Tuberculosis (TB) Immunotherapy Phase 2 Study

NCT01380119 | Completed Phase 2

• 2 other identifiers: imm02LisichnskRTD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

sputum conversion; liver biochemistry; weight loss; quality of life

Outcome Measures

Primary Outcomes (1)

• 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:

  2 months

Secondary Outcomes (1)

• safety

  1 and 2 months

Study Arms (2)

V7

EXPERIMENTAL

Oral pill containing heat-killed Mycobacterium vaccae

Biological: V7

Placebo pill

PLACEBO COMPARATOR

Identically appearing placebo pills

Other: placebo

Interventions

V7 BIOLOGICAL

experimental arm

V7

placebo OTHER

placebo pill

Placebo pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lisichansk Regional Tuberculosis Dispensary: lead
• National Medical University, Ukraine: collaborator
• Immunitor USA Inc.: collaborator

Study Sites (1)

Lisichansk TB Dispensary

Lisichansk, Luhansk Oblast, Ukraine

Location

Related Publications (5)

• 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.

  PMID: 21182457 BACKGROUND

• 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.

  PMID: 20635986 BACKGROUND

• 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.

  PMID: 21244690 BACKGROUND

• 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.

  PMID: 23782489 RESULT

• 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.

  PMID: 24088075 RESULT

MeSH Terms

Conditions

Tuberculosis; Weight Loss

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aldar Bourinbaiar, MD/PhD

  Immunitor USA Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 27, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

UA (1)