Abstract:
:Background. First- and second-generation smallpox vaccines are contraindicated in individuals infected with human immunodeficiency virus (HIV). A new smallpox vaccine is needed to protect this population in the context of biodefense preparedness. The focus of this study was to compare the safety and immunogenicity of a replication-deficient, highly attenuated smallpox vaccine modified vaccinia Ankara (MVA) in HIV-infected and healthy subjects. Methods. An open-label, controlled Phase II trial was conducted at 36 centers in the United States and Puerto Rico for HIV-infected and healthy subjects. Subjects received 2 doses of MVA administered 4 weeks apart. Safety was evaluated by assessment of adverse events, focused physical exams, electrocardiogram recordings, and safety laboratories. Immune responses were assessed using enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT). Results. Five hundred seventy-nine subjects were vaccinated at least once and had data available for analysis. Rates of ELISA seropositivity were comparably high in vaccinia-naive healthy and HIV-infected subjects, whereas PRNT seropositivity rates were higher in healthy compared with HIV-infected subjects. Modified vaccinia Ankara was safe and well tolerated with no adverse impact on viral load or CD4 counts. There were no cases of myo-/pericarditis reported. Conclusions. Modified vaccinia Ankara was safe and immunogenic in subjects infected with HIV and represents a promising smallpox vaccine candidate for use in immunocompromised populations.
journal_name
Open Forum Infect Disjournal_title
Open forum infectious diseasesauthors
Overton ET,Stapleton J,Frank I,Hassler S,Goepfert PA,Barker D,Wagner E,von Krempelhuber A,Virgin G,Meyer TP,Müller J,Bädeker N,Grünert R,Young P,Rösch S,Maclennan J,Arndtz-Wiedemann N,Chaplin Pdoi
10.1093/ofid/ofv040subject
Has Abstractpub_date
2015-05-05 00:00:00pages
ofv040issue
2issn
2328-8957pii
ofv040journal_volume
2pub_type
杂志文章abstract:BACKGROUND:Amphotericin B is the preferred treatment for cryptococcal meningitis, but it has cumulative severe side effects, including nephrotoxicity, hypokalemia, and hypomagnesemia. Amphotericin-induced severe hypokalemia may predispose the patient to cardiac arrhythmias and death, and there is very little data avail...
journal_title:Open forum infectious diseases
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pub_type: 杂志文章,评审
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