ABSTRACT: To evaluate the effect of an adjunct immunotherapy in randomized double-blind, placebo-controlled Phase IIb trial involving 123 TB patients.
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.
After 1 month, 55 out of 62 patients (88.7%) became sputum smear-negative in the V5 arm (p < 0.0001), whereas in the placebo group, nine out of 61 (14.8%) had converted. The conversion rate among V5 recipients was similar, regardless of whether TB was drug-sensitive, drug-resistant or with HIV. V5 downregulated TB-associated inflammation, as shown by the normalization of elevated leukocyte counts (8.7 vs 6.3 × 10 (9)/l; p < 0.0001) and decreased erythrocyte sedimentation rate (22.8 vs 12.6 mm/h; p < 0.0001), whereas among placebo recipients, changes were smaller (8.9 vs 8.2 × 10 (9)/l and 25.1 vs 19.9 mm/h). Thirty three (54.1%) placebo patients gained on average 0.8 kg (p = 0.0002); by contrast, 57 (91.9%) out of 62 patients in the V5 group gained a mean weight of 2.9 kg (p < 0.0001). No adverse side effects or reactivation of TB were seen at any time.
V5 is safe and effective as an immune adjunct to chemotherapy for TB and can potentially reduce the treatment duration down to 1 month.
Immunotherapy 07/2012; 4(7):687-95. · 1.85 Impact Factor