Clinical trial NCT01380119: Tuberculosis (TB) Immunotherapy Phase 2 Study
Official title: Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tuberculosis
Keywords: sputum conversion
liver biochemistry
weight loss
quality of life
Lead sponsor: Lisichansk Regional Tuberculosis Dispensary
Sponsor class: OTHER
Collaborators: name: National Medical University, Ukraine
name: Immunitor USA Inc.
First posted: 2011-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: sputum conversion
timeFrame: 2 months
Secondary outcomes:
measure: safety
timeFrame: 1 and 2 months
Other outcomes:
Locations:
city: Lisichansk
country: Ukraine
facility: Lisichansk TB Dispensary
state: Luhansk
Study officials:
affiliation: Immunitor USA Inc.
name: Aldar Bourinbaiar, MD/PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Arjanova 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.
citation: Butov 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.
citation: Efremenko 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.
citation: Butov 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.