Journal article
Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial
Open forum infectious diseases, Vol.2(2), pp.ofv040-ofv040
04/01/2015
DOI: 10.1093/ofid/ofv040
PMCID: PMC4567089
PMID: 26380340
Abstract
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.
Details
- Title: Subtitle
- Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial
- Creators
- Jack Stapleton - Dept. of Internal Medicine, Microbiology & Immunology, University of Iowa, Iowa CityEdgar Turner Overton - Division of Infectious Diseases, University of Alabama at Birmingham, School of Medicine, Birmingham, AlabamaIan Frank - Dept. of Infectious Diseases Section, University of Pennsylvania, PhiladelphiaShawn Hassler - Optimus Medical Group, San Francisco, CaliforniaPaul A Goepfert - Division of Infectious Diseases, University of Alabama at Birmingham, School of Medicine, Birmingham, AlabamaDavid Barker - Core Center, Chicago, Illinois, USAEva Wagner - Bavarian Nordic, MartinsriedAlfred von Krempelhuber - GlaxoSmithKline GmbH & Co. KG, Munich, GermanyGarth Virgin - Vifor Pharma Ltd, Glattbrugg, SwitzerlandJosef Weigl - Public Health Institute Ploen, Hamburgerstr, GermanyThomas Peter Meyer - Bavarian Nordic, MartinsriedJutta Müller - Bavarian Nordic, MartinsriedNicole Bädeker - Bavarian Nordic, MartinsriedRobert Grünert - Bavarian Nordic, MartinsriedPhilip Young - Bavarian Nordic, MartinsriedSiegfried Rösch - Bavarian Nordic, MartinsriedJane Maclennan - Bavarian Nordic, MartinsriedNathaly Arndtz-Wiedemann - Bavarian Nordic, MartinsriedPaul Chaplin - Bavarian Nordic, Martinsried
- Resource Type
- Journal article
- Publication Details
- Open forum infectious diseases, Vol.2(2), pp.ofv040-ofv040
- DOI
- 10.1093/ofid/ofv040
- PMID
- 26380340
- PMCID
- PMC4567089
- NLM abbreviation
- Open Forum Infect Dis
- ISSN
- 2328-8957
- eISSN
- 2328-8957
- Publisher
- Oxford University Press
- Grant note
- DOI: 10.13039/100000002, name: NIH
- Language
- English
- Date published
- 04/01/2015
- Academic Unit
- Microbiology and Immunology; Infectious Diseases; Internal Medicine
- Record Identifier
- 9984094364502771
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