title: Safety of Recombinant Fusion Protein ESAT6-CFP10 as a Skin Test Reagent for Tuberculosis Diagnosis: an Open-Label, Randomized, Single-Center Phase I Clinical Trial.
abstract: This trial was conducted to explore the safety of recombinant fusion protein ESAT6-CFP10 as a skin test reagent for the diagnosis of Mycobacterium tuberculosis infection. Twenty-four healthy adult volunteers were recruited and randomized into four groups (groups A to D) to study four increasing doses of ESAT6-CFP10. All subjects in each dose group received an intradermal injection of reagent (0.1 ml) via the Mantoux technique. Then, the vital signs of all subjects were monitored, and skin reactions around injection sites and adverse events were recorded at different detection time points after the skin test. No serious adverse events were observed in this study. A total of 3 subjects had unexpected events. One subject in group A developed subcutaneous hemorrhage 24 h after the skin test, one subject in group B was found with red spots 15 min after the skin test, and another subject in group A showed abnormity during a chest X-ray after the skin test without affecting her health. One of three adverse events (red spots) was probably related to the recombinant ESAT6-CFP10 reagent. A single dose of 1, 5, 10, or 20 μg/ml of recombinant ESAT6-CFP10 as a skin test reagent for M. tuberculosis infection diagnosis is well tolerated and safe in China. (This study has been registered at ClinicalTrials.gov under registration no. NCT01999231.).
authors.affiliation: Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Li
authors.affiliation: Institute for Biological Products Control, National Institutes for Food and Drug Control, Beijing, China.
authors.forename: Miao
authors.initials: M
authors.lastname: Xu
authors.affiliation: Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
authors.forename: Lijun
authors.initials: L
authors.lastname: Zhou
authors.affiliation: Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
authors.forename: Yanqing
authors.initials: Y
authors.lastname: Xiong
authors.affiliation: Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
authors.forename: Lu
authors.initials: L
authors.lastname: Xia
authors.affiliation: Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
authors.forename: Xiaoyong
authors.initials: X
authors.lastname: Fan
authors.affiliation: Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Gu
authors.affiliation: Anhui Longcom Biologic Pharmacy Co. Ltd, Hefei, China.
authors.forename: Jiang
authors.initials: J
authors.lastname: Pu
authors.affiliation: Shanghai Public Health Clinical Center, Fudan University, Shanghai, China lushuihua66@126.com vaccine2012@126.com.
authors.forename: Shuihua
authors.initials: S
authors.lastname: Lu
authors.affiliation: Institute for Biological Products Control, National Institutes for Food and Drug Control, Beijing, China lushuihua66@126.com vaccine2012@126.com.
authors.forename: Guozhi
authors.initials: G
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000942:Antigens, Bacterial / Q000235:genetics / Q000276:immunology*; D001426:Bacterial Proteins / Q000235:genetics / Q000276:immunology*; D002681:China; D003955:Diagnostic Tests, Routine / Q000009:adverse effects* / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D011993:Recombinant Fusion Proteins / Q000235:genetics / Q000276:immunology*; D012882:Skin Tests / Q000009:adverse effects* / Q000379:methods; D014376:Tuberculosis / Q000175:diagnosis*; D055815:Young Adult
chemical_list: D000942:Antigens, Bacterial; D001426:Bacterial Proteins; C117940:CFP-10 protein, Mycobacterium tuberculosis; C093276:ESAT-6 protein, Mycobacterium tuberculosis; D011993:Recombinant Fusion Proteins