Pulmonary TuberculosisPhase 1NCT01599897
Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
A Phase 1 study testing ID93 + GLA-SE and ID93 alone in people with Pulmonary Tuberculosis, run by Access to Advanced Health Institute (AAHI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- ID93 + GLA-SE and ID93 alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 238. 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
Who cannot join
- 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
Show all 31Show fewer
- 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
- History of or evidence of current hypertension
- History of autoimmune disease or immunosuppression
- Used immunosuppressive medication within 42 days before randomization (inhaled and topical corticosteroids are permitted)
- Received immunoglobulin or blood products within 42 days before randomization
- 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
- Received investigational Mtb vaccine at any time prior to randomization
- Unable to discontinue current chronic prescription drug therapy including hormone replacement such as thyroxin, insulin, and medications that can be hepatotoxic or toxic to the bone marrow (such as statins) etc (estrogen and progesterone replacement and contraceptives, topical medications, and nasal steroids are acceptable)
- History or laboratory evidence of immunodeficiency state including but not limited to laboratory indication of HIV 1 infection at screening
- History of allergic disease or reactions (such as an allergic reaction to eggs), including eczema, likely to be exacerbated by any component of the study vaccine
- History of allergic reaction to kanamycin-related antibiotics
- Previous medical history that may compromise the safety of the subject in the study, including but not limited to: severe impairment of pulmonary function from tuberculosis infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; or uncontrolled epilepsy or infantile spasms
- History of positive tuberculin skin test
- Evidence of chronic hepatitis (e.g., hepatitis B core antibody or hepatitis C antibody) at screening
- History of alcohol or drug abuse within the past 2 years or consumes more than 1 (women) or 2 (men) alcoholic beverage(s) per day
- Tobacco or cannabis smoking 3 or more days per week
- History of keloid formation
- Positive urine test for illicit drugs (opiates, cocaine, amphetamines) at screening
- 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, including axillary lymphadenopathy
- All female subjects: currently pregnant or lactating/nursing; or positive urine pregnancy test during screening or positive urine pregnancy test on the day of study injection
- Received a tuberculin skin test within 3 months (90 days) prior to the time of randomization
- Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- ID93 + GLA-SE, ID93 alone
- Keywords
- Tuberculosis, TB, Pulmonary, Vaccine
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID93 + GLA-SEBiological
ID93 antigen and GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.
ID93 aloneBiological
ID93 antigen alone. 3 injections and Days 0, 28, and 56.
| Study group | Role | What they receive |
|---|---|---|
| 2 µg ID93 + 2 µg GLA-SE | Experimental | Low dose and antigen and low dose of adjuvant. Receives: Biological: ID93 + GLA-SE |
| 10 µg ID93 + 2 µg GLA-SE | Experimental | High dose of antigen and low dose of adjuvant. Receives: Biological: ID93 + GLA-SE |
| 2 µg ID93 + 5 µg GLA-SE | Experimental | Low dose of antigen and high dose of adjuvant. Receives: Biological: ID93 + GLA-SE |
| 10 µg ID93 + 5 µg GLA-SE | Experimental | High dose of antigen and high dose of adjuvant. Receives: Biological: ID93 + GLA-SE |
| 2 µg ID93 alone | Active comparator | Low dose of antigen alone. Receives: Biological: ID93 alone |
| 10 µg ID93 alone | Active comparator | High dose of antigen alone. Receives: Biological: ID93 alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing adverse events.
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.
Measured: 420 days
Secondary outcomes (1)
Immunogenicity
To assess the immunogenicity of ID93 + GLA-SE compared to ID93 alone by evaluating IgG antibody and T-cell responses to ID93 at specified timepoints.
