Adjunct Immune Therapy of First-Diagnosed TB, Relapsed TB, Treatment-Failed TB, Multidrug-Resistant TB and TB/HIV

Abstract

V5 is safe and effective as an immune adjunct to chemotherapy for TB and can potentially reduce the treatment duration down to 1 month.

Randomized, Placebo-Controlled Phase II Trial of Heat-Killed Mycobacterium Vaccae (Immodulon Batch) Formulated as an Oral Pill (V7)

“…Such an outcome is comparable with immune therapies, which we and others have evaluated in the past [17][18][19][20][21][22][23]. For example, in the latest trial of Immunoxel (Kiev, Ukraine) -multiherbal immunomodulator from Ukraine -the conversion rate after 1 month stood at 84.1 versus 19% in controls [22].…”

“…For example, in the latest trial of Immunoxel (Kiev, Ukraine) -multiherbal immunomodulator from Ukraine -the conversion rate after 1 month stood at 84.1 versus 19% in controls [22]. In a randomized, double-blind, placebo-controlled Phase IIb trial of V5 in newly diagnosed TB, RTB, MDR-TB and TB-HIV patients, we had 88.7 versus 14.8% patients converted after 1 month [23]. In both studies no statistical difference was observed when DS-or DR-TB and TB-HIV subsets of patients were compared in terms of smear conversion rate.…”

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

“…21 In randomized, double-blind, placebo-controlled Phase IIb trial of V5 in first-diagnosed, relapsed and MDR-TB we had 88.7% vs. 14.8% patients converted after one month. 22 In both studies no statistical difference was observed when first-diagnosed, drug-sensitive TB and MDR-TB subsets of patients were compared in regard to smear conversion rate.…”

Drug Resistance in Bacteria, Fungi, Malaria, and Cancer

“…Many studies have shown the ability of immunomodulatory drugs to improve TB treatment outcomes (Dlugovitzky et al 2006;Dheda et al 2010b;Faujdar et al 2011;Gao et al 2011;Butov et al 2012;Gupta et al 2012a, b;Skrahin et al 2014). Immunomodulatory drugs currently in clinical use include mycobacterium vaccae, interferon-γ, recombinant human interleukin 2, steroids, and tumor necrosis factor antagonists, among others.…”