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Open Forum Infect Dis. 2015 May 5;2(2):ofv040. doi: 10.1093/ofid/ofv040. eCollection 2015 Apr.

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.

Author information

1
Division of Infectious Diseases, University of Alabama at Birmingham, School of Medicine , Birmingham, Alabama.
2
Depts. of Internal Medicine, Microbiology & Immunology , University of Iowa , Iowa City.
3
Infectious Diseases Section , University of Pennsylvania , Philadelphia.
4
Optimus Medical Group , San Francisco, California.
5
Core Center , Chicago, Illinois, USA.
6
Bavarian Nordic, Martinsried.
7
GlaxoSmithKline GmbH & Co. KG , Munich, Germany.
8
Vifor Pharma Ltd , Glattbrugg, Switzerland.

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.

KEYWORDS:

HIV infection; MVA; immunocompromised; smallpox; vaccination

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