title: Effect of Mycobacterium vaccae (SRL172) immunotherapy on radiographic healing in tuberculosis.
abstract: OBJECTIVE
  Controlled trials have failed to show an effect of Mycobacterium vaccae immunotherapy on treatment outcome and mortality in patients with tuberculosis (TB); however, several studies have suggested improvement in radiographic clearing and resolution of cavitary disease.
  
  
  METHODS
  To assess the effect of M. vaccae immunotherapy on radiographic healing in pulmonary TB, chest X-rays from three randomized placebo-controlled trials of M. vaccae given as a single injection during the first 2 weeks of treatment were interpreted by a single, masked assessor using a standard scheme. Endpoints were the overall degree of radiographic improvement or deterioration and changes in cavitary disease at the end of antituberculosis treatment and follow-up.
  
  
  RESULTS
  Of 1018 patients (478 HIV-infected; 540 HIV-uninfected) with an end of treatment or end of follow-up X-ray analyzed, 496 received M. vaccae and 522 received placebo. There was no difference in radiographic improvement or deterioration or cavitary disease at the end of treatment or follow-up comparing the M. vaccae and placebo groups. Results were similar comparing HIV-infected and HIV-uninfected patients.
  
  
  CONCLUSIONS
  Adjunctive immunotherapy of drug-susceptible pulmonary TB with M. vaccae during the first 2 weeks of treatment did not improve radiographic responses to treatment or resolution of cavitary disease.
authors.affiliation: Division of Infectious Diseases, Case Western Reserve University School of Medicine and University Hospitals of Cleveland, Cleveland, Ohio 44106-5083, USA. jlj@po.cwru.edu
authors.forename: J L
authors.initials: JL
authors.lastname: Johnson
authors.forename: A J
authors.initials: AJ
authors.lastname: Nunn
authors.forename: P B
authors.initials: PB
authors.lastname: Fourie
authors.forename: L P
authors.initials: LP
authors.lastname: Ormerod
authors.forename: R D
authors.initials: RD
authors.lastname: Mugerwa
authors.forename: A
authors.initials: A
authors.lastname: Mwinga
authors.forename: C
authors.initials: C
authors.lastname: Chintu
authors.forename: B
authors.initials: B
authors.lastname: Ngwira
authors.forename: P
authors.initials: P
authors.lastname: Onyebujoh
authors.forename: A
authors.initials: A
authors.lastname: Zumla
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D001428:Bacterial Vaccines / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D013902:Radiography, Thoracic; D016037:Single-Blind Method; D016896:Treatment Outcome; D032581:Tuberculosis Vaccines / Q000627:therapeutic use*; D014397:Tuberculosis, Pulmonary / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D001428:Bacterial Vaccines; D032581:Tuberculosis Vaccines; C451081:SRL172