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INTRODUCTION: Frequent thrombotic complications have been reported in patients with severe coronavirus disease 2019 (COVID-19) infection. The risk in patients with mild disease is unknown. CASE REPORT: We report a case series of three individuals recently diagnosed with COVID-19, who presented to the emergency department with chest pain and were found to have pulmonary emboli. The patients had mild symptoms, no vital sign abnormalities, and were negative according to the pulmonary embolism rule-out criteria. CONCLUSION: This suggests that patients with active or suspected COVID-19 should be considered at elevated risk for pulmonary embolism when presenting with chest pain, even without common risk factors for pulmonary embolism.
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OBJECTIVE: Study aimed to assess safety, tolerability, and immunogenicity of novel therapeutic HPV-16 E6E7 ISCOMATRIX vaccine for treatment of human papilloma virus (HPV)-related anal intraepithelial neoplasia in HIV-infected men who have sex with men with moderate immunosuppression. DESIGN: Randomized, multicenter, blinded, placebo-controlled, dose-escalating study investigating 3 different doses of vaccine and different dose schedule. Primary objective to determine safety and tolerability, including clinical status, maintenance of virological control, and CD4 cell count for more than 252 days. RESULTS: Thirty-five men who have sex with men enrolled; median age 47 years; current CD4 count 627 cells per milliliter; nadir CD4 count 154 cells per milliliter; 94% current antiretrovirals; 100% high-risk HPV types; 69% abnormal anal cytology; and 34% anal intraepithelial neoplasia 1-3 on high-resolution anoscopy. No dose-limiting toxicities or serious adverse events in HPV-16 vaccine recipients. Most HPV-16 vaccine recipients reported moderate/severe short-term injection site reactions and systemic reactions including headache, myalgia, and fatigue. CD4 cell counts remained stable. Five participants had transiently detectable viral loads. Ninety-six percent of vaccine recipients had at least a 4-fold increase in HPV-16 antibody from prevaccination levels. Seventy-one percent had at least a 3-fold increase in interferon-gamma responses to E6E7 peptides. CONCLUSIONS: The novel therapeutic HPV-16 E6E7 ISCOMATRIX vaccine seemed safe and reasonably well tolerated. The therapeutic vaccine induces strong and durable antibody responses and moderate interferon-gamma levels that fell to prevaccination levels by week 24.