Safety and immunogenicity of modified vaccinia Ankara-Bavarian Nordic smallpox vaccine in vaccinia-naive and experienced human immunodeficiency virus-infected …
ET Overton, J Stapleton, I Frank… - Open forum …, 2015 - academic.oup.com
ET Overton, J Stapleton, I Frank, S Hassler, PA Goepfert, D Barker, E Wagner…
Open forum infectious diseases, 2015•academic.oup.comBackground 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 …
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 …
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.
Oxford University Press