Clinical phase 1 testing of the safety and immunogenicity of an epitope-based DNA vaccine in human immunodeficiency virus type 1-infected subjects receiving highly active antiretroviral therapy

dc.contributor.authorNewman, M. J.
dc.contributor.authorWilson, C. C.
dc.contributor.authorLivingston, B. D.
dc.contributor.authorMaWhinney, S.
dc.contributor.authorForster, J.E.
dc.contributor.authorScott, J.
dc.contributor.authorSchooley, R. T.
dc.contributor.authorBenson, C.A
dc.date.accessioned2012-04-30T13:57:17Z
dc.date.accessioned2017-10-19T12:10:26Z
dc.date.available2012-04-30T13:57:17Z
dc.date.available2017-10-19T12:10:26Z
dc.date.issued2008
dc.description.abstractA DNA vaccine encoding sequence-conserved human immunodeficiency virus type 1 (HIV-1)-derived cytotoxic T-lymphocyte (CTL) epitopes from multiple HIV-1 gene products (designated EP HIV-1090) was evaluated in a placebo-controlled, dose escalation phase 1 clinical trial of HIV-1-infected subjects receiving potent combination antiretroviral therapy. Patients received four intramuscular immunizations with EP HIV-1090 over a 4-month period at one of four doses (0.5, 1.0, 2.0, or 4.0 mg) or received a placebo. The vaccine was determined to be safe and well tolerated at all doses tested. CTL responses were measured from cryopreserved peripheral blood mononuclear cells using gamma interferon enzyme-linked immunospot assays, with and without in vitro peptide stimulation (IVS). Responses to one or more vaccine epitopes were detected throughout the course of vaccination in 37.5% (12/32) and 47% (15/32) of vaccine recipients measured without and with IVS, respectively, indicating possible vaccine-induced priming of epitope-specific T cells. However, differences in rates of response to HIV-1 epitopes between vaccine and placebo recipients did not achieve statistical significance. The HIV-1 epitope-specific CTL responses measured in the peripheral blood after vaccination were often low level and short-lived, and therefore, alternative immunization schedules, routes of delivery, or vaccine formulations may be required to increase vaccine potency.en_US
dc.identifier.urihttp://197.255.68.203/handle/123456789/837
dc.language.isoenen_US
dc.publisherClin. Vaccine Immunol.15(6): 986-94.en_US
dc.titleClinical phase 1 testing of the safety and immunogenicity of an epitope-based DNA vaccine in human immunodeficiency virus type 1-infected subjects receiving highly active antiretroviral therapyen_US
dc.typeArticleen_US

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