Cytomegalovirus Retinal Necrosis With Occlusive Vasculopathy Secondary to Steroid Immunosuppression for Giant Cell Arteritis

PurposeThis case report discusses an atypical case of cytomegalovirus (CMV) retinal necrosis with panretinal occlusive vasculopathy in a 77-year-old man who was immunosuppressed following treatment for giant cell arteritis (GCA).MethodsA case report is presented.ResultsClinical examination demonstrated a central retinal artery occlusion and pale disc suspicious for arteritic ischemic optic neuropathy in the right eye. Biopsy-proven GCA prompted treatment with oral prednisone. While on glucocorticoid immunosuppression, the patient suffered vision loss in the left eye from CMV-necrotizing retinitis with occlusive vasculopathy. Treatment controlled the CMV infection but tapering of his steroids resulted in worsening GCA, requiring a steroid-sparing treatment, tocilizumab.ConclusionsCorticosteroid immunosuppression for GCA may lead to immune dysfunction allowing for an atypical occlusive vasculitis with retinal necrosis from CMV. Early identification and treatment are essential to adjust the level of immunosuppression and consider alternate therapies to control the GCA and prevent worsening of this opportunistic infection

Cytomegalovirus Retinal Necrosis With Occlusive Vasculopathy Secondary to Steroid Immunosuppression for Giant Cell Arteritis

Purpose: This case report discusses an atypical case of cytomegalovirus (CMV) retinal necrosis with panretinal occlusive vasculopathy in a 77-year-old man who was immunosuppressed following treatment for giant cell arteritis (GCA). Methods: A case report is presented. Results: Clinical examination demonstrated a central retinal artery occlusion and pale disc suspicious for arteritic ischemic optic neuropathy in the right eye. Biopsy-proven GCA prompted treatment with oral prednisone. While on glucocorticoid immunosuppression, the patient suffered vision loss in the left eye from CMV-necrotizing retinitis with occlusive vasculopathy. Treatment controlled the CMV infection but tapering of his steroids resulted in worsening GCA, requiring a steroid-sparing treatment, tocilizumab. Conclusions: Corticosteroid immunosuppression for GCA may lead to immune dysfunction allowing for an atypical occlusive vasculitis with retinal necrosis from CMV. Early identification and treatment are essential to adjust the level of immunosuppression and consider alternate therapies to control the GCA and prevent worsening of this opportunistic infection. </jats:sec

Financial Hardship and its Associations with Perceived Sleep Quality in Participants with Type 2 Diabetes and Obstructive Sleep Apnea

Objectives The purpose of this study was to explore social determinants of health (SDoH), and disease severity as predictors of sleep quality in persons with both Obstructive Sleep Apnea (OSA) and type 2 diabetes (T2D). Methods Disease severity was measured by Apnea-Hypopnea Index [(AHI) ≥ 5] and HbA1c for glycemic control. SDoH included subjective and objective financial hardship, race, sex, marital status, education, and age. Sleep quality was measured by Pittsburgh Sleep Quality Index (PSQI). Results The sample (N = 209) was middle-aged (57.6 ± 10.0); 66% White and 34% African American; and 54% men and 46% women. Participants carried a high burden of disease (mean AHI = 20.7 ± 18.1, mean HbA1c = 7.9% ± 1.7%). Disease severity was not significantly associated with sleep quality (all p &gt;.05). Worse sleep quality was associated with both worse subjective (b = -1.54, p = .015) and objective (b = 2.58, p &lt;.001) financial hardship. Characteristics significantly associated with both subjective and objective financial hardship included being African American, female, ≤ 2 years post high school, and of younger ages (all p &lt; .01). Discussion: Financial hardship is a more important predictor of sleep quality than disease severity, age, sex, race, marital status, and educational attainment, in patients with OSA and T2D </jats:sec

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

International audienceAbstract Introduction The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. Methods This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. Results From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those < 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12–17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL. Discussion The PREVAC trial is evaluating—placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children. Trial registration ClinicalTrials.gov NCT02876328 . Registered on 23 August 2016

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

Abstract Introduction The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. Methods This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. Results From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those &lt; 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12–17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL. Discussion The PREVAC trial is evaluating—placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children. Trial registration ClinicalTrials.gov NCT02876328. Registered on 23 August 2016. </jats:sec