NCT01380119: imm02

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

Completed Phase 2 Last updated 25 October 2013

What this trial tests

Phase 2 trial testing V7 in Tuberculosis in 40 participants. Completed in 1 August 2012.

Timeline

1 August 2011

Primary endpoint
1 August 2012

1 August 2012

Quick facts

Lead sponsor	Lisichansk Regional Tuberculosis Dispensary
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	1 August 2011
Primary completion	1 August 2012
Estimated completion	1 August 2012
Sites	1 location across Ukraine

Drugs / interventions tested

• V7 — full drug profile →
• placebo

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Lisichansk Regional Tuberculosis Dispensary — full company profile →

Who can join

Adults 18 to 65, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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:

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Key recent advances in TB vaccine development and understanding of protective immune responses against Mycobacterium tuberculosis.
   Scriba TJ, Netea MG, Ginsberg AM. · · 2020 · cited 75× · PMID 33279383 · DOI 10.1016/j.smim.2020.101431
2. <i>Mycobacterium tuberculosis</i>: immune response, biomarkers, and therapeutic intervention.
   Zhuang L, Yang L, Li L, Ye Z, et al · · 2024 · cited 50× · PMID 38188605 · DOI 10.1002/mco2.419
3. The Research Progress in Immunotherapy of Tuberculosis.
   Mi J, Liang Y, Liang J, Gong W, et al · · 2021 · cited 27× · PMID 34869066 · DOI 10.3389/fcimb.2021.763591
4. Randomized, placebo-controlled phase II trial of heat-killed Mycobacterium vaccae (Longcom batch) formulated as an oral pill (V7).
   Efremenko YV, Butov DA, Prihoda ND, Zaitzeva SI, et al · · 2013 · cited 16× · PMID 23782489 · DOI 10.4161/hv.25280
5. Host Immune Response to &lt;i&gt;Mycobacterium tuberculosis&lt;/i&gt; Infection: Implications for Vaccine Development.
   Liu Q, Que S, Qiu Y, Tang M, et al · · 2025 · PMID 40599694 · DOI 10.2147/jir.s517034