Randomized, placebo-controlled Phase II trial of heat-killed Mycobacterium vaccae (Immodulon batch) formulated as an oral pill (V7).

Aim: A 1-month Phase II trial was conducted in 41 patients with pulmonary TB who were randomized into treatment (n = 20) and placebo (n = 21) arms to investigate the safety and efficacy of an orally-administered therapeutic TB vaccine (V7) containing 10 µg heat-killed Mycobacterium vaccae provided by Immodulon Therapeutics Ltd (London, UK).

Materials & Methods: Both arms received conventional anti-TB therapy administered along with a daily pill of V7 or placebo. The subject population had four categories of TB: drug-sensitive TB; retreated TB; drug-resistant TB; and TB with HIV distributed in V7 and placebo arms at 9:4:7:6 and 14:1:6:8 ratios, respectively.

Randomized, placebo-controlled phase II trial of heat-killed Mycobacterium vaccae (Longcom batch) formulated as an oral pill (V7).

One-month Phase II trial was conducted in 43 sputum smear-positive patients with pulmonary tuberculosis randomized into treatment (n = 22) and placebo (n = 21) arms to investigate the safety and efficacy of an orally-administered therapeutic TB vaccine (V7) containing 10 μg of heat-killed Mycobacterium vaccae provided by Longcom company. Immunotherapy and control groups comprised 8 newly diagnosed (1stDx TB; 18.6%), 6 re-treated (RTB; 14%), and 29 multidrug-resistant (MDR-TB; 67.

Adjunct immune therapy of first-diagnosed TB, relapsed TB, treatment-failed TB, multidrug-resistant TB and TB/HIV.

Aim: To evaluate the effect of an adjunct immunotherapy in randomized double-blind, placebo-controlled Phase IIb trial involving 123 TB patients.

Methods: Patients were randomly allocated into two arms: one (n = 62) received a once-daily pill of V-5 Immunitor™ (V5) and the other (control; n= 61) received placebo for 30 days in addition to first- or second-line TB drugs administered under directly observed therapy. The subjects in V5 and placebo arms had first-diagnosed, relapsed, treatment-failed and multidrug-resistant TB at ratios of 17:21:11:13 and 20:19:14:8, respectively; among them, ten and seven had HIV coinfection, respectively.

Clinical validation of sublingual formulations of Immunoxel (Dzherelo) as an adjuvant immunotherapy in treatment of TB patients.

Immunoxel (Dzherelo) is a water-alcohol extract of medicinal plants used in Ukraine as an adjunct immunotherapy to TB and HIV therapy. Four types of solid sublingual formulations of Immunoxel were made: sugar dragées, sugar-coated pills, gelatin pastilles and dried-honey lozenges. They were administered once-daily along with TB drugs.

Adjunct oral immunotherapy in patients with re-treated, multidrug-resistant or HIV-coinfected TB.

This Phase IIb, placebo-controlled study involved 55 TB patients treated with anti-TB therapy. They were divided into two groups, matched by age, gender, baseline bodyweight and clinical manifestations: one group (n = 27) received a once-daily V-5 Immunitor (V5) immunotherapy pill and the other (n = 28) received placebo. Only one (3.

Enhancement of efficacy of tuberculosis drugs with Immunoxel (Dzherelo) in HIV-infected patients with active pulmonary tuberculosis.

Immunoxel (Dzherelo) is an oral, herbal immunomodulator used in Ukraine for adjunct therapy of infectious and autoimmune diseases. Antiretroviral drug-naive, tuberculosis (TB)/HIV coinfected patients with active pulmonary TB were divided into two arms, A (n = 20) and B (n = 20), to receive first-line anti-TB therapy (ATT) or ATT + Dzherelo, respectively. As a result, three (16%) versus 12 (67%; p = 0.