Measured: Days 0, 1, 3, 7, 14, 28, 42, 56, 70, 84, 238
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- Aeras, Paul G. Allen Family Foundation
- Responsible party
- Sponsor
- Investigators
- Franco Piazza, MD, MPH, Study director, Access to Advanced Health Institute (AAHI)Anna Marie Beckmann, PhD, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599897
- Sponsor's protocol ID
- IDRI-TBVPX-113
- Status last verified
- Sep 2017
- First submitted
- 14 May 2012
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coler RN, Day TA, Ellis R, Piazza FM, Beckmann AM, Vergara J, Rolf T, Lu L, Alter G, Hokey D, Jayashankar L, Walker R, Snowden MA, Evans T, Ginsberg A, Reed SG; TBVPX-113 Study Team. The TLR-4 agonist adjuvant, GLA-SE, improves magnitude and quality of immune responses elicited by the ID93 tuberculosis vaccine: first-in-human trial. NPJ Vaccines. 2018 Sep 4;3:34. doi: 10.1038/s41541-018-0057-5. eCollection 2018.
PubMed 30210819
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01599897
- Acronym / sponsor ID
- IDRI-TBVPX-113
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Tuberculosis, TB, Pulmonary, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- Aeras, Paul G. Allen Family Foundation
- Study start
- Aug 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 2 µg ID93 + 2 µg GLA-SE | Experimental | Biological: ID93 + GLA-SELow dose and antigen and low dose of adjuvant. |
| 10 µg ID93 + 2 µg GLA-SE | Experimental | Biological: ID93 + GLA-SEHigh dose of antigen and low dose of adjuvant. |
| 2 µg ID93 + 5 µg GLA-SE | Experimental | Biological: ID93 + GLA-SELow dose of antigen and high dose of adjuvant. |
| 10 µg ID93 + 5 µg GLA-SE | Experimental | Biological: ID93 + GLA-SEHigh dose of antigen and high dose of adjuvant. |
| 2 µg ID93 alone | Active comparator | Biological: ID93 aloneLow dose of antigen alone. |
| 10 µg ID93 alone | Active comparator | Biological: ID93 aloneHigh dose of antigen alone. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 238. 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ID93 + GLA-SEID93 antigen and GLA-SE adjuvant. 3 injections at Days 0, 28, and 56. | Biological | 10 µg ID93 + 2 µg GLA-SE, 10 µg ID93 + 5 µg GLA-SE, 2 µg ID93 + 2 µg GLA-SE, 2 µg ID93 + 5 µg GLA-SE |
| ID93 aloneID93 antigen alone. 3 injections and Days 0, 28, and 56. | Biological | 10 µg ID93 alone, 2 µg ID93 alone |
Primary outcome
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.
1 secondary outcome
Immunogenicity
Time frame: Days 0, 1, 3, 7, 14, 28, 42, 56, 70, 84, 238
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Derived from this study: PubMed 30210819Coler RN, Day TA, Ellis R, Piazza FM, Beckmann AM, Vergara J, Rolf T, Lu L, Alter G, Hokey D, Jayashankar L, Walker R, Snowden MA, Evans T, Ginsberg A, Reed SG; TBVPX-113 Study Team. The TLR-4 agonist adjuvant, GLA-SE, improves magnitude and quality of immune responses elicited by the ID93 tuberculosis vaccine: first-in-human trial. NPJ Vaccines. 2018 Sep 4;3:34. doi: 10.1038/s41541-018-0057-5. eCollection 2018.
Related trials for Pulmonary Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
RecruitingPhase 2
BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
Tuberculosis
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
Recruiting
Channa Striata and Curcuma Domestica Supplementation in Patients With Active Pulmonary Tuberculosis
Pulmonary Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Piazza, MD, MPH study director
Access to Advanced Health Institute (AAHI)
Anna Marie Beckmann, PhD study director
Access to Advanced Health Institute (AAHI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ID93 + GLA-SE and ID93 alone in people with Pulmonary Tuberculosis, run by Access to Advanced Health Institute (AAHI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing adverse events. (time frame: 420 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.