Tuberculosis (TB) Immunotherapy Phase 2 Study

Tuberculosis Clinical Trial

— imm02  

Official title:

Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380119
• Other study ID #: imm02
• Secondary ID: LisichnskRTD
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2011
• Last updated: October 25, 2013
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2013
• Source: Lisichansk Regional Tuberculosis Dispensary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• V7
experimental arm

Other:
• placebo
placebo pill

Locations

Country	Name	City	State
Ukraine	Lisichansk TB Dispensary	Lisichansk	Luhansk

Sponsors (3)

Lead Sponsor	Collaborator
Lisichansk Regional Tuberculosis Dispensary	Immunitor USA Inc., National Medical University, Ukraine

Country where clinical trial is conducted

Ukraine, 

References & 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. — View 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. — View 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) formulat — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 and 2 months