Placebo-controlled, randomized, phase 2b trial was conducted in 34 adults comprising 18 first-diagnosed (52.9%), 6 relapsed (17.6%), and 10 MDR-TB (29.4%) cases to investigate the safety and efficacy of an oral immune adjunct (V5). The immunotherapy (N = 24) and placebo (N = 10) arms received once-daily tablet of V5 or placebo for one month in addition to conventional anti-TB therapy (ATT) administered under directly observed therapy (DOT).The enlarged liver, total bilirubin, erythrocyte sedimentation rate, lymphocyte and leukocyte counts improved significantly in V5 recipients (P = 0.002; 0.03; 8.3E-007; 2.8E-005; and 0.002) but remained statistically unchanged in the placebo group (P = 0.68; 0.96; 0.61; 0.91; and 0.43 respectively). The changes in hemoglobin and ALT levels in both treatment arms were not significant. The body weight increased in all V5-treated patients by an average 3.5 ± 1.8 kg (P = 2.3E-009), while 6 out of 10 patients on placebo gained mean 0.9 ± 0.9 kg (P = 0.01). Mycobacterial clearance in sputum smears was observed in 78.3% and 0% of patients on V5 and placebo (P = 0.009). The conversion rate in V5-receiving subjects with MDR-TB (87.5%) seemed to be higher than in first-diagnosed TB (61.5%) but the difference was not significant (P = 0.62). Scoring of sputum bacillary load (range 3-0) at baseline and post-treatment revealed score reduction in 23 out of 24 (95.8%) V5 recipients (from mean/median 2.2/3 to 0.3/0; P = 6E-010) but only in 1 out of 10 (10%) patients on placebo (1.9/1.5 vs. 1.8/1; P = 0.34). No adverse effects or TB reactivation were seen at any time during follow-up. V5 is safe as an immune adjunct to chemotherapeutic management of TB and can shorten substantially the duration of treatment.

reatment failed TB patients have very limited chances of survival. Open label trial of daily oral pill of V-5 Immunitor (V5) was conducted in 48 treatment-failed TB patients on palliative support consisting of isoniazid (H) and rifampicin (R). The subjects had the following forms of TB; cavitary: disseminated: MDR-TB: DR-TB: TB/HIV at 35:13:7:4:1 ratio. After 1 month 62.5% of V5-treated patients experienced negative sputum smear conversion (P < 0.0001), comprising 11 out of 12 (91.7%) converted among those who had drug-resistant TB and TB/HIV. TB-associated inflammation was downregulated as evidenced by normalization of leukocytosis 7.4 vs. 6.7 x 109 L (P = 0.01) and decreased erythrocyte sedimentation rate 20.5 vs. 14.9 mm/h (P < 0.0001). The mean body temperature normalized from 37.25° ± 0.6° to 36.98° ± 0.4° (P = 0.0002). The average body weight gain and body mass index (BMI) increased by 0.8 ± 0.7 kg and from 18.9 to 19.6 kg/m² respectively (P < 0.0001). Two patients (4.2%) died from illicit drug- and alcohol-abuse related causes. No adverse effects or reactivation of disease due to immune intervention were seen at any time. V5 is safe and in combination with a simple two-drug regimen was highly effective as an immune adjunct to produce favorable outcome among treatment-failed and/ or drug-resistant TB patients