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Efficacy and safety of recombinant Mycobacterium tuberculosis ESAT-6 protein for diagnosis of pulmonary tuberculosis: a phase II trial.

AbstractBACKGROUND:
This study aimed to determine the efficacy and safety of recombinant Mycobacterium tuberculosis ESAT-6 protein for diagnosis of pulmonary tuberculosis (TB).
MATERIAL AND METHODS:
A phase II trial was performed in 158 patients with pulmonary TB (145 initially-treated and 13 re-treated) and 133 healthy subjects. Skin testing was carried out by injecting purified protein derivative (PPD) (on left forearm) or recombinant ESAT-6 protein at a dosage of 2, 5, or 10 μg/mL (on the right forearm) in each subject. Reaction activity and adverse events were monitored at 24, 48, and 72 h following the injection. Receiver operating characteristic curves were plotted to determine the areas under the curves (AUCs) and the cut-off induration diameters for the optimal diagnostic performance.
RESULTS:
The reaction activity was significantly increased upon recombinant ESAT-6 injection in pulmonary TB patients compared with healthy subjects. In pulmonary TB patients, the reaction was dose-dependent, and at 48 h, 10 μg/mL recombinant ESAT-6 produced a reaction similar to that produced by PPD. The AUCs for a 10 μg/mL dosage were 0.9823, 0.9552, and 0.9266 for 24 h, 48 h, and 72 h, respectively, and the induration diameters of 4.5-5.5 mm were the optimal trade-off values between true positive rates and false positive rates. No serious adverse events occurred in any subjects.
CONCLUSIONS:
Recombinant ESAT-6 protein is efficacious and safe for diagnosing pulmonary TB. Based on the reaction, performance, safety, and practicability, we recommend that 10 μg/mL at 48 h with an induration cut-off value of 5.0 mm be used.
AuthorsQing-Feng Sun, Miao Xu, Jin-Guo Wu, Bao-Wen Chen, Wei-Xin Du, Ji-Guang Ding, Xiao-Bing Shen, Cheng Su, Jin-Sheng Wen, Guo-Zhi Wang
JournalMedical science monitor : international medical journal of experimental and clinical research (Med Sci Monit) Vol. 19 Pg. 969-77 (Nov 12 2013) ISSN: 1643-3750 [Electronic] United States
PMID24217560 (Publication Type: Clinical Trial, Phase II, Journal Article)
Chemical References
  • Antigens, Bacterial
  • Bacterial Proteins
  • ESAT-6 protein, Mycobacterium tuberculosis
  • Recombinant Proteins
Topics
  • Adult
  • Analysis of Variance
  • Antigens, Bacterial (adverse effects, genetics)
  • Area Under Curve
  • Bacterial Proteins (adverse effects, genetics)
  • China
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Middle Aged
  • ROC Curve
  • Recombinant Proteins (adverse effects, genetics)
  • Skin Tests
  • Tuberculosis, Pulmonary (diagnosis)

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