TB Immunotherapy Trial With Heat-killed M. Vaccae (imm03)

Immunitor

Status and phase: Completed; Phase 3

Conditions: Tuberculosis

Treatments: Biological: V7; Biological: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01977768

imm03 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials in intended registration countries, such as China, Russia and South Africa, etc.

Full description

Main end-point is negative sputum conversion rate after one month in patients on V7 vs placebo arm, both arms will receive conventional anti-tuberculosis chemotherapy consisting of 1st and/or 2nd line TB drugs according to baseline diagnosis

Enrollment: 152 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of TB
• sputum smear positive

Exclusion criteria

• pregnant
• likely to be non-compliant due to drug and/or alcohol abuse
• mentally unfit to comply with treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups, including a placebo group

V7: Heat-inactivated M. vaccae pill

Experimental group

Description:

Daily pill of V7 together with standard tuberculosis therapy

Treatment:

Biological: V7

Placebo pill

Placebo Comparator group

Description:

one pill of placebo pill once per day together with standard of care TB drugs

Treatment:

Biological: Placebo