NCT01977768: imm03

Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)

Completed Phase 3 Last updated 23 July 2019

What this trial tests

Phase 3 trial testing V7 in Tuberculosis in 152 participants. Completed in 1 December 2018.

Timeline

1 March 2014

Primary endpoint
1 October 2018

1 December 2018

Quick facts

Lead sponsor	Immunitor LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	152
Start date	1 March 2014
Primary completion	1 October 2018
Estimated completion	1 December 2018
Sites	2 locations across Mongolia, Ukraine

Drugs / interventions tested

• V7 — full drug profile →
• Placebo

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Immunitor LLC — full company profile →

Who can join

Adults 18 to 80, 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.

• bacillary sputum smear clearance
  Time frame: two years
  blinded assessment of sputum clearance score

Sponsor's own description

The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials in intended registration countries, such as China, Russia and South Africa, etc.

Publications & conference data

8 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. Therapeutic Vaccines for Tuberculosis: An Overview.
   Bouzeyen R, Javid B. · · 2022 · cited 47× · PMID 35812462 · DOI 10.3389/fimmu.2022.878471
3. An Overview of the Development of New Vaccines for Tuberculosis.
   Whitlow E, Mustafa AS, Hanif SNM. · · 2020 · cited 33× · PMID 33027958 · DOI 10.3390/vaccines8040586
4. 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
5. Phase III, placebo-controlled, randomized, double-blind trial of tableted, therapeutic TB vaccine (V7) containing heat-killed <i>M. vaccae</i> administered daily for one month.
   Bourinbaiar AS, Batbold U, Efremenko Y, Sanjagdorj M, et al · · 2020 · cited 15× · PMID 31890902 · DOI 10.1016/j.jctube.2019.100141
6. Practical considerations for a TB controlled human infection model (TB-CHIM); the case for TB-CHIM in Africa, a systematic review of the literature and report of 2 workshop discussions in UK and Malawi.
   Gordon SB, Sichone S, Chirwa AE, Hazenberg P, et al · · 2023 · cited 10× · PMID 37007907 · DOI 10.12688/wellcomeopenres.18767.2
7. Current development of therapeutic vaccines for the treatment of chronic infectious diseases.
   Park PG, Fatima M, An T, Moon YE, et al · · 2024 · cited 5× · PMID 38362373 · DOI 10.7774/cevr.2024.13.1.21
8. 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