TuberculosisPhase 2imm02NCT01380119
Tuberculosis (TB) Immunotherapy Phase 2 Study
A Phase 2 study testing V7 in people with Tuberculosis, run by Lisichansk Regional Tuberculosis Dispensary at 1 site in Ukraine.
Trial summary
This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- V7
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUkraine
- Study dates
- Aug 2011to Aug 2012
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
- TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test.
- TB score status at baseline.
- Agreement to participate in the study and to give a sample of blood for lab testing.
- Readily available home or other address where patient can be found.
Who cannot join
- Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded.
- Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry.
- Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients
This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.
- Conditions
- Tuberculosis
- Being tested
- V7, placebo
- Keywords
- sputum conversion, liver biochemistry, weight loss, quality of life
- Medical subject headings
- Tuberculosis, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V7Biological
experimental arm
placeboOther
placebo pill
| Study group | Role | What they receive |
|---|---|---|
| V7 | Experimental | Oral pill containing heat-killed Mycobacterium vaccae Receives: Biological: V7 |
| Placebo pill | Placebo comparator | Identically appearing placebo pills Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sputum conversion
To compare the efficacy of combination of V7 with anti-TB treatment versus anti-TB treatment+placebo in adults with pulmonary tuberculosis including:
Measured: 2 months
Secondary outcomes (1)
safety
- Liver functions tests (AST and ALT, and bilirubin) as main biochemical tests
- To confirm quality of life improvement by specially designed questionnaire TB score
- The beneficial effect on TB-associated wasting by measuring body weight.
Measured: 1 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisichansk Regional Tuberculosis Dispensary
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical University, Ukraine, Immunitor USA Inc.
- Responsible party
- Sponsor
- Investigators
- Aldar Bourinbaiar, MD/PhD, Study director, Immunitor USA Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380119
- Sponsor's protocol ID
- imm02
- Other IDs
- LisichnskRTD
- Acronym
- imm02
- Status last verified
- Oct 2013
- First submitted
- 21 Jun 2011
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Frolov VM, Tarakanovskaya MG, Batdelger D, Jirathitikal V, Bourinbaiar AS. Adjunct oral immunotherapy in patients with re-treated, multidrug-resistant or HIV-coinfected TB. Immunotherapy. 2011 Feb;3(2):181-91. doi: 10.2217/imt.10.96. Epub 2010 Dec 24.
PubMed 21182457Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Vihrova LA, Pylypchuk VS, Frolov VM, Kutsyna GA. Enhancement of efficacy of tuberculosis drugs with Immunoxel (Dzherelo) in HIV-infected patients with active pulmonary tuberculosis. Immunotherapy. 2009 Jul;1(4):549-56. doi: 10.2217/imt.09.25.
PubMed 20635986Butov DA, Pashkov YN, Stepanenko AL, Choporova AI, Butova TS, Batdelger D, Jirathitikal V, Bourinbaiar AS, Zaitzeva SI. Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB. J Immune Based Ther Vaccines. 2011 Jan 18;9:3. doi: 10.1186/1476-8518-9-3.
PubMed 21244690Efremenko YV, Butov DA, Prihoda ND, Zaitzeva SI, Yurchenko LV, Sokolenko NI, Butova TS, Stepanenko AL, Kutsyna GA, Jirathitikal V, Bourinbaiar AS. Randomized, placebo-controlled phase II trial of heat-killed Mycobacterium vaccae (Longcom batch) formulated as an oral pill (V7). Hum Vaccin Immunother. 2013 Sep;9(9):1852-6. doi: 10.4161/hv.25280. Epub 2013 Jun 19.
PubMed 23782489Butov DA, Efremenko YV, Prihoda ND, Zaitzeva SI, Yurchenko LV, Sokolenko NI, Butova TS, Stepanenko AL, Kutsyna GA, Jirathitikal V, Bourinbaiar AS. Randomized, placebo-controlled Phase II trial of heat-killed Mycobacterium vaccae (Immodulon batch) formulated as an oral pill (V7). Immunotherapy. 2013 Oct;5(10):1047-54. doi: 10.2217/imt.13.110.
