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Completed

NCT Number: NCT01380119

Tuberculosis (TB) Immunotherapy Phase 2 Study

This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Body Weight Body Weight Changes Gram-Positive Bacterial Infections Infections Mycobacterium Infections Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lisichansk TB Dispensary

Lisichansk, Luhansk Oblast, Ukraine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
  • TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test.
  • TB score status at baseline.
  • Agreement to participate in the study and to give a sample of blood for lab testing.
  • Readily available home or other address where patient can be found.

Exclusion criteria

  • Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded.
  • Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry.
  • Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.

Treatment and study plan

V7

Biological

experimental arm

Placebo

Other

placebo pill

Primary outcomes

  1. sputum conversion

    Time frame: 2 months

    To compare the efficacy of combination of V7 with anti-TB treatment versus anti-TB treatment+placebo in adults with pulmonary tuberculosis including:

Secondary outcomes

  1. safety

    Time frame: 1 and 2 months

    • Liver functions tests (AST and ALT, and bilirubin) as main biochemical tests
    • To confirm quality of life improvement by specially designed questionnaire TB score
    • The beneficial effect on TB-associated wasting by measuring body weight.

Sponsors and collaborators

Lead sponsor

Lisichansk Regional Tuberculosis Dispensary

Other

Collaborators

  • Immunitor USA Inc.
  • National Medical University, Ukraine

Registry information

Official study title

Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients

Acronym: imm02

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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