Phase III, placebo-controlled, randomized, double-blind trial of tableted, therapeutic TB vaccine (V7) containing heat-killed administered daily for one month.

Objective: Immunotherapy of tuberculosis (TB) to shorten treatment duration represents an unmet medical need. Orally delivered, tableted TB vaccine (V7) containing heat-killed (NCTC 11659) has been demonstrated in prior clinical studies to be safe and fast-acting immune adjunct.

Methods: The outcome of Phase III trial of V7 containing 10 µg of hydrolyzed was evaluated in 152 patients randomized at 2:1 ratio: V7 ( = 100), placebo ( = 52).

Double-blind, placebo-controlled, 1:1 randomized Phase III clinical trial of Immunoxel honey lozenges as an adjunct immunotherapy in 269 patients with pulmonary tuberculosis.

Aim: Safer and shorter antituberculosis treatment (ATT) regimens represent the unmet medical need.

Patients & Methods: The patients were randomly assigned into two arms: the first (n = 137) received once-daily sublingual honey lozenge formulated with botanical immunomodulator Immunoxel and the second (n = 132) received placebo lozenges along with conventional ATT. Immunoxel and placebo arms were demographically similar: 102 versus 106 had drug-susceptible TB; 28 versus 20 multidrug-resistant TB (MDR-TB); 7 versus 7 extensively drug-resistant TB (XDR-TB); and 22 versus 20 TB-HIV.