Pulmonary TuberculosesPhase 1NCT03159975
Safety and Immunogenicity Study of GX-70 in TB Patient
A Phase 1 study testing GX-70 by electroporation in people with Pulmonary Tuberculoses and High Risk Factors for Relapse, run by Yonsei University.
Trial summary
The purpose of this study is to determine the safety, tolerability, and immunogenicity in patients with pulmonary tuberculosis of an investigational DNA vaccine being developed for the prevention of relapse of tuberculosis. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Pulmonary Tuberculoses, High Risk Factors for Relapse, Treatment Failure
- What is being tested?
- GX-70 by electroporation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Aug 2018
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.
- Adults between 19 and 65 years.
- TB patients without a history of TB diagnosis, who show positive on both AFB smear and TB-PCR
- TB patients who satisfy following conditions: cavity spotted from chest imaging before TB therapy, positive on AFB smear 2 months after TB therapy.
Who cannot join
- At 2 months after therapy started, AFB smear shows 1+ or higher, but TB PCR shows NTM positive.
- If positive on AFB smear is resulted from dead MTB
- Serious TB such as tuberculous encephalomeningitis
- Patients with serious pulmonary symptom except TB
- Patients show poor vital sign considered to be difficult to participate
- Patients with heart, renal, or liver failure
Show all 11Show fewer
- Patients with infection, ulcer, edema, tattoo, scar, wound and other conditions in skin around 3cm of deltoid muscle that result inappropriate to inject through electroporation.
- When thickness of skin around deltoid muscle which is to be injected exceeds 40mm
- Patients with QTc prolongation on 12-lead ECG
- Patients with a cardiac device (such as a pacemaker)
- Patients that the researchers do not think fit into the group, including patients failed in compliance assessment
About this study
Official title: A Open-label, Dose Escalation, Phase 1 Clinical Trial to Evaluate the Tolerability, Safety and Immunogenicity of GX-70, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in Patients With Pulmonary Tuberculosis Who Have High Risk Factors for Relapse or Treatment Failure
The purpose of this study is to determine the safety, tolerability, and immunogenicity in patients with pulmonary tuberculosis of an investigational DNA vaccine being developed for the prevention of relapse of tuberculosis.
Read the detailed description
Tuberculosis still matters in domestic as well as global public health. According to WHO, 8,700,000 cases of tuberculosis occured in 2011, and 1,400,000 of them resulted dead. Tuberculosis patients with the cavity and positive on AFB show high rate of relapse and treatment failure. Those with high risk of relapse and treatment failure may need more effective treatment before acquiring resistance and infecting others. GX-70, which consists of the four-antigen plasmids from MTB together with recombinant Flt3 ligand is an investigational DNA vaccine designed to prevent relapse or treatment failure.
The purpose of this study is to assess safety of GX-70, in pulmonary TB patients with high risk factors for treatment failure or relapse.
- Being tested
- GX-70 by electroporation
- Keywords
- Tuberculosis, DNA vaccine, Electroporation, GX-70
- 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.
GX-70 by electroporationDrug
Gx-70 0.26mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
GX-70 by electroporationDrug
Gx-70 1mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
GX-70 by electroporationDrug
Gx-70 4mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 (GX-70 0.26mg) | Experimental | Administrating GX-70 0.26mg Receives: Drug: GX-70 by electroporation |
| Dose level 2 (GX-70 1mg) | Experimental | Administrating GX-70 1mg Receives: Drug: GX-70 by electroporation |
| Dose level 3 (GX-70 4mg) | Experimental | Administrating GX-70 4mg Receives: Drug: GX-70 by electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD (Maximum Tolerant Dose)
Measured: Every 4 weeks up to 16 weeks
Secondary outcomes (2)
IFN-γ (SFC/106 cells)
IFN-γ response stimulated by TB antigens
Measured: Every 8 weeks up to 24 weeks
Flt3L concentration (pg/ml)
Every 8 weeks up to 24 weeks
Measured: Every 8 weeks up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startMar 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: Unconfirmed research expenses
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- 1. Dose level 1 : GX-70 0.26mg 2. Dose level 2 : GX-70 1mg 3. Dose level 3 : GX-70 4mg
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159975
- Sponsor's protocol ID
- 4-2016-1144
- Status last verified
- Jan 2019
- First submitted
- 14 May 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flynn JL, Chan J. Tuberculosis: latency and reactivation. Infect Immun. 2001 Jul;69(7):4195-201. doi: 10.1128/IAI.69.7.4195-4201.2001. No abstract available.
PubMed 11401954Chang KC, Leung CC, Yew WW, Ho SC, Tam CM. A nested case-control study on treatment-related risk factors for early relapse of tuberculosis. Am J Respir Crit Care Med. 2004 Nov 15;170(10):1124-30. doi: 10.1164/rccm.200407-905OC. Epub 2004 Sep 16.