PubMed 24088075
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients
- ClinicalTrials.gov ID
- NCT01380119
- Acronym / sponsor ID
- imm02 / imm02
- Conditions
- Tuberculosis
- Keywords
- sputum conversion, liver biochemistry, weight loss, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lisichansk Regional Tuberculosis DispensaryUniversity, hospital or other
- Collaborators
- National Medical University, Ukraine, Immunitor USA Inc.
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Jun 2011 (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.
This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V7 | Experimental | Biological: V7Oral pill containing heat-killed Mycobacterium vaccae |
| Placebo pill | Placebo comparator | Other: placeboIdentically appearing placebo pills |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
- TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test.
- TB score status at baseline.
- Agreement to participate in the study and to give a sample of blood for lab testing.
- Readily available home or other address where patient can be found.
Key exclusion criteria (3 listed)
- Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded.
- Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry.
- Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
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 |
|---|---|---|
| V7experimental arm | Biological | V7 |
| placeboplacebo pill | Other | Placebo pill |
Primary outcome
sputum conversion
Time frame: 2 months
To compare the efficacy of combination of V7 with anti-TB treatment versus anti-TB treatment+placebo in adults with pulmonary tuberculosis including:
1 secondary outcome
safety
Time frame: 1 and 2 months
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 29 Oct 2013.
- Background: PubMed 21182457Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Frolov VM, Tarakanovskaya MG, Batdelger D, Jirathitikal V, Bourinbaiar AS. Adjunct oral immunotherapy in patients with re-treated, multidrug-resistant or HIV-coinfected TB. Immunotherapy. 2011 Feb;3(2):181-91. doi: 10.2217/imt.10.96. Epub 2010 Dec 24.
- Background: PubMed 20635986Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Vihrova LA, Pylypchuk VS, Frolov VM, Kutsyna GA. Enhancement of efficacy of tuberculosis drugs with Immunoxel (Dzherelo) in HIV-infected patients with active pulmonary tuberculosis. Immunotherapy. 2009 Jul;1(4):549-56. doi: 10.2217/imt.09.25.
- Background: PubMed 21244690Butov DA, Pashkov YN, Stepanenko AL, Choporova AI, Butova TS, Batdelger D, Jirathitikal V, Bourinbaiar AS, Zaitzeva SI. Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB. J Immune Based Ther Vaccines. 2011 Jan 18;9:3. doi: 10.1186/1476-8518-9-3.
- Results publication: PubMed 23782489Efremenko YV, Butov DA, Prihoda ND, Zaitzeva SI, Yurchenko LV, Sokolenko NI, Butova TS, Stepanenko AL, Kutsyna GA, Jirathitikal V, Bourinbaiar AS. Randomized, placebo-controlled phase II trial of heat-killed Mycobacterium vaccae (Longcom batch) formulated as an oral pill (V7). Hum Vaccin Immunother. 2013 Sep;9(9):1852-6. doi: 10.4161/hv.25280. Epub 2013 Jun 19.
- Results publication: PubMed 24088075Butov DA, Efremenko YV, Prihoda ND, Zaitzeva SI, Yurchenko LV, Sokolenko NI, Butova TS, Stepanenko AL, Kutsyna GA, Jirathitikal V, Bourinbaiar AS. Randomized, placebo-controlled Phase II trial of heat-killed Mycobacterium vaccae (Immodulon batch) formulated as an oral pill (V7). Immunotherapy. 2013 Oct;5(10):1047-54. doi: 10.2217/imt.13.110.
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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.
Aldar Bourinbaiar, MD/PhD study director
Immunitor USA Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V7 in people with Tuberculosis, run by Lisichansk Regional Tuberculosis Dispensary at 1 site in Ukraine.
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 5 inclusion and 3 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 29 Oct 2013. 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 Ukraine. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
sputum conversion (time frame: 2 months). 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 NCT01380119, which also lists 5 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 29 Oct 2013.