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Distinctions in ESAT6 Immune Response by Gender Among Clear II Study Participants
Description
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A4815 - Distinctions in ESAT6 Immune Response by Gender Among Clear II Study Participants
Author Block: A. Abad1, R. P. Baughman2, D. A. Culver3, G. R. Bernard4, W. P. Drake5; 1Infectious Disease, Vanderbilt University Medical Center, Nashville, TN, United States, 2Univ of Cincinnati Med Ctr, Cincinnati, OH, United States, 3Cleveland Clinic Foundation, Cleveland, OH, United States, 4Vanderbilt Univ Ctr for Lung Research, Nashville, TN, United States, 5Vanderbilt Univ, Nashville, TN, United States.
Rationale:
Sarcoidosis is a granulomatous disease of unknown etiology. Ninety percent of individuals with sarcoidosis display pulmonary involvement. The mycobacterial protein Early Secreted Antigen 6 (ESAT6) has been shown by multiple labs to induce immune responses in sarcoidosis patients. Given these responses, we assessed for correlations between ESAT6 immune responses in sarcoidosis patients and their age, race, gender, and geographic location. Due to the high incidence of pulmonary sarcoidosis, we evaluated the connection between pulmonary function and ESAT6 immune responses in sarcoidosis patients using Force Vital Capacity (FVC) as a measure of lung function.
Methods:
As of October 2017, 76 patients have been screened for ESAT6 immune response and 72 of these patients have been enrolled into the Clear II study and randomized to either an anti-mycobacterial regimen or placebo. Demographic information was collected and pulmonary function was measured as %FVC. Peripheral blood mononuclear cells (PBMC) were isolated from the whole blood of sarcoidosis patients and Enzyme-Linked ImmunoSpot (ELISPOT) assay was used as previously described with 1 of 17 overlapping ESAT6 peptides. PBMC stimulated by phytohemagglutinin (PHA) and PBMC alone were used as positive and negative controls, respectively. The number of spot forming units (SFU) per 106 cells was counted. The SFU for the ESAT6 peptide which generated the greatest response for each patient was analyzed. A value greater than or equal to 20 SFU per million PBMC was considered a positive response.
Results:
Patients screened were 54 (SD=10) years, 53% male with 28% black and 72% white. The prevalence of ESAT6 response did not differ between the sites involved in our study with 86.84% of all patients screened positive for ESAT6, 90.62% for Vanderbilt, 85% for Cleveland, and 83.33% for Cincinnati (p=0.986). %FVC did not differ by site (p=0.17), race (p=0.86), age (0.189), or gender (p=0.54). ESAT6 values did not differ by site (p=0.32), race (p=0.87), or age (p=0.827). ESAT6 was significantly different by gender with females displaying a mean SFU of 246±316 compared to males with mean SFU of 123±212 (p=0.022, two-tailed T test).
Conclusions:
In this study, we found a significant difference in ESAT6 SFU by gender but not by age, race, or site or in %FVC. To investigate the relationship of ESAT6 to these other measures further, more patients will be screened and enrolled into the study, a longitudinal study of ESAT6 immune response by enrolled patients will be conducted, and T-cell function will be assessed.
Author Block: A. Abad1, R. P. Baughman2, D. A. Culver3, G. R. Bernard4, W. P. Drake5; 1Infectious Disease, Vanderbilt University Medical Center, Nashville, TN, United States, 2Univ of Cincinnati Med Ctr, Cincinnati, OH, United States, 3Cleveland Clinic Foundation, Cleveland, OH, United States, 4Vanderbilt Univ Ctr for Lung Research, Nashville, TN, United States, 5Vanderbilt Univ, Nashville, TN, United States.
Rationale:
Sarcoidosis is a granulomatous disease of unknown etiology. Ninety percent of individuals with sarcoidosis display pulmonary involvement. The mycobacterial protein Early Secreted Antigen 6 (ESAT6) has been shown by multiple labs to induce immune responses in sarcoidosis patients. Given these responses, we assessed for correlations between ESAT6 immune responses in sarcoidosis patients and their age, race, gender, and geographic location. Due to the high incidence of pulmonary sarcoidosis, we evaluated the connection between pulmonary function and ESAT6 immune responses in sarcoidosis patients using Force Vital Capacity (FVC) as a measure of lung function.
Methods:
As of October 2017, 76 patients have been screened for ESAT6 immune response and 72 of these patients have been enrolled into the Clear II study and randomized to either an anti-mycobacterial regimen or placebo. Demographic information was collected and pulmonary function was measured as %FVC. Peripheral blood mononuclear cells (PBMC) were isolated from the whole blood of sarcoidosis patients and Enzyme-Linked ImmunoSpot (ELISPOT) assay was used as previously described with 1 of 17 overlapping ESAT6 peptides. PBMC stimulated by phytohemagglutinin (PHA) and PBMC alone were used as positive and negative controls, respectively. The number of spot forming units (SFU) per 106 cells was counted. The SFU for the ESAT6 peptide which generated the greatest response for each patient was analyzed. A value greater than or equal to 20 SFU per million PBMC was considered a positive response.
Results:
Patients screened were 54 (SD=10) years, 53% male with 28% black and 72% white. The prevalence of ESAT6 response did not differ between the sites involved in our study with 86.84% of all patients screened positive for ESAT6, 90.62% for Vanderbilt, 85% for Cleveland, and 83.33% for Cincinnati (p=0.986). %FVC did not differ by site (p=0.17), race (p=0.86), age (0.189), or gender (p=0.54). ESAT6 values did not differ by site (p=0.32), race (p=0.87), or age (p=0.827). ESAT6 was significantly different by gender with females displaying a mean SFU of 246±316 compared to males with mean SFU of 123±212 (p=0.022, two-tailed T test).
Conclusions:
In this study, we found a significant difference in ESAT6 SFU by gender but not by age, race, or site or in %FVC. To investigate the relationship of ESAT6 to these other measures further, more patients will be screened and enrolled into the study, a longitudinal study of ESAT6 immune response by enrolled patients will be conducted, and T-cell function will be assessed.
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