PubMed 15374844Ahn SS, Jeon BY, Kim KS, Kwack JY, Lee EG, Park KS, Sung YC, Cho SN. Mtb32 is a promising tuberculosis antigen for DNA vaccination in pre- and post-exposure mouse models. Gene Ther. 2012 May;19(5):570-5. doi: 10.1038/gt.2011.140. Epub 2011 Sep 29.
PubMed 21956689
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Dose Escalation, Phase 1 Clinical Trial to Evaluate the Tolerability, Safety and Immunogenicity of GX-70, a DNA-based Therapeutic Vaccine, Administered Intramuscularly by Electroporation (EP) in Patients With Pulmonary Tuberculosis Who Have High Risk Factors for Relapse or Treatment Failure
- ClinicalTrials.gov ID
- NCT03159975
- Acronym / sponsor ID
- 4-2016-1144
- Keywords
- Tuberculosis, DNA vaccine, Electroporation, GX-70
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unconfirmed research expenses
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 May 2017 (actual)
- 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 patients with pulmonary tuberculosis of an investigational DNA vaccine being developed for the prevention of relapse of tuberculosis.
Detailed description
Tuberculosis still matters in domestic as well as global public health. According to WHO, 8,700,000 cases of tuberculosis occured in 2011, and 1,400,000 of them resulted dead. Tuberculosis patients with the cavity and positive on AFB show high rate of relapse and treatment failure. Those with high risk of relapse and treatment failure may need more effective treatment before acquiring resistance and infecting others. GX-70, which consists of the four-antigen plasmids from MTB together with recombinant Flt3 ligand is an investigational DNA vaccine designed to prevent relapse or treatment failure.
The purpose of this study is to assess safety of GX-70, in pulmonary TB patients with high risk factors for treatment failure or relapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. Dose level 1 : GX-70 0.26mg 2. Dose level 2 : GX-70 1mg 3. Dose level 3 : GX-70 4mg
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 (GX-70 0.26mg) | Experimental | Drug: GX-70 by electroporationAdministrating GX-70 0.26mg |
| Dose level 2 (GX-70 1mg) | Experimental | Drug: GX-70 by electroporationAdministrating GX-70 1mg |
| Dose level 3 (GX-70 4mg) | Experimental | Drug: GX-70 by electroporationAdministrating GX-70 4mg |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.
- Adults between 19 and 65 years.
- TB patients without a history of TB diagnosis, who show positive on both AFB smear and TB-PCR
- TB patients who satisfy following conditions: cavity spotted from chest imaging before TB therapy, positive on AFB smear 2 months after TB therapy.
Key exclusion criteria (11 listed)
- At 2 months after therapy started, AFB smear shows 1+ or higher, but TB PCR shows NTM positive.
- If positive on AFB smear is resulted from dead MTB
- Serious TB such as tuberculous encephalomeningitis
- Patients with serious pulmonary symptom except TB
- Patients show poor vital sign considered to be difficult to participate
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 |
|---|---|---|
| GX-70 by electroporationGx-70 0.26mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times | Drug | Dose level 1 (GX-70 0.26mg) |
| GX-70 by electroporationGx-70 1mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times | Drug | Dose level 2 (GX-70 1mg) |
| GX-70 by electroporationGx-70 4mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times | Drug | Dose level 3 (GX-70 4mg) |
Primary outcome
MTD (Maximum Tolerant Dose)
Time frame: Every 4 weeks up to 16 weeks
2 secondary outcomes
IFN-γ (SFC/106 cells)
Time frame: Every 8 weeks up to 24 weeks
Flt3L concentration (pg/ml)
Time frame: Every 8 weeks up to 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Results publication: PubMed 11401954Flynn JL, Chan J. Tuberculosis: latency and reactivation. Infect Immun. 2001 Jul;69(7):4195-201. doi: 10.1128/IAI.69.7.4195-4201.2001. No abstract available.
- Results publication: PubMed 15374844Chang KC, Leung CC, Yew WW, Ho SC, Tam CM. A nested case-control study on treatment-related risk factors for early relapse of tuberculosis. Am J Respir Crit Care Med. 2004 Nov 15;170(10):1124-30. doi: 10.1164/rccm.200407-905OC. Epub 2004 Sep 16.
- Results publication: PubMed 21956689Ahn SS, Jeon BY, Kim KS, Kwack JY, Lee EG, Park KS, Sung YC, Cho SN. Mtb32 is a promising tuberculosis antigen for DNA vaccination in pre- and post-exposure mouse models. Gene Ther. 2012 May;19(5):570-5. doi: 10.1038/gt.2011.140. Epub 2011 Sep 29.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GX-70 by electroporation in people with Pulmonary Tuberculoses and High Risk Factors for Relapse, run by Yonsei University.
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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
MTD (Maximum Tolerant Dose) (time frame: Every 4 weeks up to 16 weeks). 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 NCT03159975, which also lists 3 linked publications.
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 11 Jan 2019.