (90 days) prior to Study Day 0
  25. Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol or may compromise the safety of the participant
  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): NCT01927159


Locations
South Africa
SATVI
Worcester, Western Cape, South Africa, 6850
Sponsors and Collaborators
IDRI
Aeras
South African Tuberculosis Vaccine Initiative
Investigators
Principal Investigator: Michele Tameris, M.B.Ch.B. SATVI
  More Information

Responsible Party: IDRI
ClinicalTrials.gov Identifier: NCT01927159     History of Changes
Other Study ID Numbers: IDRI-TBVPX-114
First Submitted: August 15, 2013
First Posted: August 22, 2013
Last Update Posted: September 15, 2017
Last Verified: September 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